Interventions for improving medication‐taking ability and adherence in older adults prescribed multiple medications

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To evaluate the effectiveness of interventions designed to improve medication‐taking ability and/or adherence in older community‐dwelling people (or their carers). We will focus on interventions that target medication‐taking behaviour by consumers who are being treated with multiple long‐term, prescribed medications, and will include measures of both medication‐taking ability and adherence to the prescribed medication regimen.

Background

Description of the condition

Older people, conventionally defined as those aged 65 years and above, often have multiple chronic health problems that require ongoing healthcare interventions (Hilmer 2007; WHO 2000). An expanding evidence base supporting multidrug regimens in the management of many chronic diseases means that polypharmacy (use of multiple medications) is often unavoidable in older people. Polypharmacy has a range of definitions, but is commonly defined as the use of four or more medications (Department of Health (UK) 2001; Patterson 2014). About two‐thirds of people aged over 60 years who live in community settings use four or more medicines daily (Elliott 2014). There is also a substantial subgroup who are prescribed an average of 10 or more different medications, which is sometimes referred to as hyperpolypharmacy (Elliott 2014).

Medication‐taking ability refers to a person’s ability to accurately follow a prescribed medication regimen. It includes knowing what medications to take and when to take them, and being able to correctly administer the medication (Maddigan 2003). Managing multiple long‐term medications can be a complex and challenging task, especially for older adults who may experience a decline in the cognitive and physical abilities required for taking medication (Barbas 2001; Beckman 2005). More than a quarter of older adults experience difficulties in opening medication packages, including opening bottles and removing medication from blister packs (Philbert 2014). Older people with visual impairment are more than twice as likely to require help in managing their medication than those without visual impairment (McCann 2012). Many older adults receive assistance from informal or non‐professional carers with taking medication (ACSQHC 2012). Thus, interventions that aim to improve medication‐taking ability in older adults may need to target carers as well as consumers.

Medication adherence refers to the extent to which a person’s medication‐taking behaviour corresponds with agreed treatment recommendations from a healthcare provider (WHO 2003). Non‐adherence refers to deviations from that agreed treatment, and includes under‐utilisation, over‐utilisation and incorrect use of medication. There are two broad types of non‐adherence: unintentional non‐adherence – which may be due to factors such as forgetfulness, lack of understanding, physical problems or the complexity of the regimen; and intentional non‐adherence – which occurs when a person decides not to take their treatment as instructed (Wroe 2002). A person is generally considered adherent if they take between 80% and 120% of their prescribed medication over a given time period (WHO 2003). Non‐adherence to medications has been reported in up to 50% of older people in different countries and settings (George 2006; Gilbert 1993;Gray 2001; Hemminki 1975;Lau 1996; Lee 2010; Mansur 2008; McElnay 1997;Okuno 1999;Sewitch 2008; Spagnoli 1989;Stoehr 2008; Thorpe 2009; Vik 2006). The World Health Organization (WHO) has recognised the importance of enhancing adherence as a strategy to tackle chronic health conditions effectively (WHO 2003).

Consequences of poor medication‐taking ability and non‐adherence may include suboptimal response to treatment, recurrence of illness, adverse drug events, increased healthcare service utilisation, unplanned hospitalisations, increased morbidity and mortality, and increased healthcare costs (Balkrishnan 2003; Col 1990;DiMatteo 2002;Howard 2003; Leendertse 2008; Tafreshi 1999). Among older adults, adverse drug events are a significant and increasing problem (Burgess 2005;Elliott 2014). Almost a quarter of preventable adverse drug events in older people are attributable to consumer errors (Field 2007; Gurwitz 2003). Between USD 100 and USD 300 billion of avoidable healthcare costs have been attributed to non‐adherence in the US annually (IMS 2013).

Medication‐taking ability and adherence are influenced by a range of factors related to healthcare consumers, their therapies, medical conditions, and social‐, healthcare provider‐, and health system‐related factors (Balkrishnan 1998; Jin 2008; WHO 2003). Age itself is generally not an independent predictor of poor medication‐taking ability or non‐adherence (DiMatteo 2004; Vik 2004). Nevertheless, the prevalence of risk factors for medication use problems increases with age (Col 1990). These include polypharmacy (Gray 2001;Vik 2006), medication regimen complexity (Corsonello 2009; Jansa 2010; Vik 2006), cognitive and functional decline (Gray 2001; Hutchison 2006; Spiers 1995;Vik 2006), inadequate contact with health professionals (George 2006), depressive symptoms (Vik 2006), poor social support (DiMatteo 2000; Spiers 1995), and absence of assistance with administration of medications (Vik 2006). The risk factors for suboptimal use of medications by older people have been studied extensively in cross‐sectional studies (George 2006; Gilbert 1993; Gray 2001; Hemminki 1975; Jerant 2011; Lau 1996; McElnay 1997; Okuno 1999; Sears 2012; Spagnoli 1989; Tavares 2013; Vik 2006). Many adverse health outcomes may be preventable if appropriate measures are taken to address these risk factors and optimise medication‐taking ability and adherence (George 2008; Jokanovic 2016; Sorensen 2004).

Description of the intervention

A range of simple to complex behavioural and educational interventions, alone or in combination, have been tested for improving the medication‐taking ability and adherence of consumers (George 2008). Behavioural strategies include:

• alarm/beeper,

• calendar/diary,

• reminder chart/medication list,

• large print labels,

• packaging change,

• pillbox/calendar pack (also known as dose administration aid),

• contracting (verbal or written agreement),

• adherence monitoring with or without feedback,

• reminders (mail, telephone, email),

• inpatient programs of self‐administration of medications,

• simplification of medication regimens,

• skill building (supervised, group),

• tailoring (routinisation), and

• follow‐up (home visit, scheduled clinic visit, video/teleconferencing).

Educational strategies comprise group (in‐patient, family, and group) and/or individual (oral, audiovisual, visual, written, telephone, mail) education provided by physicians, pharmacists, nurses, and others. We plan to evaluate which types of interventions targeted for consumers improve medication‐taking ability and adherence in older adults prescribed multiple medications.

How the intervention might work

Behavioural and educational interventions, used alone or in combination, are intended to improve older peoples' (and/or their carers’) ability to manage medications and adhere to medication regimens.

These interventions may also lead to: improvements in knowledge about medications and confidence regarding medication management; greater satisfaction with treatment; better health‐related quality of life; reductions in the incidence of adverse drug events; and reductions in health service utilisation.

Why it is important to do this review

Evidence from well‐designed studies testing interventions to improve medication‐taking ability and adherence in older people prescribed multiple long‐term medications could provide valuable information for practitioners, researchers, and consumers to help optimise medication use among older people living in the community. Older people taking multiple medications represent a large and growing proportion of consumers seen by health professionals in clinical practice. They are also the group most likely to experience adverse drug events.

Interventions to improve medication adherence have been widely investigated (Bosch‐Capblanch 2007; Campbell 2012; Chong 2011; Conn 2009; Conn 2015; Haynes 2008; Kripalani 2007; Krueger 2003; Linn 2011; McDonald 2002; Nieuwlaat 2014; Peterson 2003; Roter 1998; Ruppar 2008; Russell 2006; Sapkota 2015; Schedlbauer 2010; Schlenk 2004; Van Eijken 2003; Van Wijk 2005; Viswanathan 2012; Williams 2008). Most studies, and therefore most reviews, have focussed on one health condition and/or the use of one medication or one medication class. However, older people form a heterogeneous population in terms of their medication consumption and disease patterns; therefore studies recruiting relatively homogenous samples of people experiencing one specific disease or consuming one type of medication have limited generalisability. We found only one systematic review focusing on older people taking multiple medications (George 2008). That review analysed adherence only, and is now almost 10 years old.

To date, no systematic review has included measures of medication taking other than adherence, such as medication errors or ability to manage medications. Standardised methods for measuring the ability of people to manage medications have been developed (Elliott 2009; Elliott 2015), some of which have recently been used in studies of medication use in older people (Lam 2011). Two of the most well‐studied medication assessment tools are the Drug Regimen Unassisted Grading Scale (DRUGS) (Edelberg 1999), which utilises a person’s own medications, and the Medication Management Ability Assessment (MMAA) (Patterson 2002), which uses a simulated medication regimen.

