NCT02399332

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

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2016

Status
completed

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

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

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

EXPERIMENTAL

Patients 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.

Other: Community pharmacist involvement

Usual care

NO INTERVENTION

Patients 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

Community Pharmacist Involvement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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