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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Long-term Care, Polypharmacy, Frailty

Intervention / Treatment
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* Other: Medication Reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months. | |
| Experimental: TAPER<br>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 | Other: Medication Reduction<br>* Systematic approach to reduction in polypharmacy<br>* Other names: Medication discontinuation/dose reduction;|

What is the study measuring?
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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 |
| --- | --- | --- |
| Difference in level of cognition | The Mini Mental Status Examination | Baseline, 6 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Difference in level of physical functioning capacity and ability | Time on the timed-up-and-go test | Baseline, 6 months | 
| 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 | 
| 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 | 
| Difference in level of healthcare utilization use (hospitalizations) | Number of hospitalizations | Baseline, 6 months | 
| Difference in level of healthcare utilization use (emergency department visits) | Number of emergency department visits | Baseline, 6 months | 
| Difference in level of healthcare utilization use (physician visits) | Number of physician visits | Baseline, 6 months | 
| Enrollment rate | Number of participants that enroll in study relative to number of participant invited to participant | 6 months | 
| Completion rate | Number of participants that complete 6-month collection relative to number of participants enrolled | 6 months | 
| Time to complete measures | Average duration of data collection appointments | Baseline, 6 months | 
| 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 | 
| 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 | 
| 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 | 
| Difference in level of incontinence | Frequency of incontinence as recorded in patient electronic medical record | Baseline, 6 months |