We will focus on interventions to improve medication‐taking ability or adherence, or both, in older adults who are prescribed multiple medications, or their non‐professional carers.

This review will complement previous Cochrane reviews looking at interventions for improving medication adherence in the general population (Nieuwlaat 2014), including the impact of dose reminder packaging (Mahtani 2011), and interventions for improving clinical outcomes in people with multi‐morbidities (Smith 2016). The appropriateness of people's medication regimens will not be considered as part of this review, but only their ability to take the medications and their adherence to the agreed regimen. There has been a previous Cochrane review of interventions, targeted at health professionals, designed to improve the appropriateness of prescribing and polypharmacy (Patterson 2014).

Objectives

To evaluate the effectiveness of interventions designed to improve medication‐taking ability and/or adherence in older community‐dwelling people (or their carers). We will focus on interventions that target medication‐taking behaviour by consumers who are being treated with multiple long‐term, prescribed medications, and will include measures of both medication‐taking ability and adherence to the prescribed medication regimen.

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials (RCTs), cluster RCTs and quasi‐RCTs as specified by the Cochrane Consumers and Communication Review Group (CCCRG 2014).

Types of participants

We will include studies in which:

• most participants (80% or more) were aged 65 years and over, or the mean age was over 65 years. If studies are identified that do not meet these criteria, but have relevant data regarding older people that can be extracted separately, these will also be included.

• participants were living in the community or were discharged from a hospital or other healthcare facility to the community (living in the community includes in a person’s own home or retirement village/independent living unit, with or without additional support; it does not include situations in which professional carers or nurses administer the person's medications, such as in nursing homes, residential care facilities or full nursing care in the home).

• participants used at least four long‐term regular prescription medications, or the group mean/median was more than four (irrespective of the participants’ number of medical conditions).

Studies that involve carers of consumers who meet these criteria will also be included. Carers are defined as “people who provide unpaid care and support to family members and friends who have disability, mental illness, chronic condition, terminal illness or general frailty” (ACSQHC 2012).

Types of interventions

We will include studies that tested single interventions or combinations of interventions directed at the consumer or their carer that sought to improve medication‐taking ability and/or adherence by the consumer.

Examples include the following behavioural and educational interventions:

• support for behaviour change;

• provision of medication aids (e.g. dose administration aids, medication lists);

• medication regimen simplification;

• remote monitoring of medication use with or without feedback;

• facilitation of communication and decision making about medications;

• provision of information or education; and

• acquisition of skills and competencies.

This list of interventions is not exhaustive, since the types of interventions that might be used to improve the medication‐taking ability and adherence of consumers is potentially unlimited. Acknowledging that this is the case, the search strategy (see Appendix 1) to be used will focus on terms that describe the outcomes of interest to avoid missing potentially‐relevant studies that tested novel interventions.

We will include the following comparisons:

• interventions to improve medication‐taking ability and/or adherence versus no intervention;

• interventions to improve medication‐taking ability and/or adherence versus standard or usual care; and

• one form of intervention to improve medication‐taking ability and/or adherence versus another ‐ including simple versus complex interventions.

Types of outcome measures

Primary outcomes

This review will focus on two outcomes directly related to the medication‐taking behaviour of older adults (or their carers): ability to manage medications and adherence to medication regimens. To be eligible for inclusion in this review, studies must have assessed at least one of these outcome measures for at least four medications (which could be either the person’s own medications or, for assessment of ability to manage medication, a validated, simulated medication regimen instrument) (Elliott 2009). These two outcomes will be evaluated separately.

Ability to manage medications

This outcome may include objective and subjective measures of participant or carer ability to manage medications.

1. Objective measures: direct observation using standardised assessment instruments/methods (e.g. Drug Regimen Unassisted Grading Scale (DRUGS) tool, Medication Management Ability Assessment (MMAA), inhaler technique checklists) (Elliott 2006; Elliott 2009; Patterson 2002).

2. Subjective measures: self‐reported ability or self‐efficacy (e.g. Self‐efficacy for Appropriate Medication Use Scale (SEAMS)) (Risser 2007).

Adherence to medication regimens

This outcome will be assessed in terms of consumer adherence to their prescribed medication regimens, using objective and/or subjective measures as listed below:

1. Objective measures: refill data, pharmaceutical claims data, electronic monitoring, biological assay, measure of used/unused medications (e.g. pill count).

2. Subjective measures: self‐report of missed/used doses, validated questionnaires (e.g. Morisky scale; Morisky 1986).

If an included study measures adherence and/or ability using more than one type of outcome measure, then the most reliable measure will be extracted (i.e. objective measures will be preferentially reported over subjective measures).

Secondary outcomes

The following secondary outcomes will be analysed from studies that also measured at least one of the primary outcomes listed above:

• consumer (or carer) knowledge about their medications;

• consumer (or carer) satisfaction with the intervention;

• health‐related quality of life;

• adverse clinical health outcomes (e.g. unplanned hospital presentations, general practitioner visits, adverse drug events);

• condition‐specific outcomes (e.g. cardiovascular events, blood pressure, blood glucose levels or lung function); and

• cost effectiveness of the intervention.

Timing of outcome assessment

For adherence outcomes the minimum duration of follow‐up must be four weeks. For ability outcomes a follow‐up period of at least 48 hours after the intervention is required.

If an included study measures adherence and/or ability more than once, then the outcome measure with the longest follow‐up will be extracted.

If sufficient trials exist, studies with different lengths of follow up will be compared. For adherence this will involve short‐term (4 weeks), medium‐term (3 months) and long‐term (6 months) follow up. For ability outcomes this will involve short‐term (48 hours), medium‐term (1 week) and long‐term (1 month) follow up.

Search methods for identification of studies

Electronic searches

We will search the following electronic databases using search strategies tailored to each database:

• Cochrane Central Register of Controlled Trials (CENTRAL,Cochrane Library, latest issue);

• MEDLINE (OvidSP) (1966 to present);

• Embase (OvidSP) (1973 to present);

• PsycINFO (OvidSP) (1967 to present);

• CINAHL Plus (1981 to present); and

• International Pharmaceutical Abstracts (IPA) (1971 to present).

The strategy for MEDLINE (OvidSP) is presented in Appendix 1. We will tailor strategies to other databases and report them in the review.

There will be no language restrictions (provided the title and abstract are in English).

Searching other resources

For grey literature, we will search:

• the Joanna Briggs Institute Evidence Based Practice (EBP) Database; and

• conference proceedings (e.g. Scopus).

We will check the reference lists of included studies and previously published relevant systematic reviews to locate potential studies that have not been identified via electronic searches.

We will contact experts in the field and authors of included studies for advice as to other relevant studies.

We will also search the following online trial registries for ongoing and recently‐completed studies:

• World Health Organization International Clinical Trials Registry Platform (ICTRP);

• ClinicalTrials.gov;

• ClinicalTrials.com;

• TrialsCentral;

• Australian New Zealand Clinical Trials Registry (ANZCTR);

• United Kingdom Clinical Research Network (UKCRN);

• Networked Digital Library of Theses and Dissertations (NDLTD); and

• ISRCTN registry.

Non‐English language studies will be translated and included if they meet the eligibility criteria.

Data collection and analysis

Selection of studies

Abstracts will be screened independently by two review authors and full text of any papers identified as potentially relevant by at least one author will be retrieved. Two authors will independently screen full‐text articles for inclusion or exclusion, with discrepancies resolved by discussion and by consulting a third author if necessary to reach consensus. Review authors will not be responsible for the screening of studies in which they were involved or associated. All potentially‐relevant papers excluded from the review at this stage will be listed as excluded studies, with reasons provided in the ‘Characteristics of excluded studies’ table. We will also provide citation details and any available information about ongoing studies, and collate and report details of duplicate publications, so that each study (rather than each report) is the unit of interest in the review. We will report the screening and selection process in an adapted PRISMA flow cart (Liberati 2009).

Data extraction and management

Two review authors will extract data independently from included studies. Any discrepancies will be resolved by discussion until consensus is reached, or through consultation with a third author where necessary. We will develop and pilot a data extraction form using the Cochrane Consumers and Communication Review Group Data Extraction Template (cccrg.cochrane.org/author‐resources). Data to be extracted will include the following study details: aim of the intervention, study design, study population, intervention details, risk factor(s) for poor medication adherence and/or medication‐taking ability targeted by the intervention(s), control/comparison group(s), outcome(s), and follow‐up period(s). All extracted data will be entered into Review Manager (RevMan 2014, v. 5.3) by one review author, and will be checked for accuracy against the data extraction sheets by a second review author working independently.

Assessment of risk of bias in included studies

We will assess and report on the methodological risk of bias of included studies in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and Cochrane Consumers and Communication guidelines (CCCRG 2014), which recommend the explicit reporting of the following individual elements for RCTs: random sequence generation; allocation sequence concealment; blinding (participants, personnel); blinding (outcome assessment); completeness of outcome data, selective outcome reporting; and other sources of bias. We will consider blinding separately for different outcomes where appropriate (for example, blinding may have the potential to differently affect subjective versus objective outcome measures). We will judge each item as being at high, low or unclear risk of bias as set out in the criteria provided by Higgins 2011, and provide a quote from the study report and a justification for our judgement for each item in the 'Risk of bias' table.

Studies will be deemed to be at the highest risk of bias if they are scored at high or unclear risk of bias for either the sequence generation or allocation concealment domains, based on growing empirical evidence that these factors are particularly important potential sources of bias (Higgins 2011).

We will assess and report quasi‐RCTs as being at high risk of bias on the random sequence generation item of the 'Risk of bias' tool. For cluster‐RCTs we will also assess and report risk of bias associated with an additional domain: selective recruitment of cluster participants.

In all cases, two authors will independently assess the risk of bias of included studies, with any disagreements resolved by discussion to reach consensus. We will contact study authors for additional information about the included studies, or for clarification of the study methods as required. We will incorporate the results of the 'Risk of bias' assessment into the review through standard tables, and systematic narrative description and commentary about each of the elements, leading to an overall assessment of the risk of bias of included studies and a judgement about the internal validity of the review’s results.

Measures of treatment effect

The primary outcomes will be considered as dichotomous variables where possible. That is, the person (or carer) would be assessed as able to manage medications or not, and similarly have satisfactory (80% to 120%) or not satisfactory adherence. If sufficient studies that use the same outcome measure for a primary outcome exist, or if a study does not report its outcome as dichotomous, then additional analyses using continuous variables may be performed.

For dichotomous outcomes, we will analyse data based on the number of events and the number of people assessed in the intervention and comparison groups. We will use these to calculate the risk ratio (RR) and 95% confidence interval (CI). For continuous measures, we will analyse data based on the mean, standard deviation (SD) and number of people assessed for both the intervention and comparison groups to calculate mean difference (MD) and 95% CI. If the MD is reported without individual group data, we will use this to report the study results. If more than one study measures the same outcome using different tools, we will calculate the standardised mean difference (SMD) and 95% CI using the inverse variance method in Review Manager 5.

Unit of analysis issues

If cluster‐RCTs are included we will check for unit of analysis errors. If errors are found, and sufficient information is available, we will re‐analyse data using the appropriate unit of analysis, by taking account of the intracluster correlation (ICC). We will obtain estimates of the ICC by contacting authors of included studies, or impute the ICC using estimates from external sources. If it is not possible to obtain sufficient information to re‐analyse data we will report effect estimates and annotate "unit of analysis error".

Dealing with missing data

We will attempt to contact study authors to obtain missing data (participant, outcome, or summary data). Where possible we will conduct analysis of participant data on an intention‐to‐treat basis; otherwise data will be analysed as reported. We will report on levels of loss to follow‐up and assess this as a potential source of bias.

For missing outcome or summary data we will impute missing data where possible and report any assumptions in the review. We will investigate, through sensitivity analyses, the effects of any imputed data on pooled effect estimates.

