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

NCT05751980 | Completed

• 4 other identifiers: 2022-1605Pharmacy-GenProtocol Version 1/9/2024A561000
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 4

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.

Conditions

Communication Research

Keywords

Comprehensive Medication Review; Older Adults; Pharmacists; Multiple Medications

Outcome Measures

Primary Outcomes (6)

• Change in Number of Participant Reported CMRs

  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

  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

  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 Knowledge about what a pharmacist can do to help as measured by Participant Survey

  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 Services Requested

  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

  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)

Study Arms (2)

Med Wise Rx

EXPERIMENTAL

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

Behavioral: Med Wise Rx

Waitlist Control

ACTIVE COMPARATOR

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

Behavioral: Med Wise Rx

Interventions

Med Wise Rx 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.

Med Wise Rx; Waitlist Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (4)

ADRC of Eau Claire County

Eau Claire, Wisconsin, 54703, United States

Location

Village of Greendale Public Health

Greendale, Wisconsin, 53129, United States

Location

Aging and Disability Resource Center (ADRC) of Kenosha County

Kenosha, Wisconsin, 53143, United States

Location

ADRC of Calumet, Outagamie & Waupaca County

Waupaca, Wisconsin, 54981, United States

Location

Study Officials

• Beth Martin, PhD, MS, RPh, FAPhA

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: January 23, 2023
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)