Clinical trial NCT03557944: Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)
Official title: Team Approach to Polypharmacy Evaluation and Reduction Pharmacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multi-morbidity
Medication Therapy Management
Polypharmacy
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: 2018-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, longitudinal cohort feasibility study.
Primary purpose: OTHER

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 taking ≥5 medications will receive the TAPER program. 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 whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.

Detailed description: This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information 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 5 or more long-term medications
* Has not had a recent 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: Feasibility (recruitment number)
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility (proportion consented)
timeFrame: 6 months
measure: Feasibility (proportion completed)
timeFrame: 6 months
measure: Feasibility (barriers to recruitment)
timeFrame: 6 months
measure: Feasibility (time to complete surveys)
timeFrame: Baseline, 6 months
measure: Feasibility (capacity for pharmacist to implement)
timeFrame: 6 months
measure: Feasibility (issues with TaperMD tool)
timeFrame: 6 months
measure: Feasibility (missing data)
timeFrame: 6 months
measure: Feasibility (variance of measures)
timeFrame: Baseline, 6 months
measure: Feasibility (intervention implementation proportion)
timeFrame: 6 months
Other outcomes:
measure: Successful discontinuation
timeFrame: 6 months
measure: Successful discontinuation or dose reduction
timeFrame: 6 months
measure: Successful discontinuation or dose reduction (proportion)
timeFrame: 6 month
measure: Quality of life (EQ5D-5L)
timeFrame: Baseline, 6 months
measure: Quality of life (SF36v2)
timeFrame: Baseline, 6 months
measure: Falls
timeFrame: Baseline, 6 months
measure: Fatigue
timeFrame: Baseline, 6 months
measure: Pain severity and interference
timeFrame: Baseline, 6 months
measure: Sleep
timeFrame: Baseline, 6 months
measure: Treatment Burden
timeFrame: Baseline, 6 months
measure: Physical function capacity and ability (MANTY)
timeFrame: Baseline, 6 months
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: 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: Baseline, 6 months
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: 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
Locations:
city: Hamilton
country: Canada
facility: Dr. Dee Mangin
state: Ontario
Study officials:
References: