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Team Approach to Polypharmacy Evaluation and Reduction (TAPER-RCT)

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ClinicalTrials.gov Identifier: NCT02942927
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : August 25, 2022
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
Information provided by (Responsible Party):
McMaster University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Multi-morbidity Medication Therapy Management Polypharmacy Other: Medication reduction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
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)
  6. Pause of medication and clinical monitoring
Other: Medication reduction
Systematic approach to reduction in polypharmacy.
Other Name: Medication discontinuation/dose reduction

No Intervention: Control
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.



Primary Outcome Measures :
  1. Successful discontinuation (mean difference in number of medications) [ Time Frame: Baseline, 6 months ]
    Difference in mean number of medications


Secondary Outcome Measures :
  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. 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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942927


Contacts
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Contact: Dee Mangin, MBChB, DPH, FRNZC, MD 905-525-9140 ext 21219 mangind@mcmaster.ca
Contact: Larkin Lamarche, PhD 905-525-9140 ext 21224 lamarche@mcmaster.ca

Locations
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Canada, Ontario
Dr. Dee Mangin Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Dee Mangin    9055259140    mangind@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02942927    
Other Study ID Numbers: RN293982 - 367123
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Polypharmacy
Multimorbidity
Randomized Control Trial
Drug Discontinuation
Patient Preference
eHealth