We will also conduct a sensitivity analysis that excludes studies presenting data with loss to follow‐up greater than 20%, including total reported lost to follow‐up and differential loss to follow‐up between groups. This is due to potential serious threats to validity associated with high loss to follow‐up (Sackett 2000).

Assessment of heterogeneity

We anticipate substantial variations in types of interventions, populations studied, study designs and settings. Where studies are considered similar enough to enable data pooling using meta‐analysis, we will assess the degree of heterogeneity by visual inspection of forest plots and examining the Chi² test for heterogeneity. Heterogeneity will be quantified using the I² statistic. An I² value of 50% or more will be considered to represent substantial levels of heterogeneity, but this value will be interpreted in light of the size and direction of effects and the strength of the evidence for heterogeneity, based on the P value from the Chi² test (Higgins 2011). Where heterogeneity is present in pooled effect estimates we will explore possible reasons for variability by conducting subgroup analysis.

Where we detect substantial clinical, methodological or statistical heterogeneity across included studies we will not report pooled results from meta‐analysis but will instead use a narrative approach to data synthesis.

Assessment of reporting biases

We will assess reporting bias qualitatively based on the characteristics of the included studies (e.g. if only small studies that indicate positive findings are identified for inclusion), and if information that we obtain from contacting experts and authors of studies suggests that there are relevant unpublished studies.

If we identify sufficient studies (at least 10) for inclusion in the review we will construct a funnel plot to investigate small study effects, which may indicate the presence of publication bias. We will formally test for funnel plot asymmetry, with the choice of test made based on advice in Higgins 2011, and bearing in mind that there may be several reasons for funnel plot asymmetry when interpreting the results.

Data synthesis

We will decide whether to meta‐analyse data based on whether the interventions in included trials are similar enough in terms of participants, settings, intervention, comparison and outcome measures to ensure meaningful conclusions from a statistically pooled result. Due to the anticipated variability in the interventions of included studies, we will use a random‐effects model for meta‐analysis.

If we are unable to pool data for meta‐analysis we will conduct a narrative synthesis of results. We will group data based on the category that best explores the heterogeneity of studies and makes most sense to the reader (such as by interventions, populations or outcomes). We will present data in tables and narratively summarise the results for each category.

Subgroup analysis and investigation of heterogeneity

Subgroup analyses are proposed if adequate studies exist for each variable. These include:

• duration of intervention (short versus long);

• duration of follow‐up (short, medium and long term) as described in ‘Timing of outcome assessment’;

• type of outcome measure (objective versus subjective);

• person managing the medication (consumer versus carer);

• number of medications (up to 10 versus 11 or more medications);

• frailty and/or functional ability (e.g. level of home‐assistance required); and

• health professional group delivering the intervention (e.g. pharmacist versus nurse versus medical professional versus automated).

Sensitivity analysis

Should meta‐analysis be possible for the outcomes of interest, two sensitivity analyses will be performed that exclude studies assessed to have losses to follow‐up of greater than 20% and high risk of bias (determined by conducting 'Risk of bias' assessment).

'Summary of findings' table

We will prepare a 'Summary of findings' table to present the results of the meta‐analysis, based on the methods described in chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions (Schünemann 2011). We will present the results of meta‐analysis for the major comparisons of the review and for each of the primary outcomes, as outlined in Types of outcome measures. We will provide a source and rationale for each assumed risk cited in the table(s) and will use the GRADE criteria to rank the quality of the evidence using the GRADEprofile (GRADEpro) software (Schünemann 2011). If meta‐analysis is not possible, we will present results in a narrative 'Summary of findings' table format, such as that used by Chan 2011.

Ensuring relevance to decisions in health care

The review will receive feedback from at least one consumer referee in addition to a health professional as part of Cochrane Consumers and Communication’s standard editorial process.

Appendices

Appendix 1. MEDLINE (Ovid SP) search strategy

1. exp aged/

2. ((old or older or aged or senior) adj2 (person? or people or adult? or patient* or consumer* or carer* or caregiver* or care giver*)).ti,ab,kw.

3. (late life or ag?ing or old age or seniors).ti,ab,kw.

4. (elder* or geriatric* or veteran*).mp.

5. or/1‐4

6. exp Pharmaceutical Preparations/

7. (medication* or medicine? or medicament* or pharmaceutical* or pharmacotherap* or drug?).ti,ab,kw.

8. exp drug therapy/

9. exp pharmaceutical services/

10. exp therapeutic uses/

11. or/6‐10

12. 5 and 11

13. primary health care/

14. (primary adj2 care).ti,ab,kw.

15. ambulatory care/

16. ambulatory.ti,ab,kw.

17. exp general practice/

18. general practitioners/

19. physicians primary care/

20. physicians family/

21. ((general or family) adj practi*).ti,ab,kw.

22. exp ambulatory care facilities/

23. home care services/

24. exp community health services/

25. patient discharge/

26. (hospital adj3 discharge).ti,ab,kw.

27. continuity of patient care/

28. (community or home or domicil* or outreach or post‐discharge or post‐acute or discharge plan*).ti,ab,kw.

29. or/13‐28

30. 12 and 29

31. patient education as topic/

32. ((educat* or instruct* or advis* or advice* or counsel* or teach* or train* or coach* or learn*) and (patient* or client* or consumer* or user* or carer* or caregiver* or care giver*)).mp.

33. exp counseling/

34. information services/

35. drug information services/

36. (inform* adj5 (patient* or client* or consumer* or user* or carer* or caregiver* or care giver*)).ti,ab,kw.

37. reminder systems/

38. drug packaging/

39. drug prescriptions/

40. medication therapy management/

41. ((patient* or client* or consumer* or user* or subject? or carer* or caregiver* or care giver*) and (manag* adj5 (medication* or medicines)).ti,ab,kw

42. pharmac* care.ti,ab,kw.

43. or/31‐42

44. medication adherence/ or patient compliance/

45. self efficacy/

46. ((patient* or client* or consumer* or user* or subject? or carer* or caregiver* or care giver*) and (competen* or confident or confidence or abilit* or capacit* or skill* or self‐efficacy or cope? or coping or complian* or noncomplian* or adher* or nonadher* or underadheren* or concordan* or nonconcordan* or persisten* or nonpersist*)).ti,ab,kw.

47. ((patient* or client* or consumer* or user* or subject? or carer* or caregiver* or care giver*) adj5 (error* or mistak* or misus* or mismanag*)).ti,ab,kw.

48. (patient* or client* or consumer* or user* or subject? or carer* or caregiver* or care giver*).ti,ab,kw. and medication errors/

49. self‐administration/

50. or/44‐49

51. 30 and (43 or 50)

52. randomized controlled trial.pt.

53. controlled clinical trial.pt.

54. random*.tw.

55. placebo.ab.

56. clinical trials as topic.sh.

57. randomly.ab.

58. trial.ti.

59. or/52‐58

60. 51 and 59

Contributions of authors

The review guarantor is JG.

• Writing of protocol and review: AC, RE, JG

• Screening of titles and abstracts: AC, RE, JG

• Assessment of studies for inclusion: AC, RE, JG

• Quality assessment: AC, RE, JG

• Data extraction: AC, RE, JG

• Data entry into RevMan: AC

• Data analysis: AC in consultation with RE and JG

• Disagreement resolution: AC, RE, JG

• Conduct the review update: AC, RE, JG

Declarations of interest

Amanda J Cross: Mrs Cross is a member of the Australian Association of Consultant Pharmacy and provides home medicine reviews as a private consultant pharmacist.

Rohan A Elliott: None known.

Johnson George: Dr George is a chief investigator on investigator‐initiated research grants supported by Pfizer Australia, Boehringer‐Ingelheim and Australian Lung Foundation. These organisations had no involvement in the design of those studies, analysis of data or publications resulting from those studies.

Review authors may also have been authors of studies suitable for inclusion in this review. To avoid bias, selection, data extraction and management of such studies will be performed by other independent members of the review team. We will also discuss the potential bias with the contact editor or the review and include this in the Discussion, if appropriate.

Notes

This protocol is based on standard text and guidance provided by Cochrane Consumers and Communication (CCCRG 2014).

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