Health Promoters and Pharmacists in Diabetes Team Management

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ben Gerber, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01498159
First received: December 15, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

This research evaluates a diabetes management intervention designed to improve medication adherence and intensify therapy to reach goals in blood sugar, blood pressure, and cholesterol levels. This study will determine the benefit and cost of adding community health promoters to pharmacist disease management services. If there is benefit, then this approach may help reduce the burden of diabetes and its related complications among minorities with diabetes.


Condition Intervention
Diabetes Mellitus
Behavioral: Pharmacist disease/medication management
Behavioral: Pharmacist-patient encounters
Behavioral: Pharmacist medication intensification and adherence support
Behavioral: Pharmacist communication with primary care physicians
Behavioral: Pharmacist documentation in electronic medical record
Behavioral: Health promoter-patient encounters in-person or by phone
Behavioral: Health promoter medication and lifestyle support
Behavioral: Health promoter communication with pharmacists

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Health Services Research
Official Title: Health Promoters and Pharmacists in Diabetes Team Management

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Knowledge [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Autonomous Self-Regulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Perceived Competence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Medication Adherence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Diabetes Self-Care Behaviors [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Healthcare Utilization [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacist + Health Promoter Behavioral: Pharmacist disease/medication management Behavioral: Pharmacist-patient encounters Behavioral: Pharmacist medication intensification and adherence support Behavioral: Pharmacist communication with primary care physicians Behavioral: Pharmacist documentation in electronic medical record Behavioral: Health promoter-patient encounters in-person or by phone Behavioral: Health promoter medication and lifestyle support Behavioral: Health promoter communication with pharmacists
Active Comparator: Pharmacist Behavioral: Pharmacist disease/medication management Behavioral: Pharmacist-patient encounters Behavioral: Pharmacist medication intensification and adherence support Behavioral: Pharmacist communication with primary care physicians Behavioral: Pharmacist documentation in electronic medical record

Detailed Description:

Many African-Americans and Latinos with diabetes do not achieve the recommended goals for normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for complications. This study will evaluate the impact of a novel intervention designed to improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals. The first component of the intervention includes a clinic-based pharmacist disease management program. The program includes detailed patient assessments, physician-approved treatment plans, patient education and support services to enhance medication adherence. In addition, this program includes intensification of medication therapy to improve blood sugar, blood pressure, and cholesterol levels to reach recommended goals. The second component of the intervention includes health promoters (HPs), or community-based lay health workers. Health promoters are commonly found in minority communities and provide assistance for neighbors overcoming language, cultural, and other barriers to conventional health care services. They may provide autonomy support and solve problems related to medication adherence barriers. Furthermore, health promoters may complement pharmacist activities by improving access to medications, assisting in continuity of care with providers, monitoring response to therapy, and reinforcing educational messages. The proposed study will determine whether the addition of health promoters to clinic based pharmacist service delivery improves care. The study will involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes through the University of Illinois Medical Center in Chicago and randomization to one of two groups: (1) pharmacist management (Pharm) for 12 months; or (2) pharmacist management with HP support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm group will be intensified by the addition of HP support and HP support will be phased out from the Pharm+HP group to assess maintenance. The specific aims include: (1) To evaluate the effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels; (2) To evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1; (3) To evaluate the intensification offered by adding an HP after one year of Pharm alone; and (4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identified as Latino/Hispanic or African-American
  • Verbal fluency in English or Spanish
  • Age 21 or above
  • History of type 2 diabetes (> 1 year)
  • Hemoglobin A1c ≥ 8.0% (within 1 year)
  • Receives primary care at UIMC (> 1 year)
  • Taking at least one oral medication for diabetes or hypertension

Exclusion Criteria:

  • Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
  • Lives outside Chicago communities of recruitment (3+ months/year)
  • Household member already participating in same study
  • Plans to move from the Chicago area within the next year
  • Pregnant or trying to get pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498159

Locations
United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Ben S Gerber, MD, MPH University of Illinois at Chicago
Principal Investigator: Lisa K Sharp, PhD University of Illinois at Chicago
  More Information

Additional Information:
Publications:
Responsible Party: Ben Gerber, Associate Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01498159     History of Changes
Other Study ID Numbers: 2011-0099, R01DK091347
Study First Received: December 15, 2011
Last Updated: May 6, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Diabetes Mellitus
Pharmacists
Community Health Aides

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014