NCT06374277 · University of Tennessee
Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence
(MedAAAction)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
Adherence to chronic disease medications
Time frame: Adherence measured at 3, 6, 9, and 12 months
Adherence to oral chronic disease medications will be assessed for the groups every 3 months using the pill count method (primary method). Additionally, we will measure patient self-reported adherence to chronic disease medications at 3-month, 6-month, and 12-month follow-up by using the following question "On how many of the last seven days, did you take your recommended medication" for each of their chronic disease medications (secondary method).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Knoxville, Tennessee
- Memphis, Tennessee
Collaborators
Sponsor GmbH
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations