Team Approach to Polypharmacy Evaluation and Reduction

NCT ID: NCT02942927

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2025-07-31

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.

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.

Conditions

Multi-morbidity; Medication Therapy Management; Polypharmacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

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.

Control

Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 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

• 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

Countries

Canada

References

Mangin D, Lamarche L, Agarwal G, Banh HL, Dore Brown N, Cassels A, Colwill K, Dolovich L, Farrell B, Garrison S, Gillett J, Griffith LE, Holbrook A, Jurcic-Vrataric J, McCormack J, O'Reilly D, Raina P, Richardson J, Risdon C, Savelli M, Sherifali D, Siu H, Tarride JE, Trimble J, Ali A, Freeman K, Langevin J, Parascandalo J, Templeton JA, Dragos S, Borhan S, Thabane L. Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):746. doi: 10.1186/s13063-021-05685-9.

Reference Type: DERIVED

PMID: 34702336 (View on PubMed)

Other Identifiers

RN293982 - 367123

Identifier Type: -

Identifier Source: org_study_id