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Impact of Pharmacy Clinic on Diabetes Management (PharmaMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377127
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Alexandra Halalau, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Pharmacy Managed Diabetes Clinic (PMDC) Other: Standard of Care (SOC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
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)
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.
Primary Purpose: Treatment
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
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : November 22, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arm Intervention/treatment
Active Comparator: 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.
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.

Other: Standard of Care (SOC)
Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations




Primary Outcome Measures :
  1. Hemoglobin A1c at 6 months [ Time Frame: 6 months ]
    change from baseline in Hemoglobin A1c

  2. Hemoglobin A1c at 12 months [ Time Frame: 12 months ]
    change from baseline in Hemoglobin A1c


Secondary Outcome Measures :
  1. Hemoglobin A1c less than 8% at 6 months [ Time Frame: 6 months ]
    Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%

  2. Hemoglobin A1c less than 8% at 12 months [ Time Frame: 12 months ]
    Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%

  3. change in Hemoglobin A1c from 6 to 12 months [ Time Frame: 12 months ]
    - The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization

  4. Achievement of annual lipid panel testing [ Time Frame: 12 months ]
    percentage of patients complying with annual lipid testing

  5. Statin compliance [ Time Frame: 12 months ]
    Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.

  6. Blood pressure [ Time Frame: 12 months ]
    Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.

  7. annual retinopathy examination [ Time Frame: 12 months ]
    Percentage of patients compliant with annual retinopathy examination

  8. annual nephropathy examination [ Time Frame: 12 months ]
    Percentage of patients compliant with annual nephropathy examination

  9. annual neuropathy examination [ Time Frame: 12 months ]
    Percentage of patients compliant with annual neuropathy examination

  10. annual influenza vaccine [ Time Frame: 12 months ]
    Percentage of patients compliant with annual influenza vaccine

  11. annual pneumonia vaccine [ Time Frame: 12 months ]
    Percentage of patients compliant with annual pneumonia vaccine

  12. quality of life assessment [ Time Frame: 12 months ]
    Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life.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

  13. Diabetes related EC visits at 6 months [ Time Frame: 6 months ]
    Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia

  14. Diabetes related EC visits at 12 months [ Time Frame: 12 months ]
    Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia

  15. Total EC visits at 6 months [ Time Frame: 6 months ]
    Number of Emergency Center (EC) visits

  16. Total EC visits at 12 months [ Time Frame: 12 months ]
    Number of Emergency Center (EC) visits

  17. Inpatient visits [ Time Frame: 12 months ]
    Total number of inpatient visits

  18. outpatient visits [ Time Frame: 12 months ]
    total number of outpatient visits

  19. no-show [ Time Frame: 12 months ]
    percentage of visits missed in clinic



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377127


Locations
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United States, Michigan
Beaumont Geriatric Assessment Center
Berkley, Michigan, United States, 48072
Beaumont Outpatient Clinic
Royal Oak, Michigan, United States, 48073
Beaumont Internal Medicine Center
Southfield, Michigan, United States, 48034
Norton, Klein, Hug, Sabin and Maddens Internal Medicine & Primary Care Practice
Troy, Michigan, United States, 48084
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Alexandra I Halalau, MD Director of Internal Medicine Research
  Study Documents (Full-Text)

Documents provided by Alexandra Halalau, William Beaumont Hospitals:
Informed Consent Form  [PDF] February 7, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexandra Halalau, Director of Internal Medicine Research, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03377127    
Other Study ID Numbers: 2017-494
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandra Halalau, William Beaumont Hospitals:
diabetes
pharmacy clinic
education
diabetes complications
hemoglobin A1c
health-care cost
'no show' rate
compliance
diabetes core measures
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases