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

Primary Purpose

Chronic Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Task-focused facilitation
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Diseases focused on measuring Pharmacist, Pharmacy practice, Patient care, Community pharmacy, Hypertension, Diabetes, Dyslipidemia, Pharmaceutical care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EPICORE Centre, University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Task-focused facilitation

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Service Counts From Baseline to End of Intervention Period
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)

Secondary Outcome Measures

Full Information

First Posted
July 14, 2014
Last Updated
April 8, 2022
Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, University of Waterloo, University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02191111
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, University of Waterloo, University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
Pharmacist, Pharmacy practice, Patient care, Community pharmacy, Hypertension, Diabetes, Dyslipidemia, Pharmaceutical care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-focused facilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These sites will continue practice as usual, with no contact from study staff.
Intervention Type
Behavioral
Intervention Name(s)
Task-focused facilitation
Intervention Description
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 Measure Information:
Title
Change in Service Counts From Baseline to End of Intervention Period
Description
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)
Time Frame
6 month intervention period vs. 6 month baseline prior to intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross T Tsuyuki, PharmD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meagen M Rosenthal, BA, MA, PhD
Organizational Affiliation
University of Alberta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherilyn KD Houle, BSP, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Study Director
Facility Information:
Facility Name
EPICORE Centre, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2M8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27017157
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.
Results Reference
derived
PubMed Identifier
27965782
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.
Results Reference
derived
Links:
URL
http://www.pilotfeasibilitystudies.com/content/1/1/2
Description
Study protocol

Learn more about this trial

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

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