Clinical trial NCT06374277: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence
Official title: Pharmacy-led Transitions of Care Intervention to Address System-Level Barriers and Improve Medication Adherence in Socioeconomically Disadvantaged Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Hypertension
High Cholesterol/Hyperlipidemia
Coronary Artery Disease
Congestive Heart Failure
Chronic Lung Disease
Chronic Kidney Diseases
Arrythmia
Stroke
Depression
Anxiety
Pulmonary Embolism
Heart Attack
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2024-04-18
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Care transitions are a critical time for managing medications. Socioeconomically disadvantaged populations with multiple chronic conditions (MCC) and polypharmacy have high rates of medication discrepancies and nonadherence to essential chronic disease medications following hospitalization. Medication nonadherence after hospital discharge is significantly associated with increases in readmissions, costs, and mortality among patients with MCC. Barriers to medication adherence for low-income patients are particularly acute during care transitions from the hospital to the community setting, where patients experience difficulties accessing and affording essential medications. Studies including our own, have shown that major patient-reported barriers to essential medication use after hospital discharge among low-income, primarily African American individuals are related to social determinants of health (SDOH) and include: 1) financial barriers (i.e., inability to afford medications), 2) transportation barriers (i.e., inability to access prescribed medications or needed follow-up care), and 3) system-level barriers (i.e., lack of availability of discharge medications and care coordination services to ensure rapid primary care follow-up).

Although medication therapy management (MTM) and medication reconciliation services are important during care transitions, these services have not proven effective in improving essential medication use and adherence after hospital discharge, highlighting a critical need for innovative interventions that address the major barriers to adherence following hospitalization. The PI Dr. Surbhi's pilot research has demonstrated the feasibility and potential to improve medication adherence among adult Medicaid and uninsured inpatients by directly addressing these barriers through full medication subsidy and bedside and subsequent home delivery of medications. Additionally, our previous research demonstrates that care coordination services provided by pharmacy technicians trained as coaches effectively increases rapid primary care follow-up after hospital discharge and has potential to help improve medication adherence. However, the effectiveness of interventions that directly address affordability, accessibility, and availability to improve post-discharge medication adherence in vulnerable populations is still unknown.

The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will examine the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital inpatients with MCC from three large non-profit healthcare systems serving a disproportionate share of low-income patients in Tennessee. The Med AAAction intervention will consist of 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. Furthermore, to understand patient experience with the care received during and after care transitions, we will obtain qualitative data through interviews with patients enrolled in the study. This study has a long-term goal to demonstrate the effectiveness of a care transitions adherence intervention model for vulnerable populations that can be readily adopted and sustained by health care delivery systems across the US. The specific aims are as follows:

Aim 1: To test the effectiveness of the intervention on essential chronic disease medication adherence (primary outcome) assessed by pill counts and a patient-reported adherence scale. Hypothesis: Intervention group participants will have higher mean adherence at 12 months compared with those randomized to the usual care.

Aim 2: To test the effectiveness of the intervention on following secondary outcomes:

Aim 2a. Health care utilization outcomes including: 1) primary care follow-up within 14 days of hospital discharge, 2) 30-day readmissions, 3) overall and preventable hospitalizations at one year, and 4) overall and preventable emergency department (ED) visits at one year using Tennessee Medicaid claims data and electronic medical records. Hypothesis: Intervention group participants will be more likely to have rapid primary care follow-up, less likely to have 30-day readmissions, and will have lower incidence of hospitalizations and ED visits over a one-year period compared with those randomized to usual care.

Aim 2b: Net cost savings associated with avoidable hospitalization and ED visits. Hypothesis: The intervention group will incur lower costs compared to usual care.

Aim 3: To understand study participants' experience with the intervention received during and after care transitions using qualitative key informant interviews.

Impact: By examining the effects of the intervention on medication adherence, health care utilization, costs, and patient experience, the study will provide valuable results to help health systems, payers, and policymakers achieve the Triple Aim - improving health outcomes and patient experience and reducing costs, among socioeconomically disadvantaged populations.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to chronic disease medications
timeFrame: Adherence measured at 3, 6, 9, and 12 months
Secondary outcomes:
measure: Health care utilization
timeFrame: 12 months
measure: Cost
timeFrame: 12 months
measure: Qualitative Evaluation
timeFrame: 1 month and 12 month
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center/Regional One Health
state: Tennessee
Study officials:
affiliation: UTHSC
name: Satya Surbhi, PhD
role: PRINCIPAL_INVESTIGATOR
References: