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, 16:425

First Online: 23 September 2015Received: 28 August 2014Accepted: 11 September 2015DOI: 10.1186-s13063-015-0956-y

Cite this article as: Liu, H., Massi, L., Eades, AM. et al. Trials 2015 16: 425. doi:10.1186-s13063-015-0956-y


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 registrationACTRN126080005833347

KeywordsPragmatic randomised controlled trial Primary healthcare Indigenous health services Implementation Clinical trial AbbreviationsACCHSAboriginal Community Controlled Health Service

AHWAboriginal health worker

CONSORTConsolidated Standards of Reporting Trials

CVDcardiovascular disease

GPgeneral practitioner

IHSIndigenous health service

Kanyini GAPKanyini Guidelines Adherence to Polypill Study

PBRNpractice-based research networks

PRCTpragmatic randomised controlled trial

PRECISPragmatic-Explanatory Continuum Indicator Summary

RCTrandomised controlled trial

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-015-0956-y contains supplementary material, which is available to authorized users.

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Autor: Hueiming Liu - Luciana Massi - Anne-Marie Eades - Kirsten Howard - David Peiris - Julie Redfern - Tim Usherwood - Alan Cas


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