Pharmacy Intervention for Medication Adherence

(MedAAAction Trial)

Recruiting at 1 trial location

Overseen By Satya Surbhi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee

Must be taking: Chronic disease medications

Disqualifiers: Cancer, Pregnancy, Active psychosis, others

Compensation: Varies

Number of Visits: 6

388 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help individuals with complex chronic conditions adhere to their medication routines after hospital discharge. The study compares a pharmacy-led program, called the Med AAAction intervention, with usual care to determine which better supports timely medication adherence, reduces hospital visits, and lowers costs. Participants in the program receive free medication delivery to their hospital bed and home, along with support from pharmacy technicians or health coaches. Suitable candidates include those relying on Medicaid or without insurance, managing two or more chronic conditions like diabetes or heart issues, and using multiple medications. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions that could enhance medication management for many.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on improving medication adherence and access, so it's likely you will continue your current medications with additional support.

What prior data suggests that this pharmacy intervention is safe for socioeconomically disadvantaged populations?

Research shows that pharmacist-led programs, such as the Med AAAction intervention, are generally easy for people to manage. Studies have found that when pharmacists assist patients with their medication plans, adherence improves and health outcomes follow suit. These programs present no major safety concerns. Instead, they enhance medication management, increasing the likelihood of patients taking their medications as prescribed without negative side effects.

The Med AAAction intervention focuses on simplifying access to medications. It includes providing medications for free and delivering them directly to patients' homes. These measures, along with support from pharmacy technicians and health coaches, aim to eliminate barriers to medication adherence.

In terms of safety, this type of program is not only safe but also effective in ensuring patients maintain their treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Med AAAction intervention because it offers a fresh approach to improving medication adherence after hospital discharge. Unlike typical care, which often involves patients picking up prescriptions themselves, this intervention provides medications with zero copay, bedside delivery, and home delivery, making access much easier. Additionally, certified pharmacy technicians and health coaches offer care coordination to ensure patients have ongoing support, which is a game-changer in preventing medication-related issues and improving overall health outcomes. This comprehensive approach aims to reduce the barriers many patients face, potentially leading to better long-term health results.

What evidence suggests that the Med AAAction intervention is effective for improving medication adherence?

Research has shown that programs designed to help people take their medications can significantly impact health outcomes. One study found that when community pharmacists led these programs, participants adhered better to their medication regimens and experienced improved health results. Another study discovered that nearly half of the strategies tested led to more regular medication adherence. This increased likelihood of following doctor's instructions can enhance health and reduce hospital visits. The CDC states that maintaining medication adherence can help manage long-term diseases and lower death rates from these conditions. In this trial, participants will receive either the Med AAAction intervention or usual care. These findings suggest that the Med AAAction program, which includes components like zero copay medications and care coordination, could effectively help people manage their medications better after leaving the hospital. ^{1 6 7 8 9}

Who Is on the Research Team?

Satya Surbhi, PhD

Principal Investigator

UTHSC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 21 years old or older.

I am either uninsured or covered by TennCare.

I get my long-term medication from the hospital pharmacy.

Exclusion Criteria

Patients with diagnoses of active psychosis, substance abuse, or suicidal ideation during the index admission

Medicare and Medicaid dual eligible patients

Patients with planned discharge location not home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Med AAAction intervention, which includes medications with zero copay, bedside delivery, home delivery, and care coordination by pharmacy technicians/health coaches.

12 months

Regular follow-up visits every 3 months

Follow-up

Participants are monitored for medication adherence, healthcare utilization, and costs. Key informant interviews are conducted to assess patient experience.

12 months

Follow-up visits at 3, 6, 9, and 12 months

Qualitative Evaluation

Key informant interviews conducted at 1 month and 12 months to explore patient experience with the intervention.

1 month and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Med AAAction intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Med AAAction intervention Active Control 1 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 Intervention Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Sponsor GmbH

Collaborator

Trials

36

Recruited

11,000+

Published Research Related to This Trial

A qualitative study involving 15 pharmacists from Rite Aid in Pennsylvania identified key facilitators and barriers to implementing targeted medication adherence interventions, emphasizing the importance of aligning patient care programs with the pharmacy's corporate vision.

The study highlighted five critical themes for successful implementation, including the need for individualized support for pharmacists, proactive identification of potential barriers, and fostering active patient engagement in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of targeted medication adherence interventions within a community chain pharmacy practice: The Pennsylvania Project. Bacci, JL., McGrath, SH., Pringle, JL., et al.[2022]

A study involving 60 participants across 78 community pharmacies revealed that pharmacists were often inconsistent in addressing medication adherence, failing to ask about questions or provide adequate consultations.

The findings highlight a significant need for improved systems in pharmacy practice to better educate patients and monitor medication adherence, as insurers also rarely contacted participants about adherence issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence communications in community pharmacies: A naturalistic investigation. Rickles, NM., Young, GJ., Hall, JA., et al.[2017]

A survey of 123 pharmacy interns in Ireland revealed that half felt uncomfortable discussing medication adherence with patients, indicating a need for better training in communication skills.

Interns with positive attitudes towards medication monitoring were more likely to offer adherence advice, but factors like the type of pharmacy and time pressures negatively impacted their willingness to engage, suggesting that educational programs should address these contextual barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication monitoring attitudes and perceived determinants to offering medication adherence advice to older hypertensive adults: a factorial survey of community pharmacy interns. Dillon, P., Smith, SM., Gallagher, P., et al.[2019]

Pharmacist-led interventions significantly improved blood pressure control in patients with hypertension, with 29 out of 35 studies showing positive results, indicating their effectiveness in managing this chronic condition.

Additionally, these interventions also enhanced medication adherence in patients, with 9 out of 20 studies demonstrating significant improvements, highlighting the role of pharmacists in supporting patients' treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist Interventions in the Management of Blood Pressure Control and Adherence to Antihypertensive Medications: A Systematic Review of Randomized Controlled Trials. Reeves, L., Robinson, K., McClelland, T., et al.[2022]

In a study involving patients with low medication adherence, pharmacist interventions significantly improved adherence scores for ACE inhibitors/ARBs and statins, with notable increases in PDC scores from baseline to post-intervention.

The study identified 89 barriers to medication adherence and implemented 208 interventions, demonstrating that clinical pharmacists can effectively address adherence issues in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Pharmacist-Driven Interventions in a Primary Care Setting to Improve Proportion of Days Covered and Medication Adherence. Davis, DD., Hale, G., Moreau, C., et al.[2023]

The 'Support for Diabetes' intervention, designed to improve adherence to type 2 diabetes treatment, was found to be feasible and well-received by both pharmacy teams and patients, indicating its potential for implementation in community pharmacies.

Challenges such as poor cooperation with general practitioners and lack of financial compensation were identified as barriers to broader implementation, highlighting the need for collaboration among pharmacists, policymakers, and researchers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pilot study to influence medication adherence of patients with diabetes mellitus type-2 by the pharmacy. Adhien, P., van Dijk, L., de Vegter, M., et al.[2021]

Community pharmacist-led interventions significantly improve medication adherence and health outcomes, particularly in managing blood pressure, cholesterol, and respiratory conditions, based on a review of 22 studies.

However, these interventions did not show statistically significant effects on managing diabetes or depression, indicating that their effectiveness may vary by condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review. Milosavljevic, A., Aspden, T., Harrison, J.[2019]

A pharmacy care intervention involving motivational interviews significantly improved medication adherence among 71 patients with acute coronary syndrome, with adherence scores at 3 months showing a notable difference between the intervention group and controls (p=0.026).

While the intervention was well-received and showed promise in enhancing adherence, no significant differences were found in clinical outcomes like blood pressure or cholesterol levels over the 6-month period, indicating the need for further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacy care upon adherence to cardiovascular medicines: a feasibility pilot controlled trial. M A Jalal, ZS., Smith, F., Taylor, D., et al.[2022]

A review of 29 studies on pharmacist interventions to improve medication adherence revealed that while many interventions showed positive effects, these effects often diminished once the interventions were stopped, indicating a need for sustainable practices.

Pharmacy education is evolving to emphasize the importance of teaching adherence-related skills, but many community pharmacists do not routinely assess or intervene on medication adherence, highlighting a gap between training and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence: a review of education, research, practice, and policy in the United States. Rickles, NM., Brown, TA., Mcgivney, MS., et al.[2021]

A new framework was developed to help pharmacy teams create strategies for improving medication adherence, which was tested by 10 pharmacy teams during a pilot day involving 325 patient encounters.

The framework was well-received by pharmacy teams, who found it feasible and adaptable, with 64% of patients fitting the target profile and 22.5% receiving adherence counseling, indicating its potential effectiveness in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a framework for defining a strategy to address medication adherence during patient encounters in community pharmacies. Baumgartner, PC., Comment, N., Hersberger, KE., et al.[2022]

Pharmacists play a crucial role in improving patient adherence to medications through activities like screening, monitoring, and providing memory aids, which can lead to better health outcomes.

Utilizing technology can enhance pharmacists' ability to manage adherence programs, emphasizing that these services can be independent of traditional medication distribution, ultimately benefiting patients and healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence screening and monitoring. Felkey, BG.[2019]

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