Clinical trial NCT03202264: Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care
Official title: Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multi-morbidity
Medication Therapy Management
Polypharmacy
Keywords: Polypharmacy
Mobility
Multimorbidity
Drug Discontinuation
Patient Preference
eHealth
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Labarge Optimal Aging Initiative
First posted: 2017-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)
timeFrame: 6 months
Secondary outcomes:
measure: Mobility-related Fatigue
timeFrame: Baseline, 6 months
measure: Level of Physical Functioning
timeFrame: Baseline, 6 Months
measure: Pain
timeFrame: Baseline, 6 Months
measure: Falls
timeFrame: Baseline, 6 Months
measure: Sleep
timeFrame: Baseline, 6 Months
measure: Decrease in Medication Side Effects and Symptoms
timeFrame: 1-week, 3-month, 6-month
measure: Serious Adverse Events
timeFrame: 1-week, 3-month, 6-month
measure: Quality of Life
timeFrame: Baseline, 6-months
measure: Physical Functioning Performance
timeFrame: Baseline, 6-months
measure: Physical Functioning Performance
timeFrame: Baseline, 6-months
measure: Performance of Activities of Daily Living
timeFrame: Baseline, 6-months
measure: Strength
timeFrame: Baseline, 6-months
measure: Functional Ability
timeFrame: Baseline, 6-months
measure: Healthcare Utilization
timeFrame: Baseline, 6-months
measure: Healthcare Utilization
timeFrame: Baseline, 6-months
measure: Healthcare Utilization
timeFrame: Baseline, 6-months
measure: Feasibility Outcomes
timeFrame: 6 months
measure: Feasibility Outcomes
timeFrame: 6 months
measure: Feasibility Outcomes
timeFrame: Baseline, 6 months
measure: Feasibility Outcomes
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: