Clinical trial NCT05751980: Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program
Official title: Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication Research
Keywords: Comprehensive Medication Review
Older Adults
Pharmacists
Multiple Medications
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 121
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Participant Reported CMRs
timeFrame: 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)
measure: Change in Communication Confidence measured by validated Participant Survey
timeFrame: 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)
measure: Change in Worries as measured by Participant Survey
timeFrame: 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)
measure: Change in Knowledge about what a pharmacist can do to help as measured by Participant Survey
timeFrame: baseline, 8 weeks post-intervention (up to 12 weeks on study)
measure: Change in Number of Services Requested
timeFrame: 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)
measure: Number of Changes in Medication List or Schedule
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Eau Claire
country: United States
facility: ADRC of Eau Claire County
state: Wisconsin
city: Greendale
country: United States
facility: Village of Greendale Public Health
state: Wisconsin
city: Kenosha
country: United States
facility: Aging and Disability Resource Center (ADRC) of Kenosha County
state: Wisconsin
city: Waupaca
country: United States
facility: ADRC of Calumet, Outagamie & Waupaca County
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Beth Martin, PhD, MS, RPh, FAPhA
role: PRINCIPAL_INVESTIGATOR
References: