NCT02191111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

January 5, 2023

Completed
Last Updated

January 5, 2023

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

July 14, 2014

Results QC Date

September 15, 2016

Last Update Submit

April 8, 2022

Conditions

Chronic Diseases

Keywords

PharmacistPharmacy practicePatient careCommunity pharmacyHypertensionDiabetesDyslipidemiaPharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 month intervention period vs. 6 month baseline prior to intervention

Study Arms (2)

Task-focused facilitation

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Task-focused facilitationBEHAVIORAL

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.

Task-focused facilitation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPICORE Centre, University of Alberta

Edmonton, Alberta, T6G 2M8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 27965782DERIVED

  • 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.

    PMID: 27017157DERIVED

Related Links

MeSH Terms

Conditions

Chronic DiseaseHypertensionDiabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Results Point of Contact

Title
Dr. Meagen Rosenthal
Organization
University of Mississippi
mmrosent@olemiss.edu
662-915-2475

Study Officials

  • Ross T Tsuyuki, PharmD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Meagen M Rosenthal, BA, MA, PhD

    University of Alberta

    STUDY DIRECTOR

  • Sherilyn KD Houle, BSP, PhD

    University of Waterloo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

January 5, 2023

Results First Posted

January 5, 2023

Record last verified: 2018-05

Locations

CA(1)