Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)
Part of paid clinical trials in Fort Worth, Texas.
- Sponsor
- University of North Texas Health Science Center
- Study ID
- NCT03437694
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Medication optimization intervention — OTHERPharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).
Study Details
This is a clinical trial. The purpose of this clinical trial is to see if study participants have better health outcomes if their pharmacist has access to their medical records. The study will take place primarily in Fort Worth and Dallas, Texas. The trial will enroll adult, African-Americans with HIV. Study participants must also have either diabetes, high blood pressure or they may have both. Study participants will agree to have their medical records from all of their health providers released to UNTHSC. UNTHSC will provide the study pharmacist the medical records for half of the participants. Using the medical records, the study pharmacist will provide 'enhanced' patient counseling services to half of the participants. This enhanced service is called 'medication optimization'. For half of the participants that the study pharmacist does not see the medical records, they will receive usual and customary patient counseling. Not seeing the medical records is considered standard of care. In both groups, the counseling frequency will be based on the participant's needs but the study pharmacist will contact every participant to check on them at least every 90 days. These visits will happen for 2 years. The two groups will be compared to see if those participants having medical information supported medication optimization have better health than those getting routine, the standard of care medication optimization.
Key Dates
- Start date
- Aug 3, 2018
- Status verified
- Jul 2025
- Primary completion
- Jan 31, 2024
- Completion
- Feb 27, 2025
Study Design
- Enrollment
- 129 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Medication Optimization InterventionThis group will represent those participants whose medical records have been provided to the pharmacist.
- Active Comparator: Medication Optimization ControlThis group will represent those participants whose medical records have not been provided to the pharmacist.
Primary Outcome Measure
Average A1c [ Time Frame: Through study completion, up to 3 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Crystal Hodge | Fort Worth | Texas | 76107 | - |
| University of North Texas Health Science Center | Fort Worth | Texas | 76107 | - |
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