Impact of Pharmacy Clinic on Diabetes Management

NCT03377127 | Completed Results

• 1 other identifier: 2017-494
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; pharmacy clinic; education; diabetes complications; hemoglobin A1c; health-care cost; 'no show' rate; compliance; diabetes core measures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Hemoglobin A1c Less Than 8% at 6 Months

  6 months

• Hemoglobin A1c Less Than 8% at 12 Months

  12 months

• Change in Hemoglobin A1c From 6 to 12 Months

  12 months

• Achievement of Annual Lipid Panel Testing

  12 months

• Statin Compliance

  12 months

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

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)

SOC and PMDC

EXPERIMENTAL

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.

Behavioral: Pharmacy Managed Diabetes Clinic (PMDC); Other: Standard of Care (SOC)

Interventions

Pharmacy Managed Diabetes Clinic (PMDC) BEHAVIORAL

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.

SOC and PMDC

Standard of Care (SOC) OTHER

Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations

SOC and PMDC; Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (4)

Beaumont Geriatric Assessment Center

Berkley, Michigan, 48072, United States

Location

Beaumont Outpatient Clinic

Royal Oak, Michigan, 48073, United States

Location

Beaumont Internal Medicine Center

Southfield, Michigan, 48034, United States

Location

Norton, Klein, Hug, Sabin and Maddens Internal Medicine & Primary Care Practice

Troy, Michigan, 48084, United States

Location

Related Publications (2)

• 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.

  PMID: 35296307 DERIVED

• 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.

  PMID: 30143033 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Complications; Patient Compliance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Alexandra Halalau
• Organization: Beaumont Health

alexandra.halalau@beaumont.org

2485513481

Study Officials

• Alexandra I Halalau, MD

  Director of Internal Medicine Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Internal Medicine Research

Model Details: 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 Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: February 19, 2018
• Primary Completion: May 22, 2020
• Study Completion: November 30, 2020
• Last Updated: June 30, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)