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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Med AAAction intervention treatment?

Research shows that pharmacist-led interventions, like the Med AAAction treatment, can improve how well patients stick to their medication plans, leading to better health outcomes. Studies highlight that pharmacists are well-positioned to help patients take their medications correctly, which is crucial for successful treatment. ^{1 2 3 4 5}

Is the Pharmacy Intervention for Medication Adherence safe for humans?

The research articles reviewed do not provide specific safety data for the Pharmacy Intervention for Medication Adherence or its variations like Med AAAction intervention. They focus on improving medication adherence rather than evaluating safety. ^{1 6 7 8 9}

How is the Med AAAction intervention treatment different from other treatments for medication adherence?

The Med AAAction intervention is unique because it involves a pharmacy-based approach to improve medication adherence, focusing on personalized support and monitoring within community pharmacies, which is not typically part of standard treatments for medication adherence. ^{6 7 8 10 11}

Research Team

Satya Surbhi, PhD

Principal Investigator

UTHSC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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 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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence screening and monitoring. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review. [2019]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluating Pharmacist-Driven Interventions in a Primary Care Setting to Improve Proportion of Days Covered and Medication Adherence. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

Adherence: a review of education, research, practice, and policy in the United States. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Medication adherence communications in community pharmacies: A naturalistic investigation. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Implementation of targeted medication adherence interventions within a community chain pharmacy practice: The Pennsylvania Project. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Impact of pharmacy care upon adherence to cardiovascular medicines: a feasibility pilot controlled trial. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a pilot study to influence medication adherence of patients with diabetes mellitus type-2 by the pharmacy. [2021]

11. England 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. [2019]