Nursing Home Team-Care Deprescribing Study

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.

Study Overview

• Status: Completed
• Conditions: Medication Therapy Management; Fall in Nursing Home
• Intervention / Treatment: Other: Team-care deprescribing with deprescribing guide

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Nursing homes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For interview questionnaire:

Inclusion criteria are:

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

Exclusion criteria are:

1) Decline/unable to provide consent.

For team-care deprescribing study:

Inclusion criteria are:

1. Accepted informed consent (unless cognitive-impaired, with no or un-contactable next-of-kin),
2. Adult aged 65 years and above,
3. Currently on five or more medications.

Exclusion criteria are:

1. Below the age of 65 years of age,
2. Life expectancy of less than 6 months or respite care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: naive Deprescribing arm; Team-based deprescribing practice, Deprescribing Guide	Other: Team-care deprescribing with deprescribing guide; Beers criteria 2015, STOPP criteria 2014, drug interaction
NO_INTERVENTION: naive Wait-list Control arm
EXPERIMENTAL: non-naive Deprescribing arm; Team-based deprescribing practice, Deprescribing Guide	Other: Team-care deprescribing with deprescribing guide; Beers criteria 2015, STOPP criteria 2014, drug interaction
NO_INTERVENTION: non-naive Wait-list Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors affecting deprescribing	Interview questionnaire	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
Change from baseline in mean medication cost per subject		Change from baseline in mean medication cost at 6 months
Change from baseline in mean medication cost per subject		Change from baseline in mean medication cost at 12 months
Change from baseline in deprescribing intervention acceptance rate		Change from baseline in deprescribing intervention acceptance rate at 3 months
Change from baseline in deprescribing intervention acceptance rate		Change from baseline in deprescribing intervention acceptance rate at 6 months
Change from baseline in deprescribing intervention acceptance rate		Change from baseline in deprescribing intervention acceptance rate at 12 months
Change from baseline in percentage of drug-related problems (DRPs)	Medication review form (Hepler/Strand DRP classification system)	Change from baseline in percentage of DRPs at 3 months
Change from baseline in percentage of drug-related problems (DRPs)	Medication review form (Hepler/Strand DRP classification system)	Change from baseline in percentage of DRPs at 6 months
Change from baseline in percentage of drug-related problems (DRPs)	Medication review form (Hepler/Strand DRP classification system)	Change from baseline in percentage of DRPs at 12 months

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Monash University; National Healthcare Group, Singapore
• Investigators: Principal Investigator: Chong Han Kua, Monash University/Tan Tock Seng Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: July 31, 2016
• First Submitted That Met QC Criteria: August 7, 2016
• First Posted (ESTIMATE): August 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2016/00422