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ComorbidityTAPERNCT02562352

Team Approach to Polypharmacy Evaluation and Reduction

A study testing TAPER program in people with Comorbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Comorbidity, Medication Therapy Management
What is being tested?
TAPER program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteCanada
Study dates
Oct 2015to Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • English language or cognitive skills inadequate to understand and respond to rating scales
  • Terminal illness or other circumstance precluding 13 month study period

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8P 1H6

Other trials in Canada

About this study

Official title: Team Approach to Polypharmacy Evaluation and Reduction: Feasibility Study

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.

Read the 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.

Being tested
TAPER program
Keywords
polypharmacy, multimorbidity, randomized controlled trial, drug discontinuation, patient preference, eHealth
Medical subject headings
Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAPER programOther

    Also called Medication Discontinuation/Dose Reduction

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

Study groups in NCT02562352
Study groupRoleWhat they receive
TAPER programExperimentalThe intervention arm is comprised of: 1. Identification of medications that are appropriate for discontinuation/dose reduction. 2. Linked pharmacist/family physician consultations with patient to discuss medication discontinuation/dose reduction.
Receives: Other: TAPER program
ControlNo interventionStandard of Care as wait list control

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Difference in mean number of medications per patient.

    Measured: 6 months

Secondary outcomes (12)

  1. Quality of Life (EQ-5D)

    EQ-5D

    Measured: 6 months

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

    Mini Nutritional Assessment Short-Form;

    Measured: 6 months

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

    Thematic analysis of semi structured interviews

    Measured: 6 months

  4. Physical Functional Capacity (Manty structured validated interview)

    Manty structured validated interview

    Measured: 6 months

  5. Falls (self report number of falls)

    self report number of falls

    Measured: 6 months

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

    patient self report or clinician report

    Measured: 6 months

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

    Number of hospital admissions and emergency dept visits

    Measured: 6 months

  8. Cognition (The Mini Mental Status Examination)

    The Mini Mental Status Examination

    Measured: 6 months

  9. Fatigue (Avlund Mob-T Scale)

    Avlund Mob-T Scale

    Measured: 6 months

  10. Patient Enablement (Patient Enablement Index)

    Patient Enablement Index

    Measured: 6 months

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

    Stanford Self-Efficacy Scale

    Measured: 6 months

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

    Global Impression Scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2019
  4. Study completionNov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02562352
Sponsor's protocol ID
TAPER-001-19-Aug-15
Acronym
TAPER
Status last verified
Sep 2020
First submitted
21 Aug 2015
Last updated
4 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • Mangin D, Lamarche L, Agarwal G, Ali A, Cassels A, Colwill K, Dolovich L, Brown ND, Farrell B, Freeman K, Frizzle K, Garrison SR, Gillett J, Holbrook A, Jurcic-Vrataric J, McCormack J, Parascandalo J, Richardson J, Risdon C, Sherifali D, Siu H, Borhan S, Templeton JA, Thabane L, Trimble J. Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy. Pilot Feasibility Stud. 2023 May 18;9(1):84. doi: 10.1186/s40814-023-01315-0.

    PubMed 37202822

Questions about this trial

What is this clinical trial studying?

A study testing TAPER program in people with Comorbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful discontinuation (Difference in mean number of medications) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02562352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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