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| ID | Type | Description | Link |
|---|---|---|---|
| Pharmacy-Gen | Other Identifier | UW Madison | |
| Protocol Version 1/9/2024 | Other Identifier | UW Madison | |
| A561000 | Other Identifier | UW Madison |
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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.
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:
Protocol Amendment 1/31/24 to remove 6-month follow up time point for cohorts enrolled this spring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Med Wise Rx | Experimental | An evidence-informed two-session interactive behavioral workshop. Participants will begin intervention within 3 weeks of enrollment. |
|
| Waitlist Control | Active Comparator | Participants will be crossed over to Med Wise Rx intervention up to 2 months after enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Martin, PhD, MS, RPh, FAPhA | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADRC of Eau Claire County | Eau Claire | Wisconsin | 54703 | United States | ||
| Village of Greendale Public Health |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2023 | Aug 28, 2024 | ICF_000.pdf |
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Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews
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| 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) |
| Greendale |
| Wisconsin |
| 53129 |
| United States |
| Aging and Disability Resource Center (ADRC) of Kenosha County | Kenosha | Wisconsin | 53143 | United States |
| ADRC of Calumet, Outagamie & Waupaca County | Waupaca | Wisconsin | 54981 | United States |