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NCT Number: NCT02562352

Team Approach to Polypharmacy Evaluation and Reduction

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.

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Key information

Conditions

Comorbidity Behavior Health Behavior Medication Therapy Management Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8P 1H6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAPER program

Other

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

Other names: Medication Discontinuation/Dose Reduction

Primary outcomes

  1. Successful discontinuation (Difference in mean number of medications)

    Time frame: 6 months

    Difference in mean number of medications per patient.

Secondary outcomes

  1. Quality of Life (EQ-5D)

    Time frame: 6 months

    EQ-5D

  2. Nutritional Status (Mini Nutritional Assessment Short-Form)

    Time frame: 6 months

    Mini Nutritional Assessment Short-Form;

  3. Patient experience of deprescribing (Thematic analysis of semi structured interviews)

    Time frame: 6 months

    Thematic analysis of semi structured interviews

  4. Physical Functional Capacity (Manty structured validated interview)

    Time frame: 6 months

    Manty structured validated interview

  5. Falls (self report number of falls)

    Time frame: 6 months

    self report number of falls

  6. Adverse Events (patient self report or clinician report)

    Time frame: 6 months

    patient self report or clinician report

  7. Health Resource Utilization (Number of hospital admissions and emergency dept visits)

    Time frame: 6 months

    Number of hospital admissions and emergency dept visits

  8. Cognition (The Mini Mental Status Examination)

    Time frame: 6 months

    The Mini Mental Status Examination

  9. Fatigue (Avlund Mob-T Scale)

    Time frame: 6 months

    Avlund Mob-T Scale

  10. Patient Enablement (Patient Enablement Index)

    Time frame: 6 months

    Patient Enablement Index

  11. Self-Efficacy (Stanford Self-Efficacy Scale)

    Time frame: 6 months

    Stanford Self-Efficacy Scale

  12. Patient self report of change in quality of life/morbidity (Global Impression Scale)

    Time frame: 6 months

    Global Impression Scale

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • David Braley and Nancy Gordon Chair in Family Medicine
  • Health Canada
  • RxISK
  • The Labarge Optimal Aging Initiative

Registry information

Official study title

Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

Acronym: TAPER

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2015
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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