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Tailored Medication Management Intervention

A Tailored Medication Management Intervention for Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04717297
Enrollment
33
Registered
2021-01-22
Start date
2021-02-19
Completion date
2022-12-31
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Non Adherence, Polypharmacy

Keywords

Medication Management, Occupational Therapy, Older adults

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.

Detailed description

Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process. Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a one size fits all approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered. Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management. We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.

Interventions

BEHAVIORALMedication Management Remote Intervention

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.

BEHAVIORALWaitlist Control

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.

BEHAVIORALMedication Management In-Person Intervention

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention Modification Cost6 monthsadaptive equipment cost
Intervention Safety6 monthsNumber of therapy visits
Intervention Pharmacy Cost6 monthsPharmacist time
Intervention OT Cost6 monthsOT time
Recruitment6 monthsRecruitment and retention rate
Dose6 monthsTreatment minutes and number of treatment sessions
Treatment Fidelity6 monthsAbility to deliver required treatment session elements
Intervention Safety- ER Visits6 monthsNumber of ER visits
Intervention Safety- Hospitalizations6 monthsNumber of unplanned hospitalizations
Intervention Safety- Doctor Visits6 monthsNumber of unplanned doctor visits
Intervention Safety- Falls6 monthsNumber of falls

Secondary

MeasureTime frameDescription
Potentially Inappropriate Medications6 monthsBEERS Criteria for Inappropriate Medication Use in Older Patients
Equivalency6 monthsEquivalency of remote vs in person intervention on all primary outcome measures
Medication Management Ability6 monthsIn-Home Medication Management Evaluation (HOME-Rx) which includes measures of ability to independently manage mediations and barriers to medication management

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026