System change interventions for smoking cessation

  • Protocol
  • Intervention

Authors


Abstract

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

To assess the effectiveness of system change interventions within healthcare settings, for increasing smoking cessation.

Background

Description of the condition

The consequences of tobacco use are increasingly recognised and understood, and the benefits of smoking cessation are well documented (Critchley 2004; Ebbert 2005; Peto 2000; Taylor 2002). Quitting smoking can reduce the risk of morbidity and mortality for smokers. Smoking cessation leads to significant health benefits immediately and also decreases most of the related risks within a few years of quitting (WHO 2011). Even patients who quit later in life gain benefits. For example, among smokers who quit at the age of 65 years, on average, men gain two years of life and women gain three (Taylor 2002). Quitting smoking is associated with a 36% reduction in risk of all-cause mortality among patients with coronary heart disease, which is significant when compared with other secondary preventive therapies such as cholesterol lowering (Critchley 2004). Given the high prevalence of smoking, even minor improvement in smoking cessation rates could potentially translate to major health and economic benefits.

Description of the intervention

“System change smoking cessation interventions describe specific strategies that health care administrators, managed care organisations, and purchasers of health plans can implement to treat tobacco dependence” (AHRQ 2012).They involve systematic identification of smokers and subsequent offering and receipt of evidence-based cessation treatments (Fiore 2007). Fiore et al suggested six system-level strategies to facilitate treatment of tobacco dependence: 1) implement a system for identifying smokers and documenting the tobacco use status in every clinic and hospital; 2) provide education, resources and feedback to promote provider intervention; 3) dedicating staff to provide smoking cessation treatment and assess its delivery in staff performance evaluations; 4) promote hospital policies that support and provide smoking cessation services; 5) include tobacco dependence treatments (both counselling and pharmacotherapy) identified as effective; and 6) reimburse providers for the delivery of effective tobacco dependence treatments and include these services among the defined duties of them (Fiore 2007).

How the intervention might work

Addressing tobacco use requires clinical, program, and system level changes.  According to clinical practice guidelines for treating tobacco use and dependence, all healthcare institutions should develop plans to support the consistent and effective identification, documentation and treatment of tobacco smokers (Fiore 2008). As a minimum requirement, all clinicians should ask the tobacco use status of their clients, briefly advise all smokers to quit, and refer them to Quitline or other smoking cessation services (Revell 2005).

Even though there are guidelines and evidence to provide smoking cessation services at every clinical encounter, some reports suggest that healthcare providers are not delivering recommended levels of support to their patients who smoke (Braun 2004). Prior studies have reported sub-optimal rates of smoking cessation services by different types of healthcare professionals in different healthcare settings (Aquilino 2003; Braun 2004; Thorndike 1998). The levels of smoking cessation support in hospitals are also low (Freund 2005; Freund 2008). It is evident that current healthcare systems, even of developed countries, are not well organised to address the issue of smoking.

The barriers to providing effective smoking cessation include a lack of support from the organisation, perceived objections from patients, a lack of systems for identifying smokers, a lack of staff time and skill, perceived inability to change practices, a perceived lack of efficacy of tobacco dependence treatments and the cost of providing care (Wolfenden 2009). A strategic system change approach may be effective in addressing these multidimensional factors associated with low smoking care provision. Outcomes for chronically ill patients will really improve only when health care systems reconfigure themselves to address the needs and concerns of patients (Wagner 1998). Tobacco smoking is a chronic relapsing condition that often requires ongoing medical and behavioural interventions, thus it is considered a chronic health condition (Hudson 2010). Therefore a system level change might be essential in dealing with the issue.

Why it is important to do this review

The system change interventions may vary significantly in their nature and it is not clear if this approach is effective; and in particular which types of approaches are more effective than the others. A summary of this evidence is critical as, to our knowledge, a systematic review assessing the effectiveness of such interventions has not yet been published. This review is intended to identify various system change interventions for smoking cessation and to evaluate the effectiveness of such approaches in different healthcare settings.

Objectives

To assess the effectiveness of system change interventions within healthcare settings, for increasing smoking cessation.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials, cluster randomised controlled trials with at least two intervention sites and two comparator sites, quasi-randomised trials and interrupted time series studies (ITS) with a clearly defined point in time when the intervention occurred and at least three data points before and after the intervention.

Types of participants

People who smoke and are receiving care in a healthcare delivery setting.

Types of interventions

System change interventions for smoking cessation are policies and practices designed by organisations to integrate the identification of smokers and the subsequent offering and receipt of evidence-based tobacco dependence treatments into the usual care (Fiore 2007). Thus interventions which have been developed for identifying people who smoke, documenting smoking status and providing tobacco dependence treatment at different healthcare settings (primary, secondary or tertiary care settings) will be included in the review.

Studies utilising the components of Fiore et al’s model will be considered (Fiore 2007).

  1. Implement a system for identifying smokers and documenting the tobacco use status in every clinic and hospital;

  2. Provide education, resources and feedback to promote provider intervention;

  3. Dedicating staff to provide smoking cessation treatment and assess its delivery in staff performance evaluations;

  4. Promote hospital policies that support and provide smoking cessation services;

  5. Include tobacco dependence treatments (both counselling and pharmacotherapy) identified as effective; and

  6. Reimburse providers for the delivery of effective tobacco dependence treatments and include these services among the defined duties of them.

Those studies focusing only on training health professionals or identification of smokers (electronic health records) or smoking cessation counselling without a system change approach will not be considered. It should be designed for integrating the provision of smoking cessation services within the routine delivery of health care. Each potential study will be reviewed by two authors, including a content expert before including in the review.

Types of outcome measures

Primary outcomes

Following the standard methodology of the Cochrane Tobacco Addiction Group, the primary outcome will be abstinence from smoking at the longest follow-up, assessed as point prevalence (defined as prevalence of abstinence during a time window immediately preceding the follow-up) and/or continued or prolonged abstinence (defined as abstinence between quit day or predetermined grace period and a follow-up time). The strictest available criteria to define abstinence will be used; thus continuous or prolonged abstinence will be preferred over point prevalence, and biochemically validated abstinence over self reported abstinence. We will distinguish between short term abstinence, assessed less than six months from the initiation of intervention with a patient, and long term abstinence, assessed after six months or longer.

Studies that do not assess smoking cessation will be eligible for inclusion if they report any secondary outcome and meet other inclusion criteria. The classification of primary and secondary outcomes in each included study will be examined and reported.

Secondary outcomes

Increase in the provision of smoking cessation support services as a part of routine care measured as either organisational or patient or health professional level strategies.

Organisational level outcome measures may include number of smokers identified and smoking status documented, and number of health professionals trained or dedicated to provide cessation support.

Patient level outcome measures may include number of smokers who were counselled, given self help materials, offered nicotine replacement therapy (NRT) or other pharmacotherapy, nominated a quit date and given follow-up appointment.

Health professional level outcome measures may include number of referrals made to other health professionals and/or to local smoking cessation services.

We will present the main outcomes of the review in a Summary of Findings table.

Search methods for identification of studies

Electronic searches

We will search the following databases:

  • Cochrane Central Register of Controlled Trials (CENTRAL);

  • MEDLINE (1946 to present);

  • EMBASE (1947 to present);

  • PsycINFO (1806 to present); and

  • CINAHL (1938 to present).

The search strategies will be developed to comprise searches both for key words and Medical Subject Headings/Emtree. We will aim to identify articles reporting randmised control trials (RCTs), cluster RCTs, Quasi RCTs and ITS studies that comprise intervention and a measure of the effect on system change approach. No language restriction will be employed. The strategy for MEDLINE is presented in Appendix 1.

Searching other resources

Studies will also be identified by screening references given in relevant reviews and identified studies (citation tracking). Personal bibliographies and communication with experts in the field will also be considered to identify any hidden studies.

