Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting

NCT04055896 | Terminated

• 1 other identifier: 2727 (Amendment)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. This trial will be a randomized control trial with an adaptive trial design.

Conditions

Long-term Care; Polypharmacy; Frailty

Outcome Measures

Primary Outcomes (1)

• Successful Discontinuation (Difference in mean number of medications; reduction in dose)

  Difference in mean number of medications; number of medications reduced in dose

  6 months

Secondary Outcomes (20)

• Difference in level of cognition

  Baseline, 6 months

• Difference in level of quality of life

  Baseline, 6 months

• Difference in number of falls

  Baseline, 6 months

• Difference in level of sleep

  Baseline, 6 months

• Changes in medication side effects and symptoms (adverse)

  1-week, 3 months, 6 months

Other Outcomes (1)

• Loved one's perspective of deprescribing

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

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

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) 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:

• residing in 2 long-term care facilities in Brampton, ON
• on 5 or more long-term medications
• years of age or older
• adequate English language

You may not qualify if:

• terminal illness or other circumstance precluding 6 month study period
• recent (within 12 months) comprehensive medication review

Sponsors & Collaborators

• McMaster University: lead
• Labarge Optimal Aging: collaborator
• Canadian Frailty Network: collaborator

Study Sites (2)

Holland Christian Homes - Faith Manor

Brampton, Ontario, L6Y 5P2, Canada

Location

Holland Christian Homes - Grace Manor

Brampton, Ontario, L6Y 5P2, Canada

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dee Mangin, MBChB, DPH, FRNZC, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Associate Chair and Director, Research David Braley & Nancy Gordon Chair in Family Medicine

Model Details: The study will be an adaptive trial design with two phase. * Phase 1 will be an internal pilot to allow for refinement. * Phase 2 will be a larger randomized controlled trial after Phase 1 refinement

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: October 15, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

CA (2)