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

Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting

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.

Study Overview

• Status: Terminated
• Conditions: Polypharmacy; Multi-morbidity; Medication Therapy Management
• Intervention / Treatment: Other: TAPER

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P 1H6
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TAPERMD; 80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities

Other: TAPER; The intervention is medication reduction. This arm is comprised of: Medication reconciliation; Identification of patient priorities for care; Identification of medications that are potentially appropriate for discontinuation/dose reduction; Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce; Identification of medications for trial of discontinuation/dose reduction (shared decision making); Pause of medication and clinical monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)	Difference in mean number of medications; number of medications reduced in dose	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility-related Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Level of Physical Functioning	Manty survey	Baseline, 6 Months
Pain	Brief Pain Inventory	Baseline, 6 Months
Falls	Total count of falls recorded in hospital admissions, primary care records and patient report	Baseline, 6 Months
Sleep	Pittsburgh Sleep Quality Index	Baseline, 6 Months
Decrease in Medication Side Effects and Symptoms	Patient self-report change in symptoms, side effects, health improvements and problems	1-week, 3-month, 6-month
Serious Adverse Events	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)	1-week, 3-month, 6-month
Quality of Life	EQ5D-5L	Baseline, 6-months
Physical Functioning Performance	Timed-up and go Test	Baseline, 6-months
Physical Functioning Performance	Timed 8-foot walk test	Baseline, 6-months
Performance of Activities of Daily Living	Barthel Index	Baseline, 6-months
Strength	Hand grip	Baseline, 6-months
Functional Ability	Functional ability scale for the elderly	Baseline, 6-months
Healthcare Utilization	Cost of hospitalizations	Baseline, 6-months
Healthcare Utilization	Count of Emergency room visits	Baseline, 6-months
Healthcare Utilization	Number of clinic visits	Baseline, 6-months
Feasibility Outcomes	Number of participants that refuse recruitment	6 months
Feasibility Outcomes	Retention rates	6 months
Feasibility Outcomes	number of canceled appointments	Baseline, 6 months
Feasibility Outcomes	Time to complete measures	Baseline, 6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Labarge Optimal Aging Initiative

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Polypharmacy; eHealth; Mobility; Patient Preference; Multimorbidity; Drug Discontinuation
• Other Study ID Numbers: TAPER-Mobility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No