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Medication Reduction for Overmedication (TAPER-RCT Trial)

N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently taking 5 or more long-term medications
Aged 70 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 3 month, 6 month
Awards & highlights

TAPER-RCT Trial Summary

This trial will test the effects of reducing the number of medications seniors take. The program will focus on discontinuing/reducing the dose of medications where possible. The results will be used to determine whether this system can be implemented as part of routine preventative care in primary care for older adults.

Who is the study for?
This trial is for seniors aged 70 or older who are taking 5 or more long-term medications and haven't had a thorough medication review in the past year. They must have a family doctor, be willing to try stopping some meds, and be able to understand study materials. Those with terminal illness or inadequate English/cognitive skills to participate fully are excluded.Check my eligibility
What is being tested?
The trial tests a program aimed at reducing the number of medications and their doses for seniors dealing with polypharmacy. Participants will either start this program immediately or after six months, involving reviews by pharmacists and doctors using an electronic system that flags drug issues.See study design
What are the potential side effects?
While not directly testing drugs, reducing medication may lead to withdrawal symptoms or return of conditions previously managed by these medicines. The 'pause and monitor' approach aims to minimize such risks as patients adjust.

TAPER-RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on 5 or more long-term medications.
Select...
I am 70 years old or older.

TAPER-RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 3 month, 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful discontinuation (mean difference in number of medications)
Secondary outcome measures
Changes in medication side effects and symptoms (adverse)
Changes in medication side effects and symptoms (positive)
Cognition
+21 more
Other outcome measures
Cost effectiveness
Implementation processes
Patient experience with deprescribing process (diary)
+7 more

TAPER-RCT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAPERExperimental Treatment1 Intervention
The intervention is medication reduction. This arm is comprised of: Medication reconciliation Identification of patient priorities for care Identification of medications that are potentially appropriate for discontinuation/dose reduction Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring
Group II: ControlActive Control1 Intervention
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,526 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,057 Total Patients Enrolled
David Braley and Nancy Gordon Chair in Family MedicineOTHER
3 Previous Clinical Trials
676 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit of individuals participating in this clinical trial?

"Affirmative. On clinicaltrials.gov, information suggests that this investigation is actively recruiting patients; it was initially posted on June 4th 2018 and recently updated August 23rd 2022. This trial requires 360 participants to be enrolled from one medical location."

Answered by AI

Are there still opportunities to join this clinical research effort?

"Affirmative. According to the content on clinicaltrials.gov, this research project is still searching for participants since it was initially posted in June 2018 and last amended August 2022. The study requires 360 people at a single medical centre."

Answered by AI
~33 spots leftby Dec 2024