Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program

August 28, 2024 updated by: University of Wisconsin, Madison
This study's overall goal is to enhance older adults' communication skills to access medication information and services to manage their medications safely and effectively. Med Wise Rx is an online 2-session program to improve communication skills for accessing medication information and services, leading to improved medication management. 160 adults age 65 years or older taking 4 or more medications will be on study for up to 9 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study's overall goal is to enhance older adults' communication skills to access medication information and services to manage their medications safely and effectively. Older adults are 2-3 times more likely to experience adverse drug events (ADEs) which are linked to falls, morbidity, hospitalization, loss of independence and death. More complicated regimens, poor adherence and poor communication contribute to this greater risk.

The Med Wise Rx Program is an evidence-informed two-session interactive behavioral workshop that has been delivered in partnership with Aging and Disability Resource Centers (ADRCs) who informed the program design. This program was evaluated with 198 older adults in 8 Wisconsin counties and found a significant increase in participants' reported self-efficacy, communication skills and requests for medication checkups or comprehensive medication reviews (CMRs). There is a need for updating the Med Wise Rx program for dissemination virtually and to systematically examine the new design's effectiveness and implementation in organizations serving older adults.

The study team will conduct a Type 2 hybrid effectiveness-implementation study of Med Wise Rx delivered through a new technology-supported mode of education. A randomized patient to group treatment trial with a waitlist control group for older adults and/or caregivers aged 65 or older will be used. A mixed-methods approach will be used, incorporating surveys, observational data collection, and interviews. The RE-AIM Framework will guide and inform the processes. In collaboration with the Community Academic Aging Research Network (CAARN) and five community partners associated with 7 counties, this dissemination and implementation study will:

  • AIM 1. Refine strategies to disseminate and implement the Med Wise Rx communication program through enhanced digital delivery methods.
  • AIM 2. Develop a facilitator training program that maximizes Med Wise Rx delivery fidelity in its new format.
  • AIM 3. Evaluate the reach, effectiveness, adoption/ acceptability, implementation/ enactment, and maintenance of the Med Wise Rx program delivery by Aging and Disability Resource Centers (ADRCs) and participants at 8 weeks and 6 months post-delivery.

Protocol Amendment 1/31/24 to remove 6-month follow up time point for cohorts enrolled this spring.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • ADRC of Eau Claire County
      • Greendale, Wisconsin, United States, 53129
        • Village of Greendale Public Health
      • Kenosha, Wisconsin, United States, 53143
        • Aging and Disability Resource Center (ADRC) of Kenosha County
      • Waupaca, Wisconsin, United States, 54981
        • ADRC of Calumet, Outagamie & Waupaca County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • community-dwelling
  • age 65 or older
  • use 4 or more medications
  • must have the cognitive ability to participate
  • speak and read English
  • be able to use a computer

Exclusion Criteria:

  • unable to attend either of the two Med Wise sessions (the first or the second, wait-listed control)
  • under age 65
  • unable to read/write English
  • taking fewer than 4 chronic medications
  • did not pass cognitive screener

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Med Wise Rx
An evidence-informed two-session interactive behavioral workshop. Participants will begin intervention within 3 weeks of enrollment.
Behavioral: Med Wise Rx
The program consists of two 120-minute classes led by trained community site-based facilitators, designed to help older adults communicate more effectively with their pharmacists.
Active Comparator: Waitlist Control
Participants will be crossed over to Med Wise Rx intervention up to 2 months after enrollment.
Behavioral: Med Wise Rx
The program consists of two 120-minute classes led by trained community site-based facilitators, designed to help older adults communicate more effectively with their pharmacists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knowledge about what a pharmacist can do to help as measured by Participant Survey
Time Frame: baseline, 8 weeks post-intervention (up to 12 weeks on study)
Participant Survey has 6 items, scored yes, no, and unsure. A change in participant response for each item will be reported.
baseline, 8 weeks post-intervention (up to 12 weeks on study)
Change in Number of Participant Reported CMRs
Time Frame: 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Specific questions included on survey tool will identify whether participant's report receiving a CMR, verifying (via protocol) Hometown Pharmacy CMRs reported.
8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Change in Communication Confidence measured by validated Participant Survey
Time Frame: baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
The participant survey has 24 items and follows Bandura's self-efficacy theory and 0-10 scale. Total score (0-240) and individual items using repeated measures ANOVA will be used (survey administered at all 3 time points). Higher scores indicate increased communication confidence.
baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Change in Worries as measured by Participant Survey
Time Frame: baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
The survey has 7-items scored on a 0-3 scale Total score of 0-21 with higher scores indicating increased worries.
baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Change in Number of Services Requested
Time Frame: baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
In addition to the participant CMR request, this measure captures the number of other reasons the participants have visited the pharmacist for.
baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Number of Changes in Medication List or Schedule
Time Frame: baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)
Changes in a medication list or schedule (i.e. time of day) that can improve medication safety and efficacy for older adults will be tallied.
baseline, 8 weeks post-intervention (up to 12 weeks on study), 6 months post-intervention (up to 9 months on study for cohorts enrolled prior to Spring 2024)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Beth Martin, PhD, MS, RPh, FAPhA, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Actual)

August 25, 2024

Study Completion (Actual)

August 25, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-1605
  • A561000 (Other Identifier: UW Madison)
  • Pharmacy-Gen (Other Identifier: UW Madison)
  • Protocol Version 1/9/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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