protocolSection identificationModule nctId: NCT06374277, orgStudyIdInfo id: 23-09339-IAA, briefTitle: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence, acronym: MedAAAction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Tennessee, class: OTHER, collaborators name: Sponsor GmbH, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes, conditions: Hypertension, conditions: High Cholesterol/Hyperlipidemia, conditions: Coronary Artery Disease, conditions: Congestive Heart Failure, conditions: Chronic Lung Disease, conditions: Chronic Kidney Diseases, conditions: Arrythmia, conditions: Stroke, conditions: Depression, conditions: Anxiety, conditions: Pulmonary Embolism, conditions: Heart Attack, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible patients who sign consent forms and complete baseline surveys will be randomized to the Med AAAction intervention group or the usual care in a 1:1 ratio, stratified by health system. The participants will be enrolled before hospital discharge. 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 388, type: ESTIMATED, armsInterventionsModule interventions name: Med AAAction intervention, outcomesModule primaryOutcomes measure: Adherence to chronic disease medications, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Cost, secondaryOutcomes measure: Qualitative Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Tennessee Medical Center, status: NOT_YET_RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: Shauntá M Chamberlin, role: CONTACT, phone: 865-305-5061, email: schamberlin@utmck.edu, geoPoint lat: 35.96064, lon: -83.92074, locations facility: University of Tennessee Health Science Center/Regional One Health, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38103, country: United States, contacts name: Kay Ryan, PharmD, role: CONTACT, phone: 901-545-7840, email: kryan@regionalonehealth.org, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False