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Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)

Primary Purpose

Long-term Care, Polypharmacy, Frailty

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medication Reduction
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long-term Care

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Holland Christian Homes - Faith Manor
  • Holland Christian Homes - Grace Manor

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

TAPER

Arm Description

Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

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

Outcomes

Primary Outcome Measures

Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Difference in mean number of medications; number of medications reduced in dose

Secondary Outcome Measures

Difference in level of cognition
The Mini Mental Status Examination
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).
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
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).
Changes in medication side effects and symptoms (adverse)
Patient self-report of appearance (new or worsening) of side effects associated with medications
Changes in medication side effects and symptoms (positive)
Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
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)
Difference in level of physical functioning capacity and ability
Time on the timed-up-and-go test
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.
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).
Difference in level of healthcare utilization use (hospitalizations)
Number of hospitalizations
Difference in level of healthcare utilization use (emergency department visits)
Number of emergency department visits
Difference in level of healthcare utilization use (physician visits)
Number of physician visits
Enrollment rate
Number of participants that enroll in study relative to number of participant invited to participant
Completion rate
Number of participants that complete 6-month collection relative to number of participants enrolled
Time to complete measures
Average duration of data collection appointments
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.
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)
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.
Difference in level of incontinence
Frequency of incontinence as recorded in patient electronic medical record

Full Information

First Posted
August 12, 2019
Last Updated
June 2, 2021
Sponsor
McMaster University
Collaborators
Labarge Optimal Aging, Canadian Frailty Network
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1. Study Identification

Unique Protocol Identification Number
NCT04055896
Brief Title
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting
Acronym
TAPER-LTC
Official Title
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 precautions precluded recruitment in long-term care facilities
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Labarge Optimal Aging, Canadian Frailty Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long-term Care, Polypharmacy, Frailty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
Arm Title
TAPER
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Medication Reduction
Other Intervention Name(s)
Medication discontinuation/dose reduction
Intervention Description
Systematic approach to reduction in polypharmacy
Primary Outcome Measure Information:
Title
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Description
Difference in mean number of medications; number of medications reduced in dose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in level of cognition
Description
The Mini Mental Status Examination
Time Frame
Baseline, 6 months
Title
Difference in level of quality of life
Description
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).
Time Frame
Baseline, 6 months
Title
Difference in number of falls
Description
Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
Time Frame
Baseline, 6 months
Title
Difference in level of sleep
Description
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).
Time Frame
Baseline, 6 months
Title
Changes in medication side effects and symptoms (adverse)
Description
Patient self-report of appearance (new or worsening) of side effects associated with medications
Time Frame
1-week, 3 months, 6 months
Title
Changes in medication side effects and symptoms (positive)
Description
Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
Time Frame
1-week, 3 months, 6 months
Title
Difference in number of serious adverse events
Description
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)
Time Frame
1-week, 3 months, 6 months
Title
Difference in level of physical functioning capacity and ability
Description
Time on the timed-up-and-go test
Time Frame
Baseline, 6 months
Title
Difference in level of performance of activities of daily living
Description
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.
Time Frame
Baseline, 6 months
Title
Difference in level of frailty
Description
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).
Time Frame
Baseline, 6 months
Title
Difference in level of healthcare utilization use (hospitalizations)
Description
Number of hospitalizations
Time Frame
Baseline, 6 months
Title
Difference in level of healthcare utilization use (emergency department visits)
Description
Number of emergency department visits
Time Frame
Baseline, 6 months
Title
Difference in level of healthcare utilization use (physician visits)
Description
Number of physician visits
Time Frame
Baseline, 6 months
Title
Enrollment rate
Description
Number of participants that enroll in study relative to number of participant invited to participant
Time Frame
6 months
Title
Completion rate
Description
Number of participants that complete 6-month collection relative to number of participants enrolled
Time Frame
6 months
Title
Time to complete measures
Description
Average duration of data collection appointments
Time Frame
Baseline, 6 months
Title
Difference in level of mood
Description
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.
Time Frame
Baseline, 6 months
Title
Difference in level of concern over falling
Description
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)
Time Frame
Baseline, 6 months
Title
Difference in level of pain
Description
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.
Time Frame
Baseline, 6 months
Title
Difference in level of incontinence
Description
Frequency of incontinence as recorded in patient electronic medical record
Time Frame
Baseline, 6 months
Other Pre-specified Outcome Measures:
Title
Loved one's perspective of deprescribing
Description
Perspectives from focus groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dee Mangin, MBChB, DPH, FRNZC, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Christian Homes - Faith Manor
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y 5P2
Country
Canada
Facility Name
Holland Christian Homes - Grace Manor
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y 5P2
Country
Canada

12. IPD Sharing Statement

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

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