Impact of Providing Medical Records in a Patient-Centered, Community Pharmacy Based, HIV Care Model (HIV-MOI)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), HIV / AIDS, Diabetes, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2018 |
| Start Date: | July 2018 |
| End Date: | July 2021 |
| Contact: | Patrick G Clay, PharmD |
| Email: | Patrick.Clay@unthsc.edu |
| Phone: | 8177352798 |
Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model
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 at a Walgreens community pharmacy in Dallas, Texas. The trial will
enroll adult, African-Americans with HIV. They must also have diabetes, high blood pressure
or both. Study participants will agree to have their medical records from all of their health
providers released to UNTHSC. UNTHSC will provide the Walgreens pharmacist the medical
records for half of the participants. Using the medical records, the pharmacist will provide
'enhanced' patient counseling services to half of the participants. This enhanced service is
called 'medication optimization'. For the half of participants that the 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 pharmacist will contact every participant to
check on them at least every 90 days. These visits will happen for 2 years. The groups will
be compared to see if those participants having medication optimization have better health
than those getting routine patient counseling.
have better health outcomes if their pharmacist has access to their medical records. The
study will take place at a Walgreens community pharmacy in Dallas, Texas. The trial will
enroll adult, African-Americans with HIV. They must also have diabetes, high blood pressure
or both. Study participants will agree to have their medical records from all of their health
providers released to UNTHSC. UNTHSC will provide the Walgreens pharmacist the medical
records for half of the participants. Using the medical records, the pharmacist will provide
'enhanced' patient counseling services to half of the participants. This enhanced service is
called 'medication optimization'. For the half of participants that the 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 pharmacist will contact every participant to
check on them at least every 90 days. These visits will happen for 2 years. The groups will
be compared to see if those participants having medication optimization have better health
than those getting routine patient counseling.
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 200 adult African-Americans with HIV (1:1 men: women) and either
diabetes mellitus type 2 (DM) and/or hypertension (HTN) (Figure 4) Data will be collected
from individual participants for a 2 year period with enrollment expected to be completed
within 2 years. Further details on recruitment, consenting, enrollment, randomization, data
collection and data safety monitoring are in Data Management and Statistical Analysis Plans
section.
Beginning in year 2 of the project, enrollment will commence. Once properly screened,
consented and enrolled, medical records from participant's medical provider(s) will be
obtained. Upon receipt of the medical records at the pharmacy, the study coordinator (working
closely with the project biostatistician) will provide only records belonging to those
participants randomized to receive HIV-MOI to the pharmacist. The HIV-MOI pharmacists then
assess the information and then analyze the clinical effectiveness and appropriateness of the
current medical plan's medications. Upon completion, the pharmacist will develop a
prioritized medication problem list, create a plan, discussed/collaborated with the medical
provider/healthcare team member and then set up an initial HIV-MOI visit with the patient. At
the initial visit, an individualized care plan would be implemented. Also at the initial
HIV-MOI visit, the patient receives an accurate (and reconciled with medical providers)
personal medication record (PMR) (Figure 3). Participants also receive an individualized care
plan called a medication action plan (MAP) (Figure 3). The MAP can include
non-pharmacological instructions and education and guided in part by data obtained in year 1
of Aim 2. Follow-up visits will occur not less than quarterly (more frequent visits may be
clinically indicated). Follow-up visits may occur face-to-face or using telecommunication
methods (phone, Skype, Face Time, etc.). Research study coordinator, a trained professional
with experience in medical chart review, will extract clinical data from the medical
information for both intervention and control groups. The 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 will be entered
into study database
HIV-MOI: standard of care), clinical trial, comparing disease-specific clinical and
humanistic outcomes in 200 adult African-Americans with HIV (1:1 men: women) and either
diabetes mellitus type 2 (DM) and/or hypertension (HTN) (Figure 4) Data will be collected
from individual participants for a 2 year period with enrollment expected to be completed
within 2 years. Further details on recruitment, consenting, enrollment, randomization, data
collection and data safety monitoring are in Data Management and Statistical Analysis Plans
section.
Beginning in year 2 of the project, enrollment will commence. Once properly screened,
consented and enrolled, medical records from participant's medical provider(s) will be
obtained. Upon receipt of the medical records at the pharmacy, the study coordinator (working
closely with the project biostatistician) will provide only records belonging to those
participants randomized to receive HIV-MOI to the pharmacist. The HIV-MOI pharmacists then
assess the information and then analyze the clinical effectiveness and appropriateness of the
current medical plan's medications. Upon completion, the pharmacist will develop a
prioritized medication problem list, create a plan, discussed/collaborated with the medical
provider/healthcare team member and then set up an initial HIV-MOI visit with the patient. At
the initial visit, an individualized care plan would be implemented. Also at the initial
HIV-MOI visit, the patient receives an accurate (and reconciled with medical providers)
personal medication record (PMR) (Figure 3). Participants also receive an individualized care
plan called a medication action plan (MAP) (Figure 3). The MAP can include
non-pharmacological instructions and education and guided in part by data obtained in year 1
of Aim 2. Follow-up visits will occur not less than quarterly (more frequent visits may be
clinically indicated). Follow-up visits may occur face-to-face or using telecommunication
methods (phone, Skype, Face Time, etc.). Research study coordinator, a trained professional
with experience in medical chart review, will extract clinical data from the medical
information for both intervention and control groups. The 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 will be entered
into study database
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
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