Interventions in primary care for reducing preventable medication errors that lead to hospital admissions, mortality and emergency department visits

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

We plan to systematically identify and evaluate studies of interventions delivered in primary care settings that aim to reduce preventable medication errors that lead to hospital admissions, mortality and emergency department visits.

Background

Description of the condition

Medication-related (drug-related) adverse events in primary care represent an important cause of mortality and hospital admissions (Howard 2003). Medication-related adverse events could be the result of patients either experiencing adverse events (not usually preventable) or as a result of drug administration or medication errors (usually preventable) (Ioannidis 2001).

According to Edwards 2000, adverse drug reactions can be defined as "an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product". Medication errors on the other hand, are mostly preventable. A medication error is defined by Ferner 2006 as "a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient". They are mainly due to either negligence or prescribing errors. A reduction of these types of prescribing errors has been a high priority for healthcare policy in order to improve the safety profile of the healthcare delivery system (Howard 2003; Soe 2013).

A prospective cohort study has shown that within four weeks of receiving a primary care prescription, 25% of patients experience an adverse drug event, 11% of which are judged preventable (Gandhi 2003). A systematic review and meta-analysis by Winterstein 2002 reported that a median 7.1% (inter-quartile range 5.7% to 16.2%) of hospital admissions result from drug-related problems, of which 59% were considered preventable (i.e. attributable to error), while Howard 2007 reported a median of 3.7% of hospital admissions were preventable and drug-related. Improving patient safety is, as a consequence, now a government priority in many economically developed and underdeveloped countries, including the United Kingdom (UK), the United States (US) and five African countries (Brown 2008; WHO 2004).

Description of the intervention

In this review we will examine interventions in primary care to reduce preventable medication errors that result in hospital admissions, mortality and emergency department visits. The three main types of interventions we will examine include: professional, organisational and structural interventions as described by the Cochrane Effective Practice and Organisation of Care (EPOC) Group (EPOC 2013a). We will use these interventions for any type of population, irrespective of their characteristics.

How the intervention might work

The three main interventions, mentioned above, will use different approaches to achieve a reduction in medication errors that lead to hospital admissions, mortality and emergency department visits. Professional interventions include continuing education and quality assurance interventions that provide educational interventions for practitioners or patients, such as teaching the use of structured assessments with general practitioners. Organisational interventions include revision of professional roles (e.g. nurse- or pharmacist-led chronic disease clinics and nurse prescribing) and revision of clinical multidisciplinary teams (e.g. pharmacist-managed medication reviews). Such interventions aim at engaging workers in the management of risk to increase patient safety. Structural interventions include the presence and organisation of quality monitoring services. Examples of these interventions include structural approaches such as social, economic, and political interventions that can improve public health outcomes by increasing the willingness and ability of individuals to practice prevention. Together, the three types of interventions will address the various stakeholders involved in providing health care to individuals in primary care (Benning 2011).

Why it is important to do this review

To date, there is little information on those types of interventions mentioned above, aimed at reducing preventable medication-related adverse events in primary care due to errors. A review undertaken by Ioannidis 2001 addressed interventions of all types of medical errors in both primary and secondary care. It highlighted the complexity involved in studying those types of interventions aimed at minimising errors in healthcare delivery. Other reviews by Durieux 2012 and O'Brien 2008 focused on interventions to improve professional practice and healthcare outcomes, including prescribing. A review by Royal 2006 found that there was little evidence to support pharmacist-led medication interventions as being effective in reducing hospital admissions. None of these reviews have focused on other types of interventions such as professional, organisational and structural that could possibly reduce medication errors in the primary care setting.

Given that preventable medication errors in primary care are associated with hospital admissions, mortality and emergency department visits, it is important to know whether there are any interventions that have been found to be effective in reducing the occurrence of these outcomes. While members of our team published a related systematic review on this topic (Royal 2006), there has been no Cochrane systematic review of interventions aimed at reducing the incidence of preventable medication errors that lead to hospital admissions, mortality and emergency department visits.

Objectives

We plan to systematically identify and evaluate studies of interventions delivered in primary care settings that aim to reduce preventable medication errors that lead to hospital admissions, mortality and emergency department visits.

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials (RCTs) in this review. We will exclude controlled before-after studies as they provide much weaker evidence due to the non-randomisation of participants to experimental and control groups. We will not impose any restriction on the language or country in which the studies are carried out.

Types of participants

We will include studies of healthcare professionals involved in the provision of primary care in the community setting who are authorised to prescribe, sell or administer medications, including primary care physicians (general practitioners, family doctors, family physicians, family practitioners), dental practitioners, community nurses, nurse practitioners, community pharmacists, dispensers in community pharmacies and any other relevant healthcare providers. We will include all patients, irrespective of age, who are receiving a medication through the intervention of the aforementioned primary healthcare professionals.

Examples of community settings include general practice, emergency departments, community pharmacies and nursing and residential homes. We will exclude studies of interventions to outpatients in a clinic attached to a hospital or a day hospital, where patients are being seen by a non-healthcare professional.

Types of interventions

Using the latest taxonomy of interventions developed by the Cochrane Effective Practice and Organisation of Care (EPOC) Group (EPOC 2013a), we will categorise interventions that improve patient safety by reducing mortality, emergency department visits, and hospital admissions. We will compare the interventions with inactive control interventions such as placebo, no treatment and standard or conventional care. We will divide interventions into the following categories.

Professional Interventions

Continuing education and quality assurance interventions that provide educational interventions for practitioners or patients fall under this heading. Examples include distribution of educational materials, educational meetings, local consensus processes, educational outreach visits, audit and feedback, reminders (including computer aided decision support and drug dosage), marketing and mass mailing.

Organisational Interventions

Examples of organisational interventions include revision of professional roles (e.g. nurse- or pharmacist-led chronic disease clinics, nurse prescribing) and clinical multidisciplinary teams (e.g. pharmacist-managed medication reviews) and the presence of quality monitoring services.

Structural Interventions

Interventions in this category include the presence and organisation of quality monitoring services. Structural approaches include social, economic, and political interventions that can improve public health outcomes by increasing the willingness and ability of individuals to practice prevention.

Types of outcome measures

We will include studies addressing preventable medication errors with the following outcomes.

Primary outcomes
  • Hospital admissions, determined by the number of hospital admissions.

Secondary outcomes
  • Mortality, given as the number of deaths following an intervention.

  • Emergency department visits, determined by the number of emergency department visits.

We will include a 'Summary of findings' table in the review, using the GRADE approach (Schünemann 2011) to evaluate the quality of evidence for the primary outcome.

Search methods for identification of studies

Search strategies will be developed by Michelle Fiander, Trials Search Co-ordinator (TSC) for the EPOC Group, in consultation with the authors. The TSC will search the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects (DARE) for related systematic reviews, and the databases listed below for primary studies.

Electronic searches

Databases
  • Cochrane Central Register of Controlled Trials (CENTRAL), Wiley

  • Health Technology Assessment, Cochrane Library, Wiley

  • NHS Economic Evaluation Database, Cochrane Library, Wiley

  • MEDLINE(R) In-Process and other non-indexed citations, OvidSP

  • EMBASE, OvidSP

  • CINAHL (Cumulative Index to Nursing and Allied Health Literature), EbscoHost

  • PubMed http://www.ncbi.nlm.nih.gov/pubmed

We will translate the MEDLINE search strategy (Appendix 1) for other databases using appropriate syntax and vocabulary for those databases. Two methodological search filters will limit results: the Cochrane Highly Sensitive Search Strategy (sensitivity- and precision-maximizing version, 2008 revision) to identify randomised trials (Lefebvre 2011); and an EPOC methodology filter to identify non-randomised controlled trial (NRCT) designs. We will not impose any date or language restrictions. We will search all databases from start date forward. In PubMed we will use a truncated search strategy of high-value terms to identify citations from journals not indexed in MEDLINE.

Searching other resources

Grey Literature

We will conduct a grey literature search to identify studies not indexed in the databases listed above. Sources will include the sites listed below. (Additional sources, if any, will be documented in the review).

