Clinical trial NCT02562352: Team Approach to Polypharmacy Evaluation and Reduction
Official title: Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comorbidity
Medication Therapy Management
Keywords: polypharmacy
multimorbidity
randomized controlled trial
drug discontinuation
patient preference
eHealth
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Health Canada
name: The Labarge Optimal Aging Initiative
name: David Braley and Nancy Gordon Chair in Family Medicine
name: RxISK
First posted: 2015-09-29
Enrollment: 38
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Successful discontinuation (Difference in mean number of medications)
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (EQ-5D)
timeFrame: 6 months
measure: Nutritional Status (Mini Nutritional Assessment Short-Form)
timeFrame: 6 months
measure: Patient experience of deprescribing (Thematic analysis of semi structured interviews)
timeFrame: 6 months
measure: Physical Functional Capacity (Manty structured validated interview)
timeFrame: 6 months
measure: Falls (self report number of falls)
timeFrame: 6 months
measure: Adverse Events (patient self report or clinician report)
timeFrame: 6 months
measure: Health Resource Utilization (Number of hospital admissions and emergency dept visits)
timeFrame: 6 months
measure: Cognition (The Mini Mental Status Examination)
timeFrame: 6 months
measure: Fatigue (Avlund Mob-T Scale)
timeFrame: 6 months
measure: Patient Enablement (Patient Enablement Index)
timeFrame: 6 months
measure: Self-Efficacy (Stanford Self-Efficacy Scale)
timeFrame: 6 months
measure: Patient self report of change in quality of life/morbidity (Global Impression Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Dee Mangin, MBChB, DPH, FRNZC, MD
role: PRINCIPAL_INVESTIGATOR
References: