Interventions for preventing delirium in older people in institutional long-term care

  • Review
  • Intervention

Authors


Abstract

Background

Delirium is a common and distressing complication of a range of stressor events including infection, new medications and environment change that is often experienced by older people with frailty and dementia. Older people living in institutional long-term care (LTC) are at high risk of delirium, which increases the risk of admission to hospital, development of or worsening of dementia, and mortality. Delirium is also associated with substantial healthcare costs. Although it is possible to prevent delirium in the hospital setting by providing multicomponent delirium prevention interventions it is currently unclear whether interventions to prevent delirium in LTC are effective.

Objectives

To assess the effectiveness of interventions for preventing delirium in older people in long term care.

Search methods

We searched ALOIS (www.medicine.ox.ac.uk/alois) - the Cochrane Dementia and Cognitive Improvement Group’s Specialised Register - on 23 April 2013. The search was as sensitive as possible to identify all studies on ALOIS relating to delirium. We ran additional separate searches in major healthcare databases, trial registers, the Cochrane Central Register of Controlled Trials (CENTRAL) and grey literature sources, to ensure that the search was as comprehensive as possible.

Selection criteria

We included randomised controlled trials (RCTs) and cluster-randomised controlled trials (cluster-RCTs) of single- and multicomponent non-pharmacological and pharmacological interventions for preventing delirium in older people (aged 65 years and over) in permanent LTC residence.

Data collection and analysis

Two independent review authors examined the titles and abstracts of citations identified by the search for eligibility and extracted data, with any disagreements settled by consensus. Primary outcomes were prevalence, incidence and severity of delirium. Secondary outcomes included new diagnosis of dementia, activities of daily living, quality of life and adverse outcomes. We used risk ratios (RRs) as measures of treatment effect for dichotomous outcomes and hazard ratios (HR) for time to event data.

Main results

We included two trials that recruited 3636 participants. Both were complex single-component non-pharmacological delirium prevention interventions. Risk of bias for many items was unclear due to inadequate reporting. Notably, there was no evidence of blinding of trial participants or assessors in either trial. One small cluster-RCT (n = 98) of a hydration-based intervention reported no reduction in delirium incidence in the intervention group compared to control (RR 0.85, 95% confidence interval (CI) 0.18 to 4.00, analysis not adjusted for clustering, very low quality evidence). Results were imprecise and there were serious limitations evident in trial design. One large cluster-RCT (n = 3538) of a computerised system to identify medications that may contribute to delirium risk and trigger a pharmacist-led medication review reported a large reduction in delirium incidence (12-month HR 0.42, CI 0.34 to 0.51, moderate quality evidence) but no clear evidence of reduction in hospital admissions (HR 0.89, CI 0.72 to 1.10, moderate quality evidence), in mortality (HR 0.88, CI 0.66 to 1.17, moderate quality evidence) or in falls risk (HR 1.03, CI 0.92 to 1.15, moderate quality evidence).

Authors' conclusions

Our review identified very limited evidence on interventions for preventing delirium in older people in LTC. Introduction of a software-based intervention to identify medications that could contribute to delirium risk so that a pharmacist-led medication review and monitoring plan can be initiated may reduce incidence of delirium for older people in institutional LTC. This is based on one large RCT in the United States and may not be practical in other countries which do not have comparable information technology services available in care homes. Our review identified only one ongoing pilot trial of a multicomponent delirium prevention intervention and no trials of pharmacological agents. Future trials of computerised medication management systems and multicomponent non-pharmacological and pharmacological delirium prevention interventions for older people in LTC are needed to help inform the provision of evidence-based care for this vulnerable group.

Résumé scientifique

Interventions dans la prévention du syndrome confusionnel (délirium) chez les personnes âgées dans des établissements de soins à long terme

Contexte

Le délirium est une complication courante et stressante d'une série de facteurs de stress, incluant une infection, de nouveaux médicaments et un changement d'environnement qui est souvent ressenti par les personnes âgées atteintes de fragilité et de démence. Les personnes âgées vivant dans des établissements de soins à long terme (SLT) présentent un risque élevé de délirium, ce qui augmente le risque d'hospitalisation, de développement ou d'aggravation de la démence et de mortalité. Le délirium est également associé à des coûts de santé importants. Bien qu'il soit possible de prévenir le délirium dans le cadre hospitalier en fournissant des interventions de prévention sur le délirium à composantes multiples, on ignore actuellement si les interventions visant à prévenir le délirium dans les SLT sont efficaces.

Objectifs

Évaluer l'efficacité des interventions pour prévenir le délirium chez les personnes âgées dans les soins à long terme.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans ALOIS (www.medicine.ox.ac.uk/alois) - le registre spécialisé du groupe Cochrane sur la démence et les autres troubles cognitifs : le 23 avril 2013. La recherche a été aussi sensible que possible pour identifier toutes les études sur ALOIS relatives au délirium. Nous avons effectué des recherches dans les principales bases de données médicales, les registres d'essais, le registre Cochrane des essais contrôlés (CENTRAL) et les sources de littérature grise pour s'assurer que la recherche soit la plus exhaustive possible.

Critères de sélection

Nous avons inclus des essais contrôlés randomisés (ECR) et des essais contrôlés randomisés par groupes (ECR en groupes) d'interventions à composantes simples et multiples, non pharmacologiques et pharmacologiques, pour prévenir le délirium chez les personnes âgées (âgés de 65 ans et plus) résidant en permanence dans les SLT.

Recueil et analyse des données

Deux auteurs indépendants de la revue ont examiné les titres et les résumés des références bibliographiques identifiées par la recherche pour l'éligibilité et extrait les données, les désaccords ont été résolus par consensus. Les critères de jugement principaux étaient la prévalence, l'incidence et la gravité de délirium. Les critères de jugement secondaires incluaient les nouveaux diagnostics de démence, les activités de la vie quotidienne, la qualité de vie et les résultats indésirables. Nous avons utilisé les risques relatifs (RR) en tant que mesures de l'effet du traitement pour les résultats dichotomiques et les hazard ratios (HR) pour les données de temps et d'évènements.

Résultats principaux

Nous avons inclus deux essais ayant recruté 3 636 participants. Les deux étaient des interventions pour prévenir le délirium à composantes simples et complexes non pharmacologiques. Le risque de biais pour de nombreux éléments était incertain en raison d'une documentation inadéquate. Notamment, aucun essai ne rapportait de preuve d'assignation en aveugle des participants ou des évaluateurs. Un petit ECR en groupes (n = 98) d'une intervention basée sur la réduction de l'hydratation dans le délirium n'a rapporté aucune incidence dans le groupe d'intervention par rapport au groupe témoin (RR 0,85, intervalle de confiance à 95 % (IC) de 0,18 à 4,00, l'analyse n'était pas ajustée en cluster, preuves de très faible qualité). Les résultats étaient imprécis et il y avait des limites manifestes dans les plans d'étude. Un grand ECR en groupes (n = 3 538) d'un système informatisé pour identifier les médicaments, qui pourrait contribuer aux risques de délirium et amener un pharmacien à revoir le traitement médicamenteux, a rapporté une réduction importante d'incidence de délirium (12 mois HR 0,42, IC entre 0,34 et 0,51, preuves de qualité moyenne), mais aucune preuve de réduction des hospitalisations (HR 0,89, IC entre 0,72 et 1,10, preuves de qualité modérée), de la mortalité (HR 0,88, IC entre 0,66 et 1,17, preuves de qualité modérée) ou des risques de chutes (HR 1,03, IC entre 0,92 et 1,15, preuves de qualité modérée).

Conclusions des auteurs

Notre revue a identifié des preuves très limitées sur les interventions pour prévenir le délirium chez les personnes âgées dans les SLT. L'introduction d'une intervention basée sur un logiciel afin d'identifier des médicaments pouvant contribuer au risque de délirium, pour amener un pharmacien à revoir et à contrôler le traitement médicamenteux, pourrait réduire l'incidence du délirium chez les personnes âgées dans des établissements de SLT. Ceci est basé sur un seul ECR à grande échelle aux États-Unis et pourrait ne pas être pratique dans d'autres pays qui ne disposent pas de services informatiques similaires dans les établissements de soins. Notre revue a identifié un seul essai pilote en cours d'une intervention de prévention du délirium à composantes multiples et aucun essai portant sur des agents pharmacologiques. De futurs essais de systèmes informatisés de gestion des médicaments et d'interventions de préventions du délirium à composantes multiples, non pharmacologiques et pharmacologiques, pour les personnes âgées dans les SLT, sont nécessaires pour aider à guider l'apport de soins probants pour ce groupe vulnérable.

Resumo

Intervenções para prevenir delírio em idosos em instituições de cuidados de longo prazo

Introdução

Delírio é uma complicação comum e angustiante de uma série de eventos estressantes, incluindo infecções, novos medicamentos e mudança de ambiente, que muitas vezes é vivida por pessoas idosas com fragilidade e demência. Idosos que vivem em instituições de cuidados de longo prazo (LTC – “long-term care”) estão em alto risco de delírio, o que aumenta o risco de internação hospitalar, desenvolvimento ou agravamento de demência e, mortalidade. O delírio também está associado a custos substanciais de saúde. Embora seja possível prevenir o delírio em ambientes hospitalares por meio de intervenções com multicomponentes, não está claro se estas intervenções são efetivas para prevenir o delírio em LTC.

Objetivos

Avaliar a efetividade de intervenções para a prevenção de delírio em idosos em instituições de cuidados de longo prazo.

Métodos de busca

Procuramos na base de dados ALOIS (www.medicine.ox.ac.uk / Alois) - CochraneDementia and Cognitive Improvement Group's Specialised Register -no dia 23 de abril 2013. A pesquisa foi tão sensível quanto possível para identificar todos os estudos relacionados à delírio. Realizamos pesquisas adicionais separadas nas principais bases de dados da saúde, registros de ensaios clínicos, the Cochrane Central Register of Controlled Trials (CENTRAL) e em outras fontes de bibliografia, para garantir que a pesquisa fosse o mais abrangente possível.

Critério de seleção

Foram incluídos ensaios clínicos randomizados controlados (RCTs) e ensaios clínicos cluster-randomizados (cluster-RCTs) de intervenções não-farmacológicas e farmacológicas únicas ou com multicomponentes para prevenir delírio em idosos (com 65 anos ou mais) em residência permanente de instituições de cuidados de longo prazo.

Coleta dos dados e análises

Dois revisores independentes examinaram os títulos e resumos de citações identificadas pela busca de elegibilidade e extraíram os dados, com quaisquer divergências resolvidas por consenso. Os desfechos principais foram prevalência, incidência e severidade de delírio. Os desfechos secundários incluíram novo diagnóstico de demência, atividades da vida diária, qualidade de vida e desfechos adversos. Usamos razões de risco (RR) como medidas de efeito do tratamento para variáveis dicotômicas e taxas de razão de chances (RC) para tempo dos dados de eventos.

Principais resultados

Foram incluídos dois estudos que recrutaram 3.636 participantes. Ambos eram intervenções complexas de componente único não farmacológico para prevenção de delírio. O risco de viés para muitos dos itens foi classificado como incerto devido ao inadequado relato. Notavelmente, não houve evidências sobre ,mascaramento dos participantes ou avaliadores em qualquer um dos ensaios clínicos. Um pequeno ensaio clínico do tipo cluster (n = 98) que avaliou intervenção baseada em hidratação reportou não haver nenhuma redução na incidência de delírio no grupo de intervenção comparado ao grupo controle (RR 0,85, 95% intervalo de confiança (IC) 0,18-4,00, análise não ajustada para o desenho do tipo cluster, evidências de baixa qualidade). Os resultados foram imprecisos e haviam sérias limitações evidentes no desenho do estudo. Um ensaio clínico grande do tipo cluster (n = 3538) sobre um sistema informatizado para identificar medicamentos que podem contribuir para o risco de delírio e desencadear desta forma, uma revisão medicamentosa pelo farmacêutico, reportou uma grande redução na incidência de delírio (12 meses RC 0,42, IC 0,34-0,51, evidências de qualidade moderada), mas não houve evidências claras sobre a redução de internações hospitalares (RC 0,89, IC 0,72-1,10, evidências de qualidade moderada), na mortalidade (RC 0,88, IC 0,66-1,17, evidências de qualidade moderada) ou no risco de quedas (RC 1,03, IC 0,92-1,15, evidências de qualidade moderada).

Conclusão dos autores

Nossa revisão identificou evidências limitadas sobre as intervenções para a prevenção de delírio em idosos em LTC. A introdução de uma intervenção baseada em software para identificar medicamentos que possam contribuir para o risco de delírio e, desta forma realizar uma revisão de medicamentos pelo farmacêutico e plano de monitoramento, pode reduzir a incidência de delírio nos idosos em instituições de cuidados de longo prazo. Isso é baseado em um ensaio clínico grande realizado nos Estados Unidos e pode não ser praticável em outros países que não têm serviços de tecnologia de informação comparável e disponível em cuidados domiciliares. Nossa revisão identificou apenas um ensaio clínico piloto em andamento avaliando intervenção com multicomponentes de prevenção de delírio e nenhum ensaio clínico de agentes farmacológicos. Futuros ensaios clínicos sobre sistemas de gestão de medicamentos computadorizado e intervenções com multicomponentes não-farmacológicas e farmacológicas para prevenção de delírio em idosos em instituições de cuidados de longo prazo são necessários para ajudar a informar a provisão de cuidados baseados em evidências para este grupo de população vulnerável.

Notas de tradução

Traduzido por: Raíssa Pierri Carvalho, Unidade de Medicina Baseada em Evidências da Unesp, Brasil Contato: portuguese.ebm.unit@gmail.com

Plain language summary

Interventions for preventing delirium in older people in institutional long-term care (LTC)

Review question

We reviewed the evidence about the effectiveness of interventions for preventing delirium in older people living in long-term care (LTC).

Background

LTC is the name used for residential homes, which provide personal care, supervision with medications and some help with day to day activities, and nursing homes, which provide 24-hour nursing care. Delirium is a common and serious illness for older people living in LTC. People with delirium usually become more confused over a few hours or a couple of days. Some people with delirium become quiet and sleepy but others become agitated and disorientated, so it can be a very distressing condition. It can also increase the chances of being admitted to hospital and developing dementia, and LTC residents who develop delirium are at increased risk of death.

Importantly, studies of people in hospital have shown that it is possible to prevent around a third of cases of delirium by providing an environment and care plan that target the main risk factors for delirium. For example: providing better lighting and signs to avoid disorientation; avoiding unnecessary use of catheters to help prevent infection; avoiding medications which increase delirium risk.

This review has searched for and assessed research on preventing delirium in older people living in LTC.

Study characteristics

The evidence is current to 04/2013. We found two studies that included 3636 participants. Both studies were done in the United States.

The first study tested whether delirium can be prevented by calculating how much fluid an older person in a care home needs each day and ensuring that hydration was provided by giving regular drinks. 98 people participated in the study, which lasted four weeks.

The second study tested the effect of a computer programme which searched prescriptions for medications that might increase the chance of developing delirium so that a pharmacist could adjust or stop them. 3538 people participated in the study, which lasted 12 months.

Key findings

The first study found that the hydration intervention did not reduce delirium. However, this was a small study of short duration with serious design problems.

The second study found that the computerised medication search programme and pharmacist review reduced delirium but there was no clear reduction in hospital admissions, deaths or falls. One problem with the findings of this study is that it might not be possible to use this computer programme in different countries that do not have similar computer systems.

Quality of the evidence

There is very low-quality evidence on the effectiveness of hydration interventions for reducing the incidence of delirium in older people in LTC. It is therefore not possible to draw firm conclusions.

There is moderate-quality evidence that a computerised medication search programme and pharmacist review may reduce the incidence of delirium in older people in LTC.

There is no clear evidence that a computerised medication search programme and pharmacist review reduces hospitalisation, mortality or falls for older people in LTC.

As this review only found a very small number of research studies, we have recommended that further research should be conducted testing different ways of preventing delirium for older people living in LTC. This may help improve the quality of care for this vulnerable group.

External funding

There was no source of external funding for this review.

Conflicts of interest

NS is chief investigator for a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant to investigate the effects of a delirium prevention intervention for older people in long term care.

JY is a co-applicant for a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant to investigate the effects of a delirium prevention intervention for older people in long term care.

AC, RH and AH declare that they have no known conflicts of interest.

Résumé simplifié

Interventions dans la prévention du syndrome confusionnel (délirium) chez les personnes âgées dans des établissements de soins à long terme (SLT)

Question de la revue

Nous avons examiné les preuves concernant l'efficacité des interventions pour prévenir le syndrome confusionnel (délirium) chez les personnes âgées vivant dans des soins à long terme (SLT)

Contexte

SLT est le nom utilisé pour les résidences médicalisées qui fournissent des soins, supervisent les traitements médicamenteux et certaines aides aux activités quotidiennes, ainsi que pour les maisons de soins infirmiers qui fournissent des soins 24/24. Le délirium est une maladie grave et courante chez les personnes âgées résidant en SLT. Les personnes atteintes de délirium deviennent généralement plus confuses pendant quelques heures ou quelques jours. Certaines personnes atteintes de délirium deviennent paisibles et somnolentes, mais d'autres se montrent agitées et désorientées, ce qui peut être une affection très éprouvante. Elle peut également accroître les chances d'être admis à l'hôpital et de développer de la démence et les résidents en SLT qui développent le délirium présentent un risque accru de décès.

Surtout, les études portant sur des patients à l'hôpital ont montré qu'il est possible de prévenir environ un tiers des cas de délirium en fournissant un environnement et des soins qui ciblent les principaux facteurs de risque pour le délirium. Par exemple : en fournissant une meilleure luminosité et des signes afin d'éviter d'être désorienté ; en évitant l'utilisation excessive de cathéters pour aider à prévenir une infection ; en évitant les médicaments qui augmentent le risque de délirium.

Cette revue a étudié et évalué les recherches sur la prévention du délirium chez les personnes âgées vivant dans les SLT.

Les caractéristiques de l'étude

Les preuves sont à jour en avril 2013. Nous avons trouvé deux études portant sur 3 636 participants. Les deux études ont été réalisées aux États-Unis.

La première étude avait testé si le délirium peut être prévenu en calculant la quantité quotidienne de liquide dont requiert une personne âgée dans une maison de soins et en veillant à ce que l'hydratation soit fournie par l'administration régulière de boissons. 98 personnes ont participé à l'étude qui avait duré 4 semaines.

La deuxième étude a testé l'effet d'un programme informatique qui recherchait des prescriptions pour des médicaments qui pourraient accroître les chances de développer le délirium pour qu'un pharmacien puisse les ajuster ou les arrêter. 3 538 personnes ont participé à l'étude qui avait duré 12 mois.

Les principaux résultats

La première étude a révélé que l'intervention par l'hydratation n'a pas réduit le délirium. Cependant, il s'agissait d'une étude de petite taille et de courte durée, avec de graves problèmes de conception.

La deuxième étude a révélé que les programmes informatisés de recherche de médicaments et les revues des pharmaciens réduisaient le délirium, mais il n'y avait pas de réduction nette du nombre d'hospitalisations, de décès ou de chutes. Un problème avec les résultats de cette étude est qu'il pourrait ne pas être possible d'utiliser ces programmes informatiques dans certains pays qui ne possèdent pas de systèmes informatiques similaires.

Qualité des preuves

Il existe des preuves de très faible qualité sur l'efficacité des interventions par hydratation pour réduire l'incidence du délirium chez les personnes âgées dans les SLT. Il n'est donc pas possible d'apporter des conclusions définitives.

Il existe des preuves de qualité modérée selon lesquelles un programme informatisé de recherches de médicaments et de revues des pharmaciens pourrait réduire l'incidence du délirium chez les personnes âgées dans les SLT.

Il n'existe aucune preuve claire qu'un programme informatisé de recherches de médicaments et de revues des pharmaciens permette de réduire l'hospitalisation, la mortalité ou les chutes chez les personnes âgées dans les SLT.

Étant donné que cette revue n'a trouvé qu'un très petit nombre d'études, nous avons recommandé que des recherches supplémentaires, évaluant différentes façons de prévenir le délirium chez les personnes âgées résidant en SLT, soient réalisées. Cela pourrait aider à améliorer la qualité des soins pour ce groupe vulnérable.

Financement externe

Il n'y avait aucune source de financement externe pour cette revue.

Conflits d'intérêts

NS est l'enquêteur en chef à l'Institut National de la Santé et de la Recherche ainsi qu'à l'Institut National de la Recherche et les Soins au Bénéfice des Patients subventionné pour étudier les effets d'une intervention prévenant le délirium chez les personnes âgées dans les soins à long terme.

JY est un collaborateur à l'Institut National de la Santé et de la Recherche ainsi qu'à l'Institut National de la Recherche et les Soins au Bénéfice des Patients subventionné pour étudier les effets d'une intervention prévenant le délirium chez les personnes âgées dans les soins à long terme.

AC, RH et AH informent qu'ils n'ont pas connus de conflit d'intérêt.

Notes de traduction

Traduit par: French Cochrane Centre 15th June, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

Resumo para leigos

Intervenções para prevenir delírio em idosos em instituições de cuidados de longo prazo

Questão da revisão

Nós revisamos as evidências sobre a efetividade das intervenções para a prevenção de delírio em idosos que vivem em instituições de cuidados de longo prazo (LTC).

Introdução

LTC é o nome usado para casas residenciais, que fornecem cuidados pessoais, supervisão com medicamentos e alguma ajuda com atividades do dia-a-dia, além de casas de repouso, que fornecem 24 horas cuidados de enfermagem. Delírio é uma doença comum e grave para os idosos que vivem em LTC. Pessoas com delírio geralmente tornam-se mais confusas durante algumas horas ou alguns dias. Alguns indivíduos com delírio tornam-se calmos e sonolentos, mas outros ficam agitados e desorientados, por isso pode ser uma condição muito angustiante. Pode também aumentar as chances de internação hospitalar e desenvolvimento de demência, e os moradores de LTC que desenvolvem delírio estão em maior risco de morte.

Mais importante, estudos de indivíduos em hospital têm mostrado que é possível evitar cerca de um terço dos casos de delírio proporcionando um ambiente e planos de cuidados que visem os principais fatores de risco para delírio. Por exemplo: fornecer uma melhor iluminação e sinais para evitar desorientação; evitar o uso desnecessário de cateteres para ajudar a prevenir infecções e; evitar medicamentos que aumentem o risco de delírio.

Esta revisão pesquisou sobre prevenção de delírio em idosos que vivem em LTC.

Características do estudo

As evidências foram revisadas até 04/2013. Encontramos dois estudos que incluíram 3.636 participantes. Ambos os estudos foram feitos no Estados Unidos.

O primeiro estudo testou se delírio pode ser prevenido por meio do cálculo de quanto fluido um idoso em cuidados domiciliares precisa diariamente, garantindo a hidratação por meio de bebidas regulares. 98 pessoas participaram do estudo, que durou quatro semanas.

O segundo estudo testou o efeito de um programa de computador que identifica prescrições de medicamentos que possam aumentar as chances de desenvolver delírio de modo que um farmacêutico possa ajustar ou deter estes medicamentos. 3.538 pessoas participaram do estudo, que durou 12 meses.

Resultados principais

O primeiro estudo verificou que a hidratação como intervenção não reduziu o delírio. No entanto, este foi um pequeno estudo de curta duração com problemas graves no desenho do estudo.

O segundo estudo constatou que o programa de pesquisa de medicamentos computadorizado e uma revisão farmacêutica reduz delírio, porém não foi observada redução clara nas internações hospitalares, mortes ou quedas. Um problema com as conclusões deste estudo é que pode não ser possível usar este programa de computador em diferentes países que não possuem sistemas de computador semelhantes.

Qualidade da evidência

Há evidências de muito baixa qualidade sobre a efetividade de intervenções de hidratação para reduzir a incidência de delírio em idosos em instituições de cuidados de longo prazo. Portanto, não é possível tirar conclusões definitivas.

Há evidências de qualidade moderada que um programa de pesquisa de medicamentos computadorizado e uma revisão farmacêutica podem reduzir a incidência de delírio em idosos em instituições de cuidados de longo prazo.

Não há nenhuma evidência clara de que um programa de pesquisa computadorizado de medicamentos e uma revisão farmacêutica reduzam hospitalização, mortalidade ou quedas de idosos em instituições de cuidados de longo prazo.

Como esta revisão só encontrou um número muito pequeno de estudos, nós recomendamos que mais pesquisas devem ser conduzidas testando diferentes formas de prevenir delírio em idosos que vivem em instituições de cuidados de longo prazo. Isso pode ajudar a melhorar a qualidade dos cuidados para esse grupo vulnerável.

Financiamento externo

Não houve fonte de financiamento externo para esta revisão.

Conflitos de interesse

NS é o investigador-chefe do National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) concedido para investigar os efeitos de uma intervenção para prevenção de delírio em idosos em instituições de cuidados de longo prazo.

JY é um co-requerente do National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB)) concedido para investigar os efeitos de uma intervenção para prevenção de delírio em idosos em instituições de cuidados de longo prazo.

AC, RH e AH declaram que não têm nenhum conflito de interesse.

Notas de tradução

Traduzido por: Raíssa Pierri Carvalho, Unidade de Medicina Baseada em Evidências da Unesp, Brasil Contato: portuguese.ebm.unit@gmail.com

Laienverständliche Zusammenfassung

Maßnahmen zur Vorbeugung von Delirien bei älteren Patienten in Langzeitpflegeeinrichtungen

Fragestellung

Wir untersuchten die Evidenz zur Wirksamkeit von Maßnahmen, die Delirien bei älteren Menschen in Langzeitpflegeeinrichtungen vorbeugen sollen.

Hintergrund

Zu den sogenannten Langzeitpflegeeinrichtungen gehören Seniorenheime, in denen Körperpflege, Überwachung der Medikamenteneinnahme und leichte Hilfe bei täglichen Verrichtungen angeboten werden, sowie Pflegeheime, in denen die Patienten rund um die Uhr pflegerisch versorgt werden. Das Delirium ist eine häufige und schwerwiegende Erkrankung bei älteren Menschen in Langzeitpflegeeinrichtungen. Beim Eintritt eines Deliriums kommt es in der Regel im Laufe weniger Stunden oder einiger Tage zu zunehmender Verwirrtheit. Manche Patienten werden im Delirium still und schläfrig, andere dagegen sind erregt und desorientiert. Dieser Zustand kann daher sehr belastend sein. Zusätzlich erhöht ein Delirium die Wahrscheinlichkeit, in ein Krankenhaus eingewiesen zu werden und eine Demenz zu entwickeln. Bei Bewohnern von Langzeitpflegeeinrichtungen, die ein Delirium entwickeln, besteht ein erhöhtes Sterberisiko.

Studien an Krankenhauspatienten lieferten die wichtige Erkenntnis, dass etwa ein Drittel der Delirium-Fälle sich vermeiden lassen, wenn Umgebung und Pflegeplan den größten Risikofaktoren für ein Delirium entgegenwirken. Beispiele dafür sind eine bessere Beleuchtung und Hinweisschilder zur Vermeidung von Orientierungsverlust; Vermeidung unnötiger Einsätze von Kathetern, um Infektionen vorzubeugen; Vermeidung von Medikamenten, die das Deliriumrisiko erhöhen.

Dieser Review hat nach Studien zur Vorbeugung von Delirien bei älteren Menschen in Langzeitpflegeeinrichtungen gesucht und diese ausgewertet.

Studienmerkmale

Die untersuchte Evidenz ist auf dem Stand von April 2013. Wir fanden zwei Studien mit 3636 Teilnehmern. Beide Studien wurden in den USA durchgeführt.

Die erste Studie untersuchte, ob einem Delirium vorgebeugt werden kann, indem durch regelmäßige Gabe von Getränken die Zufuhr der Flüssigkeitsmenge sichergestellt wurde, die für ältere Menschen in einem Pflegeheim berechnet worden war. 98 Patienten nahmen an der vierwöchigen Studie teil.

In der zweiten Studie wurde die Wirkung eines Computerprogramms getestet, das Verordnungen auf Medikamente untersuchte, die das Risiko eines Deliriums erhöhen können, damit ein Apotheker sie anpassen oder absetzen konnte. An dieser zwölfmonatigen Studie nahmen 3538 Menschen teil.

Hauptergebnisse

Die erste Studie kam zu dem Ergebnis, dass die optimale Flüssigkeitszufuhr das Auftreten von Delirien nicht verringerte. Allerdings handelte es sich um eine kleine Studie von kurzer Dauer und mit schwerwiegenden Fehlern im Studienaufbau.

Die zweite Studie belegte, dass das computergestützte Medikamenten-Suchprogramm in Kombination mit einer Überprüfung durch den Apotheker das Auftreten von Delirien verringerte, jedoch gab es keinen deutlichen Rückgang bei Krankenhauseinweisungen, Todesfällen oder Stürzen. Die Ergebnisse dieser Studie waren u.a. auch deswegen problematisch, weil das Computerprogramm in verschiedenen Ländern, die über kein ähnliches Computersystem verfügen, möglicherweise gar nicht eingesetzt werden kann.

Qualität der Evidenz

Es besteht Evidenz von sehr niedriger Qualität zur Wirksamkeit von Maßnahmen, die für eine ausreichende Flüssigkeitszufuhr sorgen, auf die Verringerung von Delirien bei älteren Menschen in Langzeitpflegeeinrichtungen. Es können daher keine fundierten Schlussfolgerungen gezogen werden.

Es besteht Evidenz von moderater Qualität, dass ein computergestütztes Medikamenten-Suchprogramm zusammen mit einer Überprüfung durch den Apotheker das Auftreten von Delirien bei älteren Menschen in Langzeitpflegeeinrichtungen verringern kann.

Es gibt keine eindeutige Evidenz dafür, dass ein computergestütztes Medikamenten-Suchprogramm zusammen mit einer Überprüfung durch den Apotheker bei älteren Menschen in Langzeitpflegeeinrichtungen Krankenhauseinweisungen, Sterblichkeit oder Stürze verringert.

Da für diesen Review nur eine sehr geringe Zahl von Studien gefunden wurde, empfehlen wir, dass weitere Studien durchgeführt werden sollten, in denen verschiedene Möglichkeiten untersucht werden, Delirien bei älteren Menschen in Langzeitpflegeeinrichtungen vorzubeugen. Dies könnte zu einer Verbesserung der Pflegequalität für diese gefährdete Gruppe beitragen.

Drittmittelfinanzierung

Für diesen Review gab es keine externe Finanzierungsquelle.

Interessenkonflikte

NS ist leitende Forscherin in einem vom britischen National Institute for Health Research (NIHR) bezuschussten Forschungsprojekt mit dem Namen „Research for Patient Benefit“ (RfPB = Forschung zum Wohle des Patienten), das die Wirkung einer Maßnahme zur Vermeidung von Delirien bei älteren Menschen in der Langzeitpflege untersucht.

JY ist Mitantragsteller in einem vom britischen National Institute for Health Research (NIHR) bezuschussten Forschungsprojekt mit dem Namen „Research for Patient Benefit“ (RfPB = Forschung zum Wohle des Patienten), das die Wirkung einer Maßnahme zur Vermeidung von Delirien bei älteren Menschen in der Langzeitpflege untersucht.

AC, RH und AH erklären, dass für sie keine bekannten Interessenkonflikte bestehen.

Anmerkungen zur Übersetzung

S. Schmidt-Wussow, Koordination durch Cochrane Schweiz

Laički sažetak

Intervencije za sprječavanje delirija u starijih osoba dugoročno zbrinutih u ustanovama za skrb

Istraživačko pitanje

U ovom Cochrane sustavnom pregledu analizirani su podatci o djelotvornosti postupaka za sprječavanje delirija u starijih osoba koje su dugoročno zbrinute u ustanovama za skrb.

Dosadašnje spoznaje

Dugoročno zbrinjavanje u ustanovama za skrb odnosi se na domove za stanovanje koji osiguravaju osobnu njegu, nadzor uzimanja lijekova i određenu pomoć u svakodnevnim aktivnostima, te na domove za starije i nemoćne koji osiguravaju 24-h njegu. Delirij je uobičajena i ozbiljna bolest kod starijih ljudi koji žive u dugoročnoj njezi. Osobe s delirijem obično postaju zbunjene nakon nekoliko sati ili nekoliko dana. Neke osobe s delirijem mogu postati tihe i pospane dok druge postaju uzbuđene i dezorijentirane, tako da to može biti vrlo uznemirujuće stanje. To također može povećati mogućnost za prijem u bolnicu i razvoj demencije, a stanovnici domova koji su u stanju delirija imaju i povećan rizik od smrti.

Što je najvažnije, istraživanja provedeno na osobama u bolnicama pokazuje da je moguće prevencijom izbjeći trećinu slučajeva delirija osiguravanjem odgovarajućeg okoliša i plana skrbi koji su usmjereni na glavne rizične faktore delirija. Primjerice: omogućavanjem boljeg osvjetljenja i znakova kako bi se izbjegla dezorijentacija, izbjegavanje nepotrebne uporabe katetera kako bi se spriječile infekcije, izbjegavanje lijekova koji mogu povećati rizik od delirija.

Ovaj Cochrane sustavni pregled literature analizirao je i procijenio istraživanja o prevenciji delirija kod starijih osoba koje žive u domovima.

Obilježja uključenih istraživanja

Dokazi se temelje na literaturi objavljenoj do travnja 2013. Našli smo dvije studije koje su uključivale 3636 sudionika. Obje su studije provedene u SAD-u.

Prva je studija ispitala može li se delirij spriječiti izračunavanjem koliko tekućine starija osoba u domu treba svakodnevno i osiguravanjem da joj se omogući davanje redovitoga pića. U istraživanju je sudjelovalo 98 ispitanika i trajala je četiri tjedna.

Druga je studija ispitala utjecaj računalnih programa koji su pretraživali recepte za lijekove koji bi mogli povećati vjerojatnost razvoja delirija tako da su ih farmaceuti mogli prilagoditi ili ih prestati davati. U tom je istraživanju sudjelovalo 3538 osoba i trajalo je 12 mjeseci.

Ključni rezultati

Prva je studija otkrila da intervencija vezana za hidraciju nije smanjila pojavu delirija. No, to je bila mala studija kratkoga trajanja s ozbiljnim problemima u ustroju eksperimenta.

Druga je studija pronašla da program računalne pretrage lijekova i farmaceutski osvrt smanjuje delirij, ali nije bilo jasnoga smanjenja u prijemu u bolnice, smrti ili padova. Jedan od problema sa zaključcima te studije bilo je kako možda nije moguće koristiti računalne programe u različitim zemljama koje nemaju slične računalne sustave.

Kvaliteta dokaza

O učinkovitosti intervencije vezane za hidraciju za smanjenje pojave delirija u starijih osoba u dugoročnoj skrbi imamo dokaze vrlo niske kvalitete. Stoga nije moguće izvesti čvrste zaključke.

Postoje dokazi umjerene kvalitete kako računalna potraga za lijekovima i farmaceutski nadzor mogu smanjiti slučajeve delirija kod starijih ljudi u dugoročnoj njezi.

Nema jasnih dokaza kako računalna pretraga lijekova i farmaceutski nadzor smanjuju hospitalizacije, mortalitet ili padove kod starijih osoba u domovima za dugoročnu njegu.

Kako je ovaj sustavni pregled pronašao mali broj istraživačkih studija, preporučuje se provedba daljnjih istraživanja u kojima bi trebalo ispitati različite načine sprječavanja delirija u starijih osoba koje žive u domovima. To bi moglo poboljšati kvalitetu skrbi za ovu ranjivu skupinu.

Financiranje istraživanja

Za provedbu ovog sustavnog pregleda autori nisu primili nikakve vanjske izvore financiranja.

Sukobi interesa

NS je glavni istraživač za National Insitute for Health Research (NIHR) Research for PAtiet Benefit (RfPB) na projektu koji omogućuje istraživanje učinka intervencije za prevenciju delirija kod starijih osoba s dugoročnom skrbi.

JY je suradnik National Institute for Health Research (NINHR) Research for Patiet Benefit (RfPB) na projektu za istraživanje učinaka interevencija na prevenciju delirija kod starijih osoba u dugotrajnoj skrbi.

Autori AC, RH i AH izjavljuju kako nemaju poznatih sukoba interesa.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Ivana Turudić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Summary of findings(Explanation)

Summary of findings for the main comparison. Single-component medication monitoring and adjustment intervention versus control for preventing delirium in older people in institutional long term care
  1. 1Assumed risk based on control group risk in included study.
    2Number of participants is number of resident months, defined as number of days from first assessment to the first outcome occurrence, the last date in the nursing home, the death date, or December 31 2004.
    3The trial was assessed at high risk of methodological bias for blinding of participants and personnel.
    4Only one trial therefore unable to assess consistency.
    5Large effect size observed but only one trial therefore not eligible for upgrade.

Single-component medication monitoring and adjustment intervention versus control for preventing delirium in older people in institutional long term care
Patient or population: People at risk of delirium in institutional long term care
Settings: Long term care institutions
Intervention: Single-component medication monitoring and adjustment intervention versus control
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of resident months
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Single-component medication monitoring and adjustment intervention versus control
Incidence of delirium 1
NH CAM
Follow-up: mean 12 months
Study population HR 0.42
(0.34 to 0.51)
7311
(1 study)2
⊕⊕⊕⊝
moderate 3,4,5
 
104 per 1000 45 per 1000
(37 to 54)
Medium risk population
99 per 1000 43 per 1000
(35 to 52)
Unplanned hospitalisation 1
Admissions to hospital
Follow-up: mean 12 months
Study population HR 0.89
(0.72 to 1.10)
7599
(1 study)2
⊕⊕⊕⊝
moderate 3,4,5
 
55 per 1000 49 per 1000
(40 to 60)
Medium risk population
57 per 1000 51 per 1000
(41 to 63)
Mortality 1
Mortality
Follow-up: mean 12 months
Study population HR 0.88
(0.66 to 1.17)
9412
(1 study)2
⊕⊕⊕⊝
moderate 3,4,5
 
25 per 1000 22 per 1000
(17 to 29)
Medium risk population
25 per 1000 22 per 1000
(17 to 29)
Falls 1
Fall events
Follow-up: mean 12 months
Study population RR 1.03
(0.92 to 1.15)
2275
(1 study)2
⊕⊕⊕⊝
moderate 3,4,5
 
523 per 1000 539 per 1000
(481 to 601)
Medium risk population
523 per 1000 539 per 1000
(481 to 601)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio; HR: Hazard ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2 Single-component hydration intervention versus control for preventing delirium in older people in institutional long term care

Summary of findings 2. Single-component hydration intervention versus control for preventing delirium in older people in institutional long term care
  1. 1Assumed risk based on control group risk in included study.
    2Assessed as at high risk of methodological bias for blinding, outcome data and other bias.
    3One trial only so not possible to assess for consistency.
    4Very low rate of delirium events. Wide confidence limits indicate uncertainty.

Single-component hydration intervention versus control for preventing delirium in older people in institutional long term care
Patient or population: People at risk of delirium in institutional long term care
Settings: Long term care institutions
Intervention: Single-component hydration intervention versus control
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Single-component hydration intervention versus control
Incidence of delirium 1
NEECHAM confusion scale
Follow-up: mean 4 weeks
Study population RR 0.85
(0.18 to 4.0)
98
(1 study)
⊕⊝⊝⊝
very low 2,3,4
 
67 per 1000 57 per 1000
(12 to 268)
Medium risk population
67 per 1000 57 per 1000
(12 to 268)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Delirium is a distressing complication of a range of stressor events, including infection, new medications and dehydration, and is often experienced by older people with frailty and dementia. Although a single event can precipitate delirium, it is more common for multiple factors to interact and a multifactorial model of delirium has been established to help illustrate how delirium is precipitated in people at risk (Inouye 1996). Using this model, a seemingly small insult such as a minor infection or new medication in those at high risk can lead to delirium.

Delirium is associated with increased morbidity, functional decline, risk of developing or worsening dementia and death (Inouye 2006; Witlox 2010). It is common throughout the health and social care system and has substantial health and socioeconomic costs (Inouye 2006; Leslie 2008). The majority of delirium research has focused on hospitalised people, but long-term care (LTC) residents are also at high risk, with the point prevalence of delirium at around 15% in these settings (Siddiqi 2009). The multifactorial model of delirium has been validated in the LTC setting (Voyer 2010) and LTC residents with moderate to severe cognitive impairment are at particularly high risk (McCusker 2011). The development of delirium in older people in LTC is associated with increases in risk of admission to hospital, rates of re-admission and mortality (Siddiqi 2009). Notably, the duration of delirium in LTC residents is typically increased, compared to delirium in hospitalised people (Cole 2012). Although it is possible to prevent delirium in the hospital setting by providing multicomponent delirium prevention interventions (Inouye 1999; Marcantonio 2001), it is currently unclear whether interventions to prevent delirium in LTC are effective.

LTC facilities have expanded over recent decades in response to the ageing population. In the UK, 4.5% of people aged over 65 live in LTC, rising to 20% of people aged over 85 (Soule 2005). The environment and systems of care in LTC share features with hospitals that are likely to increase the risk of delirium. As age over 65 and presence of cognitive impairment or dementia are important risk factors for delirium, the high point prevalence of delirium is likely to be a reflection of clustering of these risk factors in LTC.

LTC facilities are considered to be the 'usual place of residence', which distinguishes them from other more temporary facilities, including respite care, intermediate care and post-acute care. LTC is the broad umbrella term for facilities including residential homes, which provide personal care, supervision with medications and some help with activities of daily living, and nursing homes, which provide 24-hour nursing care by staff with specialist skills in management of physical and mental health conditions (Ames 2005).

Description of the condition

Delirium is characterised by the rapid onset of fluctuating confusion, disturbed awareness and inattention. The diagnostic criteria for delirium have been operationalised in the Diagnostic and Statistical Manual of Mental Disorders Volumes III, III-revised, IV and 5 (APA 1980; APA 1987; APA 1994; APA 2013) and the International Classification of Diseases Volume 10 (WHO 1992).

A key feature of delirium is change and fluctuation in a range of key symptoms and behaviours including:

  1. Cognitive function (e.g. worsened concentration, slow responses, confusion);

  2. Perception (e.g. visual or auditory hallucinations);

  3. Physical function (e.g. reduced mobility, reduced movement, restlessness, agitation, changes in appetite, sleep disturbance);

  4. Social behaviour (e.g. lack of co-operation, withdrawal, or alterations in communication, mood or attitude or both (NICE 2010)).

Delirium is triggered when a susceptible individual is exposed to often multiple precipitating factors, including infection, medications, pain and dehydration (Inouye 1998). These multiple factors are considered to interact in a cumulative manner; the greater the number of factors, the greater the risk of delirium. The pathophysiology of delirium is incompletely understood, but a complex interaction between acetylcholine and multiple neurotransmitters including dopamine, noradrenaline, glutamate and gamma-amino hydroxybutyric acid (GABA) is considered important (Alagiakrishnan 2004; Hshieh 2008; Clegg 2011).

Description of the intervention

This review examines the effectiveness of single- and multicomponent non-pharmacological and pharmacological interventions for preventing delirium in older people in LTC.

Non-pharmacological interventions target the important precipitating factors for delirium and usually incorporate a multicomponent approach to address the multiple potential factors, including: actively looking for and treating infection; avoiding unnecessary urinary catheterisation; undertaking a medication review to identify medications associated with increased risk of delirium; assessing for pain and initiating treatment where appropriate; addressing sensory impairment by providing visual and hearing aids (NICE 2010). Multicomponent delirium prevention interventions incorporating such strategies have been demonstrated to be effective at reducing delirium in hospitalised people (Inouye 1999; Marcantonio 2001; NICE 2010). Introduction of protocols, staff education or systems redesign are methods that have been used to introduce these interventions (Inouye 1999; Rockwood 1999). As many of the reported risk factors for delirium are similar in both hospitalised people and LTC residents (Siddiqi 2009), non-pharmacological interventions that have been shown to be effective in hospitals by targeting these risk factors may have a role in reducing the incidence of delirium in LTC, with appropriate modification to account for differences in environmental factors and care processes (McCusker 2013).

Although it is biologically plausible that pharmacological agents could prevent delirium by acting on neurotransmitter pathways, a small number of trials of pharmacological interventions for preventing delirium in hospitalised people have demonstrated limited effectiveness (Kalisvaart 2005; Siddiqi 2007; Tabet 2009) and require further investigation (NICE 2010).

How the intervention might work

Non-pharmacological interventions target the multiple potential precipitating factors for delirium to reduce their cumulative effect. Pharmacological interventions target the important neurotransmitter pathways that have been implicated in the complex pathophysiology of delirium.

Why it is important to do this review

This review examines evidence from randomised controlled trials (RCTs) and cluster-randomised controlled trials (cluster-RCTs) for the clinical and cost effectiveness of non-pharmacological and pharmacological interventions to prevent delirium in older people in LTC. This evidence will help inform the development and future commissioning of evidence-based services to improve the health and well-being of this vulnerable group. It will also help improve knowledge about delirium in LTC, inform the development of LTC staff education programmes and help stimulate future research into prevention of delirium in LTC residents.

Objectives

To assess the effectiveness of interventions for preventing delirium in older people in LTC.

Methods

Criteria for considering studies for this review

Types of studies

We considered randomised controlled trials (RCTs) and cluster-randomised controlled trials (cluster-RCTs) for this review.

Types of participants

For this review, LTC is defined as an institution that is the permanent residence of an individual, providing accommodation together with personal or nursing care.

Inclusion criteria

Trials investigating interventions for preventing delirium in older people in LTC were eligible for inclusion. It is possible that any general health intervention for older people in LTC will have the effect of reducing delirium. However, we only considered trials that used a validated method of delirium diagnosis, such as DSM-III, DSM-III-R, DSM-IV and ICD-10 (APA 1980; APA 1987; APA 1994; WHO 1992), or a diagnostic tool validated against these, e.g. confusion assessment method (CAM) (Inouye 1990), delirium rating scale (DRS) (Trzepacz 1988).

Trials in which the mean age of participants was 65 years or older.

Exclusion criteria

Trials of hospitalised people.
Trials taking place in a setting that was not the permanent residence of study participants (e.g. post-acute care, intermediate care, continuing care).
Trials taking place in a palliative care setting.
Non-randomised intervention trials, observational studies.

Types of interventions

We considered interventions designed to prevent delirium, including non-pharmacological and pharmacological single- and multicomponent interventions which included a control group for comparison.

Types of outcome measures

We identified the primary, secondary and adverse outcome measures that are important both for older people in LTC and for health and social care systems.

Primary outcomes

Prevalence and incidence of delirium, using a validated diagnostic method (see Types of studies).

Severity of delirium, using a validated diagnostic method (e.g. delirium rating scale (Trzepacz 1988)).

Secondary outcomes

Length of delirium episode.
Proportion of time spent with delirium (total number of days of delirium/length of follow-up period).
Total number of delirium episodes.
Cognitive function, using any validated continuous scale.
New diagnosis of dementia.
Worsening severity of dementia, using a validated diagnostic method e.g. clinical dementia rating (CDR) scale (Morris 1993), dementia severity rating scale (DSRS) (Clark 1996).
Quality of life.
Direct costs of intervention.
Health utility change and cost effectiveness of intervention.
Activities of daily living.

Adverse outcomes (adverse medication outcomes, falls, new pressure ulcers, unplanned hospitalisation, mortality).

We will include the following outcomes in the final 'Summary of findings' tables:

Prevalence of delirium.
Incidence of delirium.
Severity of delirium.
Length of delirium episode.
Cognitive function, using any validated continuous scale.
Cost effectiveness of intervention.
Adverse outcomes.

Search methods for identification of studies

Electronic searches

We searched ALOIS (www.medicine.ox.ac.uk/alois) - the Cochrane Dementia and Cognitive Improvement Group’s Specialised Register - on 23 April 2013. The search was as sensitive as possible to identify all studies on ALOIS relating to delirium.

ALOIS is maintained by the Trials Search Co-ordinator of the Cochrane Dementia and Cognitive Improvement Group and contains dementia and cognitive improvement studies identified from:  

  1. Monthly searches of a number of major healthcare databases: MEDLINE, EMBASE, PsycINFO, CINAHL, and LILACS.

  2. Monthly searches of a number of trial registers: meta Register of Controlled Trials; Umin Japan Trial Register; WHO portal (which covers ClinicalTrials.gov; ISRCTN; Chinese Clinical trials Register; German Clinical trials register; Iranian Registry of Clinical trials; Netherlands National Trials Register, plus others).

  3. Quarterly search of the Central Register of Controlled Trials (CENTRAL) on The Cochrane Library.

  4. Monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings; Index to Theses; Australasian Digital Theses.

To view a list of all sources searched for ALOIS see About ALOIS on the ALOIS website.

We ran additional separate searches in Medline (OVID SP), EMBASE (OVID SP), PschInfo (OVID SP), CINAHL (EBSCO host), Web of Science and conference proceedings (Web of Knowledge), LILACS (BIREME), CENTRAL (The Cochrane Library), Clinicaltrials.gov (www.clinicaltrials.gov) and ICTRP Search Portal (apps.who.int/trialsearch) to ensure that the search was as comprehensive as possible. All search strategies and the number of hits retrieved can be viewed in Appendix 1.

Searching other resources

We checked the reference lists of all papers of included studies for further potentially eligible studies.

Data collection and analysis

Selection of studies

Two independent review authors (AC and AH) examined the titles and abstracts of citations identified by the search for eligibility, with any disagreements settled by consensus. We retrieved full-text copies and two review authors (AC and AH) independently assessed them for inclusion on the basis of the stated eligibility criteria. We settled any disagreements by consensus.

Data extraction and management

Two review authors (AC and AH) independently extracted data from included trials using a piloted data extraction form, and settled any disagreements by consensus. We created Characteristics of included studies tables and Summary of findings for the main comparison and Summary of findings 2 using GRADEpro and Review Manager 5 software (RevMan 2012).

Assessment of risk of bias in included studies

Two review authors (AC and AH) independently assessed risks of bias using Cochrane criteria as described in the Cochrane Handbook for Systematic Reviews of Interventions (Cochrane 2011). We assessed included trials for adequacy of sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other potential sources of bias. For each domain, we made a judgement of low risk, high risk or unclear risk of bias. We settled any disagreements by consensus. We generated 'Risk of bias' summary figures using Review Manager 5 (RevMan) software (RevMan 2012).

Measures of treatment effect

We used risk ratios (RR) as measures of treatment effect for dichotomous outcomes. We used hazard ratios (HR) when time to event data were reported.

Unit of analysis issues

Both included trials were cluster-randomised. Where the authors reported analyses which had adjusted for the effects of clustering, we extracted the adjusted effect measures (RR, HR) and their 95% confidence intervals (CIs) directly. If unadjusted analyses had been performed, we sought to calculate approximately correct analyses by extracting data on number of clusters, mean size of each cluster, primary outcome data and estimates of the intra-cluster correlation coefficient (ICC). If an approximately correct analysis was not possible, then we extracted primary data and calculated risk ratios with 95% CIs.

Dealing with missing data

Where data were missing due to loss of participants or clusters from follow-up, we recorded this with reasons where possible. We preferred Intention-to-treat data. If these were not available, we recorded per protocol data.

Assessment of heterogeneity

We anticipated that national and international models of LTC may lead to clinical heterogeneity. For example, in the UK residential homes and nursing homes comprise residents who have different levels of dependence and associated care needs. Furthermore, different interventions for preventing delirium in older people in long term care were likely to lead to methodological and statistical heterogeneity. For example, there may be heterogeneity between strategies targeting LTC residents or LTC facilities, or heterogeneity due to timing of the delirium prevention intervention.

We planned separate categorisation and analysis of non-pharmacological/pharmacological single/multicomponent interventions to help address trial heterogeneity. Due to clear clinical heterogeneity (see Included studies), we did not conduct any meta-analysis of the included trials.

Assessment of reporting biases

We sought clinical trial registration databases and trial protocols to assess potential reporting biases, and documented the funding source for all trials to assist the assessment.

Data synthesis

Where adjusted hazard ratios were presented, we analysed data using generic inverse variance methods, deploying natural logarithms of hazard ratios and associated standard errors. We did not perform a meta-analysis because of clinical and methodological differences between the trials.

Subgroup analysis and investigation of heterogeneity

See Differences between protocol and review.

Sensitivity analysis

See Differences between protocol and review.

Results

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies.

Results of the search

The results of the search are outlined in a PRISMA diagram (Figure 1). We retrieved 15 full-text studies, 13 of which we excluded (see Excluded studies), leaving two eligible for inclusion (see Included studies). One potentially eligible trial is ongoing (see Ongoing studies).

Figure 1.

Study flow diagram.

Included studies

We include two trials that recruited 3636 participants (Culp 2003; Lapane 2011). Both trials were complex single-component non-pharmacological delirium prevention interventions.

The first trial (Culp 2003) was a cluster-RCT of a four-week hydration management intervention that recruited 98 residents across seven nursing homes in the United States. All residents were considered eligible for inclusion; those with acute confusion at baseline, terminal illness, uncontrolled diabetes, nasogastric or gastrostomy tube, severe renal failure, severe congestive heart failure, current urinary tract infection or serum sodium < 135 mEq/L were excluded. The intervention was a hydration management programme whereby an individual fluid intake goal was calculated according to participant body weight. Seventy-five per cent of the fluid intake goal was delivered with meals, and the remaining 25% during non-meal times. Nursing staff were instructed on the treatment regimen. A research assistant calculated the fluid goal and measured fluid intake randomly to ensure protocol compliance. No individual fluid intake goal was calculated for control arm participants. Follow-up was at four weeks post-randomisation.

The second trial (Lapane 2011) was a cluster-RCT of the Geriatric Risk Assessment MedGuide (GRAM) software programme that included 3538 residents across 25 care homes in the United States. Medicare- and Medicaid-certified nursing homes with contracts with Omnicare pharmacies, 50 or more geriatric beds and few short-stay residents were considered for inclusion. All residents were considered eligible; individual resident consent was assessed as not required on the basis that the intervention involved a wholesale change in clinical and administrative practices at the nursing home. The GRAM was used to identify medications that may contribute to delirium and falls risk for individual residents. Pharmacy automatically generated a GRAM report within 24 hours of nursing home admission. For those identified as being on medication contributing to risk of delirium or falls, an automatic report was sent to the pharmacist to coincide with a monthly visit to the nursing home. A medication review was then undertaken at the visit and a proactive monitoring plan was initiated by the care-home staff to assess for medication side effects. Control nursing homes did not receive the triggered pharmacist visit or proactive monitoring plan. All outcomes were recorded electronically by participating care-home staff over a 12-month period. The trial used resident months rather than individuals as its unit of outcome measurement. Results apply only to new admissions during 2004.

Excluded studies

We excluded 13 trials: 11 were not delirium prevention trials (Greendyke 1986; Hofferberth 1989; Mittal 2004; Moretti 2004; Ushijima 2008; Kim 2010; Overshott 2010; Pellfolk 2010; Tahir 2010; Grover 2011; Yoon 2011), with the focus either on delirium treatment or on health conditions other than delirium; two were not conducted in a long term care setting (Isaia 2009; Marcantonio 2010).

Risk of bias in included studies

Our assessment of risk of bias in the two included trials is presented in the 'Characteristics of included studies' table and is summarised here in the text and in Figure 2. Neither trial was assessed as being at low risk of methodological bias across all domains. Notably, there was no evidence of blinding of trial participants or assessors in either trial. Risk of bias for many domains was unclear because insufficient information was reported.

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Neither trial reported sufficient information on sequence generation or allocation concealment, so risk of selection bias was assessed as unclear.

Blinding

There was no evidence of participant or assessor blinding in either trial, so both were assessed as being at high risk of bias. Culp 2003 reported that the study was not blinded and members of the research team who were not blind to allocation completed outcome assessments. Similarly, Lapane 2011 reported that participants and personnel were aware of allocated intervention. The minimum data set (MDS) was used for outcome data and was completed by care staff with knowledge of allocation.

Incomplete outcome data

Culp 2003 did not report information on losses to follow-up and did not perform an intention-to-treat analysis, so was assessed as being at high risk of attrition bias. Lapane 2011 did not report an intention-to-treat analysis, so risk of attrition bias was assessed as unclear.

Selective reporting

There was no evidence of selective outcome reporting in either trial, so both were assessed as being at low risk of reporting bias.

Other potential sources of bias

Culp 2003 reported that staff alerted researchers to change in cognition, so identification of delirium was partly dependent on staff knowledge. The nursing facility director recommended which unit should be used in the study, which may have introduced further potential for bias. There was a significantly higher baseline blood urea nitrogen (BUN):creatinine ratio in the intervention group, indicating that this group were more dehydrated at baseline and results were not adjusted to account for this. No adjustments were made for the potential effects of clustering. There may have been potential for between-cluster contamination of the relatively simple hydration-based intervention, and measures to prevent this were not reported by the investigators. On the basis of these additional considerations, Culp 2003 was assessed as being at high risk of bias in this domain.

Lapane 2011 reported that only one cluster was lost and Poisson regression was used to account for the cluster design. This trial was therefore assessed as being at low risk of bias for this domain.

Effects of interventions

See: Summary of findings for the main comparison Single-component medication monitoring and adjustment intervention versus control for preventing delirium in older people in institutional long term care; Summary of findings 2 Single-component hydration intervention versus control for preventing delirium in older people in institutional long term care

Primary outcomes

Both trials reported data on one of the primary outcome measures, incidence of delirium. Culp 2003 reported no effect of a hydration-based intervention on delirium incidence (risk ratio (RR) 0.85, 95% confidence interval (CI) 0.18 to 4.00). No adjustment was made for the effects of clustering and it was not possible to calculate an approximately correct analysis due to limitations in data reporting.

Lapane 2011 reported that the introduction of the intervention (GRAM report, pharmacist-led medication review and subsequent proactive monitoring plan) was associated with a significant reduction in delirium incidence, compared to control (12-month hazard ratio (HR) 0.42, CI 0.34 to 0.51). Adjustments were made for the effects of clustering. No data were reported on the other primary outcomes.

Secondary outcomes

Culp 2003 did not report data for any of the secondary outcomes. Lapane 2011 reported adjusted analyses for additional outcomes of unplanned hospitalisation, mortality and falls. There was no clear evidence of reduction in unplanned hospitalisation (HR 0.89, CI 0.72 to 1.10), in mortality (HR 0.88, CI 0.66 to 1.17) or in falls (HR 1.03, CI 0.92 to 1.15). Neither study reported data on direct costs or cost effectiveness of the interventions.

Clear intervention heterogeneity precluded synthesis of data for meta-analysis. Limitations of data reporting precluded subgroup analysis for participants with and without dementia.

Discussion

Summary of main results

Our review has identified two randomised controlled trials (RCTs) of delirium prevention interventions for older people in institutional long term care, recruiting 3636 participants. One small cluster-RCT (n = 98) of a hydration-based intervention reported no reduction in delirium incidence in the intervention group compared to control. Results were imprecise, not adjusted for the effects of clustering and with serious limitations evident in trial design. Importantly, the investigators reported that both intervention and control groups were consuming approximately the same volume of fluids over the follow-up period, but only 51% of intervention participants had 90% or greater compliance with the fluid goal. Previous research has identified that many LTC residents do not consume adequate fluid (Armstrong-Esther 1996) and this result may indicate that achieving target fluid intake in care-home residents is challenging, even in the context of a clinical trial.

One large cluster-RCT (n = 3538) of a computerised system to identify medications that may contribute to delirium risk and trigger a pharmacist-led medication review reported a large reduction in delirium incidence but no clear evidence of reductions in hospital admissions, mortality or falls. Although the analysis was adjusted for the effects of clustering, there were limitations evident in trial design, notably an absence of either participant or assessor blinding.

Overall completeness and applicability of evidence

The very small number of included trials identify a limited body of evidence on the effectiveness of interventions for preventing delirium in older people in institutionalised long term care. We identified only two single-component non-pharmacological interventions with methodological limitations. We did not find any multicomponent non-pharmacological delirium prevention interventions or pharmacological delirium prevention interventions for this population. Both trials were conducted in the United States and international differences in the organisation of long term care mean that the results may not be directly applicable to other settings.

Quality of the evidence

We used GRADEpro software to inform the generation of evidence quality statements.

On the basis of one large RCT there is moderate-quality evidence that a single component medication monitoring and adjustment intervention may reduce the incidence of delirium in older people in institutional LTC (see Summary of findings for the main comparison). Notably, personnel, participants and outcome assessors were not blinded in this trial.

On the basis of one large RCT there is moderate-quality evidence that a single component medication monitoring and adjustment intervention does not appear to be associated with reduced hospitalisation, mortality or falls for older people in institutional LTC (Summary of findings for the main comparison). Notably, personnel, participants and outcome assessors were not blinded in this trial.

On the basis of a single RCT with serious limitations in trial design and very imprecise results, there is very low-quality evidence on the effectiveness of hydration-based interventions for reducing the incidence of delirium in older people in institutional LTC. It is therefore not possible to draw firm conclusions about this intervention (Summary of findings 2).

Potential biases in the review process

This review has followed Cochrane procedures and there were only a small number of minor amendments to the review protocol following initial publication. The very small number of included trials precluded an accurate assessment of consistency of results or a statistical assessment of reporting bias.

Agreements and disagreements with other studies or reviews

To our knowledge there are no previous systematic reviews on the effectiveness of delirium prevention interventions for older people in institutional long term care.

Authors' conclusions

Implications for practice

Introduction of a software-based intervention to identify medications that could contribute to delirium risk so that a pharmacist-led medication review and monitoring plan can be initiated may reduce the incidence of delirium for older people in institutional LTC. This is based on one large RCT in the United States and may not be practical in other countries which do not have comparable information technology services available in care homes. There was no clear evidence of reduction in hospital admissions, mortality or falls. One small RCT of a weight-based hydration intervention for older people in nursing homes had serious methodological limitations and it is not possible to use the results from this trial to support the use of this intervention.

Implications for research

There is very limited evidence on the effectiveness of interventions for preventing delirium in older people in institutional LTC. Adequately powered trials are justified of computerised medication management interventions for delirium prevention in LTC residents that incorporate blinding of outcome assessors. These trials should be supported by research investigating methods of implementation across different care systems. There is evidence for the effectiveness of multicomponent non-pharmacological interventions to prevent delirium in hospitalised older people and trials to test these interventions in LTC residents are indicated. There have been no trials of pharmacological agents for preventing delirium in LTC residents and future trials should be considered.

Acknowledgements

There are no additional acknowledgements.

Data and analyses

Download statistical data

Comparison 1. Single component hydration intervention versus control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Incidence of delirium1 Risk Ratio (M-H, Random, 95% CI)Subtotals only
Analysis 1.1.

Comparison 1 Single component hydration intervention versus control, Outcome 1 Incidence of delirium.

Comparison 2. Single component medication monitoring and adjustment intervention versus control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Incidence of delirium1 Hazard Ratio (Random, 95% CI)Subtotals only
2 Unplanned hospitalisation1 Hazard Ratio (Random, 95% CI)Subtotals only
3 Mortality1 Hazard Ratio (Random, 95% CI)Subtotals only
4 Falls1 Hazard Ratio (Random, 95% CI)Subtotals only
Analysis 2.1.

Comparison 2 Single component medication monitoring and adjustment intervention versus control, Outcome 1 Incidence of delirium.

Analysis 2.2.

Comparison 2 Single component medication monitoring and adjustment intervention versus control, Outcome 2 Unplanned hospitalisation.

Analysis 2.3.

Comparison 2 Single component medication monitoring and adjustment intervention versus control, Outcome 3 Mortality.

Analysis 2.4.

Comparison 2 Single component medication monitoring and adjustment intervention versus control, Outcome 4 Falls.

Appendices

Appendix 1. Update and pre-publication searches: July 2012 and April 2013

SourceSearch strategyHits retrieved
1. ALOIS (www.medicine.ox.ac.uk/alois)delirium

Jul 2012: 96

Apr 2013: 9

2. MEDLINE In-process and other non-indexed citations and MEDLINE 1950 - present (Ovid SP)

1. Delirium/

2. deliri*.mp.

3. "acute confusion*".ti,ab.

4. "acute organic psychosyndrome".ti,ab.

5. "acute brain syndrome".ti,ab.

6. "metabolic encephalopathy".ti,ab.

7. "acute psycho-organic syndrome".ti,ab.

8. "clouded state".ti,ab.

9. "clouding of consciousness".ti,ab.

10. "exogenous psychosis".ti,ab.

11. "toxic psychosis".ti,ab.

12. "toxic confusion".ti,ab.

13. Delirium, Dementia, Amnestic, Cognitive Disorders/su [Surgery]

14. obnubilat*.ti,ab.

15. or/1-14

16. Primary Prevention/

17. prevent*.mp.

18. reduc*.ti,ab.

19. stop*.ti,ab.

20. taper*.ti,ab.

21. avoid*.ti,ab.

22. "cut* down".ti,ab.

23. or/16-22

24. 15 and 23

25. randomized controlled trial.pt.

26. controlled clinical trial.pt.

27. randomi?ed.ab.

28. placebo.ab.

29. drug therapy.fs.

30. randomly.ab.

31. trial.ab.

32. groups.ab.

33. or/25-32

34. (animals not (humans and animals)).sh.

35. 33 not 34

36. 24 and 35

Jul 2012: 821

Apr 2013: 118

3. EMBASE

1980 - 2012 week 30 (Ovid SP)

1. Delirium/

2. deliri*.mp.

3. "acute confusion*".ti,ab.

4. "acute organic psychosyndrome".ti,ab.

5. "acute brain syndrome".ti,ab.

6. "metabolic encephalopathy".ti,ab.

7. "acute psycho-organic syndrome".ti,ab.

8. "clouded state".ti,ab.

9. "clouding of consciousness".ti,ab.

10. "exogenous psychosis".ti,ab.

11. "toxic psychosis".ti,ab.

12. "toxic confusion".ti,ab.

13. Delirium, Dementia, Amnestic, Cognitive Disorders/su [Surgery]

14. obnubilat*.ti,ab.

15. or/1-14

16. primary prevention/

17. prevent*.mp.

18. reduc*.ti,ab.

19. stop*.ti,ab.

20. taper*.ti,ab.

21. avoid*.ti,ab.

22. "cut* down".ti,ab.

23. or/16-22

24. 15 and 23

25. randomized controlled trial/

26. random*.ti,ab.

27. placebo.ti,ab.

28. trial.mp.

29. controlled clinical trial/

30. or/25-29

31. 24 and 30

Jul 2012: 835

Apr 2013: 161

4. PsycINFO

1806 - July week 4 2012 (Ovid SP)

1. Delirium/

2. deliri*.mp.

3. "acute confusion*".ti,ab.

4. "acute organic psychosyndrome".ti,ab.

5. "acute brain syndrome".ti,ab.

6. "metabolic encephalopathy".ti,ab.

7. "acute psycho-organic syndrome".ti,ab.

8. "clouded state".ti,ab.

9. "clouding of consciousness".ti,ab.

10. "exogenous psychosis".ti,ab.

11. "toxic psychosis".ti,ab.

12. "toxic confusion".ti,ab.

13. obnubilat*.ti,ab.

14. or/1-13

15. Prevention/

16. prevent*.mp.

17. reduc*.ti,ab.

18. stop*.ti,ab.

19. taper*.ti,ab.

20. avoid*.ti,ab.

21. "cut* down".ti,ab.

22. or/15-21

23. 14 and 22

24. random*.mp.

25. trial.mp.

26. placebo*.mp.

27. group.ab.

28. or/24-27

29. 23 and 28

Jul 2012: 163

Apr 2013: 19

5. CINAHL (EBSCO host)

S1 (MH "Delirium") OR (MH "Delirium Management (Iowa NIC)") OR (MH "Delirium, Dementia, Amnestic, Cognitive Disorders/SU")

S2 TX deliri*

S3 TX "acute confusion*"

S4 TX "acute organic psychosyndrome"

S5 TX "acute brain syndrome"

S6 TX "metabolic encephalopathy"

S7 TX "acute psycho-organic syndrome"

S8 TX "clouded state"

S9 TX "clouding of consciousness"

S10 TX "exogenous psychosis"

S11 TX "toxic psychosis"

S12 TX "toxic confusion"

S13 TX obnubilat*

S14 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13

S15 (MH "Preventive Trials") OR (MH "Preventive Health Care")

S16 TX prevent*

S17 TX reduc*

S18 TX stop*

S19 TX taper*

S20 TX avoid*

S21 TX "cut* down"

S22 S15 or S16 or S17 or S18 or S19 or S20 or S21

S23 S14 and S22

S24 TX random*

S25 TX placebo

S26 TX trial

S27 (MH "Clinical Trials") OR (MH "Intervention Trials")

S28 S24 or S25 or S26 or S27

S29 S23 and S28

Jul 2012: 189

Apr 2013: 0

6. Web of Science and conference proceedings (Web of Knowledge)

Topic=(deliri* OR "acute confusion*" OR "acute organic psychosyndrome" OR "acute brain syndrome" OR "metabolic encephalopathy" OR "acute psycho-organic syndrome" OR "clouded state" OR "clouding of consciousness" OR "exogenous psychosis" OR "toxic psychosis" OR "toxic confusion" OR obnubilat*) AND Topic=(prevent* OR reduc* OR stop* OR taper* OR avoid* OR "cut* down") AND Topic=(random* or placebo or "double-blind" or trial OR groups OR "controlled study" OR "time series" OR "Comparative Study" OR "Pretest-Posttest Design")

Timespan=All Years. Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH.

Lemmatization=On

Jul 2012: 654

Apr 2013: 163

7. LILACS (BIREME)randomly OR randomised OR randomized OR trial OR ensaio clínico OR control OR controlled [Words] and delirium OR delious OR deliria OR delirio OR loucura [Words]

Jul 2012: 47

Apr 2013: 1

8. CENTRAL (The Cochrane Library) (Issue 2 of 4, 2012)

#1 MeSH descriptor Delirium, this term only

#2 deliri*

#3 "acute confusion*"

#4 "acute organic psychosyndrome"

#5 "acute brain syndrome"

#6 "metabolic encephalopathy"

#7 "acute psycho-organic syndrome"

#8 "clouded state"

#9 "clouding of consciousness"

#10 "exogenous psychosis"

#11 "toxic psychosis"

#12 "toxic confusion"

#13 obnubilat*

#14 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13)

#15 MeSH descriptor Primary Prevention, this term only

#16 prevent*

#17 reduc*

#18 stop*

#19 taper*

#20 avoid*

#21 "cut* down"

#22 (#15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21)

#23 (#14 AND #22), trials

Jul 2012: 230

Apr 2013: 7

9. Clinicaltrials.gov (www.clinicaltrials.gov)care home OR institutionalised OR institutionalized OR long term care OR home | Interventional Studies | delirium OR toxic psychosis OR toxic confusion OR metabolic encephalopathy OR clouded state OR exogenous psychosis | Senior

Jul 2012: 156

Apr 2013: 23

10. ICTRP Search Portal (apps.who.int/trialsearch) [includes: Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; ISRCTN; Chinese Clinical Trial Registry; Clinical Trials Registry – India; Clinical Research Information Service – Republic of Korea; German Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; Pan African Clinical Trial Registry; Sri Lanka Clinical Trials Registry; The Netherlands National Trial Register]care home OR institutionalised OR institutionalized OR long term care OR home | Interventional Studies | delirium OR toxic psychosis OR toxic confusion OR metabolic encephalopathy OR clouded state OR exogenous psychosis

Jul 2012: 72

Apr 2013: 0

TOTAL before de-duplication

July 2012: 3263

April 2013: 501

TOTAL after de-duplication and first assessment

July 2012: 120

April 2013: 15

Contributions of authors

AC, NS, RH and JY all contributed to the writing of the protocol for this review. AC and AH completed the handsearch and extracted data for all studies. AC completed 'Summary of findings' tables and generated GRADE Evidence Profiles. All authors contributed to the writing of the review.

Declarations of interest

NS is chief investigator for a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant to investigate the effects of a delirium prevention intervention for older people in long term care.

JY is a co-applicant for a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant to investigate the effects of a delirium prevention intervention for older people in long term care.

AC, RH and AH declare that they have no known conflicts of interest.

Sources of support

Internal sources

  • University of Leeds, UK.

    Salary support for AC and JY.

External sources

  • No sources of support supplied

Differences between protocol and review

An additional co-author (Anne Heaven) was added to the review between the protocol and review stage. Following publication of the protocol, amendments were made to Measures of treatment effect and Data synthesis to incorporate the analysis of adjusted data from cluster-randomised trials using generic inverse variance methods. A post hoc decision was made to include the adverse outcome of falls in the 'Summary of findings' tables. We planned participant-level subgroup analyses for those with and without dementia, but we were unable to conduct these analyses because of limitations in reporting. We planned sensitivity analyses for trials at low risk of methodological bias, but these were not possible because of the very small number of included trials.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Culp 2003

MethodsCluster-randomised controlled trial with nursing home as the unit of randomisation.
Participants

98 residents of 7 care homes in Iowa, USA.

Mean age 84.5 (SD 9.3) years in intervention group; 83.8 (SD 8.1) years in control group.

54.7% women in intervention group; 53.3% female in control group.

Interventions

A 4-week weight-based hydration management intervention for nursing-home residents. Individual fluid intake goal was calculated according to body weight. 75% of the fluid intake goal was delivered with meals, the remaining 25% during non-meal times. Nursing staff were instructed on the treatment regimen. A research assistant calculated the fluid goal and measured fluid intake randomly to ensure protocol compliance.

No individual fluid intake goal calculated for control arm participants.

OutcomesIncidence of delirium, measured using the Neelon & Champagne (NEECHAM) confusion scale (Neelon 1996). Outcomes recorded at 4 weeks post-randomisation.
NotesFunding source: National Institute for Nursing Research
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskNo information provided on generation of allocation sequence.
Allocation concealmentUnclear riskCluster randomised trial. Unclear if all care homes recruited prior to randomisation.
Blinding
All outcomes
High riskNo. Stated not double-blind and research team conducted all assessments. Assessments conducted weekly or if acute change in mental status was noted by either the research team or care-home staff.
Incomplete outcome data addressed
All outcomes
High riskNo information on loss to follow-up. No intention-to-treat analysis.
Free of selective reportingLow riskNo evidence of selective outcome reporting.
Free of other biasHigh riskStaff alerted researchers to change in cognition so dependent on staff knowledge. Nursing facility director recommended which unit should be used in the study. A higher blood urea nitrogen (BUN):creatinine ratio in the intervention group, indicating that this group were more dehydrated at baseline. No adjustment made for effects of clustering. Potential for between-cluster contamination of the relatively simple hydration-based intervention, and measures to prevent this were not reported by the investigators.

Lapane 2011

  1. a

    MDS: minimum data set

MethodsCluster-randomised controlled trial with nursing home as the unit of randomisation.
Participants

3538 residents of 25 nursing homes in Virginia, USA, recruited between 2003 and 2004.

Medicare- and Medicaid-certified nursing homes with contracts with Omnicare pharmacies, 50 or more geriatric beds and few short-stay residents were considered for inclusion.

73.9% women.

39.0% aged > 85.

Interventions

Geriatric Risk Assessment MedGuide (GRAM) software used to identify resident-specific medications that may contribute to delirium and falls risk. Pharmacy automatically generated GRAM report within 24 hours of nursing-home admission. For those who triggered GRAM resident assessment protocols (RAPS) for delirium or falls risk, an automatic report was sent to the pharmacist to coincide with a monthly visit to the nursing home. A medication review was then undertaken at the visit and a proactive monitoring plan was initiated by the care home staff to assess for medication side effects.

Control nursing homes did not receive the triggered pharmacist visit or proactive monitoring plan.

Outcomes

Incidence of delirium, measured using the Nursing Home Confusion Assessment Method (NH-CAM) (Dosa 2007).

Fall events, measured using MDS records.

Hospital admissions, measured using MDS records.

Mortality, measured using MDS records.

The trial used resident months (defined as the number of days from date of first assessment to the first outcome occurrence, the last date in the nursing home, the death date, or December 31, 2004), rather than individuals as its unit of outcome measurement.

Results apply only to new admissions during 2004.

All outcomes were recorded electronically by participating care-home staff over a 12-month period.

NotesFunding source: Agency for Healthcare Research and Quality
Risk of bias
BiasAuthors' judgementSupport for judgement
Adequate sequence generationUnclear riskMethod of allocation sequence generation not provided.
Allocation concealmentUnclear riskUnclear if all care homes recruited prior to randomisation.
Blinding
All outcomes
High riskParticipants and personnel aware of allocated intervention. MDS used for outcome data and completed by care staff with knowledge of allocation.
Incomplete outcome data addressed
All outcomes
Unclear riskNo information on intention-to-treat analysis.
Free of selective reportingLow riskNo evidence of selective outcome reporting.
Free of other biasLow riskOnly one cluster was lost. Poisson regression accounting for the cluster design was used.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Greendyke 1986Not a delirium prevention trial.
Grover 2011Not a delirium prevention trial.
Hofferberth 1989Not a delirium prevention trial.
Isaia 2009Trial not conducted in a long term care setting.
Kim 2010Not a delirium prevention trial.
Marcantonio 2010Trial not conducted in a long term care setting.
Mittal 2004Not a delirium prevention trial.
Moretti 2004Not a delirium prevention trial.
Overshott 2010Not a delirium prevention trial.
Pellfolk 2010Not a delirium prevention trial.
Tahir 2010Not a delirium prevention trial.
Ushijima 2008Not a delirium prevention trial.
Yoon 2011Not a delirium prevention trial.

Characteristics of ongoing studies [ordered by study ID]

Siddiqi 2012

Trial name or titleA cluster-randomised controlled pilot trial of 'Stop Delirium!' a complex intervention to prevent delirium in care homes for older people
MethodsCluster-randomised controlled trial.
Participants288 care home residents.
InterventionsSTOP delirium! intervention.
OutcomesIncidence of delirium, severity of delirium.
Starting date26th March 2012
Contact informationDr Najma Siddiqi, Leeds Insitute of Health Sciences, University of Leeds, LS2 9JT
Notes