NCT03202264

Brief Summary

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes, including mobility. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. The study will also assess for any signals of reversal of medications related mobility impairments to reduce medications-related mobility impairment (fatigue, pain, falls) using the intervention. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. Findings will inform the design of a randomized controlled trial to test the effect of this intervention on health outcomes.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

February 23, 2017

Results QC Date

August 11, 2021

Last Update Submit

August 11, 2021

Conditions

Keywords

PolypharmacyMobilityMultimorbidityDrug DiscontinuationPatient PreferenceeHealth

Outcome Measures

Primary Outcomes (1)

  • Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)

    Difference in mean number of medications; number of medications reduced in dose

    6 months

Secondary Outcomes (20)

  • Mobility-related Fatigue

    Baseline, 6 months

  • Level of Physical Functioning

    Baseline, 6 Months

  • Pain

    Baseline, 6 Months

  • Falls

    Baseline, 6 Months

  • Sleep

    Baseline, 6 Months

  • +15 more secondary outcomes

Study Arms (1)

TAPERMD

80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities

Other: TAPER

Interventions

TAPEROTHER

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

TAPERMD

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.

You may qualify if:

  • residing in 2 long-term care facilities in Brampton, ON
  • on 5 or more medications
  • years of age or older
  • adequate English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P 1H6, Canada

Location

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Dee Mangin
Organization
McMaster University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

June 28, 2017

Study Start

July 1, 2017

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

September 8, 2021

Results First Posted

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.

Locations