Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

Team Approach to Polypharmacy Evaluation and Reduction Pharmacy

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.

Study Overview

• Status: Recruiting
• Conditions: Polypharmacy; Multi-morbidity; Medication Therapy Management
• Intervention / Treatment: Other: Medication reduction

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dee Mangin, MBChB, DPH, FRNZC, MD; Phone Number: 21219 905-525-9140; Email: mangind@mcmaster.ca
• Study Contact Backup: Name: Larkin Lamarche, PhD; Phone Number: 21224 905-525-9140; Email: lamarche@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Recruiting
      • Dr. Dee Mangin
      • Contact: Dee Mangin; Phone Number: 21219 9055259140; Email: mangind@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TAPER; The intervention is medication reduction. This arm is comprised of: Medication reconciliation; Identification of patient priorities for care; Identification of medications that are potentially appropriate for discontinuation/dose reduction; Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce; Identification of medications for trial of discontinuation/dose reduction (shared decision making); Pause of medication and clinical monitoring

Other: Medication reduction; Systematic approach to reduction in polypharmacy.; Other Names: Medication discontinuation/dose reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (recruitment number)	Number of people who are invited to participate in the study.	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Sleep	15-D Scale (Sleep Question)	Baseline, 6 months
Successful discontinuation or dose reduction	Composite variable calculate to represent mean number of medications stopped or dose reductions	6 months
Pharmacists/family physician 5 best/worst aspects of intervention	Open ended list	6 months
Pharmacists/family physician confidence in medication discontinuation	5 point Likert scale single question developed for study	Baseline, 6 months
Pharmacists/family physician experiences with the deprescribing process	Semi-structured interviews; field notes	6 months
Patient experience with deprescribing process (interview)	Semi-structured interview	6 months
Satisfaction with intervention	5 point Likert scale single question developed for study	6 months
Satisfaction with care around medications	5 point Likert scale single question developed for study	Baseline, 6 months
Successful discontinuation	Mean difference in number of medications	6 months
Successful discontinuation or dose reduction (proportion)	Proportion of patients with successful discontinuation or dose reduction	6 month
Quality of life (EQ5D-5L)	EuroQol five dimensions questionnaire (EQ5D-5L).	Baseline, 6 months
Quality of life (SF36v2)	The Short Form (36) Health Survey (SF-36-V2).	Baseline, 6 months
Falls	Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient.	Baseline, 6 months
Pain severity and interference	Brief Pain Inventory (Pain interference and Pain severity sub-scales)	Baseline, 6 months
Treatment Burden	Brief Treatment Burden Scale	Baseline, 6 months
Physical function capacity and ability (MANTY)	Manty structured validated interview	Baseline, 6 months
Physical function capacity and ability (balance)	Global Rating of Change (Balance).	Baseline, 6 months
Healthcare resource utilization (hospital admissions)	Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization.	Baseline, 6 months
Healthcare resource utilization (ED/urgent care visits)	Number of emergency department and urgent care visits from administrative data and self-report.	Baseline, 6 months
Healthcare resource utilization (primary care visits)	Number of primary care visits from administrative data	Baseline, 6 months
Changes in medication side effects and symptoms (adverse)	Patient self-report of appearance (new or worsening) of side effects associated with medications.	1 week, 3 month, 6 month
Changes in medication side effects and symptoms (positive)	Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications.	1 week, 3 month, 6 month
Serious adverse events	Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products).	Baseline, 6 months
Implementation processes	NoMAD survey	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); David Braley and Nancy Gordon Chair in Family Medicine; RxISK

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 4619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No