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

NCT ID: NCT02191111

Last Updated: 2023-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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

Conditions

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Chronic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Task-focused facilitation

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alberta Innovates Health Solutions

OTHER

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross T Tsuyuki, PharmD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Meagen M Rosenthal, BA, MA, PhD

Role: STUDY_DIRECTOR

University of Alberta

Sherilyn KD Houle, BSP, PhD

Role: STUDY_DIRECTOR

University of Waterloo

Locations

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EPICORE Centre, University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27965782 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27017157 (View on PubMed)

Related Links

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Other Identifiers

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201300643

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00047475

Identifier Type: -

Identifier Source: org_study_id

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