Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)

Study Overview
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Brief Summary
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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.

Detailed Description
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This study examines HIV medication optimization (HIV-MOI) in a prospective, randomized (1:1 HIV-MOI: standard of care), clinical trial, comparing disease-specific clinical and humanistic outcomes in up to 200 adult African-Americans with HIV (1:1 men: women) and either diabetes mellitus type 2 (DM) and/or hypertension (HTN). Data will be collected from individual participants for a 2 year period. Once properly screened, consented and enrolled, medical records from participant's medical provider(s) will be obtained. Upon receipt of the medical records, research team personnel (working closely with the project biostatistician) will provide medical information only for those participants randomized to receive HIV-MOI to the study pharmacist. The study pharmacist then assesses the information to determine the clinical effectiveness and appropriateness of the current medical plan's medications. Upon completion, the study pharmacist will develop a prioritized medication problem list, create a plan, discuss/collaborate with the medical provider/healthcare team member as needed and then conduct the initial HIV-MOI visit with the patient. At the initial visit, an individualized care plan would be finalized with study participant input. Also at the initial HIV-MOI visit, the patient should receive an accurate (and reconciled with medical providers) personal medication record (PMR). Participants should also receive an individualized care plan called a medication action plan (MAP). The MAP can include non-pharmacological instructions and education. This may be guided in part by qualitative survey data obtained as part of the study visit. Follow-up visits will occur (ideally) not less than quarterly. Follow-up visits may occur face-to-face or using telecommunication methods. The study pharmacist will only be provided the medical information for the intervention group. Standard of care for pharmacists is not having access to medical information when providing HIV-MOI. Extracted data and study obtained data will be entered into the study database for analyses.

Official Title
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Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model

Conditions
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HIV/AIDS, Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Other: Medication optimization intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older African-American HIV positive At least one of the following: hypertension or diabetes type 2 Exclusion Criteria: Pregnant (at screening, may enroll 6 months post-delivery) Have a life expectancy < 2 years Refusal to provide medical record release

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: Participants will be randomized in a 1:1 ratio to either the intervention or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Optimization Intervention<br>This group will represent those participants whose medical records have been provided to the pharmacist. | Other: Medication optimization intervention<br>* Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).<br>* Other names: medication therapy management;|
| Active Comparator: Medication Optimization Control<br>This group will represent those participants whose medical records have not been provided to the pharmacist. | Other: Medication optimization intervention<br>* Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).<br>* Other names: medication therapy management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes mellitus | Participants will be assessed for improvement in clinical markers associated with diabetes | 6 months | 
| Hypertension | Participants will be assessed for improvement in clinical markers associated with hypertension. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Therapy Management, HIV, AIDS, Diabetes Melllitus, Type 2, Hypertension, Pharmacist, Medication optimization, MTM