Service organisation for the secondary prevention of ischaemic heart disease
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To determine the effectiveness of service organisation interventions which are intended to improve secondary prevention of ischaemic heart disease and which are delivered in primary care and community settings.
Ultimately the comparisons undertaken in the review will be determined by the studies identified by the review, but may include:
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Any organisational intervention aimed at improving adherence to secondary prevention recommendations versus normal care;
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Clinician‐centred organisational strategies aimed at improving clinician adherence to secondary prevention recommendations relating to medication and monitoring versus normal care (i.e. register‐based regular patient recall for risk factor monitoring and prophylaxis management);
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Specific clinician‐centred organisational strategies for improving clinician adherence to secondary prevention recommendations versus other strategies (i.e. register‐based regular patient recall for routine physician consultation versus regular recall to in‐practice secondary prevention clinics versus regular practice secondary prevention audit);
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One‐off patient‐centred behavioural interventions aimed at improving patient adherence to secondary prevention recommendations (i.e. patient education, motivation) versus normal care;
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Sustained (repeated contact) patient‐centred behavioural interventions aimed at improving patient adherence to secondary prevention recommendations versus normal care;
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Clinician‐centred organisational strategies versus patient‐centred interventions;
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Nurse‐delivery versus doctor‐delivery of comparable interventions;
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In‐practice delivery versus community setting delivery of comparable interventions;
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Delivery of comparable interventions to individual patients versus groups of patients.
Background
Ischaemic heart disease ‐ burden of disease
Ischaemic heart disease (IHD) is a major cause of mortality and morbidity and is a growing problem. Worldwide it is estimated that some 50 million people have existing IHD (Neal 2004) with a one in four (25%) risk of suffering a further serious event in the next 10 years (Law 2002; WHO 2002). Although in recent decades IHD mortality rates have fallen in many developed countries, rates of morbidity are increasing as a result of improved diagnosis and more successful treatment of acute illness which, for example, has led to an increasing number of survivors of myocardial infarction (HDA 2000; Law 2002; Neal 2004; NSF 2000; SIGN 2000). Another major factor affecting increased prevalence of IHD morbidity is the growing elderly population in many countries. Age plays a major role in IHD: the prevalence of angina in particular rises sharply with age (Task Force 1997); the incidence of myocardial infarction also increases with age and varies between geographical regions (HDA 2000).
Secondary prevention of IHD
The primary prevention of IHD is desirable and is considered to be most appropriately targeted in the first instance at those considered to be at a high risk of developing IHD because of combinations of risk factors ‐ including smoking, raised blood pressure and serum cholesterol levels, family history of IHD, obesity and diabetes (De Backer 2003; Wood 1998a). However, multi‐factorial interventions aimed at primary prevention appear to offer only modest benefit in terms of risk factor reduction, so that their clinical‐ and cost‐effectiveness is still a matter for debate (Ebrahim 2006).
Secondary prevention (the prevention of further acute IHD events amongst those with established IHD) is more easily targeted and widely advocated and is considered a priority in countries with high prevalence of IHD (DoHC Ireland 1999; HDA 2000; NSF 2000; Moher 1997; SIGN 2000; Wood 1998a; Wood 1998b). Secondary prevention of IHD potentially comprises both patient‐ and clinician‐centred activities aimed at reducing risk of further IHD events through effective management of modifiable clinical risk factors:
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patient education and motivation in relation to healthy lifestyle choices ‐ smoking cessation, healthy diet and regular exercise;
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effective monitoring of patients' risk and prophylactic use of appropriate medications ‐ antiplatelets, beta blockers, angiotensin converting enzyme (ACE) inhibitors, statins, angiotensin II receptor blockers, calcium channel blockers (De Backer 2003).
Secondary preventive care using exercise‐based programmes amongst people with IHD reduces mortality (Jolliffe 2001). Broader interventions focusing on wider lifestyle modification, risk factor monitoring and management and prophylactic medication have shown some improvements in health status and in terms of levels of risk factor monitoring and prescribing. However, questions regarding the optimal design, frequency and duration of interventions remain unanswered (McAlister 2001).
Whilst the effectiveness of secondary preventive measures is in little doubt, their use has been found to be suboptimal (Bowker 1996; Brady 2001; Campbell 1998a; Campbell 1998b; Campbell 1998c; Carroll 2003; Cupples 1994; Cupples 1999; Flanagan 1999; Jolly 1999; Moher 1995; Moher 2001; Ramsay 2006; Williams 2003). Uncertainty regarding best practice in the delivery of these measures can only serve to perpetuate this situation. Systematic reviews of existing evidence have the potential to offer improved clarity regarding the relative effectiveness of strategies devised to improve the delivery of secondary prevention in primary care/community settings.
Service organisational interventions
For the purposes of the review, a service organisational intervention for the secondary prevention of IHD is defined as: an intervention which comprises a systematic change, or changes, in the organisation of existing care provision aimed at improved levels of appropriate and available secondary preventive medication and risk factor monitoring and/or improved patient adherence to medication and to secondary prevention recommendations relating to modifiable lifestyle factors.
Primary care/community settings
Primary care is described by Starfield as "that level of a health service system that provides… person focused care over time… Primary care addresses the most common problems in the community by providing preventive, curative and rehabilitative services to maximize health and well being. It integrates care when there is more than one health problem and deals with the context in which illness exists and influences the responses of people to their health problems. It is care … directed at promoting, maintaining, and improving health" (Starfield 1998). By such definition primary care is ideally suited to the long‐term healthcare interventions which are needed to deliver secondary prevention of IHD at community level.
In countries in which the term is in use, primary care is widely understood as referring to those multidisciplinary health services which provide the first point of access to healthcare services, are designed to maintain a long term relationship with the patients, families and communities and are based primarily in units of varying size and function within the community rather than in hospitals. Primary care is not, however, a term which is in use universally and so in this review the term "community settings" is also used to highlight the fact that studies conducted in countries in which primary care is not a commonly used term need not be excluded.
A systematic review will best be able to inform practice in primary care if it considers evidence generated within ‐ or at least principally within ‐ primary care which relates to populations that are broadly representative of the primary care IHD population. There has been some debate about whether study populations identified in secondary and tertiary care settings are representative of the community population of people with IHD as defined in this review. It has been argued, for example, that populations identified in secondary and tertiary care settings for angina studies have been disproportionately white and male, mostly with previous acute myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty at a time when angina is increasingly diagnosed in primary care in the absence of such co‐morbidity (Timmis 2007); and that participants in a high‐profile randomised controlled trials, which heavily influenced the British Hypertension Society's guidelines for the management of blood pressure in post‐stroke patients, were more likely to be male, younger and hypertensive than the general practice population of patients with previous stroke (Mant 2006).
Objectives
To determine the effectiveness of service organisation interventions which are intended to improve secondary prevention of ischaemic heart disease and which are delivered in primary care and community settings.
Ultimately the comparisons undertaken in the review will be determined by the studies identified by the review, but may include:
-
Any organisational intervention aimed at improving adherence to secondary prevention recommendations versus normal care;
-
Clinician‐centred organisational strategies aimed at improving clinician adherence to secondary prevention recommendations relating to medication and monitoring versus normal care (i.e. register‐based regular patient recall for risk factor monitoring and prophylaxis management);
-
Specific clinician‐centred organisational strategies for improving clinician adherence to secondary prevention recommendations versus other strategies (i.e. register‐based regular patient recall for routine physician consultation versus regular recall to in‐practice secondary prevention clinics versus regular practice secondary prevention audit);
-
One‐off patient‐centred behavioural interventions aimed at improving patient adherence to secondary prevention recommendations (i.e. patient education, motivation) versus normal care;
-
Sustained (repeated contact) patient‐centred behavioural interventions aimed at improving patient adherence to secondary prevention recommendations versus normal care;
-
Clinician‐centred organisational strategies versus patient‐centred interventions;
-
Nurse‐delivery versus doctor‐delivery of comparable interventions;
-
In‐practice delivery versus community setting delivery of comparable interventions;
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Delivery of comparable interventions to individual patients versus groups of patients.
