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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02191111
Enrollment
10
Registered
2014-07-16
Start date
2014-07-31
Completion date
2015-08-31
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diseases

Keywords

Pharmacist, Pharmacy practice, Patient care, Community pharmacy, Hypertension, Diabetes, Dyslipidemia, Pharmaceutical care

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

Interventions

BEHAVIORALTask-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.

Sponsors

Alberta Innovates Health Solutions
CollaboratorOTHER
University of Waterloo
CollaboratorOTHER
University of Mississippi Medical Center
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Service Counts From Baseline to End of Intervention Period6 month intervention period vs. 6 month baseline prior to interventionDifference 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)

Countries

Canada

Participant flow

Participants by arm

ArmCount
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. 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.
0
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. 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.
5
Control
These sites will continue practice as usual, with no contact from study staff.
0
Control
These sites will continue practice as usual, with no contact from study staff.
5
Total10

Baseline characteristics

CharacteristicTask-focused FacilitationControlTotal
Age, Customized
Pharmacies
0 Age data not collected0 Age data not collected0 Age data not collected
Alberta context tool, semi-structured interviews, medication management counts, close out interviews2.86 units on a scale3.14 units on a scale3 units on a scale
Sex/Gender, Customized
Pharmacies
0 Pharmacies0 Pharmacies0 Pharmacies

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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)

Time frame: 6 month intervention period vs. 6 month baseline prior to intervention

Population: Units of measure were community pharmacies

ArmMeasureCategoryValue (COUNT_OF_UNITS)
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco Follow-Up (Study Period)5 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodInfluenza Vaccinations (Study Period)3199 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodCACP (Baseline)172 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodCACP (Study Period)121 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodCACP Follow-Up (Baseline)295 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodCACP Follow-Up (Study Period)106 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA (Baseline)50 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA (Study Period)46 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Follow-Up (Baseline)67 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Follow-Up (Study Period)41 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes (Baseline)3 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes (Study Period)1 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes Follow-Up (Baseline)8 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes Follow-Up (Study Period)4 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco (Baseline)21 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco (Study Period)8 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco Follow-Up (Baseline)4 Billable pharmacy services
Task-focused FacilitationChange in Service Counts From Baseline to End of Intervention PeriodInfluenza Vaccinations (Baseline)406 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodInfluenza Vaccinations (Study Period)4140 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes (Baseline)4 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco (Study Period)12 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodCACP (Baseline)284 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes (Study Period)1 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodCACP (Study Period)166 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodInfluenza Vaccinations (Baseline)2 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodCACP Follow-Up (Baseline)507 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes Follow-Up (Baseline)5 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodCACP Follow-Up (Study Period)372 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco Follow-Up (Baseline)4 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA (Baseline)115 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Diabetes Follow-Up (Study Period)5 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA (Study Period)64 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco Follow-Up (Study Period)6 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Follow-Up (Baseline)105 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Tobacco (Baseline)6 Billable pharmacy services
ControlChange in Service Counts From Baseline to End of Intervention PeriodSMMA Follow-Up (Study Period)88 Billable pharmacy services

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026