Impact of Pharmacy Clinic on Diabetes Management
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.

      Methods:

      The study will be conducted at the listed recruiting sites at Beaumont Hospital. Michigan.
      The outpatient clinic is a resident clinic that delivers medical care to over 920 patients
      with diabetes mellitus. The clinic is based on campus at Beaumont Hospital, Royal Oak.
      Potential subjects with high-risk diabetes mellitus will be identified through weekly reports
      and from the daily schedule and will be recruited from this pool of patients exclusively.

      Intervention The patients will be enrolled over a 6-month period and will be randomly
      assigned to control group (usual care) and the intervention group (usual care plus PMDC
      visits). The PMDC is a pharmacist-led clinic that has been functioning in our outpatient
      clinic since January 2015 and is considered an available resource.

      The intervention group patients will be managed by their assigned primary care physicians
      (PCPs), per standard of care and will have scheduled six extra face-to-face visits with the
      pharmacists for the 6 month duration of the intervention. The PMDC visits will be scheduled
      more frequent in the first 2 months of the intervention to ensure patients' engagement and
      provide enough opportunities and time to address all the patients' goals and concerns. The
      PMDC visit encounters will focus on patient identified goals for the management of their
      diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45
      minutes. Patients will be asked to describe their own gaps in knowledge and to identify their
      own management goals. Identification of knowledge gaps will allow targeted patient education
      to close those gaps. Other educational opportunities will potentially include diabetes
      mellitus pathophysiology, blood glucose goals, HbA1c goals, management of hyperglycemic and
      hypoglycemic episodes, review of medications, and counseling regarding diet and exercise.
      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.

      The control group patients will be managed by their assigned PCPs, per standard of care.
      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.

      Outside the intervention, the participants in both groups will be treated identical. They
      will participate in the standard of care visits at baseline, at 3 months and at 6 months.
      These visits (visit 1, 6 and 9 in the intervention group and visit 1, 2 and 3 in the standard
      of care group) will be provided by each patient's primary care physician
    

Intervention name(s): Pharmacy Managed Diabetes Clinic (PMDC); Standard of Care (SOC)
Intervention type(s): Behavioral; Other
Intervention description(s): The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.; Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; pharmacy clinic; education; diabetes complications; hemoglobin A1c; health-care cost; 'no show' rate; compliance; diabetes core measures