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Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study

Liu, Hueiming, Massi, Luciana, Eades, Anne-Marie, Howard, Kirsten, Peiris, David, Redfern, Julie, Usherwood, Tim, Cass, Alan, Patel, Anushka, Jan, Stephen and Laba, Tracey-Lea (2015). Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study. Trials,16(Article No. 425).

Document type: Journal Article
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IRMA ID 81144320xPUB113
Title Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study
Author Liu, Hueiming
Massi, Luciana
Eades, Anne-Marie
Howard, Kirsten
Peiris, David
Redfern, Julie
Usherwood, Tim
Cass, Alan
Patel, Anushka
Jan, Stephen
Laba, Tracey-Lea
Journal Name Trials
Publication Date 2015
Volume Number 16
Issue Number Article No. 425
ISSN 1745-6215   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-84955412809
Total Pages 11
Place of Publication United Kingdom
Publisher BioMed Central Ltd.
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
Pragmatic 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.

Methods
Qualitative 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).

Results

PRCT 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.

Conclusions
Conducting 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 registration
ACTRN126080005833347
Keywords Pragmatic randomised controlled trial
Primary healthcare
Indigenous health services
Implementaion
Clinical trial
DOI http://dx.doi.org/10.1186/s13063-015-0956-y   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 4.0 License
URL https://creativecommons.org/licenses/by/4.0/au


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