Team Approach to Polypharmacy Evaluation and Reduction

NCT02562352 | Completed

• 1 other identifier: TAPER-001-19-Aug-15
• Study Type: interventional
• Target: 38
• 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 so many together can do more harm than good. This study will test a program focused on medication reduction involving patient, pharmacist and physician using current technology aimed at reducing the harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between them involves prioritizing the most important ones according to the patient's preference and stopping those which may no longer be necessary. Reducing the dose also reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, medication review with the pharmacist and then a consultation with the family doctor 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 a clinical pathway incorporating monitoring and follow up systems. This study will examine effects on patient and health relevant outcome measures as well as patients' and clinicians' experiences of the program. The results will be used to determine whether this system can be implemented as part of routine preventative care in older adults.

Conditions

Comorbidity; Medication Therapy Management

Keywords

polypharmacy; multimorbidity; randomized controlled trial; drug discontinuation; patient preference; eHealth

Outcome Measures

Primary Outcomes (1)

• Successful discontinuation (Difference in mean number of medications)

  Difference in mean number of medications per patient.

  6 months

Secondary Outcomes (12)

• Quality of Life (EQ-5D)

  6 months

• Nutritional Status (Mini Nutritional Assessment Short-Form)

  6 months

• Patient experience of deprescribing (Thematic analysis of semi structured interviews)

  6 months

• Physical Functional Capacity (Manty structured validated interview)

  6 months

• Falls (self report number of falls)

  6 months

Study Arms (2)

TAPER program

EXPERIMENTAL

The intervention arm is comprised of: 1. Identification of medications that are appropriate for discontinuation/dose reduction. 2. Linked pharmacist/family physician consultations with patient to discuss medication discontinuation/dose reduction.

Other: TAPER program

Control

NO INTERVENTION

Standard of Care as wait list control

Interventions

TAPER program OTHER

Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.

Also known as: Medication Discontinuation/Dose Reduction

TAPER program

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
• Participating family doctor as most responsible provider
• Patient of McMaster Family Health Team
• Currently taking 5 or more medications
• Have not had a recent comprehensive medication review
• Patient consents

You may not qualify if:

• English language or cognitive skills inadequate to understand and respond to rating scales
• Terminal illness or other circumstance precluding 13 month study period

Sponsors & Collaborators

• McMaster University: lead
• Health Canada: collaborator
• The Labarge Optimal Aging Initiative: collaborator
• David Braley and Nancy Gordon Chair in Family Medicine: collaborator
• RxISK: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P 1H6, Canada

Location

Related Publications (1)

• Mangin D, Lamarche L, Agarwal G, Ali A, Cassels A, Colwill K, Dolovich L, Brown ND, Farrell B, Freeman K, Frizzle K, Garrison SR, Gillett J, Holbrook A, Jurcic-Vrataric J, McCormack J, Parascandalo J, Richardson J, Risdon C, Sherifali D, Siu H, Borhan S, Templeton JA, Thabane L, Trimble J. Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy. Pilot Feasibility Stud. 2023 May 18;9(1):84. doi: 10.1186/s40814-023-01315-0.

  PMID: 37202822 DERIVED

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

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

Study Officials

• Dee Mangin, MBChB, DPH, FRNZC, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 29, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

CA (1)