Clinical trial NCT04055896: Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting
Official title: Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Long-term Care
Polypharmacy
Frailty
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Labarge Optimal Aging
name: Canadian Frailty Network
First posted: 2019-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be an adaptive trial design with two phase.

* Phase 1 will be an internal pilot to allow for refinement.
* Phase 2 will be a larger randomized controlled trial after Phase 1 refinement
Primary purpose: TREATMENT

Brief summary: Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes. 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. 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. This trial will be a randomized control trial with an adaptive trial design.

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. The study will be an adaptive trial design with two phases. Phase 1 will be an internal pilot. This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary. Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* terminal illness or other circumstance precluding 6 month study period
* recent (within 12 months) comprehensive medication review

Primary outcomes:
measure: Successful Discontinuation (Difference in mean number of medications; reduction in dose)
timeFrame: 6 months
Secondary outcomes:
measure: Difference in level of cognition
timeFrame: Baseline, 6 months
measure: Difference in level of quality of life
timeFrame: Baseline, 6 months
measure: Difference in number of falls
timeFrame: Baseline, 6 months
measure: Difference in level of sleep
timeFrame: Baseline, 6 months
measure: Changes in medication side effects and symptoms (adverse)
timeFrame: 1-week, 3 months, 6 months
measure: Changes in medication side effects and symptoms (positive)
timeFrame: 1-week, 3 months, 6 months
measure: Difference in number of serious adverse events
timeFrame: 1-week, 3 months, 6 months
measure: Difference in level of physical functioning capacity and ability
timeFrame: Baseline, 6 months
measure: Difference in level of performance of activities of daily living
timeFrame: Baseline, 6 months
measure: Difference in level of frailty
timeFrame: Baseline, 6 months
measure: Difference in level of healthcare utilization use (hospitalizations)
timeFrame: Baseline, 6 months
measure: Difference in level of healthcare utilization use (emergency department visits)
timeFrame: Baseline, 6 months
measure: Difference in level of healthcare utilization use (physician visits)
timeFrame: Baseline, 6 months
measure: Enrollment rate
timeFrame: 6 months
measure: Completion rate
timeFrame: 6 months
measure: Time to complete measures
timeFrame: Baseline, 6 months
measure: Difference in level of mood
timeFrame: Baseline, 6 months
measure: Difference in level of concern over falling
timeFrame: Baseline, 6 months
measure: Difference in level of pain
timeFrame: Baseline, 6 months
measure: Difference in level of incontinence
timeFrame: Baseline, 6 months
Other outcomes:
measure: Loved one's perspective of deprescribing
timeFrame: 6 months
Locations:
city: Brampton
country: Canada
facility: Holland Christian Homes - Faith Manor
state: Ontario
city: Brampton
country: Canada
facility: Holland Christian Homes - Grace Manor
state: Ontario
Study officials:
affiliation: McMaster University
name: Dee Mangin, MBChB, DPH, FRNZC, MD
role: PRINCIPAL_INVESTIGATOR
References: