Team Approach to Polypharmacy Evaluation and Reduction

NCT02942927 | Completed DMC

• 1 other identifier: RN293982 - 367123
• Study Type: interventional
• Target: 345
• 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 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.

Conditions

Multi-morbidity; Medication Therapy Management; Polypharmacy

Keywords

Polypharmacy; Multimorbidity; Randomized Control Trial; Drug Discontinuation; Patient Preference; eHealth

Outcome Measures

Primary Outcomes (1)

• Successful discontinuation (mean difference in number of medications)

  Difference in mean number of medications

  Baseline, 6 months

Secondary Outcomes (24)

• Quality of life (EQ5D-5L)

  Baseline, 6 months

• Quality of life (SF36v2)

  Baseline, 6 months

• Cognition

  Baseline, 6 months

• Fatigue

  Baseline, 6 months

• Patient experience of pain

  Baseline, 6 months

Other Outcomes (10)

• Implementation processes

  baseline, 3 months, 6 months

• Pharmacists/family physician 5 best/worst aspects of intervention

  6 months

• Pharmacists/family physician confidence in medication discontinuation

  Baseline, 6 months

Study Arms (2)

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

Control

NO INTERVENTION

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

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 more 5 or more long-term medications
• Have not had a recent (past 12 months) 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

Location

Related Publications (1)

• 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.

  PMID: 34702336 DERIVED

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI and Data analyst were blinded to allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: October 24, 2016
• Study Start: June 4, 2018
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2023-10

Locations

CA (1)