A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies

Not Applicable

Completed

• Conditions: Chronic Diseases
• Interventions: Behavioral: Task-focused facilitation

• Registration Number: NCT02191111
• Lead Sponsor: University of Alberta

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Results First Submitted: 2016-09-15
• Status Verified: 2018-05
• Results First Submitted QC: 2022-04-08
• Last Update Submitted: 2022-04-08
• Results First Posted: 2023-01-05
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Task-focused facilitation	Task-focused facilitation	An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.

Primary Outcome Measures

Name	Time	Method
Change in Service Counts From Baseline to End of Intervention Period	6 month intervention period vs. 6 month baseline prior to intervention	Difference in the number of billable services (influenza vaccinations, Comprehensive Annual Care Plans and follow-ups, and Standard Medication Management Assessments and follow-ups) between the intervention period and the 6-months prior to intervention (baseline)

Trial Locations

Locations (1)

EPICORE Centre, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada