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Long-term CareTAPER-LTCNCT04055896

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

A study testing Medication Reduction in people with Long-term Care and Polypharmacy, run by McMaster University at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Long-term Care, Polypharmacy, Frailty
What is being tested?
Medication Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesCanada
Study dates
15 Oct 2019to 30 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Holland Christian Homes - Faith Manor

    Brampton, Ontario, L6Y 5P2

  • Holland Christian Homes - Grace Manor

    Brampton, Ontario, L6Y 5P2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Medication Reduction
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication ReductionOther

    Also called Medication discontinuation/dose reduction

    Systematic approach to reduction in polypharmacy

Study groups in NCT04055896
Study groupRoleWhat they receive
Control GroupNo interventionStandard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
TAPERExperimentalThe 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
Receives: Other: Medication Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Difference in mean number of medications; number of medications reduced in dose

    Measured: 6 months

Secondary outcomes (20)

  1. Difference in level of cognition

    The Mini Mental Status Examination

    Measured: Baseline, 6 months

  2. 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).

    Measured: Baseline, 6 months

  3. 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

    Measured: Baseline, 6 months

  4. 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).

    Measured: Baseline, 6 months

  5. Changes in medication side effects and symptoms (adverse)

    Patient self-report of appearance (new or worsening) of side effects associated with medications

    Measured: 1-week, 3 months, 6 months

  6. Changes in medication side effects and symptoms (positive)

    Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications

    Measured: 1-week, 3 months, 6 months

  7. 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)

    Measured: 1-week, 3 months, 6 months

  8. Difference in level of physical functioning capacity and ability

    Time on the timed-up-and-go test

    Measured: Baseline, 6 months

  9. 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.

    Measured: Baseline, 6 months

  10. 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).

    Measured: Baseline, 6 months

  11. Difference in level of healthcare utilization use (hospitalizations)

    Number of hospitalizations

    Measured: Baseline, 6 months

  12. Difference in level of healthcare utilization use (emergency department visits)

    Number of emergency department visits

    Measured: Baseline, 6 months

  13. Difference in level of healthcare utilization use (physician visits)

    Number of physician visits

    Measured: Baseline, 6 months

  14. Enrollment rate

    Number of participants that enroll in study relative to number of participant invited to participant

    Measured: 6 months

  15. Completion rate

    Number of participants that complete 6-month collection relative to number of participants enrolled

    Measured: 6 months

  16. Time to complete measures

    Average duration of data collection appointments

    Measured: Baseline, 6 months

  17. 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.

    Measured: Baseline, 6 months

  18. 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)

    Measured: Baseline, 6 months

  19. 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.

    Measured: Baseline, 6 months

  20. Difference in level of incontinence

    Frequency of incontinence as recorded in patient electronic medical record

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2019
  2. Study start15 Oct 2019
  3. Primary completion30 Mar 2021
  4. Study completion30 Mar 2021

Why it stopped: COVID-19 precautions precluded recruitment in long-term care facilities

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Care provider, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04055896
Sponsor's protocol ID
2727 (Amendment)
Acronym
TAPER-LTC
Status last verified
Jun 2021
First submitted
12 Aug 2019
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Medication Reduction in people with Long-term Care and Polypharmacy, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19 precautions precluded recruitment in long-term care facilities). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Discontinuation (Difference in mean number of medications; reduction in dose) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04055896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.

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