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

NCT ID: NCT05751980

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-08-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Communication Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Med Wise Rx

An evidence-informed two-session interactive behavioral workshop. Participants will begin intervention within 3 weeks of enrollment.

Group Type EXPERIMENTAL

Med Wise Rx

Intervention Type BEHAVIORAL

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.

Waitlist Control

Participants will be crossed over to Med Wise Rx intervention up to 2 months after enrollment.

Group Type ACTIVE_COMPARATOR

Med Wise Rx

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth Martin, PhD, MS, RPh, FAPhA

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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ADRC of Eau Claire County

Eau Claire, Wisconsin, United States

Site Status

Village of Greendale Public Health

Greendale, Wisconsin, United States

Site Status

Aging and Disability Resource Center (ADRC) of Kenosha County

Kenosha, Wisconsin, United States

Site Status

ADRC of Calumet, Outagamie & Waupaca County

Waupaca, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Pharmacy-Gen

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/9/2024

Identifier Type: OTHER

Identifier Source: secondary_id

A561000

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1605

Identifier Type: -

Identifier Source: org_study_id

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