- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02562352
Team Approach to Polypharmacy Evaluation and Reduction (TAPER)
September 2, 2020 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8P 1H6
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAPER program
The intervention arm is comprised of:
|
Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.
Other Names:
|
No Intervention: Control
Standard of Care as wait list control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful discontinuation (Difference in mean number of medications)
Time Frame: 6 months
|
Difference in mean number of medications per patient.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (EQ-5D)
Time Frame: 6 months
|
EQ-5D
|
6 months
|
Nutritional Status (Mini Nutritional Assessment Short-Form)
Time Frame: 6 months
|
Mini Nutritional Assessment Short-Form;
|
6 months
|
Patient experience of deprescribing (Thematic analysis of semi structured interviews)
Time Frame: 6 months
|
Thematic analysis of semi structured interviews
|
6 months
|
Physical Functional Capacity (Manty structured validated interview)
Time Frame: 6 months
|
Manty structured validated interview
|
6 months
|
Falls (self report number of falls)
Time Frame: 6 months
|
self report number of falls
|
6 months
|
Adverse Events (patient self report or clinician report)
Time Frame: 6 months
|
patient self report or clinician report
|
6 months
|
Health Resource Utilization (Number of hospital admissions and emergency dept visits)
Time Frame: 6 months
|
Number of hospital admissions and emergency dept visits
|
6 months
|
Cognition (The Mini Mental Status Examination)
Time Frame: 6 months
|
The Mini Mental Status Examination
|
6 months
|
Fatigue (Avlund Mob-T Scale)
Time Frame: 6 months
|
Avlund Mob-T Scale
|
6 months
|
Patient Enablement (Patient Enablement Index)
Time Frame: 6 months
|
Patient Enablement Index
|
6 months
|
Self-Efficacy (Stanford Self-Efficacy Scale)
Time Frame: 6 months
|
Stanford Self-Efficacy Scale
|
6 months
|
Patient self report of change in quality of life/morbidity (Global Impression Scale)
Time Frame: 6 months
|
Global Impression Scale
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
August 21, 2015
First Submitted That Met QC Criteria
September 25, 2015
First Posted (Estimate)
September 29, 2015
Study Record Updates
Last Update Posted (Actual)
September 4, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TAPER-001-19-Aug-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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