Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

NCT ID: NCT03557944

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2024-06-30

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.

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.

Conditions

Multi-morbidity; Medication Therapy Management; Polypharmacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Medication reduction

Intervention Type: OTHER

Systematic approach to reduction in polypharmacy.

Interventions

Medication reduction

Systematic approach to reduction in polypharmacy.

Intervention Type: OTHER

Other Intervention Names

Medication discontinuation/dose reduction

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

David Braley and Nancy Gordon Chair in Family Medicine

OTHER

Sponsor Role: collaborator

RxISK

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Dee Mangin

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dee Mangin, MBChB, DPH, FRNZC, MD

Role: CONTACT

mangind@mcmaster.ca

905-525-9140 ext. 21219

Larkin Lamarche, PhD

Role: CONTACT

lamarche@mcmaster.ca

905-525-9140 ext. 21224

Facility Contacts

Dee Mangin

Role: primary

mangind@mcmaster.ca

9055259140 ext. 21219

Other Identifiers

4619

Identifier Type: -

Identifier Source: org_study_id