DiabetesNCT02399332
Involvement of Community Pharmacists in Complex Care Plans for Diabetic Patients, a Pilot Study
A study testing Community pharmacist involvement in people with Diabetes, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Community pharmacist involvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patients who have diabetes with HbA1C over target (>7) and who qualify for a complex care plan completion.
Who cannot join
- Pregnancy
- Unwilling to participate/provide written consent
- Unable or unwilling to participate in planned follow-ups
About this study
Official title: A Collaborative Care Model for Chronic Disease Management in Diabetes - Involvement of Community Pharmacists in Complex Care Plans, a Pilot Study
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.
Read the detailed description
Research question: Does involvement of a community pharmacist in formulating and following a complex care plan for diabetic patients in conjunction with the patient's clinical team (physician and chronic disease management nurse) improve outcomes including glycemic control, health care utilization and medication adherence.
Hypothesis: Collaborative complex care planning for diabetic patients with the primary care physician, chronic disease management nurse and community pharmacist leads to improvement in patient health outcomes, decreases hospital visits and visits to family physician and emergency room and improves medication adherence.
Aim of the study: The aim of this study is to serve as a pilot in exploring if collaborative care provided by physicians, chronic disease nurse and community pharmacists in formulating and following complex care plans leads to better clinical outcomes when compared to care plans that are formulated and followed in isolation by the physician and chronic disease nurse. This study would be the basis for a future in depth project comparing outcomes of care plans completed in isolation by the pharmacists or physicians with those created in a collaborative environment. Our long-term objectives are improvement in patient outcomes, reduction in health care expenditure as well as preventing duplication and potential discordance of comprehensive care plans.
Methodology
Patients and study design: This is a single centre prospective case control pilot study.
A cohort of 25 eligible diabetic patients at the South Health Campus Family Medicine Teaching Clinic (an outpatient academic family medicine clinic in Calgary, Alberta) will be studied and compared against a group of 25 control diabetic patients. The intervention would be involvement of patient's community pharmacist with their clinical team in formulating the complex care plan and following up with the patient on a monthly basis. The control is a set of patients who have complex care plans completed by their clinical team with no coordination with the pharmacist.
- Conditions
- Diabetes
- Being tested
- Community pharmacist involvement
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community pharmacist involvementOther
Collaborative involvement of the community pharmacists in formulating and following complex care plans
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C from baseline at one year
Measured: 1 year
Secondary outcomes (9)
Change in systolic BP from baseline at one year
Measured: 1 year
Change in diastolic BP from baseline at one year
Measured: 1 year
Change in Low Density Lipoprotein (LDL) from baseline at one year
Measured: 1 year
Change in weight from baseline at one year
Measured: 1 year
Change in BMI from baseline at one year
Measured: 1 year
Change in hospital admissions from baseline at one year
Measured: 1 year
Change in family physician visits from baseline at one year
Measured: 1 year
Change in emergency room visits from baseline at one year
Measured: 1 year
Change in medication adherence from baseline at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Divya Garg, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399332
- Sponsor's protocol ID
- REB15-0673
- Status last verified
- May 2019
- First submitted
- 2 Mar 2015
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Care Model for Chronic Disease Management in Diabetes - Involvement of Community Pharmacists in Complex Care Plans, a Pilot Study
- ClinicalTrials.gov ID
- NCT02399332
- Acronym / sponsor ID
- REB15-0673
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research question: Does involvement of a community pharmacist in formulating and following a complex care plan for diabetic patients in conjunction with the patient's clinical team (physician and chronic disease management nurse) improve outcomes including glycemic control, health care utilization and medication adherence.
Hypothesis: Collaborative complex care planning for diabetic patients with the primary care physician, chronic disease management nurse and community pharmacist leads to improvement in patient health outcomes, decreases hospital visits and visits to family physician and emergency room and improves medication adherence.
Aim of the study: The aim of this study is to serve as a pilot in exploring if collaborative care provided by physicians, chronic disease nurse and community pharmacists in formulating and following complex care plans leads to better clinical outcomes when compared to care plans that are formulated and followed in isolation by the physician and chronic disease nurse. This study would be the basis for a future in depth project comparing outcomes of care plans completed in isolation by the pharmacists or physicians with those created in a collaborative environment. Our long-term objectives are improvement in patient outcomes, reduction in health care expenditure as well as preventing duplication and potential discordance of comprehensive care plans.
Methodology
Patients and study design: This is a single centre prospective case control pilot study.
A cohort of 25 eligible diabetic patients at the South Health Campus Family Medicine Teaching Clinic (an outpatient academic family medicine clinic in Calgary, Alberta) will be studied and compared against a group of 25 control diabetic patients. The intervention would be involvement of patient's community pharmacist with their clinical team in formulating the complex care plan and following up with the patient on a monthly basis. The control is a set of patients who have complex care plans completed by their clinical team with no coordination with the pharmacist.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Pharmacist Involvement | Experimental | Other: Community pharmacist involvementPatients 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Patients who have diabetes with HbA1C over target (>7) and who qualify for a complex care plan completion.
Key exclusion criteria (3 listed)
- Pregnancy
- Unwilling to participate/provide written consent
- Unable or unwilling to participate in planned follow-ups
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 |
|---|---|---|
| Community pharmacist involvementCollaborative involvement of the community pharmacists in formulating and following complex care plans | Other | Community Pharmacist Involvement |
Primary outcome
Change in HbA1C from baseline at one year
Time frame: 1 year
9 secondary outcomes
Change in systolic BP from baseline at one year
Time frame: 1 year
Change in diastolic BP from baseline at one year
Time frame: 1 year
Change in Low Density Lipoprotein (LDL) from baseline at one year
Time frame: 1 year
Change in weight from baseline at one year
Time frame: 1 year
Change in BMI from baseline at one year
Time frame: 1 year
Change in hospital admissions from baseline at one year
Time frame: 1 year
Change in family physician visits from baseline at one year
Time frame: 1 year
Change in emergency room visits from baseline at one year
Time frame: 1 year
Change in medication adherence from baseline at one year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Community pharmacist involvement in people with Diabetes, run by University of Calgary.
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 3 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 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HbA1C from baseline at one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2019.