Health Promoters and Pharmacists in Diabetes Team Management
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| Contact: Lauren Rapacki, MS | 312-413-1642 | lrapacki@uic.edu |
| United States, Illinois | |
| University of Illinois Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Ben S Gerber, MD, MPH | University of Illinois |
| Principal Investigator: | Lisa K Sharp, PhD | University of Illinois |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ben Gerber, Associate Professor of Medicine, University of Illinois |
| ClinicalTrials.gov Identifier: | NCT01498159 History of Changes |
| Other Study ID Numbers: | 2011-0099, R01DK091347 |
| Study First Received: | December 15, 2011 |
| Last Updated: | December 20, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Illinois:
|
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 June 17, 2013