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NCT Number: NCT02942927

Team Approach to Polypharmacy Evaluation and Reduction

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.

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.

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Key information

Conditions

Multi-morbidity Behavior Health Behavior Medication Therapy Management Patient Preference Patient Satisfaction Polypharmacy Treatment Adherence and Compliance

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Dee Mangin

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Medication reduction

Other

Systematic approach to reduction in polypharmacy.

Other names: Medication discontinuation/dose reduction

Primary outcomes

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

    Time frame: Baseline, 6 months

    Difference in mean number of medications

Secondary outcomes

  1. Quality of life (EQ5D-5L)

    Time frame: Baseline, 6 months

    EuroQol five dimensions questionnaire (EQ5D-5L)

  2. Quality of life (SF36v2)

    Time frame: Baseline, 6 months

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

  3. Cognition

    Time frame: Baseline, 6 months

    The Mini Mental Status Examination (MMSE)

  4. Fatigue

    Time frame: Baseline, 6 months

    Avlund Mob-T Scale

  5. Patient experience of pain

    Time frame: Baseline, 6 months

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

  6. Patient enablement

    Time frame: Baseline, 6 months

    The Patient Enablement Index (PEI)

  7. Sleep

    Time frame: Baseline, 6 months

    15-D Scale (Sleep Question)

  8. Disease burden

    Time frame: Baseline, 6 months

    Disease Burden Survey (Bayliss et al., 2009)

  9. Nutritional status

    Time frame: Baseline, 6 months

    Mini Nutritional Assessment Short-Form (MNA-SF)

  10. Treatment burden

    Time frame: Baseline, 6 months

    Brief Treatment Burden Scale

  11. 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

  12. Physical functional capacity and ability

    Time frame: Baseline, 6 months

    Manty structured validated interview

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

    Time frame: Baseline, 6 months

    Timed up and go test (TUG)

  14. Physical function capacity and ability (strength)

    Time frame: Baseline, 6 month

    Grip strength

  15. Physical function capacity and ability (balance)

    Time frame: Baseline, 6 months

    Global Rating of Change (Balance)

  16. Healthcare resource utilization (hospital admissions)

    Time frame: Baseline, 6 months

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

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

    Time frame: Baseline, 6 months

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

  18. Healthcare resource utilization (primary care visits)

    Time frame: baseline, 6 months

    Number of primary care visits from administrative data

  19. Successful discontinuation or dose reduction

    Time frame: 6 months

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

  20. Successful discontinuation or dose reduction (proportion)

    Time frame: 6 months

    Proportion of patients with successful discontinuations or dose reductions

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

    Time frame: 1 week, 3 month, 6 month

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

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

    Time frame: 1 week, 3 month, 6 month

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

  23. Serious adverse events

    Time frame: 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)

  24. Medication self-efficacy

    Time frame: Baseline, 6 months

    Self-efficacy for appropriate mediation use scale

Other outcomes

  1. Implementation processes

    Time frame: baseline, 3 months, 6 months

    NoMAD survey

  2. Pharmacists/family physician 5 best/worst aspects of intervention

    Time frame: 6 months

    Open ended list

  3. Pharmacists/family physician confidence in medication discontinuation

    Time frame: Baseline, 6 months

    5 point Likert scale single question developed for study

  4. Pharmacists/family physician experiences with the deprescribing process

    Time frame: 6 months

    Semi-structured interviews; field notes

  5. Strengths and weaknesses of intervention

    Time frame: 6 months

    Open ended questions

  6. Patient experience with deprescribing process (diary)

    Time frame: 6 months

    Patient diaries

  7. Patient experience with deprescribing process (interview)

    Time frame: 6 months

    Semi-structured interview

  8. Satisfaction with intervention

    Time frame: 6 months

    5 point Likert scale single question developed for study

  9. Satisfaction with care around medications

    Time frame: Baseline, 6 months

    5 point Likert scale single question developed for study

  10. Cost effectiveness

    Time frame: 6 months

    Incremental cost per Quality Adjusted Life Year (payer perspective)

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • David Braley and Nancy Gordon Chair in Family Medicine
  • RxISK

Registry information

Official study title

Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial

Acronym: TAPER-RCT

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2016
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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