NCT06374277 Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence
| NCT ID | NCT06374277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2024-04-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 388 participants in total. It began in 2024-04-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.
Eligibility Criteria
Inclusion Criteria: * Medicaid or uninsured inpatients * 21 years or older * ≥2 of the complex chronic conditions during index admission or prescribed/using ≥2 chronic medications for these conditions * Patients receiving chronic disease medications from the hospital pharmacy. * Patients will be eligible if they have multiple complex chronic conditions including diabetes, hypertension, high cholesterol, coronary artery disease, congestive heart failure, chronic lung disease, chronic kidney disease, arrhythmia, stroke, psychiatric disorders including depression and anxiety, or who are prescribed or using anticoagulants. Exclusion Criteria: * Medicare and Medicaid dual eligible patients. * If the primary reason for the index admission is related to cancer, pregnancy, or a surgical procedure for an acute problem * If patients have diagnoses of active psychosis, substance abuse, or suicidal ideation during the index admission. * If the planned discharge location is not home. * If patients are part of an existing pharmacy discharge program.
Contact & Investigator
Satya Surbhi, PhD
PRINCIPAL INVESTIGATOR
UTHSC
Frequently Asked Questions
Who can join the NCT06374277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06374277 currently recruiting?
Yes, NCT06374277 is actively recruiting participants. Contact the research team at ssurbhi@uthsc.edu for enrollment information.
Where is the NCT06374277 trial being conducted?
This trial is being conducted at Knoxville, United States, Memphis, United States.
Who is sponsoring the NCT06374277 clinical trial?
NCT06374277 is sponsored by University of Tennessee. The principal investigator is Satya Surbhi, PhD at UTHSC. The trial plans to enroll 388 participants.
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