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

April 8, 2022 updated by: University of Alberta

A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies Using the PARiHS Framework

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2M8
        • EPICORE Centre, University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Service Counts From Baseline to End of Intervention Period
Time Frame: 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)
6 month intervention period vs. 6 month baseline prior to intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

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

Investigators

  • Study Director: Meagen M Rosenthal, BA, MA, PhD, University of Alberta
  • Study Director: Sherilyn KD Houle, BSP, PhD, University of Waterloo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00047475
  • 201300643 (Other Grant/Funding Number: Alberta Innovates - Health Solutions)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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