Tailored Medication Management Intervention

NCT04717297 | Completed

• 1 other identifier: 202008139
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Non Adherence; Polypharmacy

Keywords

Medication Management; Occupational Therapy; Older adults

Outcome Measures

Primary Outcomes (11)

• 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

  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

Secondary Outcomes (3)

• Medication Management Ability

  6 months

• Potentially Inappropriate Medications

  6 months

• Equivalency

  6 months

Study Arms (3)

Tailored Medication Management Remote Intervention Treatment Arm

EXPERIMENTAL

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.

Behavioral: Medication Management Remote Intervention

Waitlist Attention Control Arm

SHAM COMPARATOR

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.

Behavioral: Waitlist Control

Tailored Medication Management In-Person Intervention Treatment Arm

EXPERIMENTAL

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.

Behavioral: Medication Management In-Person Intervention

Interventions

Medication Management Remote Intervention BEHAVIORAL

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.

Tailored Medication Management Remote Intervention Treatment Arm

Waitlist Control BEHAVIORAL

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.

Waitlist Attention Control Arm

Medication Management In-Person Intervention BEHAVIORAL

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.

Tailored Medication Management In-Person Intervention Treatment Arm

Eligibility Criteria

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

You may qualify if:

• and older
• takes 5 or more medications
• Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))

You may not qualify if:

• Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more
• Lives in institutional setting

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 40337485 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Occupational Therapy and Neurology

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: February 19, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

US (1)