Methods
Criteria for considering studies for this review
Types of studies
Randomised trials (randomised by individual or by group ‐ for example, practice or family) conducted with appropriate ethical approval, blinded and un‐blinded (given the nature of the interventions under consideration, effective blinding may not be possible) with at least one comparator (which may be a normal care control arm or a distinct intervention) and a follow up of at least 12 months.
Types of participants
For the purpose of this review, people will be considered to have IHD if they have had a previous acute myocardial infarction, previous revascularisation (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty or coronary artery stent) in response to myocardial ischaemia, or who have angina. A pragmatic approach will be taken to diagnostic standards which reflect the clinical reality in community settings: diagnosis by general practitioner or family physician and/or by objective tests and/or by specialist physician opinion and/or by another health care professional for the purposes of inclusion in a trial included in the review. (Also see subgroup and sensitivity analysis).
Types of interventions
Service organisation interventions
This review will consider service organisation interventions which comprise systematic changes in existing care provision aimed at improved adherence with recommendations on secondary prevention of IHD.
The precise nature of the interventions considered by this review will be determined by the studies identified, but may include one or more of several strategies:
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Interventions aimed at altering the way in which patient education, motivation and lifestyle advice is delivered (i.e. in practice or in community settings; through regular recall to practice or specialised clinics; remotely by post, telephone or web‐based contact);
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Interventions aimed at altering practitioner behaviours and improved monitoring and management of clinical risk factors and prophylaxis (i.e. establishment of disease registers, regular patient recall, training in delivery of patient‐centred care, regular practice audit);
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Establishment of dedicated clinics (nurse or doctor led) for monitoring and management of risk factors and prophylaxis and/or for patient education, motivation and lifestyle advice.
The review will include concise and clear descriptions of the interventions featured in the included studies in order that the review will be of use to those wishing to use its findings to inform the design of future service organisational interventions.
Primary care/community settings
For the purposes of this review, programmes will be considered to have been delivered in primary care (or community settings) if they have been delivered in contexts which fulfill the definition of primary care established by the Committee on the Future of Primary Care at the Institute of Medicine in the United States:
"Primary care is the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, developing a sustained partnership with patients, and practicing in the context of family and community" (Donaldson 1996).
Primary care clinicians are defined as "an individual who uses a recognized scientific knowledge base and has the authority to direct the provision of personal health services to patients" and are "generally considered to be physicians, nurse practitioners and physician assistants" and "a broader array of individuals in a primary care team" (Donaldson 1996). In the context of cardiovascular care, the primary care team may include community‐based physicians such as general practitioners and family physicians, community pharmacists, practice nurses, community and public health nurses and other professions allied to medicine such as dieticians, occupational therapists and physiotherapists.
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Studies will be included in the review if the interventions have been delivered in primary care or community settings by primary care clinicians.
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Studies will be included in the review if the interventions have been delivered principally in primary care or community settings by clinicians whose normal roles are in other areas within health systems ‐ including secondary care (e.g. community hospitals) and tertiary care (e.g. general hospitals, medical centres and teaching hospitals) ‐ but who have worked in a primary care context for the purposes of the programme's delivery.
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Studies from countries where the primary care model is not standard will be included if the studied care is delivered by clinicians whose practice is accessible, involves ongoing and long‐term relationships with patients and provides for a wide range of health care needs.
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Studies will not be included in the review if the interventions have been delivered primarily through secondary or tertiary care contexts by clinicians or teams of clinicians whose relationship with patients is not long term or ongoing and who do not provide for a wide range of healthcare needs.
Comparators
In many studies the comparators will be "normal care". Yet in different health services and regions baseline levels of secondary preventive care may differ significantly. Comparison of the effectiveness of interventions in countries with different levels of development may be methodologically uncertain: the effectiveness of interventions may be affected by both the baseline levels of secondary preventive care provision and by differing levels of underlying deficiencies in health, access to health services, education, standards of living and opportunity for healthy lifestyle.