  • Open Grey http://www.opengrey.eu/

  • Grey Literature Report (New York Academy of Medicine) http://greylit.org/

  • Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov/

  • National Research Register (NRR) Archive http://www.nihr.ac.uk/Pages/NRRArchive.aspx

  • Joanna Briggs Institute http://www.joannabriggs.edu.au/Search.aspx

  • National Institute for Health and Clinical Excellence (NICE) www.nice.org.uk/

Trial Registries

We will search the following Registries.

  • International Clinical Trials Registry Platform (ICTRP), Word Health Organization (WHO) http://www.who.int/ictrp/en/

  • ClinicalTrials.gov, US National Institutes of Health (NIH) http://clinicaltrials.gov/

We will also:

  • screen individual journals and conference proceedings (e.g. handsearch);

  • review reference lists of all included studies, relevant systematic reviews/primary studies/other publications;

  • contact authors of relevant studies or reviews to clarify reported published information/seek unpublished results/data;

  • contact researchers with expertise relevant to the review topic/EPOC interventions; and

  • conduct cited reference searches for all included studies in citations indexes.

Data collection and analysis

Selection of studies

Studies will be eligible for inclusion if they involve healthcare professionals providing community-based family medical services. Community settings will include family and general practice, community pharmacies, and nursing and residential homes. We will exclude studies of interventions in clinics attached to a hospital unless they were described as a primary care clinic. We will only include interventions applied in primary care that aim to reduce medication errors that lead to hospital admissions, mortality and emergency department visits.

Two review authors will independently screen the titles and abstracts retrieved to assess studies against the inclusion criteria. We will obtain full-text copies of all papers considered to be of potential relevance and we will contact first authors of studies for clarification where necessary. We will resolve any disagreement about relevance by discussion between the review authors. We will enter all included studies in the Review Manager 5 software (RevMan 2012).

Data extraction and management

Two review authors will independently complete data extraction using a customised version of the EPOC Group data collection checklist (EPOC 2013b). Both review authors will meet frequently to discuss progress, with discrepancies resolved by discussion between the review authors. We will group studies together on the basis of similar interventions and common outcomes and use Review Manager 5 (RevMan 2012) software to manage and pool data as mentioned in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The selection process will be documented in sufficient detail to complete a PRISMA flow chart and a table of ‘Characteristics of excluded studies’.

Assessment of risk of bias in included studies

Two review authors will independently assess the quality of all included studies using the criteria developed by the EPOC 'Risk of bias' tool (EPOC 2013c). We will resolve any differences through discussion. We will assess nine parameters including similarity of outcome measurements at baseline, concealment of allocation, blinding of outcome assessors, and the issue of addressing incomplete outcome data. We will meet frequently to discuss the quality of identified papers and select studies for inclusion in the meta-analysis. We will assess studies on the basis of having low, unclear or high risk bias. We will exclude high risk trials from the meta-analysis.

Measures of treatment effect

For each of the primary outcomes listed above, we will either make use of the effect size that is reported for a study or calculate an effect size from the data that is available. We will report the median and range of effect sizes across all studies that use the same effect size measure. Although we anticipate that the odds ratio will be the primary effect size in most studies, we will also include studies that use other effect sizes such as hazard ratio. We will conduct separate meta-analyses for groups of studies that use different effect size measures. We will examine funnel plots for evidence of publication bias.

Unit of analysis issues

We will note whether studies randomised patients or healthcare professionals. If an analysis does not allow for clustering of patients within healthcare professionals, we will record a unit of analysis error, as such an analysis tends to over-estimate the precision of treatment effects (Goldstein 2003). We will adjust for unit of analysis errors whenever possible.

Dealing with missing data

We will contact the study authors to obtain the relevant missing information. We will note the levels of attrition for included studies. We will explore, using sensitivity analysis, the impact of including studies with high levels of missing data in the overall assessment of treatment effect.

Assessment of heterogeneity

We will use the I2 statistic to assess the heterogeneity of the studies included in this review. Where the I2 statistic is greater or equal to 40%, we will use a random-effects model to pool results from the studies in order to derive a summary statistic. Where we detect low heterogeneity (I2 < 40%), we will use the less restrictive fixed-effect model to pool results.

Assessment of reporting biases

We will carefully assess all studies retrieved for the potential of reporting bias. This is especially likely where outcomes are assessed using patient self reports or self administered surveys. We will exclude studies that are affected by reporting bias from the review.

