Health Promoters and Pharmacists in Diabetes Team Management

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01498159
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
244
1
2
73
3.3

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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
N/A

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 individuals 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Health Promoters and Pharmacists in Diabetes Team Management
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacist + Health Promoter

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

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

Participants will receive support from 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

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c [24 months]

    Hemoglobin A1c

Secondary Outcome Measures

  1. Diabetes Knowledge [24 months]

    Diabetes Knowledge

  2. Autonomous Self-Regulation [24 months]

    Autonomous Self-Regulation

  3. Perceived Competence [24 months]

    Perceived Competence

  4. Medication Adherence [24 months]

    Medication Adherence

  5. Body mass index [24 months]

    Body mass index

  6. Diabetes Self-Care Behaviors [24 months]

    Diabetes Self-Care Behaviors

  7. Quality of Life [24 months]

    Quality of Life

  8. Healthcare Utilization [24 months]

    Healthcare Utilization

  9. Systolic Blood Pressure [24 months]

    Systolic Blood Pressure

  10. Diastolic Blood Pressure [24 months]

    Diastolic Blood Pressure

  11. LDL Cholesterol [24 months]

    LDL Cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Illinois Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Ben S Gerber, MD, MPH, University of Illinois at Chicago
  • Principal Investigator: Lisa K Sharp, PhD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ben Gerber, Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01498159
Other Study ID Numbers:
  • 2011-0099
  • R01DK091347
First Posted:
Dec 23, 2011
Last Update Posted:
May 3, 2018
Last Verified:
Apr 1, 2018
Keywords provided by Ben Gerber, Professor of Medicine, University of Illinois at Chicago
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2018