Abstract
BackgroundPragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.MethodsQualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to ‘trial impact’, ‘research motivation’ and ‘real world’ were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).ResultsPRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers’ and participants’ altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.ConclusionsConducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial registrationACTRN126080005833347Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0956-y) contains supplementary material, which is available to authorized users.
Highlights
Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice
At the end of Kanyini Kanyini Guidelines Adherence to Polypill Study (GAP), 94 semi-structured interviews were conducted by the interview team with 47 providers (25 general practitioner (GP), 13 pharmacists, 6 Aboriginal health workers (AHW) and 3 chronic care nurses) and 47 patients in NSW, Queensland and Victoria
The critical enablers and barriers to implementing this PRCT in Australian primary healthcare settings were broadly grouped within three key themes: recruitment and participation; research and primary practice settings; and participant costs
Summary
Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice. PRCTs involve a comparison of interventions and using health outcome measures that are relevant to ‘real-world’ healthcare delivery This allows for generalisability of the PRCTs’ findings which may be more accessible to decision-makers and be translated into practice and policy [1,2,3,4,5,6]. In primary care settings, given the broad spectrum of disease presentation and diverse practice settings, maximising generalisability in a PRCT without overly compromising reliability or accuracy has proven difficult [8]. In this regard, strategies to deal with design issues such as unblinded treatment allocation and recruiting representative participants have been suggested [9]. It is thought that by capturing ‘real-life’ practice variation the evidence generated will be more relevant to policy-makers [7]
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