Abstract
BackgroundMany patients with chronic heart failure (CHF), a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care.Methods/designWe describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs) and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational.The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model), patients' health-related utilities (EQ-5D), and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment, organisational changes in CHF care, and formalised cooperation with other disciplines will be assessed.DiscussionIn the tailoring of the programme we will present the GPs a list with barriers; GPs will assess relevance and possibility to solve these barriers. The list is rigorously developed and tested in various projects. The factors for ordering the barriers are related to the innovation, the healthcare professional, the patient, and the context.CHF patients do not form a homogeneous group. Subgroup analyses will be performed based on the distinction between systolic CHF and CHF with preserved left ventricular function (diastolic CHF).Trial registrationISRCTN: ISRCTN18812755
Highlights
Many patients with chronic heart failure (CHF), a common condition with high morbidity and mortality rates, receive treatment in primary care
The factors for ordering the barriers are related to the innovation, the healthcare professional, the patient, and the context
Subgroup analyses will be performed based on the distinction between systolic CHF and CHF with preserved left ventricular function
Summary
There exist various classifications of barriers (and facilitators) and multiple approaches for linking interventions to barriers [29,30,31]. The authors conclude that identifying barriers and tailoring intervention to these barriers may improve clinical practice compared to no intervention and to guideline dissemination In their meta analysis including eight studies identified with a non-tailored intervention in the control group, they report a modest effect of tailoring [13]. Within the context of the evaluation of the implementation project, it is not feasible to have data collection both at the start and at the end, but the patient registration form will have baseline data on treatment issues. This will allow for within group analyses, giving information about the effectiveness of both implementation strategies separately.
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