Chronic DiseasesNCT02191111
A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies
A study testing Task-focused facilitation in people with Chronic Diseases, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Task-focused facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Chronic Diseases
- Being tested
- Task-focused facilitation
- Keywords
- Pharmacist, Pharmacy practice, Patient care, Community pharmacy, Hypertension, Diabetes, Dyslipidemia, Pharmaceutical care
- Medical subject headings
- Chronic Disease, Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-focused facilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Task-focused facilitation |
| Control | No intervention | These sites will continue practice as usual, with no contact from study staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month intervention period vs. 6 month baseline prior to intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, University of Waterloo, University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Ross T Tsuyuki, PharmD, MSc, Principal investigator, University of AlbertaMeagen M Rosenthal, BA, MA, PhD, Study director, University of AlbertaSherilyn KD Houle, BSP, PhD, Study director, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191111
- Sponsor's protocol ID
- Pro00047475
- Other IDs
- 201300643
- Status last verified
- May 2018
- First submitted
- 14 Jul 2014
- Last updated
- 5 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27965782Houle 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.
PubMed 27017157
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies Using the PARiHS Framework
- ClinicalTrials.gov ID
- NCT02191111
- Acronym / sponsor ID
- Pro00047475
- Conditions
- Chronic Diseases
- Keywords
- Pharmacist, Pharmacy practice, Patient care, Community pharmacy, Hypertension, Diabetes, Dyslipidemia, Pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, University of Waterloo, University of Mississippi Medical Center
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-focused facilitation | Experimental | Behavioral: Task-focused facilitationAn 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 | No intervention | –These sites will continue practice as usual, with no contact from study staff. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-focused facilitationAn 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. | Behavioural | Task-focused facilitation |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27965782Rosenthal 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.
- Derived from this study: PubMed 27017157Houle 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.
- Study protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross T Tsuyuki, PharmD, MSc principal investigator
University of Alberta
Meagen M Rosenthal, BA, MA, PhD study director
University of Alberta
Sherilyn KD Houle, BSP, PhD study director
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-focused facilitation in people with Chronic Diseases, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Service Counts From Baseline to End of Intervention Period (time frame: 6 month intervention period vs. 6 month baseline prior to intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.