Data synthesis

We will carry out statistical analysis using the Review Manager software (RevMan 2012). We will use a fixed-effect inverse variance meta-analysis for combining data where trials are examining the same intervention, and the trials’ populations and methods are judged sufficiently similar. Where we suspect clinical or methodological heterogeneity between studies sufficient to suggest that treatment effects may differ between trials we will use a random-effects meta-analysis. If substantial heterogeneity is identified in a fixed-effect meta-analysis this will be noted and the analysis repeated using a random-effects method, if appropriate. If meta-analysis is not possible, we will include a narrative description of the included studies.

We will group and code studies based on the three main interventions for this review (professional, organisational and structural).

Where appropriate, we will carry out meta-analyses to establish resultant effects of interventions on medication-related hospital admissions, mortality and emergency department visits.

Subgroup analysis and investigation of heterogeneity

We will conduct planned subgroup analyses classifying whole trials by interaction tests as described by Deeks 2001. We plan to carry out the following subgroup analyses as mentioned in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2011).

  1. Professional interventions, such as provision of educational interventions for practitioners or patients.

  2. Organisational interventions, including revision of professional roles (e.g. nurse- or pharmacist-led chronic disease clinics, nurse prescribing) and clinical multidisciplinary teams (e.g. pharmacist-managed medication reviews).

  3. Structural interventions, including the presence and organisation of quality monitoring services.

Sensitivity analysis

We will carry out sensitivity analyses to explore the effect of trial quality for important outcomes in the review. Where there is risk of bias associated with a particular aspect of study quality (e.g. inadequate sequence generation and allocation concealment), we will explore this by sensitivity analyses.

Acknowledgements

The authors would like to thank the following people for commenting on the protocol: Bernard Burnand, Eric Harvey, Arash Rashidian, Pierre Durieux, and Craig Ramsay. We thank Michelle Fiander (Trials Search Co-ordinator) and Clare Dooley (Managing Editor).

Appendices

Appendix 1. Search Strategy

Database(s): Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R)  

