Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

NCT03557944 | Unknown

• 1 other identifier: 4619
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multi-morbidity; Medication Therapy Management; Polypharmacy

Outcome Measures

Primary Outcomes (1)

• Feasibility (recruitment number)

  Number of people who are invited to participate in the study.

  6 months

Secondary Outcomes (9)

• Feasibility (proportion consented)

  6 months

• Feasibility (proportion completed)

  6 months

• Feasibility (barriers to recruitment)

  6 months

• Feasibility (time to complete surveys)

  Baseline, 6 months

• Feasibility (capacity for pharmacist to implement)

  6 months

Other Outcomes (25)

• Successful discontinuation

  6 months

• Successful discontinuation or dose reduction

  6 months

• Successful discontinuation or dose reduction (proportion)

  6 month

Study Arms (1)

TAPER

EXPERIMENTAL

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

Interventions

Medication reduction OTHER

Systematic approach to reduction in polypharmacy.

Also known as: Medication discontinuation/dose reduction

TAPER

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• David Braley and Nancy Gordon Chair in Family Medicine: collaborator
• RxISK: collaborator

Study Sites (1)

Dr. Dee Mangin

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Central Study Contacts

Dee Mangin, MBChB, DPH, FRNZC, MD

CONTACT

905-525-9140; mangind@mcmaster.ca

Larkin Lamarche, PhD

CONTACT

905-525-9140; lamarche@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, longitudinal cohort feasibility study.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: June 16, 2019
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

CA (1)