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

Sponsor
University of Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT02191111
Collaborator
Alberta Innovates Health Solutions (Other), University of Waterloo (Other), University of Mississippi Medical Center (Other)
10
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2
13
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Task-focused facilitation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies Using the PARiHS Framework
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

No Intervention: Control

These sites will continue practice as usual, with no contact from study staff.

Outcome Measures

Primary Outcome Measures

  1. Process evaluation [6 months vs. baseline]

    A process evaluation is intended to evaluate the quality of the implementation of the intervention (i.e. the task-focused facilitation) and the contextual factors associated with variations across the study sites. This will be measured using the Alberta Context Tool, interviews with staff of intervention sites, facilitator field notes, and facilitation evaluation interviews with the pharmacy staff at the close of the study.

Secondary Outcome Measures

  1. Change in the number of medication management services [6 months vs. baseline]

  2. Patient care clinical outcomes [6 months]

    With the ultimate goal of improving patient care, this study also aims to identify feasible clinical outcomes for collection and analysis, including changes in clinical measures specific to diabetes, hypertension, and dyslipidemia management as recorded on applicable patients' follow-up documentation. Pharmacy staff and management will be consulted to determine if additional outcomes can be reasonably collected and are relevant for clinical and/or administrative purposes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 EPICORE Centre, University of Alberta Edmonton Alberta Canada T6G 2M8

Sponsors and Collaborators

  • University of Alberta
  • Alberta Innovates Health Solutions
  • University of Waterloo
  • University of Mississippi Medical Center

Investigators

  • Principal Investigator: Ross T Tsuyuki, PharmD, MSc, University of Alberta
  • Study Director: Meagen M Rosenthal, BA, MA, PhD, University of Alberta
  • Study Director: Sherilyn KD Houle, BSP, PhD, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ross T. Tsuyuki, Professor, University of Alberta
ClinicalTrials.gov Identifier:
NCT02191111
Other Study ID Numbers:
  • Pro00047475
  • 201300643
First Posted:
Jul 16, 2014
Last Update Posted:
May 27, 2015
Last Verified:
May 1, 2015
Keywords provided by Ross T. Tsuyuki, Professor, University of Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2015