Clinical trial NCT03377127: Impact of Pharmacy Clinic on Diabetes Management
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
pharmacy clinic
education
diabetes complications
hemoglobin A1c
health-care cost
'no show' rate
compliance
diabetes core measures
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c at 6 Months
timeFrame: 6 months
measure: Hemoglobin A1c at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Hemoglobin A1c Less Than 8% at 6 Months
timeFrame: 6 months
measure: Hemoglobin A1c Less Than 8% at 12 Months
timeFrame: 12 months
measure: Change in Hemoglobin A1c From 6 to 12 Months
timeFrame: 12 months
measure: Achievement of Annual Lipid Panel Testing
timeFrame: 12 months
measure: Statin Compliance
timeFrame: 12 months
measure: Blood Pressure
timeFrame: 12 months
measure: Annual Retinopathy Examination
timeFrame: 12 months
measure: Annual Nephropathy Examination
timeFrame: 12 months
measure: Annual Neuropathy Examination
timeFrame: 12 months
measure: Annual Influenza Vaccine
timeFrame: 12 months
measure: Annual Pneumonia Vaccine
timeFrame: 12 months
measure: Quality of Life Assessment
timeFrame: 12 months
measure: Diabetes Related EC Visits at 6 Months
timeFrame: 6 months
measure: Diabetes Related EC Visits at 12 Months
timeFrame: 12 months
measure: Total EC Visits at 6 Months
timeFrame: 6 months
measure: Total EC Visits at 12 Months
timeFrame: 12 months
measure: Inpatient Visits
timeFrame: 12 months
measure: Outpatient Visits
timeFrame: 12 months
measure: No-show
timeFrame: 12 months
Other outcomes:
Locations:
city: Berkley
country: United States
facility: Beaumont Geriatric Assessment Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Outpatient Clinic
state: Michigan
city: Southfield
country: United States
facility: Beaumont Internal Medicine Center
state: Michigan
city: Troy
country: United States
facility: Norton, Klein, Hug, Sabin and Maddens Internal Medicine & Primary Care Practice
state: Michigan
Study officials:
affiliation: Director of Internal Medicine Research
name: Alexandra I Halalau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halalau A, Sonmez M, Uddin A, Karabon P, Scherzer Z, Keeney S. Efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients, a randomized controlled trial - "Pharm-MD" : Impact of clinical pharmacists in diabetes care. BMC Endocr Disord. 2022 Mar 16;22(1):69. doi: 10.1186/s12902-022-00983-y.
citation: Halalau A, Shelden D, Keeney S, Hehar J. 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 - study protocol for a randomized controlled trial. Trials. 2018 Aug 24;19(1):458. doi: 10.1186/s13063-018-2836-8.