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Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557944
Recruitment Status : Suspended (COVID-19 protocols have curtailed recruitment. We anticipate resuming the study when safe to do so.)
First Posted : June 15, 2018
Last Update Posted : June 7, 2021
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 taking ≥5 medications will receive the TAPER program. 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 whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.


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

Detailed Description:
This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information 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 : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, longitudinal cohort feasibility study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Team Approach to Polypharmacy Evaluation and Reduction Pharmacy
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : October 2022
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




Primary Outcome Measures :
  1. Feasibility (recruitment number) [ Time Frame: 6 months ]
    Number of people who are invited to participate in the study.


Secondary Outcome Measures :
  1. Feasibility (proportion consented) [ Time Frame: 6 months ]
    Number of participants who consent divided by the number of potential participants invited.

  2. Feasibility (proportion completed) [ Time Frame: 6 months ]
    Number of participants who complete 6-month data collection divided by the number of people who consented.

  3. Feasibility (barriers to recruitment) [ Time Frame: 6 months ]
    Challenges to recruitment as identified by pharmacists via field notes and interviews.

  4. Feasibility (time to complete surveys) [ Time Frame: Baseline, 6 months ]
    Total time to complete all surveys

  5. Feasibility (capacity for pharmacist to implement) [ Time Frame: 6 months ]
    Challenges regarding implementation for pharmacists from field notes and interviews

  6. Feasibility (issues with TaperMD tool) [ Time Frame: 6 months ]
    Communication between pharmacists and research team noting TaperMD issues from regular meetings.

  7. Feasibility (missing data) [ Time Frame: 6 months ]
    Nature and percentage of missing data.

  8. Feasibility (variance of measures) [ Time Frame: Baseline, 6 months ]
    The calculated range of scores for surveys (where applicable)

  9. Feasibility (intervention implementation proportion) [ Time Frame: 6 months ]
    Number of plans containing deprescribing actions divided by the total number of plans.


Other Outcome Measures:
  1. Successful discontinuation [ Time Frame: 6 months ]
    Mean difference in number of medications

  2. Successful discontinuation or dose reduction [ Time Frame: 6 months ]
    Composite variable calculate to represent mean number of medications stopped or dose reductions

  3. Successful discontinuation or dose reduction (proportion) [ Time Frame: 6 month ]
    Proportion of patients with successful discontinuation or dose reduction

  4. Quality of life (EQ5D-5L) [ Time Frame: Baseline, 6 months ]
    EuroQol five dimensions questionnaire (EQ5D-5L).

  5. Quality of life (SF36v2) [ Time Frame: Baseline, 6 months ]
    The Short Form (36) Health Survey (SF-36-V2).

  6. 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.

  7. Fatigue [ Time Frame: Baseline, 6 months ]
    Avlund Mob-T Scale

  8. Pain severity and interference [ Time Frame: Baseline, 6 months ]
    Brief Pain Inventory (Pain interference and Pain severity sub-scales)

  9. Sleep [ Time Frame: Baseline, 6 months ]
    15-D Scale (Sleep Question)

  10. Treatment Burden [ Time Frame: Baseline, 6 months ]
    Brief Treatment Burden Scale

  11. Physical function capacity and ability (MANTY) [ Time Frame: Baseline, 6 months ]
    Manty structured validated interview

  12. Physical function capacity and ability (balance) [ Time Frame: Baseline, 6 months ]
    Global Rating of Change (Balance).

  13. 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.

  14. 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.

  15. Healthcare resource utilization (primary care visits) [ Time Frame: Baseline, 6 months ]
    Number of primary care visits from administrative data

  16. 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.

  17. 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.

  18. Serious adverse events [ Time Frame: Baseline, 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).

  19. Implementation processes [ Time Frame: Baseline, 3 months, 6 months ]
    NoMAD survey

  20. Pharmacists/family physician 5 best/worst aspects of intervention [ Time Frame: 6 months ]
    Open ended list

  21. Pharmacists/family physician confidence in medication discontinuation [ Time Frame: Baseline, 6 months ]
    5 point Likert scale single question developed for study

  22. Pharmacists/family physician experiences with the deprescribing process [ Time Frame: 6 months ]
    Semi-structured interviews; field notes

  23. Patient experience with deprescribing process (interview) [ Time Frame: 6 months ]
    Semi-structured interview

  24. Satisfaction with intervention [ Time Frame: 6 months ]
    5 point Likert scale single question developed for study

  25. Satisfaction with care around medications [ Time Frame: Baseline, 6 months ]
    5 point Likert scale single question developed for study



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 5 or more long-term medications
  • Has not had a recent 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): NCT03557944


Locations
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Canada, Ontario
Dr. Dee Mangin
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
David Braley and Nancy Gordon Chair in Family Medicine
RxISK
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03557944    
Other Study ID Numbers: 4619
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
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