Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting

Frailty Clinical Trial

— TAPER-LTC  

Official title:

Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04055896
• Other study ID #: 2727 (Amendment)
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Long-term Care
• Polypharmacy

Intervention

Other:
• Medication Reduction
Systematic approach to reduction in polypharmacy

Locations

Country	Name	City	State
Canada	Holland Christian Homes - Faith Manor	Brampton	Ontario
Canada	Holland Christian Homes - Grace Manor	Brampton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Frailty Network, Labarge Optimal Aging

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loved one's perspective of deprescribing	Perspectives from focus groups	6 months
Primary	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	Difference in level of cognition	The Mini Mental Status Examination	Baseline, 6 months
Secondary	Difference in level of quality of life	EuroQol five dimensions questionnaire (EQ5D-5L) will measure quality of life. Scores range from 0 (low quality of life) to 1 (high quality of life).	Baseline, 6 months
Secondary	Difference in number of falls	Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient	Baseline, 6 months
Secondary	Difference in level of sleep	The sleep question on the 15-Dimensional (15-D) scale will be used. Scores range from 1 (no sleep problems) to 5 (severe sleep problems).	Baseline, 6 months
Secondary	Changes in medication side effects and symptoms (adverse)	Patient self-report of appearance (new or worsening) of side effects associated with medications	1-week, 3 months, 6 months
Secondary	Changes in medication side effects and symptoms (positive)	Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications	1-week, 3 months, 6 months
Secondary	Difference in number of 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 months, 6 months
Secondary	Difference in level of physical functioning capacity and ability	Time on the timed-up-and-go test	Baseline, 6 months
Secondary	Difference in level of performance of activities of daily living	Barthel Index will be used to measure performance of activities of daily living. Ten activities are scored in terms of level of independence or assistance, with higher scores reflecting higher level of independent performance.	Baseline, 6 months
Secondary	Difference in level of frailty	The total score on the Edmonton Frail Scale will be used to measure frailty. The scale included 11 items, with scores ranging from 0 (not frail) to 17 (severe frailty).	Baseline, 6 months
Secondary	Difference in level of healthcare utilization use (hospitalizations)	Number of hospitalizations	Baseline, 6 months
Secondary	Difference in level of healthcare utilization use (emergency department visits)	Number of emergency department visits	Baseline, 6 months
Secondary	Difference in level of healthcare utilization use (physician visits)	Number of physician visits	Baseline, 6 months
Secondary	Enrollment rate	Number of participants that enroll in study relative to number of participant invited to participant	6 months
Secondary	Completion rate	Number of participants that complete 6-month collection relative to number of participants enrolled	6 months
Secondary	Time to complete measures	Average duration of data collection appointments	Baseline, 6 months
Secondary	Difference in level of mood	The total score on the Geriatric Depression Scale (Short Form) will be used to measure mood. The scale includes 15 yes/no items and score range from 0 to 15, with high scores indicating depression.	Baseline, 6 months
Secondary	Difference in level of concern over falling	The score on the Falls Efficacy Scale-International (Short Version) will be used to measure falling-related concerns. The scale includes 7 items, with scores ranging from 7 (no concern) to 28 (severe concern of falling)	Baseline, 6 months
Secondary	Difference in level of pain	The Brief Pain Inventory (short form) will be used to measure pain severity (mean of 4 items, rated 0-10) and pain interference (mean of 7 items, rated 0-10). Higher scores represent higher pain severity and interference.	Baseline, 6 months
Secondary	Difference in level of incontinence	Frequency of incontinence as recorded in patient electronic medical record	Baseline, 6 months