title: Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study.
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.
  
  
  BACKGROUND
  ACTRN126080005833347.
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. hliu@georgeinstitute.org.au.
authors.forename: Hueiming
authors.initials: H
authors.lastname: Liu
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. luciana.massi@sydney.edu.au.
authors.forename: Luciana
authors.initials: L
authors.lastname: Massi
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. aeades@georgeinstitute.org.au.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Eades
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, 2006, Australia. Kirsten.howard@sydney.edu.au.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. dpeiris@georgeinstitute.org.au.
authors.forename: David
authors.initials: D
authors.lastname: Peiris
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. jredfern@georgeinstitute.org.au.
authors.forename: Julie
authors.initials: J
authors.lastname: Redfern
authors.affiliation: Department of General Practice, Sydney Medical School Westmead, University of Sydney, Sydney, NSW, 2006, Australia. tim.usherwood@sydney.edu.au.
authors.forename: Tim
authors.initials: T
authors.lastname: Usherwood
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Casuarina, NT, 0811, Australia. alan.cass@menzies.edu.au.
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. apatel@georgeinstitute.org.au.
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. sjan@georgeinstitute.org.au.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.affiliation: The George Institute for Global Health, University of Sydney, PO Box M201, Missenden Road, Camperdown, NSW, 2050, Australia. tlaba@georgeinstitute.org.au.|Faculty of Pharmacy, University of Sydney, Sydney, Australia. tlaba@georgeinstitute.org.au.
authors.forename: Tracey-Lea
authors.initials: TL
authors.lastname: Laba
mesh_terms: D000284:Administration, Oral; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001291:Attitude of Health Personnel; D001315:Australia; D004338:Drug Combinations; D019983:Guideline Adherence; D006302:Health Services Research; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D007407:Interviews as Topic; D010349:Patient Compliance; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D019338:Polypharmacy; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards; D011320:Primary Health Care / Q000592:standards; D036301:Qualitative Research; D012107:Research Design / Q000592:standards; D013607:Tablets
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010975:Platelet Aggregation Inhibitors; D013607:Tablets