Impact of Pharmacy Clinic on Diabetes Management (PharmaMD)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Standard of Care (SOC); Behavioral: Pharmacy Managed Diabetes Clinic (PMDC)

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

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Beaumont Geriatric Assessment Center
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Outpatient Clinic
    • Southfield, Michigan, United States, 48034
      • Beaumont Internal Medicine Center
    • Troy, Michigan, United States, 48084
      • Norton, Klein, Hug, Sabin and Maddens Internal Medicine & Primary Care Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Standard of Care (SOC); Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Experimental: 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.	Other: Standard of Care (SOC); Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations; Behavioral: Pharmacy Managed Diabetes Clinic (PMDC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c at 6 Months	change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units	6 months
Hemoglobin A1c at 12 Months	change from baseline in Hemoglobin A1c	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c Less Than 8% at 6 Months	Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%	6 months
Hemoglobin A1c Less Than 8% at 12 Months	Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% DCCT units	12 months
Change in Hemoglobin A1c From 6 to 12 Months	The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization.	12 months
Achievement of Annual Lipid Panel Testing	percentage of patients complying with annual lipid testing	12 months
Statin Compliance	Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.	12 months
Blood Pressure	Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.	12 months
Annual Retinopathy Examination	Percentage of patients compliant with annual retinopathy examination	12 months
Annual Nephropathy Examination	Percentage of patients compliant with annual nephropathy examination	12 months
Annual Neuropathy Examination	Percentage of patients compliant with annual neuropathy examination	12 months
Annual Influenza Vaccine	Percentage of patients compliant with annual influenza vaccine	12 months
Annual Pneumonia Vaccine	Percentage of patients compliant with annual pneumonia vaccine	12 months
Quality of Life Assessment	Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life at baseline and 12 months.The WHOQOL-BREF consists of 4 domains, Physical Health, Psychological, Social Relationships, and Environment. Each domain is comprised of multiple questions that are considered together in the derivation of each domain score. In addition to the 4 domains, the WHOQOL-BREF includes two stand-alone questions to assess rated QOL and Satisfaction with Health questionnaire administered at baseline and at the conclusion of the trial period. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range from a minimum of 4 to a maximum of 20. The mean score of items within each domain is used to calculate the domain score.A Likert scale from 1-7 was used. (1 - not affected, 7- extremely affected) We compared and reported the mean difference in between 6 months data and baseline data.	12 months
Diabetes Related EC Visits at 6 Months	Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia	6 months
Diabetes Related EC Visits at 12 Months	Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia	12 months
Total EC Visits at 6 Months	Number of Emergency Center (EC) visits	6 months
Total EC Visits at 12 Months	Number of Emergency Center (EC) visits	12 months
Inpatient Visits	Total number of inpatient visits	12 months
Outpatient Visits	total number of outpatient visits	12 months
No-show	percentage of visits missed in clinic	12 months

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Alexandra I Halalau, MD, Director of Internal Medicine Research

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): May 22, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; compliance; education; hemoglobin A1c; pharmacy clinic; diabetes complications; health-care cost; 'no show' rate; diabetes core measures
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017-494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No