About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Med AAAction intervention
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Adherence to chronic disease medications
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).
Secondary outcomes
Health care utilization
Short-term utilization outcomes will include primary care follow-up within 14 days of hospital discharge and 30-day readmissions, measured as binary outcomes (Y/N). Long-term utilization outcomes will include number of overall and preventable hospitalizations and ED visits assessed in the 12-month follow-up period. Observation visits will be combined with inpatient visits.
Cost
Costs will be assessed from the health system and payer perspectives. We will estimate the incremental net costs of the Med AAAction intervention compared to the usual care at each site over the period of the study. Our calculation will include both implementation costs and costs associated with hospitalizations and ED in the 12 months follow-up period. To determine costs associated with inpatient and ED visits, we will use results from Aim 2 to calculate total number of inpatient and ED visits in 12 months. For TennCare patients, we will use payment records from the claims data to estimate cost. For uninsured patients, we will use average reimbursement rates (charges) from TennCare to calculate costs for uninsured patients.
Qualitative Evaluation
We will conduct key informant interviews with participants in the intervention group at two timepoints during the study. The first timepoint will include participants who completed 1 month in the program. The second timepoint will be after the participants have completed 12 months in the program. Interviews conducted at 1 months will explore the patient experience with the intervention in the hospital and post-discharge and is designed to help assess the consistency in the delivery of the intervention and enable modifications or tailoring of the intervention, based on contextual factors, if needed. Interviews at 12 months will provide a similar assessment of the participant's experience and implementation of the intervention during the period where the participant is at home.
Sponsors and contacts
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University of Tennessee
Lead sponsor
Sponsor GmbH
Collaborator