Clinical trial NCT02191111: A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies
Official title: A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies Using the PARiHS Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: Pharmacist
Pharmacy practice
Patient care
Community pharmacy
Hypertension
Diabetes
Dyslipidemia
Pharmaceutical care
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
name: University of Waterloo
name: University of Mississippi Medical Center
First posted: 2014-07-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension.

Methods: A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the intervention between the two groups, and identification of feasible quantitative outcomes for evaluating the effect of the intervention on patient care outcomes.

Results: To date, the study has identified and enrolled the ten pharmacies required and initiated the intervention process.

Conclusion: This study will be the first to examine the role of facilitation in pharmacy practice, with the goal of scalable and sustainable practice change.

Detailed description: Please see the following publication for a detailed description of the work:

Pilot and Feasibility Studies 01/2015; 1(2). DOI: 10.1186/2055-5784-1-2

Eligibility criteria: Inclusion Criteria:

* Pharmacies: Community pharmacy locations of a medium-sized pharmacy chain with an interest in and the ability to provide medication management services, but have not fully integrated these activities
* Patients: Any Alberta residents qualifying for pharmacy clinical services as defined by the Alberta Pharmacy Fee Framework

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Service Counts From Baseline to End of Intervention Period
timeFrame: 6 month intervention period vs. 6 month baseline prior to intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: EPICORE Centre, University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Ross T Tsuyuki, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Meagen M Rosenthal, BA, MA, PhD
role: STUDY_DIRECTOR
affiliation: University of Waterloo
name: Sherilyn KD Houle, BSP, PhD
role: STUDY_DIRECTOR
References:
citation: Houle SK, Charrois TL, Faruquee CF, Tsuyuki RT, Rosenthal MM. A randomized controlled study of practice facilitation to improve the provision of medication management services in Alberta community pharmacies. Res Social Adm Pharm. 2017 Mar-Apr;13(2):339-348. doi: 10.1016/j.sapharm.2016.02.013. Epub 2016 Mar 8.
citation: Rosenthal MM, Tsuyuki RT, Houle SK. A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol. Pilot Feasibility Stud. 2015 Jan 12;1:2. doi: 10.1186/2055-5784-1-2. eCollection 2015.