Baseline levels of provision and the precise nature of changes effected by interventions will be described in the review in order to inform interpretation and implementation of the results and sensitivity analysis will be used as appropriate to consider the effect on outcomes of differing baseline service provision.
Types of outcome measures
Primary outcomes
1. Improved patient adherence to medication and to secondary prevention recommendations relating to modifiable lifestyle factors.
2. Improved levels of appropriate and available prophylactic medication and risk factor monitoring.
Search methods for identification of studies
Electronic searches
Relevant trials will be identified from the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE, and CINAHL. No language or other limitations will be imposed. Consideration will be given to variations in terms used and spellings of terms in different countries so that studies are not missed by the search strategy because of such variations.
Search strategies will be designed in accordance with Cochrane Heart Group methods and guidance. The reporting of search results will be conducted in accordance with the QUOROM statement (Moher 1999). A flow diagram will be included which will provide information about the number of studies identified, included and excluded, and the reasons for exclusion.
Detailed search strategies will be developed for each electronic database searched, based on the strategy designed for CENTRAL (below) but revised appropriately.
#1 MeSH descriptor myocardial ischemia explode all trees
#2 MeSH descriptor Heart diseases this term only
#3 MeSH descriptor myocardial revascularization explode all trees
#4 angina
#5 (heart near/3 disease* )
#6 (coronary near/3 disease* )
#7 myocardial next infarct*
#8 (coronary near/3 bypass* )
#9 cabg
#10 (coronary near/3 angioplast* )
#11 ptca
#12 (heart near/3 infarct* )
#13 postmyocardial
#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 Delivery of Health Care this term only
#16 MeSH descriptor patient care management this term only
#17 MeSH descriptor comprehensive health care this term only
#18 MeSH descriptor nursing process this term only
#19 MeSH descriptor nursing assessment explode all trees
#20 MeSH descriptor patient care planning explode all trees
#21 MeSH descriptor patient‐centered care this term only
#22 MeSH descriptor Delivery of health care this term only
#23 MeSH descriptor Delivery of Health Care, Integrated this term only
#24 MeSH descriptor managed care programs explode all trees
#25 MeSH descriptor disease management this term only
#26 MeSH descriptor patient care team explode all trees
#27 MeSH descriptor Physician's Practice Patterns explode all trees
#28 MeSH descriptor primary health care explode all trees
#29 MeSH descriptor Physicians, Family this term only
#30 MeSH descriptor family practice this term only
#31 MeSH descriptor reminder systems this term only
#32 MeSH descriptor communication explode all trees
#33 MeSH descriptor guideline adherence this term only
#34 MeSH descriptor home care services this term only
#35 MeSH descriptor home nursing this term only
#36 MeSH descriptor ambulatory care this term only
#37 MeSH descriptor patient discharge this term only
#38 aftercare
#39 (manag* near/3 care )
#40 (service* near/3 reorgani* )
#41 (organis* near/2 service* )
#42 (organiz* near/3 service* )
#43 (manag* near/3 program* )
#44 (case* near/3 manag* )
#45 (patient* near/3 manag* )
#46 (home near/3 intervention* )
#47 (home near/3 care )
#48 (home near/3 visit* )
#49 MeSH descriptor Nurse's Role this term only
#50 MeSH descriptor Nurse Practitioners this term only
#51 MeSH descriptor Ambulatory Care this term only
#52 (discharg* near/3 plan* )
#53 (comprehensiv* near/3 care )
#54 (treatment* near/3 plan* )
#55 (nurse* near/3 led )
#56 (disease near/3 manag* )
#57 multidisciplin*
#58 multi‐disciplin*
#59 (#15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24)
#60 (#25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34)
#61 (#35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 or #44)
#62 (#45 or #46 or #47 or #48 or #49 or #50 or #51 or #52 or #53 or #54)
#63 (#55 or #56 or #57 or #58)
#64 (#59 or #60 or #61 or #62 or #63)
#65 (#14 and #64)
#66 MeSH descriptor Community Health Services this term only
#67 MeSH descriptor medical audit this term only
#68 MeSH descriptor nursing audit this term only
#69 audit
#70 secondary next prevention next clinic*
#71 general next practi*
#72 primary next care
#73 reminder*
#74 family next practi*
#75 recall*
#76 (nurse near/3 clinic* )
#77 (secondary next prevention near/3 intervention* )
#78 (secondary next prevention near/3 program* )
#79 MeSH descriptor Appointments and Schedules this term only
#80 appointment*
#81 (#66 or #67 or #68 or #69 or #70 or #71 or #72 or #73 or #74 or #75)
#82 (#76 or #77 or #78 or #79 or #80)
#83 (#81 or #82)
#84 (#83 and #14)
#85 (#65 or #84)
Searching other resources
Reference lists of all eligible trials and previous systematic reviews as appropriate will be searched for additional studies.
