PHARM-MD; An Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- William Beaumont Hospitals
- Enrollment
- 86
- Locations
- 4
- Primary Endpoint
- Hemoglobin A1c at 6 Months
Study Overview
Brief Summary
The Beaumont Hospital Royal Oak Outpatient Clinic (and other listed Beaumont recruiting locations) care for over 900 patients with diabetes. In an effort to improve the care provided to our patients, a pharmacist managed diabetes clinic (PMDC) was created. The investigators looked at patients with high-risk diabetes who have received education in the PMDC and compared them to patients that didn't not receive the pharmacy education. Our preliminary data showed a significant decrease in Hemoglobin A1c in the PMDC compared to our standard care cohort. Hemoglobin A1c is a marker of the severity of diabetes mellitus. Based on this data, we designed a randomized controlled trial to better assess the impact of a PMDC on diabetic outcomes.
Detailed Description
Over the past 20 years, the number of adults with diabetes has tripled in the United States. According to the Centers for Disease Control (CDC), diabetes mellitus (DM) affected 30.2 million American adults in 2015.
Previous studies showed that for each 1% reduction in hemoglobin A1c (HbA1c), there was a corresponding 14% reduction in myocardial infarction, 12% reduction in stroke, and a 37% reduction of microvascular complications.
Based on our preliminary data, a Pharmacist Managed Diabetes Clinic (PMDC) had a decrease in HbA1c of 2.2% in the high-risk diabetes patients from the PMDC cohort versus 0.9% in the standard care cohort (p=0.006). At six months there was a decrease in HbA1c of 3.2% in the PMDC and 1.2% in the standard care cohort (p=0.044).
Our hypothesis is that a pharmacist managed diabetes clinic focused on patient identified diabetes management gaps and goals would have a significant positive impact on diabetes core measures and will result in a higher quality of care at a lower price. A randomized controlled trial (RCT) of our PMDC would provide further clarity on the impact on patient outcomes and important evidence with regard to how the physicians can deliver the best care for this high-risk population.
Trial design This is a randomized open-label, controlled parallel group trial of a pharmacist managed diabetes clinic in high-risk diabetes patients, with a 1:1 allocation to either standard of care (SOC) or SOC and PMDC and a 6-month and 12-month follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The patients and physicians will not be blinded to the intervention. However, the data collectors and the data analysts will be unaware of the patients allocation. The outcome assessors will also not be aware of the allocation. The biostatistician will also be blinded.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •high risk diabetes mellitus type 2 patients (hemoglobin ≥ 9%)
- •not currently enrolled in PMDC.
- •established with a primary care resident internal medicine or medicine-pediatrics resident.
- •have a diagnosis of diabetes mellitus type 2.
Exclusion Criteria
- •Patients will be excluded if they have been seen by the PMDC within the past 3 months.
- •under 18 years of age or over 75 years of age.
- •documented as having type 1 diabetes or
- •latent autoimmune diabetes of adults.
Arms & Interventions
Standard of Care (SOC)
The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP
Intervention: Standard of Care (SOC) (Other)
SOC and PMDC
The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.
Intervention: Pharmacy Managed Diabetes Clinic (PMDC) (Behavioral)
SOC and PMDC
The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.
Intervention: Standard of Care (SOC) (Other)
Outcomes
Primary Outcomes
Hemoglobin A1c at 6 Months
Time Frame: 6 months
change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units
Hemoglobin A1c at 12 Months
Time Frame: 12 months
change from baseline in Hemoglobin A1c
Secondary Outcomes
- Statin Compliance(12 months)
- Total EC Visits at 12 Months(12 months)
- Inpatient Visits(12 months)
- Hemoglobin A1c Less Than 8% at 6 Months(6 months)
- Change in Hemoglobin A1c From 6 to 12 Months(12 months)
- Hemoglobin A1c Less Than 8% at 12 Months(12 months)
- Achievement of Annual Lipid Panel Testing(12 months)
- Annual Retinopathy Examination(12 months)
- Annual Nephropathy Examination(12 months)
- Annual Influenza Vaccine(12 months)
- Quality of Life Assessment(12 months)
- Diabetes Related EC Visits at 6 Months(6 months)
- Diabetes Related EC Visits at 12 Months(12 months)
- Blood Pressure(12 months)
- Annual Pneumonia Vaccine(12 months)
- Total EC Visits at 6 Months(6 months)
- Annual Neuropathy Examination(12 months)
- Outpatient Visits(12 months)
- No-show(12 months)
Investigators
Alexandra Halalau
Director of Internal Medicine Research
William Beaumont Hospitals