Data collection and analysis

Selection of studies

DT will implement the search strategy and the search results will be merged using reference management software (EndNote®). The titles and abstracts of the studies will be reviewed for possible inclusion, and those selected will be subjected for full text assessment. Multiple reports of the same study will be linked together. Two authors (DT and JG) will independently assess all the full text articles retrieved, and those studies meeting the inclusion criteria will be included in the review. Any discrepancies will be resolved by discussing with the third author who will act as an arbiter. A content area expert (BB) will act as an arbiter for disagreement about the intervention or content of the study. Methodological discrepancies will be checked by another arbiter (MA) who is an expert in clinical trials and meta-analysis. Characteristics of the studies excluded, (after full text assessment) including the reason for exclusion, will be listed and reported.

Data extraction and management

Two authors (DT and JG) will extract data independently and categorise trials for subgroup analysis. A pre-tested (pilot tested), standardised data collection form will be employed. Data from the data collection forms will be entered into RevMan 5.2 for analysis. Authors of the studies where data are not available or unclear will be contacted by e-mail. The following information will be extracted from each of the selected studies:

  • lead and corresponding authors’ information;

  • date of publication;

  • location and setting;

  • methods of recruitment and inclusion criteria;

  • methods of randomisation, allocation, concealment and blinding;

  • study design, duration and follow-up details;

  • characteristics of participants (e.g. age, sex and smoking status);

  • specific details of the intervention (type, duration, content, format and delivery of intervention, use of pharmacotherapy, adherence to therapy and information about the providers);

  • control group component;

  • number of participants in each arm;

  • outcome measures and definitions including any biochemical validation, and time point at which they are measured and reported;

  • results: estimate of effect with confidence intervals and subgroup analysis (summary data of intervention and control group will be entered separately into RevMan, where effect estimates can be calculated) and missing data;

  • funding, and declaration of interest for the primary investigators;

  • conclusion of the authors; and

  • additional comments and information.

If studies are reported in more than one publication (e.g. different time points of the study) the data from all publications will be extracted in separate data collection forms and combined. If there is one full journal article and multiple conference abstracts are available, only the journal article will be considered. Any disagreement in the data collection process will be resolved by discussing with a third author (MA).

Assessment of risk of bias in included studies

Two review authors (DT and JG) will independently assess the risk of bias of included studies, with any disagreements resolved by discussion and consensus, and by consulting a third review author, where necessary.

 The following criteria for assessing risk of bias will be implemented:

  •  Studies with a separate control group (RCTs, cluster RCTs and quasi RCTs) will be assessed using the nine standard criteria developed by the Cochrane EPOC Group (EPOC 2013) that include:

    • sequence generation;

    • allocation concealment;

    • blinding;

    • baseline characteristics;

    • baseline outcome measurement;

    • incomplete outcome data;

    • selective outcome reporting;

    • protection against contamination; and

    • other bias.

  •  ITS studies will be assessed using the seven standard criteria for ITS studies developed by the Cochrane EPOC Group (EPOC 2013) that include:

    • intervention independent of other changes;

    • pre-specified effect shape;

    • intervention unlikely to affect data collection;

    • blinding;

    • incomplete outcome data;

    • selective outcome reporting; and

    • other bias.

Each criterion will be judged on a 3-point scale for bias ‘low risk’, ‘high risk’ and ‘unclear risk’ (Higgins 2011) and a risk of bias table will be constructed.

  1. ‘Low risk’ when there is a low risk of bias across all key domains.

  2. ‘Unclear risk’ when there is an unclear risk of bias in one or more of the key domains.

  3. ‘High risk’ when there is a high risk of bias in one or more of the key domains.

For each included study, a summary assessment of risk of bias will be provided.

Measures of treatment effect

Wherever possible, a risk ratio (quitters in treatment group/total randomised to the treatment group)/(quitters in control group/total randomised to the control group) will be provided for the outcome of each trial.

