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Behavioural Intervention

Pharmacy Intervention for Medication Adherence (MedAAAction Trial)

N/A
Recruiting
Led By Satya Surbhi, PhD
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
21 years or older
TennCare or uninsured inpatients
Must not have
Patients with primary reason for index admission related to cancer, pregnancy, or a surgical procedure for an acute problem
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adherence measured at 3, 6, 9, and 12 months
Awards & highlights

Summary

This trial aims to help low-income individuals with multiple chronic conditions improve their medication adherence after being discharged from the hospital. The study will test a new pharmacy-led intervention that includes providing medications with zero copay

Who is the study for?
This trial is for socioeconomically disadvantaged patients with multiple chronic conditions who have recently been discharged from the hospital. Participants must be Medicaid recipients or uninsured, and they should face challenges like financial issues, transportation difficulties, or systemic barriers to medication adherence.
What is being tested?
The Med AAAction intervention is being tested against usual care in a pragmatic randomized controlled trial. It includes free medications, bedside and home delivery of meds, plus support from pharmacy techs/health coaches for better access to meds and primary care follow-up.
What are the potential side effects?
Since this study focuses on improving medication adherence rather than testing new drugs, it does not directly involve side effects of interventions. However, participants may experience issues related to their existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I am either uninsured or covered by TennCare.
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I have 2 or more chronic conditions or take 2 or more medications for them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My hospital admission was due to cancer, pregnancy, or an urgent surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adherence measured at 3, 6, 9, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and adherence measured at 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to chronic disease medications
Secondary study objectives
Cost
Health care utilization
Qualitative Evaluation

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Med AAAction interventionActive Control1 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.
Group II: Usual care InterventionPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Sponsor GmbHOTHER
33 Previous Clinical Trials
10,272 Total Patients Enrolled
University of TennesseeLead Sponsor
195 Previous Clinical Trials
144,018 Total Patients Enrolled
2 Trials studying Stroke
2,182 Patients Enrolled for Stroke
Satya Surbhi, PhDPrincipal InvestigatorUTHSC
~259 spots leftby Sep 2027
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