Team Approach to Polypharmacy Evaluation and Reduction

Overview

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.

Full Title of Study: “Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: TAPER program
    • The intervention arm is comprised of: Identification of medications that are appropriate for discontinuation/dose reduction. Linked pharmacist/family physician consultations with patient to discuss medication discontinuation/dose reduction.
  • No Intervention: Control
    • Standard of Care as wait list control

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Health Canada
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dee Mangin, MBChB, DPH, FRNZC, MD, Principal Investigator, McMaster University

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