Recruiting

Transitions of Care

Sponsor:

University of Tennessee

Code:

NCT06374277

Conditions

Diabetes

Hypertension

High Cholesterol/Hyperlipidemia

Coronary Artery Disease

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Med AAAction intervention

Study Details

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.

Conditions

Diabetes

Hypertension

High Cholesterol/Hyperlipidemia

Coronary Artery Disease

Congestive Heart Failure

Study ID

NCT06374277

Start date

Apr 6, 2024

Status verified date

Jan, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

388 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Med AAAction intervention

The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent 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 after hospital discharge. The intervention will be provided for one-year.

placebo comparator: Usual care Intervention

As part of the usual care, the participating hospitals provide medication reconciliation services before hospital discharge. Usual care may also include MTM services for patients discharged on specialty medications or Medicare beneficiaries. Patients in both groups will receive financial incentives for completing their baseline survey ($15), and 3-month ($15), 6-month ($15), and 12-month ($25) follow-up visits.

Interventions

Med AAAction intervention

The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent 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 after hospital discharge. The intervention will be provided for one-year.

Primary outcome measure

  • Adherence to chronic disease medications [ Time Frame: Adherence measured at 3, 6, 9, and 12 months ]

Central Contacts and Locations

Central contacts

Elizabeth A Tolley, PhD

901.422.6733btolley@uthsc.edu

Locations

University of Tennessee Health Science Center/Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

More Information

Sponsor

University of Tennessee

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee on 2026-01-29.