Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care

Terminated

• Conditions: Multi-morbidity; Polypharmacy; Medication Therapy Management
• Interventions: Other: TAPER

• Registration Number: NCT03202264
• Lead Sponsor: McMaster University

Brief Summary

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes, including mobility. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. The study will also assess for any signals of reversal of medications related mobility impairments to reduce medications-related mobility impairment (fatigue, pain, falls) using the intervention. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. Findings will inform the design of a randomized controlled trial to test the effect of this intervention on health outcomes.

Detailed Description

There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community. The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility. The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events. TAPERMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines, supporting evidence tools and a monitoring pathway to support medication reduction. This study will examine the feasibility of this tool in a long-term care setting as well as examine. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. Findings will inform a randomized controlled trial to measure the effect of this intervention on health outcomes.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2017-07-01
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2021-08
• Results First Submitted: 2021-08-11
• Results First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Results First Posted: 2021-09-08
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• residing in 2 long-term care facilities in Brampton, ON
• on 5 or more medications
• 70 years of age or older
• adequate English language

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAPERMD	TAPER	80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities

Primary Outcome Measures

Name	Time	Method
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)	6 months	Difference in mean number of medications; number of medications reduced in dose

Secondary Outcome Measures

Name	Time	Method
Pain	Baseline, 6 Months	Brief Pain Inventory
Performance of Activities of Daily Living	Baseline, 6-months	Barthel Index
Mobility-related Fatigue	Baseline, 6 months	Avlund Mob-T Scale
Level of Physical Functioning	Baseline, 6 Months	Manty survey
Falls	Baseline, 6 Months	Total count of falls recorded in hospital admissions, primary care records and patient report
Sleep	Baseline, 6 Months	Pittsburgh Sleep Quality Index
Serious Adverse Events	1-week, 3-month, 6-month	Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)
Quality of Life	Baseline, 6-months	EQ5D-5L
Decrease in Medication Side Effects and Symptoms	1-week, 3-month, 6-month	Patient self-report change in symptoms, side effects, health improvements and problems
Strength	Baseline, 6-months	Hand grip
Healthcare Utilization	Baseline, 6-months	Number of clinic visits
Feasibility Outcomes	Baseline, 6 months	Time to complete measures
Physical Functioning Performance	Baseline, 6-months	Timed 8-foot walk test
Functional Ability	Baseline, 6-months	Functional ability scale for the elderly

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada