Clinical trial NCT02942927: Team Approach to Polypharmacy Evaluation and Reduction
Official title: Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multi-morbidity
Medication Therapy Management
Polypharmacy
Keywords: Polypharmacy
Multimorbidity
Randomized Control Trial
Drug Discontinuation
Patient Preference
eHealth
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: David Braley and Nancy Gordon Chair in Family Medicine
name: RxISK
First posted: 2016-10-24
Enrollment: 360
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Successful discontinuation (mean difference in number of medications)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Quality of life (EQ5D-5L)
timeFrame: Baseline, 6 months
measure: Quality of life (SF36v2)
timeFrame: Baseline, 6 months
measure: Cognition
timeFrame: Baseline, 6 months
measure: Fatigue
timeFrame: Baseline, 6 months
measure: Pain
timeFrame: Baseline, 6 months
measure: Patient enablement
timeFrame: Baseline, 6 months
measure: Sleep
timeFrame: Baseline, 6 months
measure: Disease burden
timeFrame: Baseline, 6 months
measure: Nutritional status
timeFrame: Baseline, 6 months
measure: Treatment burden
timeFrame: Baseline, 6 months
measure: Falls
timeFrame: Baseline, 6 months
measure: Physical functional capacity and ability
timeFrame: Baseline, 6 months
measure: Physical function capacity and ability (timed-up-and-go)
timeFrame: Baseline, 6 months
measure: Physical function capacity and ability (strength)
timeFrame: Baseline, 6 month
measure: Physical function capacity and ability (balance)
timeFrame: Baseline, 6 months
measure: Healthcare resource utilization (hospital admissions)
timeFrame: Baseline, 6 months
measure: Healthcare resource utilization (ED/urgent care visits)
timeFrame: Baseline, 6 months
measure: Healthcare resource utilization (primary care visits)
timeFrame: baseline, 6 months
measure: Successful discontinuation or dose reduction
timeFrame: 6 months
measure: Successful discontinuation or dose reduction (proportion)
timeFrame: 6 months
measure: Changes in medication side effects and symptoms (adverse)
timeFrame: 1 week, 3 month, 6 month
measure: Changes in medication side effects and symptoms (positive)
timeFrame: 1 week, 3 month, 6 month
measure: Serious adverse events
timeFrame: 3 months, 6 months
measure: Medication self-efficacy
timeFrame: Baseline, 6 months
Other outcomes:
measure: Implementation processes
timeFrame: baseline, 3 months, 6 months
measure: Pharmacists/family physician 5 best/worst aspects of intervention
timeFrame: 6 months
measure: Pharmacists/family physician confidence in medication discontinuation
timeFrame: Baseline, 6 months
measure: Pharmacists/family physician experiences with the deprescribing process
timeFrame: 6 months
measure: Strengths and weaknesses of intervention
timeFrame: 6 months
measure: Patient experience with deprescribing process (diary)
timeFrame: 6 months
measure: Patient experience with deprescribing process (interview)
timeFrame: 6 months
measure: Satisfaction with intervention
timeFrame: 6 months
measure: Satisfaction with care around medications
timeFrame: Baseline, 6 months
measure: Cost effectiveness
timeFrame: 6 months
Locations:
city: Hamilton
country: Canada
facility: Dr. Dee Mangin
state: Ontario
Study officials:
References:
citation: Mangin D, Lamarche L, Agarwal G, Banh HL, Dore Brown N, Cassels A, Colwill K, Dolovich L, Farrell B, Garrison S, Gillett J, Griffith LE, Holbrook A, Jurcic-Vrataric J, McCormack J, O'Reilly D, Raina P, Richardson J, Risdon C, Savelli M, Sherifali D, Siu H, Tarride JE, Trimble J, Ali A, Freeman K, Langevin J, Parascandalo J, Templeton JA, Dragos S, Borhan S, Thabane L. Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):746. doi: 10.1186/s13063-021-05685-9.