Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence

NCT06374277 | Recruiting

• 1 other identifier: 23-09339-IAA
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 2

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; Arrythmia; Coronary Artery Disease; Congestive Heart Failure; Chronic Lung Disease; Chronic Kidney Diseases; Stroke; Depression; Anxiety; Pulmonary Embolism; Heart Attack

Outcome Measures

Primary Outcomes (1)

• 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).

  Adherence measured at 3, 6, 9, and 12 months

Secondary Outcomes (3)

• Health care utilization

  12 months

• Cost

  12 months

• Qualitative Evaluation

  1 month and 12 month

Study Arms (2)

Med AAAction intervention

ACTIVE COMPARATOR

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.

Other: Med AAAction intervention

Usual care Intervention

PLACEBO COMPARATOR

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.

Other: Med AAAction intervention

Interventions

Med AAAction intervention OTHER

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.

Med AAAction intervention; Usual care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicaid or uninsured inpatients
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead
• Sponsor GmbH: collaborator

Study Sites (2)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

NOT YET RECRUITING

University of Tennessee Health Science Center/Regional One Health

Memphis, Tennessee, 38103, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hypercholesterolemia; Hyperlipidemias; Coronary Artery Disease; Heart Failure; Renal Insufficiency, Chronic; Arrhythmias, Cardiac; Stroke; Depression; Anxiety Disorders; Pulmonary Embolism; Myocardial Infarction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Infarction; Ischemia; Necrosis

Study Officials

• Satya Surbhi, PhD

  UTHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satya Surbhi, PhD

CONTACT

646-438-0919; ssurbhi@uthsc.edu

Elizabeth A Tolley, PhD

CONTACT

901.422.6733; btolley@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 6, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)