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Multi-morbidityTAPER-RCTNCT02942927

Team Approach to Polypharmacy Evaluation and Reduction

A study testing Medication reduction in people with Multi-morbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Medication reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
1 siteCanada
Study dates
4 Jun 2018to 31 Jul 2025
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

  • Aged 70 years of age or older
  • Patient must have a family doctor
  • Participating family doctor as most responsible provider
  • Currently taking more 5 or more long-term medications
  • Have not had a recent (past 12 months) comprehensive medication review
  • Patient willing to try discontinuation

Who cannot join

  • English language or cognitive skills inadequate to understand and respond to rating scales
  • Terminal illness or other circumstance precluding 6 month study period

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Dr. Dee Mangin

    Hamilton, Ontario, L8S 4K1

Other trials in Canada

About this study

Official title: Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.

This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.

Read more

Patients, aged 70 years of age or older and are taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow up systems.

This study will examine effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.

Read the detailed description

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. Initial baseline data collection from the patient include data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.

Being tested
Medication reduction
Keywords
Polypharmacy, Multimorbidity, Randomized Control Trial, Drug Discontinuation, Patient Preference, eHealth
Medical subject headings
Patient Preference

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 NCT02942927
Study groupRoleWhat they receive
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) 6. Pause of medication and clinical monitoring
Receives: Other: Medication reduction
ControlNo interventionStandard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

What is being measured

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

  1. Successful discontinuation (mean difference in number of medications)

    Difference in mean number of medications

    Measured: Baseline, 6 months

Secondary outcomes (24)
  1. Quality of life (EQ5D-5L)

    EuroQol five dimensions questionnaire (EQ5D-5L)

    Measured: Baseline, 6 months

  2. Quality of life (SF36v2)

    The Short Form (36) Health Survey (SF-36-V2)

    Measured: Baseline, 6 months

  3. Cognition

    The Mini Mental Status Examination (MMSE)

    Measured: Baseline, 6 months

  4. Fatigue

    Avlund Mob-T Scale

    Measured: Baseline, 6 months

  5. Patient experience of pain

    Brief Pain Inventory (Pain interference and Pain severity sub-scales)

    Measured: Baseline, 6 months

  6. Patient enablement

    The Patient Enablement Index (PEI)

    Measured: Baseline, 6 months

  7. Sleep

    15-D Scale (Sleep Question)

    Measured: Baseline, 6 months

  8. Disease burden

    Disease Burden Survey (Bayliss et al., 2009)

    Measured: Baseline, 6 months

  9. Nutritional status

    Mini Nutritional Assessment Short-Form (MNA-SF)

    Measured: Baseline, 6 months

  10. Treatment burden

    Brief Treatment Burden Scale

    Measured: Baseline, 6 months

  11. 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

  12. Physical functional capacity and ability

    Manty structured validated interview

    Measured: Baseline, 6 months

  13. Physical function capacity and ability (timed-up-and-go)

    Timed up and go test (TUG)

    Measured: Baseline, 6 months

  14. Physical function capacity and ability (strength)

    Grip strength

    Measured: Baseline, 6 month

  15. Physical function capacity and ability (balance)

    Global Rating of Change (Balance)

    Measured: Baseline, 6 months

  16. Healthcare resource utilization (hospital admissions)

    Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization

    Measured: Baseline, 6 months

  17. Healthcare resource utilization (ED/urgent care visits)

    Number of emergency department and urgent care visits from administrative data and self-report

    Measured: Baseline, 6 months

  18. Healthcare resource utilization (primary care visits)

    Number of primary care visits from administrative data

    Measured: baseline, 6 months

  19. Successful discontinuation or dose reduction

    Composite variable calculate to represent mean number of medications stopped or dose reductions

    Measured: 6 months

  20. Successful discontinuation or dose reduction (proportion)

    Proportion of patients with successful discontinuations or dose reductions

    Measured: 6 months

  21. 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 month, 6 month

  22. 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 month, 6 month

  23. 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: 3 months, 6 months

  24. Medication self-efficacy

    Self-efficacy for appropriate mediation use scale

    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 posted24 Oct 2016 (estimated)
  2. Study start4 Jun 2018
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942927
Sponsor's protocol ID
RN293982 - 367123
Acronym
TAPER-RCT
Status last verified
Oct 2023
First submitted
22 Aug 2016
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mangin D, Lamarche L, Agarwal G, Banh HL, Dore Brown N, Cassels A, Colwill K, Dolovich L, Farrell B, Garrison S, Gillett J, Griffith LE, Holbrook A, Jurcic-Vrataric J, McCormack J, O'Reilly D, Raina P, Richardson J, Risdon C, Savelli M, Sherifali D, Siu H, Tarride JE, Trimble J, Ali A, Freeman K, Langevin J, Parascandalo J, Templeton JA, Dragos S, Borhan S, Thabane L. Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):746. doi: 10.1186/s13063-021-05685-9.

    PubMed 34702336

Questions about this trial

What is this clinical trial studying?

A study testing Medication reduction in people with Multi-morbidity and Medication Therapy Management, run by McMaster University at 1 site 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 6 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (mean difference in number of medications) (time frame: Baseline, 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 NCT02942927, which also lists 1 linked publication.

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 12 Jan 2026.

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