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

June 2, 2021 updated by: Derelie Mangin, McMaster University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Y 5P2
        • Holland Christian Homes - Faith Manor
      • Brampton, Ontario, Canada, L6Y 5P2
        • Holland Christian Homes - Grace Manor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
Experimental: TAPER

The intervention is medication reduction. This arm is comprised of:

  1. Medication reconciliation
  2. Identification of patient priorities for care
  3. Identification of medications that are potentially appropriate for discontinuation/dose reduction
  4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce
  5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring
Other: Medication Reduction
Systematic approach to reduction in polypharmacy
Other Names:
  • Medication discontinuation/dose reduction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Time Frame: 6 months
Difference in mean number of medications; number of medications reduced in dose
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in level of cognition
Time Frame: Baseline, 6 months
The Mini Mental Status Examination
Baseline, 6 months
Difference in level of quality of life
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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)
Time Frame: 1-week, 3 months, 6 months
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)
Time Frame: 1-week, 3 months, 6 months
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
Time Frame: 1-week, 3 months, 6 months
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 Frame: Baseline, 6 months
Time on the timed-up-and-go test
Baseline, 6 months
Difference in level of performance of activities of daily living
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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)
Time Frame: Baseline, 6 months
Number of hospitalizations
Baseline, 6 months
Difference in level of healthcare utilization use (emergency department visits)
Time Frame: Baseline, 6 months
Number of emergency department visits
Baseline, 6 months
Difference in level of healthcare utilization use (physician visits)
Time Frame: Baseline, 6 months
Number of physician visits
Baseline, 6 months
Enrollment rate
Time Frame: 6 months
Number of participants that enroll in study relative to number of participant invited to participant
6 months
Completion rate
Time Frame: 6 months
Number of participants that complete 6-month collection relative to number of participants enrolled
6 months
Time to complete measures
Time Frame: Baseline, 6 months
Average duration of data collection appointments
Baseline, 6 months
Difference in level of mood
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
Frequency of incontinence as recorded in patient electronic medical record
Baseline, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Loved one's perspective of deprescribing
Time Frame: 6 months
Perspectives from focus groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Frailty Network
Labarge Optimal Aging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2727 (Amendment)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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