Health Promoters and Pharmacists in Diabetes Team Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Health Promoters and Pharmacists in Diabetes Team Management

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist + Health Promoter<br>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<br> <br> Behavioral: Pharmacist-patient encounters<br> <br> Behavioral: Pharmacist medication intensification and adherence support<br> <br> Behavioral: Pharmacist communication with primary care physicians<br> <br> Behavioral: Pharmacist documentation in electronic medical record<br> <br> Behavioral: Health promoter-patient encounters in-person or by phone<br> <br> Behavioral: Health promoter medication and lifestyle support<br> <br> Behavioral: Health promoter communication with pharmacists<br> <br> |
| Active Comparator: Pharmacist<br>Participants will receive support from pharmacist. | Behavioral: Pharmacist disease/medication management<br> <br> Behavioral: Pharmacist-patient encounters<br> <br> Behavioral: Pharmacist medication intensification and adherence support<br> <br> Behavioral: Pharmacist communication with primary care physicians<br> <br> Behavioral: Pharmacist documentation in electronic medical record<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Hemoglobin A1c | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Knowledge | Diabetes Knowledge | 24 months | 
| Autonomous Self-Regulation | Autonomous Self-Regulation | 24 months | 
| Perceived Competence | Perceived Competence | 24 months | 
| Medication Adherence | Medication Adherence | 24 months | 
| Body mass index | Body mass index | 24 months | 
| Diabetes Self-Care Behaviors | Diabetes Self-Care Behaviors | 24 months | 
| Quality of Life | Quality of Life | 24 months | 
| Healthcare Utilization | Healthcare Utilization | 24 months | 
| Systolic Blood Pressure | Systolic Blood Pressure | 24 months | 
| Diastolic Blood Pressure | Diastolic Blood Pressure | 24 months | 
| LDL Cholesterol | LDL Cholesterol | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Pharmacists, Community Health Aides