NCT04717297|Completed
Tailored Medication Management Intervention
A Tailored Medication Management Intervention for Older Adults
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A Tailored Medication Management Intervention for Older Adults
Sponsor study identifier
interventional
33
1 country
1
Study Start
February 19, 2021
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Successful medication management is an essential instrumental activity of daily living (IADL) for older adults with polypharmacy; however, between 40%-70% of older adults fail to take their medications as prescribed. Providing interventions to address medication management and restore performance for this IADL is within the scope of practice for occupational therapy (OT), however, there is paucity of evidence for OT interventions to improve medication management in community-dwelling older adults. We have developed a tailored medication management intervention (TIMM) for community-dwelling older adults which recognizes the unique context in which medication management occurs (the home) and addresses the personal and environmental barriers experienced by older adults. TIMM is delivered in the home, by an OT, and in collaboration with a pharmacist to reduce inappropriate polypharmacy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2021
Actual (reported)January 22, 2021
Actual (reported)February 19, 2021
Actual (reported)December 31, 2022
Actual (reported)December 31, 2022
Actual (reported)Recruitment
Recruitment and retention rate
6 months
Dose
Treatment minutes and number of treatment sessions
6 months
Treatment Fidelity
Ability to deliver required treatment session elements
6 months
Intervention Safety- ER Visits
Number of ER visits
6 months
Intervention Safety- Hospitalizations
Medication Management Ability
6 months
Potentially Inappropriate Medications
6 months
Equivalency
6 months
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely.
The attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person.
First, the study pharmacist reviews the older adult's medication for potentially inappropriate medications. The pharmacist collaborates with the prescribing physician(s) to deprescribe as indicated. The pharmacist educates the older adult and OT on any changes that were made. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT provides training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered remotely.
Washington University
St Louis, Missouri, 63110, United States
Somerville E, Bollinger R, Keleman A, Haxton M, Sarrami B, Chen SW, Holden B, Yan Y, Stark S. Tailored medication management intervention delivered by occupational therapists for older adults: A study protocol. Br J Occup Ther. 2023 Apr;86(4):257-264. doi: 10.1177/03080226221135366. Epub 2023 Mar 21.
33 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2021
First Posted
January 22, 2021
Study Start
February 19, 2021
Actual (reported)Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
Number of unplanned hospitalizations
6 months
Intervention Safety- Doctor Visits
Number of unplanned doctor visits
6 months
Intervention Safety- Falls
Number of falls
6 months
Intervention Safety
Number of therapy visits
6 months
Intervention Pharmacy Cost
Pharmacist time
6 months
Intervention OT Cost
OT time
6 months
Intervention Modification Cost
adaptive equipment cost
6 months
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person.
A trained research assistant will complete two attention control visits in the homes of participants. Visit will consist of semi-structured interview exploring the participant's life history.
Participants in the waitlist control will be offered the medication management intervention to be completed in person. If they consent, the study pharmacist will review their medication for potentially inappropriate medications. The pharmacist will collaborate with the prescribing physician(s) to deprescribe any inappropriate medication as indicated. The pharmacist will educate the older adult and OT on any changes. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants will receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT will provide training and active practice of the compensatory strategies and supports in the home in an effective and safe manner. All components of the intervention will be delivered in person.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
March 1, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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