Data collection and analysis
Selection of studies
The titles of studies identified by the search strategy will be screened and clearly irrelevant studies discarded. The abstracts of retained studies will be accessed and screened for relevance and eligibility. The full text reports of all potentially relevant randomised and quasi‐randomised trials will be obtained and assessed independently for eligibility, based on the defined inclusion criteria, by two reviewers. Any disagreement will be resolved by discussion or where agreement cannot be reached, by consultation with an independent third person.
Data extraction and management
Standardised data extraction forms will be used. Relevant data regarding inclusion criteria (study design, participants, interventions, and outcomes), quality criteria (randomisation, blinding, and control) and results will be extracted independently by two reviewers. In cases where insufficient data are reported (e.g. method of randomisation, statistical methods) authors will be contacted where possible for further information. Excluded studies and reasons for exclusion will be detailed in a 'Characteristics of Excluded Studies' table.
Assessment of risk of bias in included studies
The quality of eligible trials will be assessed independently by the two reviewers. Factors which will be considered will include quality of random allocation and concealment (where appropriate), description of drop‐outs and withdrawals, analysis by intention to treat, blinding during intervention and at outcome assessment (where appropriate), description of and protection against possible contamination (where appropriate). Disagreements between reviewers will be resolved by discussion with the other co‐reviewers and unresolved issues will be referred to the coordinating editor of the Cochrane Heart Group.
Data synthesis
Data will be processed as described in the Cochrane Handbook. For dichotomous variables odds ratios and 95% confidence intervals (CI) will be derived for each outcome. For continuous variables mean differences and 95% CI will be calculated for each outcome. Where appropriate and possible, results from included studies will be combined for each outcome to give an overall estimate of treatment effect. However, given the diverse nature of the interventions which may be included it is possible that pooling of data may not be appropriate. If data cannot be combined, a narrative review of results of included studies will be presented. Heterogeneity amongst included studies will be explored.
Subgroup analysis and investigation of heterogeneity
The diverse nature of the interventions, participants, countries and healthcare systems in studies which may be included may mean that the results of analysis of pooled data must be interpreted with some degree of caution. Therefore further analyses will be conducted where there is concern that pooled data may be affected by characteristics within included studies.
Where the pooling of data is possible, subgroup analysis will be considered to determine the effect of interventions:
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by gender, by age bands, by IHD diagnostic category (acute myocardial infarction, angina, previous revascularisation);
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by intervention delivery ‐ for example, comparable interventions either nurse‐delivered or doctor‐delivered;
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by baseline service provision levels, setting and geographic region.
Sensitivity analysis
In subsequent sensitivity analyses, the inclusion criteria for types of study, baseline service provision, components of interventions or participants may be altered in order to establish whether specific characteristics affect the pooled results significantly. Where there is uncertainty about the results of included studies, because of the way they are reported or because of differing outcome measurements, sensitivity analyses may conducted which employ widened result ranges for these studies. This approach will assist in establishing the robustness of the review's findings.
In addition, sensitivity analysis may identify particular participant subgroups or component elements of interventions for which results are significantly better or worse. This will assist in the effective implementation of the findings of the review in the design of future service organisational interventions.
