Communication ResearchNCT05751980
Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program
A study testing Med Wise Rx in people with Communication Research, run by University of Wisconsin, Madison at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Communication Research
- What is being tested?
- Med Wise Rx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jan 2023to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ADRC of Eau Claire County
Eau Claire, Wisconsin, 54703
Village of Greendale Public Health
Greendale, Wisconsin, 53129
Aging and Disability Resource Center (ADRC) of Kenosha County
Kenosha, Wisconsin, 53143
ADRC of Calumet, Outagamie & Waupaca County
Waupaca, Wisconsin, 54981
About this study
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.
Read the 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.
- Conditions
- Communication Research
- Being tested
- Med Wise Rx
- Keywords
- Comprehensive Medication Review, Older Adults, Pharmacists, Multiple Medications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med Wise RxBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Med Wise Rx | Experimental | An evidence-informed two-session interactive behavioral workshop. Participants will begin intervention within 3 weeks of enrollment. Receives: Behavioral: Med Wise Rx |
| Waitlist Control | Active comparator | Participants will be crossed over to Med Wise Rx intervention up to 2 months after enrollment. Receives: Behavioral: Med Wise Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start23 Jan 2023
- Primary completion25 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Martin, PhD, MS, RPh, FAPhA, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751980
- Sponsor's protocol ID
- 2022-1605
- Other IDs
- Pharmacy-Gen, Protocol Version 1/9/2024, A561000
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program
- ClinicalTrials.gov ID
- NCT05751980
- Acronym / sponsor ID
- 2022-1605
- Conditions
- Communication Research
- Keywords
- Comprehensive Medication Review, Older Adults, Pharmacists, Multiple Medications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Wait-list control, a mixed-methods approach incorporating surveys, observational data collection, and interviews
| Arm | Type | Receives |
|---|---|---|
| Med Wise Rx | Experimental | Behavioral: Med Wise RxAn evidence-informed two-session interactive behavioral workshop. Participants will begin intervention within 3 weeks of enrollment. |
| Waitlist Control | Active comparator | Behavioral: Med Wise RxParticipants will be crossed over to Med Wise Rx intervention up to 2 months after enrollment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- community-dwelling
- age 65 or older
- use 4 or more medications
- must have the cognitive ability to participate
- speak and read English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Med Wise RxThe 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. | Behavioural | Med Wise Rx, Waitlist Control |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Martin, PhD, MS, RPh, FAPhA principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med Wise Rx in people with Communication Research, run by University of Wisconsin, Madison at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.