NCT02863341

Brief Summary

This is a multi-centre study in Singapore nursing homes, investigating the factors that affecting deprescribing, and if a team-care based deprescribing standard practice gives superior health and pharmacoeconomic outcomes over current medication review practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

July 31, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

July 31, 2016

Last Update Submit

April 3, 2018

Conditions

Fall in Nursing HomeMedication Therapy Management

Outcome Measures

Primary Outcomes (6)

  • Change from baseline in Fall Risk Assessment Tool (FRAT) score

    Change from baseline in FRAT score at 3 months

  • Change from baseline in Fall Risk Assessment Tool (FRAT) score

    Change from baseline in FRAT score at 6 months

  • Change from baseline in Fall Risk Assessment Tool (FRAT) score

    Change from baseline in FRAT score at 12 months

  • Change from baseline in fall rate

    Change from baseline in fall rate at 3 months

  • Change from baseline in fall rate

    Change from baseline in fall rate at 6 months

  • Change from baseline in fall rate

    Change from baseline in fall rate at 12 months

Secondary Outcomes (13)

  • Factors affecting deprescribing

    0 month

  • Change from baseline in mean number of medications per subject

    Change from baseline in mean number of medications per subject at 3 months

  • Change from baseline in mean number of medications per subject

    Change from baseline in mean number of medications per subject at 6 months

  • Change from baseline in mean number of medications per subject

    Change from baseline in mean number of medications per subject at 12 months

  • Change from baseline in mean medication cost per subject

    Change from baseline in mean medication cost at 3 months

  • +8 more secondary outcomes

Study Arms (4)

naive Deprescribing arm

EXPERIMENTAL

Team-based deprescribing practice, Deprescribing Guide

Other: Team-care deprescribing with deprescribing guide

naive Wait-list Control arm

NO INTERVENTION

non-naive Deprescribing arm

EXPERIMENTAL

Team-based deprescribing practice, Deprescribing Guide

Other: Team-care deprescribing with deprescribing guide

non-naive Wait-list Control arm

NO INTERVENTION

Interventions

Team-care deprescribing with deprescribing guideOTHER

Beers criteria 2015, STOPP criteria 2014, drug interaction

naive Deprescribing armnon-naive Deprescribing arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Accepted informed consent,
  • The healthcare professional is practicing in the involved nursing homes.

You may not qualify if:

  • \) Decline/unable to provide consent.
  • For team-care deprescribing study:
  • Accepted informed consent (unless cognitive-impaired, with no or un-contactable next-of-kin),
  • Adult aged 65 years and above,
  • Currently on five or more medications.
  • Below the age of 65 years of age,
  • Life expectancy of less than 6 months or respite care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing homes

Singapore, Singapore

Location

Related Publications (1)

  • Kua CH, Yeo CYY, Char CWT, Tan CWY, Tan PC, Mak VS, Lee SWH, Leong IY. Nursing home team-care deprescribing study: a stepped-wedge randomised controlled trial protocol. BMJ Open. 2017 May 9;7(5):e015293. doi: 10.1136/bmjopen-2016-015293.

    PMID: 28490560DERIVED

Study Officials

  • Chong Han Kua

    Monash University/Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Intern

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 11, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

SG(1)