Team Approach to Polypharmacy Evaluation and Reduction (TAPER)

September 2, 2020 updated by: McMaster University

Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. The intervention includes initial baseline data collection from the patient including data 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 his/her family physician to discuss patient preferences for discontinuation/dose reduction. Follow up appointments will take place at one week, 3 months and 6 months (study end). Questionnaires and a semi-structured interview will take place at the 6 month appointment. After six months, the control group will be offered the intervention.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8P 1H6
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAPER program

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.
Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.
Other Names:
  • Medication Discontinuation/Dose Reduction
No Intervention: Control
Standard of Care as wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful discontinuation (Difference in mean number of medications)
Time Frame: 6 months
Difference in mean number of medications per patient.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (EQ-5D)
Time Frame: 6 months
EQ-5D
6 months
Nutritional Status (Mini Nutritional Assessment Short-Form)
Time Frame: 6 months
Mini Nutritional Assessment Short-Form;
6 months
Patient experience of deprescribing (Thematic analysis of semi structured interviews)
Time Frame: 6 months
Thematic analysis of semi structured interviews
6 months
Physical Functional Capacity (Manty structured validated interview)
Time Frame: 6 months
Manty structured validated interview
6 months
Falls (self report number of falls)
Time Frame: 6 months
self report number of falls
6 months
Adverse Events (patient self report or clinician report)
Time Frame: 6 months
patient self report or clinician report
6 months
Health Resource Utilization (Number of hospital admissions and emergency dept visits)
Time Frame: 6 months
Number of hospital admissions and emergency dept visits
6 months
Cognition (The Mini Mental Status Examination)
Time Frame: 6 months
The Mini Mental Status Examination
6 months
Fatigue (Avlund Mob-T Scale)
Time Frame: 6 months
Avlund Mob-T Scale
6 months
Patient Enablement (Patient Enablement Index)
Time Frame: 6 months
Patient Enablement Index
6 months
Self-Efficacy (Stanford Self-Efficacy Scale)
Time Frame: 6 months
Stanford Self-Efficacy Scale
6 months
Patient self report of change in quality of life/morbidity (Global Impression Scale)
Time Frame: 6 months
Global Impression Scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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