Unit of analysis issues

In the case of trials with repeated observations, the longest follow-up will be considered for the analysis (Higgins 2011).

In the case of cluster RCTs, an adjusted estimate of the required effect measure will be extracted from an analysis that properly accounts for the cluster design. Where such data are unavailable, an approximate analysis will be performed if the required information can be obtained (Higgins 2011). If a comparison is re-analysed, the P value will be annotated with a comment ‘re-analysed’.

In the case of trials with multiple arms, only arms that meet the eligibility criteria will be included in the review. If there are more than one eligible intervention arms, all the relevant experimental groups will be combined to create a single pair-wise comparison to avoid the problem of including same group of participants twice in the same meta-analysis. If multiple intervention arms are eligible and not comparable, each pair-wise comparison will be included separately, but with shared intervention arms divided out approximately evenly among the comparisons (Higgins 2011). 

Dealing with missing data

The number of participants lost to follow-up will be reported by group, where available. If required, we will contact the study authors for more information. For quit rates, an intention to treat analysis will be followed. This assumes that people lost to follow-up continued smoking and will be included in the denominator for calculating relative risk.

Assessment of heterogeneity

Heterogeneity will be explored visually using tables and forest plots comparing effect sizes of studies grouped according to potential effect modifiers. This will include:

  1. type of intervention (e.g. identification of smokers, documentation of smoking status, treatment, training of health professionals, feedback of services etc.);

  2. intensity of intervention (e.g. counselling, pharmacotherapy, both counselling and pharmacotherapy, number of follow-ups etc.);

  3. type of health professional involved;

  4. settings (primary, secondary and tertiary);

  5. study design (RCTs, cluster RCTs, quasi-RCTs and ITS studies); and

  6. quality of studies.

If sufficient number of homogenous studies are available, statistical heterogeneity between study results will be assessed using Chi2 test for homogeneity (with significance defined at the alpha-level of 10%) and any statistical heterogeneity will be quantified using I² statistic. Pooling of data using a meta-analysis will be considered if the heterogeneity is less than 50% (Higgins 2011).

Assessment of reporting biases

The publication bias will be assessed using funnel plots if there are sufficient number of studies.

Data synthesis

A narrative synthesis of the included studies will be presented. The major characteristics and results will be reported. We will group the studies under different definitions of system change. If studies or groups of studies are sufficiently similar in terms of participants, intervention, outcome and/or methodology, we will consider pooling the data statistically. If meta-analysis is appropriate, a random effects model will be used as we suspect clinical and/or methodological heterogeneity between studies sufficient to suggest that intervention effects may differ between trials. If there is a substantial heterogeneity and formal meta-analysis techniques are not possible, the median (IQR - interquartile range) effect size will be calculated to quantify the expected magnitude of improvement.

Subgroup analysis and investigation of heterogeneity

We will categorise trials according to different system change interventions and type of studies identified. We may consider the following categories based on the nature of identified studies:

  1. studies in different health care settings (primary, secondary and tertiary);

  2. studies which followed ‘Russell Standards’ – a common standard for reporting outcome criteria in smoking cessation studies. ‘Russell Standards’ include six criteria  describing abstinence, duration of abstinence, biochemical verification, intention to treat analysis, protocol violations and blinding in smoking cessation studies (West 2005);

  3. randomised controlled studies and non-randomised studies;

  4. studies using self report alone and biochemically verified abstinence; and

  5. studies with minimal (less than three components) and intensive system change intervention (three or more components).

If there is an appropriate number of studies, we will consider the pooling of data and conducting analyses to determine any differential effect between different types of interventions.

Sensitivity analysis

If there are sufficient data to conduct a meta-analysis, we will consider whether the results are sensitive to the exclusion of trials judged to have a high risk of bias. We will also consider doing sensitivity analysis if there are issues identified during the review. For example, heterogeneity due to the presence of one or two outlying studies. In such cases we will consider doing analyses both including and excluding these studies. If conducted, the results of the sensitivity analyses will be reported in summary tables.

Appendices

Appendix 1. MEDLINE search strategy

  Searches Results
1smoking cessation.mp. or exp Smoking Cessation/25369
2"Tobacco-Use-Cessation"/734
3"Tobacco-Use-Disorder"/8264
4Tobacco-Smokeless/2820
5exp Tobacco-Smoke-Pollution/10511
6exp Tobacco-/24134
7exp Nicotine-/21574
8((quit$ or stop$ or ceas$ or giv$) adj5 smoking).ti,ab.10464
9exp Smoking/pc, th [Prevention & Control, Therapy]16407
101 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 989620
11(education adj5 (smok* or tobacco)).mp.5014
12(dedicat* adj2 staff*).mp.250
13(hospital adj2 policy).mp.706
14fee-for-service plans/ or reimbursement, incentive/5507
15organizational policy/12526
16"delivery of health care, integrated"/ or health care reform/ or health services accessibility/ or patient care team/ or patient-centred care/140824
17health system chang*.mp.313
18(system* adj2 chang*).mp.11151
19(system* adj2 intervention*).mp.2306
20(integrat* adj6 (smok* or tobacco)).ti,ab.493
21(Organi?ation* adj2 intervention*).mp.434
22Organi?ation* structure*.mp.2584
23(organi?ation* adj2 chang*).mp.2903
24(system* adj2 approach*).mp.14755
25((system* adj2 reform) or (Organi?ation* adj2 reform*)).mp.1017
26((system* adj modif*) or (Organi?ation* adj2 modif*)).mp.1177
27decision making, organizational/ or organizational innovation/ or patient identification systems/31556
28inservice training/16829
29((Identif* adj3 (smok* or tobacco*)) or (Document* adj3 (smok* or tobacco*))).mp.2906
3011 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29238853
31(animals not humans).sh.3909032
3210 and 304519
33 32 not 31 4453
34RANDOMIZED-CONTROLLED-TRIAL.pt.379026
35CONTROLLED-CLINICAL-TRIAL.pt.88620
36CLINICAL-TRIAL.pt.498196
37Meta analysis.pt.45250
38exp Clinical Trial/775048
39Random-Allocation/80474
40randomized-controlled trials/94219
41single-blind-method/18947
42double-blind-method/128607
43placebos/33227
44Research-Design/79501
45((clin$ adj5 trial$) or placebo$ or random$).ti,ab.857854
46((singl$ or doubl$ or trebl$ or tripl$) adj5 (blind$ or mask$)).ti,ab.127194
47(volunteer$ or prospectiv$).ti,ab.544492
48exp Follow-Up-Studies/489384
49exp Retrospective-Studies/477181
50exp Prospective-Studies/363771
51exp Evaluation-Studies/ or Program-Evaluation.mp.240380
52exp Cross-Sectional-Studies/173497
53exp Behavior-therapy/51856
54exp Health-Promotion/53929
55exp Community-Health-Services/490586
56exp Health-Education/135292
57exp Health-Behavior/97652
5834 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52 or 53 or 54 or 55 or 56 or 573347297
59 33 and 58 2781

Contributions of authors

DT wrote the first and subsequent drafts of the protocol. All authors contributed to conceptualising and designing the protocol, and provided comments on drafts of the protocol.

Declarations of interest

Dr George, Prof Abramson and A/Prof Bonevski have received an investigator-initiated grant from Pfizer for the “Give Up For Good” study which aims to evaluate the effectiveness of a pharmacist-driven multidisciplinary system-change smoking cessation program at three Australian hospitals. Pfizer has no involvement in the proposed review, nor have they influenced our decision to undertake this systematic review. Prof Abramson was a member of the Scientific Committee for a workshop on an unrelated topic that was sponsored by GlaxoSmithKline, but did not receive any honorarium.

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