# Searches Results
1((Prevent$ or reduce or reducing) adj2 (medication error? or adverse drug or adverse medication)).ti,ab.1183
2Medication errors/ and (avoid$ or intervention or prevent$ or reducing or rate or improv$ or quality).ti,ab,hw.4419
3((medication? or drug or prescription?) adj (error? or mistake?) adj5 (avoid$ or intervention? or prevent$ or reducing or quality improv$)).ti,ab.851
4Inappropriate Prescribing/ and (avoid$ or intervention or prevent$ or reducing or rate or improv$ or quality).ti,ab,hw.264
5Decision Support Systems, Clinical/ and ((drug? or medication?) adj2 (management or adverse or event? or related)).ti,ab. [July 2013]200
6((structured adj2 (assessment? or care)) and (drug? or medication?)).ti,ab.230
7(structured assessment? or structured care or Case Management).ti,ab. and (drug therapy or medication? or pharmaco$ therapy or prescription? or prescribing).ti,ab,hw.629
8("safety of medications" or prescribing safety or safe prescribing or (safely adj prescribing)).ti,ab.250
9((safe or safety or quality improv$) and ((medication? or drug?) adj management)).ti.19
10(quality improv$ adj10 ((medication? or drug?) adj management)).ab.6
11(clinical decision and Drug?).ti.62
12((clinical decision making or decision support) adj4 (prescribing or drug therap$ or drug management or medication management or (managing adj2 (drug? or drug therapy or medication?)))).ti,ab.163
13(collaborative and (drug? or medication?) and management).ti.34
14Medication Reconciliation/233
15(drug? assess$ or drug? audit? or drug? reconcil$ or ((medication or drug or prescribing or prescription?) adj2 (reconciliation or review$ or audit))).ti,ab.3992
16((medication? or prescrib$ or pharmac$) adj2 (manage? or management or service? or system?)).ti,ab.14317
17(("drug therapy" or dosage? or dose? or medication? or prescription? or prescrib$ or pharmacist? or pharmaceutical care) adj2 (managing or management or monitor$)).ti,ab.7188
18Drug Utilization Review/3044
19community pharmacy.ti. or (community adj (pharmacy or pharmacist? or pharmacies)).ab.2737
20pharmacist?.ti. or (pharmacist? adj2 (collaborat$ or driven or directed or led or managed or team$)).ab.8301
21((pharmacist? or prescription? or prescribing or medication?) adj3 (consult$ or review$ or service or services)).ab.4894
22Patient Readmission/ and (prescription? or drug therapy).ti,hw.136
23Patient Readmission/ and (((adverse drug or adverse medication?) adj2 (event or related)) or ((medication related or drug related) adj2 (event? or problem?))).ti,ab.14
24((drug related or medication related or adverse drug or adverse medication) adj5 (emergency department? or emergency unit? or emergency centre? or emergency center? or emergency room? or afterhours or after hours or (emergency adj2 (admission? or admitting)))).ti,ab.122
25((drug related or medication related or adverse drug or adverse medication) adj5 (readmission? or readmitted or emergency visit or unexpected visit?)).ti,ab.28
26(((hospital admission? or (readmit$ or readmission?)) adj3 (reduc$ or fewer or lower)) or ((avoidable or preventable or reduced or reducing) adj5 (admission? or readmission?))).ti,ab. and (drug or medication? or prescription?).ti,ab,hw.597
27or/1-26 [Preventing ADE & proxy terms]40887
28Community Pharmacy Services/2754
29Primary Health Care/ or General Practice/ or Family practice/ or General Practice, Dental/ or Primary Care Nursing/117549
30((primary adj2 care) or ((General or family) adj2 practice)).ti,ab.118608
31(primary care or family medic$ or general practice or family practi$).jn. [Added May 24]7912
32Community medicine/ or community health nursing/ or community health services/ or community health centers/ or home care services/73722
33(community or ambulatory).ti,ab,hw.457831
34Ambulatory Care Facilities/ or Ambulatory Care/47127
35((walk-in or neighbo?rhood) adj2 (clinic? or care centre or care centres or care center? or health$ centre or health$ centres or health$ center?)).ti,ab.789
36Maternal-Child Health Centers/ or Outpatient Clinics, Hospital/ or Pain Clinics/ or Community Mental Health Centers/20224
37Nursing Homes/ or Intermediate Care Facilities/ or Skilled Nursing Facilities/31718
38((patient? adj2 (home or homes)) or home visit?).ti,ab.12218
39or/29-38 [Practice Settings/Types of Care]669515
40General Practitioners/ or Physicians, Family/ or Physicians, Primary Care/ [Practitioners]17896
41((general or family) adj2 (practitioner? or physician? or doctor?)).ti,ab.57970
42((primary care or family or general practice or community or home care) adj2 (nurse or nurses)).ti,ab.5583
43or/40-42 [Primary care/community Practitioners]72486
4427 and (or/39,43) [ADE & Primary Care]10686
4544 or 28 [Results]11546
46(randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or randomly.ab. or trial.ti.903028
47exp animals/ not humans.sh.3998631
4846 not 47 [Cochrane RCT Filter 6.4.d Sens/Precision Maximizing]834781
4945 and 481541
50(review adj2 (systematic or literature or qualitative)).ti. or (meta-analys?s or metaanalys?s).ti,pt.95572
5149 and 50 [Reviews]55
5251 and ((drug or medication? or adverse).ti,ab,hw. or dt.fs.)48
53remove duplicates from 52 [Systematic Reviews to EXPORT]38
5449 not 511486
55remove duplicates from 54 [ML2.0A Results to EXPORT]1272

What's new

DateEventDescription
14 January 2013New citation required and major changesNew authors list added and new contact author for this review is listed. Title changed from 'Interventions for reducing preventable drug-related hospital admissions or preventable drug-related morbidity in primary care'. The search strategy has been significantly revised from the original protocol.

Contributions of authors

Brian Bell wrote the initial protocol; Hanan Khalil updated and edited the protocol; Helen Chambers retrieved the studies and provided support with the searching; Tony Avery, Aziz Sheikh and Brian Seramuga commented on the protocol draft.

Declarations of interest

None declared.

Sources of support

Internal sources

  • Monash University, Faculty of Medicine, Nursing and Health Sciences, School of Rural Health, Clayton, Vic 3168, Australia.

External sources

  • No sources of support supplied

Ancillary