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Team Approach to Polypharmacy Evaluation and Reduction

Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02562352
Acronym
TAPER
Enrollment
38
Registered
2015-09-29
Start date
2015-10-31
Completion date
2019-11-30
Last updated
2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbidity, Medication Therapy Management

Keywords

polypharmacy, multimorbidity, randomized controlled trial, drug discontinuation, patient preference, eHealth

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.

Interventions

OTHERTAPER program

Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.

Sponsors

Health Canada
CollaboratorOTHER_GOV
The Labarge Optimal Aging Initiative
CollaboratorOTHER
David Braley and Nancy Gordon Chair in Family Medicine
CollaboratorOTHER
RxISK
CollaboratorINDUSTRY
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful discontinuation (Difference in mean number of medications)6 monthsDifference in mean number of medications per patient.

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026