Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

Not Applicable

Recruiting

• Conditions: Multi-morbidity; Medication Therapy Management; Polypharmacy

• Registration Number: NCT03557944
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-15
• Study Start: 2019-06-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-10
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility (recruitment number)	6 months	Number of people who are invited to participate in the study.

Secondary Outcome Measures

Name	Time	Method
Feasibility (proportion consented)	6 months	Number of participants who consent divided by the number of potential participants invited.
Feasibility (proportion completed)	6 months	Number of participants who complete 6-month data collection divided by the number of people who consented.
Feasibility (barriers to recruitment)	6 months	Challenges to recruitment as identified by pharmacists via field notes and interviews.
Feasibility (time to complete surveys)	Baseline, 6 months	Total time to complete all surveys
Feasibility (capacity for pharmacist to implement)	6 months	Challenges regarding implementation for pharmacists from field notes and interviews
Feasibility (issues with TaperMD tool)	6 months	Communication between pharmacists and research team noting TaperMD issues from regular meetings.
Feasibility (variance of measures)	Baseline, 6 months	The calculated range of scores for surveys (where applicable)
Feasibility (intervention implementation proportion)	6 months	Number of plans containing deprescribing actions divided by the total number of plans.
Feasibility (missing data)	6 months	Nature and percentage of missing data.

Trial Locations

Locations (1)

Dr. Dee Mangin; 🇨🇦 Hamilton, Ontario, Canada