Team Approach to Polypharmacy Evaluation and Reduction

Not Applicable

Completed

• Conditions: Comorbidity; Medication Therapy Management
• Interventions: Other: TAPER program

• Registration Number: NCT02562352
• 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 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.

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-29
• Study Start: 2015-10
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAPER program	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.

Primary Outcome Measures

Name	Time	Method
Successful discontinuation (Difference in mean number of medications)	6 months	Difference in mean number of medications per patient.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada