Team Approach to Polypharmacy Evaluation and Reduction

Not Applicable

Recruiting

• Conditions: Medication Therapy Management; Polypharmacy; Multi-morbidity
• Interventions: Other: Medication reduction

• Registration Number: NCT02942927
• 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 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 are taking ≥5 medications, will randomly receive the program immediately or at 6 months. 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 effects on patient and health relevant outcome measures as well as qualitative research exploring patients' and clinicians' experiences of reducing medication burden. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.

Detailed Description

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. Initial baseline data collection from the patient include 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2018-06-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Aged 70 years of age or older
• Patient must have a family doctor
• Participating family doctor as most responsible provider
• Currently taking more 5 or more long-term medications
• Have not had a recent (past 12 months) comprehensive medication review
• Patient willing to try discontinuation

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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 6 month study period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAPER	Medication reduction	The intervention is medication reduction. This arm is comprised of: 1. Medication reconciliation 2. Identification of patient priorities for care 3. Identification of medications that are potentially appropriate for discontinuation/dose reduction 4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce 5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) 6. Pause of medication and clinical monitoring

Primary Outcome Measures

Name	Time	Method
Successful discontinuation (mean difference in number of medications)	Baseline, 6 months	Difference in mean number of medications

Secondary Outcome Measures

Name	Time	Method
Cognition	Baseline, 6 months	The Mini Mental Status Examination (MMSE)
Nutritional status	Baseline, 6 months	Mini Nutritional Assessment Short-Form (MNA-SF)
Fatigue	Baseline, 6 months	Avlund Mob-T Scale
Sleep	Baseline, 6 months	15-D Scale (Sleep Question)
Quality of life (SF36v2)	Baseline, 6 months	The Short Form (36) Health Survey (SF-36-V2)
Pain	Baseline, 6 months	Brief Pain Inventory (Pain interference and Pain severity sub-scales)
Quality of life (EQ5D-5L)	Baseline, 6 months	EuroQol five dimensions questionnaire (EQ5D-5L)
Patient enablement	Baseline, 6 months	The Patient Enablement Index (PEI)
Disease burden	Baseline, 6 months	Disease Burden Survey (Bayliss et al., 2009)
Successful discontinuation or dose reduction	6 months	Composite variable calculate to represent mean number of medications stopped or dose reductions
Treatment burden	Baseline, 6 months	Brief Treatment Burden Scale
Physical function capacity and ability (balance)	Baseline, 6 months	Global Rating of Change (Balance)
Healthcare resource utilization (primary care visits)	baseline, 6 months	Number of primary care visits from administrative data
Changes in medication side effects and symptoms (adverse)	1 week, 3 month, 6 month	Patient self-report of appearance (new or worsening) of side effects associated with medications
Falls	Baseline, 6 months	Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
Healthcare resource utilization (hospital admissions)	Baseline, 6 months	Number of hospital admissions from administrative data and self-report; proportion of patients with at least one hospitalization
Successful discontinuation or dose reduction (proportion)	6 months	Proportion of patients with successful discontinuations or dose reductions
Medication self-efficacy	Baseline, 6 months	Self-efficacy for appropriate mediation use scale
Physical functional capacity and ability	Baseline, 6 months	Manty structured validated interview
Physical function capacity and ability (strength)	Baseline, 6 month	Grip strength
Healthcare resource utilization (ED/urgent care visits)	Baseline, 6 months	Number of emergency department and urgent care visits from administrative data and self-report
Physical function capacity and ability (timed-up-and-go)	Baseline, 6 months	Timed up and go test (TUG)
Changes in medication side effects and symptoms (positive)	1 week, 3 month, 6 month	Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
Serious adverse events	3 months, 6 months	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)

Trial Locations

Locations (1)

Dr. Dee Mangin; 🇨🇦 Hamilton, Ontario, Canada