title: Facilitators and barriers to implementation of a pragmatic clinical trial in Aboriginal health services.
abstract: OBJECTIVE
  To identify facilitators and barriers to clinical trial implementation in Aboriginal health services.
  
  
  METHODS
  Indepth interview study with thematic analysis.
  
  
  METHODS
  Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill (KGAP) study, a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease.
  
  
  METHODS
  32 health care providers and 21 Aboriginal and Torres Strait Islander patients.
  
  
  RESULTS
  A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service. That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients. Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important. The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures. This was partially alleviated by the research team's provision of onsite support and attempts to make trial processes more streamlined. Although more intensive support was highly desired, there were usually insufficient resources to provide this.
  
  
  CONCLUSIONS
  Despite strong community and health service support, major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched, routine services. Trial budgets will necessarily be inflated as a result. Funding agencies need to consider these additional resource demands when supporting trials of a similar nature.
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia. chrislawrence80@hotmail.com.
authors.forename: Hueming
authors.initials: H
authors.lastname: Liu
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: Tracey-Lea
authors.initials: TL
authors.lastname: Laba
authors.affiliation: University of Sydney, Sydney, NSW, Australia.
authors.forename: Luciana
authors.initials: L
authors.lastname: Massi
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.affiliation: University of Sydney, Sydney, NSW, Australia.
authors.forename: Tim
authors.initials: T
authors.lastname: Usherwood
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: Anushka
authors.initials: A
authors.lastname: Patel
authors.affiliation: University of Queensland, Brisbane, QLD, Australia.
authors.forename: Noel E
authors.initials: NE
authors.lastname: Hayman
authors.affiliation: Menzies School of Health Research, Darwin, NT, Australia.
authors.forename: Alan
authors.initials: A
authors.lastname: Cass
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Eades
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Lawrence
authors.affiliation: The George Institute for Global Health, Sydney, NSW, Australia.
authors.forename: David P
authors.initials: DP
authors.lastname: Peiris
mesh_terms: D000328:Adult; D001315:Australia; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000517:prevention & control; D003144:Communication Barriers; D003150:Community Health Workers / Q000458:organization & administration; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006303:Health Services, Indigenous / Q000458:organization & administration*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology / Q000706:statistics & numerical data*; D000095283:Australian Aboriginal and Torres Strait Islander Peoples