Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments pharmacist disease/medication management, pharmacist-patient encounters, pharmacist medication intensification and adherence support, pharmacist communication with primary care physicians, pharmacist documentation in electronic medical record, health promoter-patient encounters in-person or by phone, health promoter medication and lifestyle support, health promoter communication with pharmacists
Sponsor University of Illinois at Chicago
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date December 2011
End date December 2016
Trial size 300 participants
Trial identifier NCT01498159, 2011-0099, R01DK091347

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
pharmacist disease/medication management
pharmacist-patient encounters
pharmacist medication intensification and adherence support
pharmacist communication with primary care physicians
pharmacist documentation in electronic medical record
health promoter-patient encounters in-person or by phone
health promoter medication and lifestyle support
health promoter communication with pharmacists
(Active Comparator)
Participants will receive support from pharmacist.
pharmacist disease/medication management
pharmacist-patient encounters
pharmacist medication intensification and adherence support
pharmacist communication with primary care physicians
pharmacist documentation in electronic medical record

Primary Outcomes

Measure
Hemoglobin A1c
time frame: 24 months
Blood Pressure
time frame: 24 months
LDL Cholesterol
time frame: 24 months

Secondary Outcomes

Measure
Diabetes Knowledge
time frame: 24 months
Autonomous Self-Regulation
time frame: 24 months
Perceived Competence
time frame: 24 months
Medication Adherence
time frame: 24 months
Body mass index
time frame: 24 months
Diabetes Self-Care Behaviors
time frame: 24 months
Quality of Life
time frame: 24 months
Healthcare Utilization
time frame: 24 months

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Health Promoters and Pharmacists in Diabetes Team Management
Principal investigator Ben S Gerber, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.