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Clinical Trials/NCT02562352
NCT02562352
Completed
Not Applicable

Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

McMaster University1 site in 1 country38 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Comorbidity
Sponsor
McMaster University
Enrollment
38
Locations
1
Primary Endpoint
Successful discontinuation (Difference in mean number of medications)
Status
Completed
Last Updated
5 years ago

Overview

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 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.

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
November 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Successful discontinuation (Difference in mean number of medications)

Time Frame: 6 months

Difference in mean number of medications per patient.

Secondary Outcomes

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

Study Sites (1)

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