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

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 improve