Involvement of Community Pharmacists in Complex Care Plans for Diabetic Patients, a Pilot Study
A Collaborative Care Model for Chronic Disease Management in Diabetes - Involvement of Community Pharmacists in Complex Care Plans, a Pilot Study
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
This project is an initiative to bring physicians, nurses, community pharmacists and patients together in collaborative planning in the management of diabetes, which aligns with the collaborative, team based aspects of family medicine as a community based discipline. Alberta funds both physicians and community pharmacists to complete a comprehensive assessment and plan for patients with qualifying medical conditions. Our research hypothesis is that a collaborative approach between healthcare providers involved in delivering care will improve individual patient outcomes with the primary outcome being improved glycemic control. Health care utilization and medication adherence will also be assessed. This project will compare the results of comprehensive annual health care plans implemented over a period of twelve months with or without involvement from community pharmacists. It is hypothesized that involvement of community pharmacists and their collaboration with physicians will lead to improved outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Mar 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 24, 2019
May 1, 2019
1.8 years
March 2, 2015
May 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1C from baseline at one year
1 year
Secondary Outcomes (9)
Change in systolic BP from baseline at one year
1 year
Change in diastolic BP from baseline at one year
1 year
Change in Low Density Lipoprotein (LDL) from baseline at one year
1 year
Change in weight from baseline at one year
1 year
Change in BMI from baseline at one year
1 year
- +4 more secondary outcomes
Study Arms (2)
Community Pharmacist Involvement
EXPERIMENTALPatients would have a complex care plan completed by their clinical team, which will involve chronic disease management nurse and the family physician. This complex care plan would also involve discussion with the patient's community pharmacist who would follow-up with the patient monthly and send a report to the patient's physician. Patients would also continue to receive routine care at the clinic. The monthly follow-ups with the community pharmacist would involve review of the goals of complex care plan and monitoring clinical targets, medication review and discussing adherence as well as patient education. This follow-up can be completed in person or by telephone. The pharmacist would then send a monthly report to patient's family physician.
Usual care
NO INTERVENTIONPatients have a complex care plan completed by their clinical team, which will involve the chronic disease management nurse and the family physician and then receive routine care and follow up. They will receive usual care from their community pharmacist.
Interventions
Collaborative involvement of the community pharmacists in formulating and following complex care plans
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Patients who have diabetes with HbA1C over target (\>7) and who qualify for a complex care plan completion.
You may not qualify if:
- Pregnancy
- Unwilling to participate/provide written consent
- Unable or unwilling to participate in planned follow-ups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 26, 2015
Study Start
March 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 24, 2019
Record last verified: 2019-05