Clinical trial NCT02863341: Nursing Home Team-Care Deprescribing Study
Official title: Nursing Home Team-Care Deprescribing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall in Nursing Home
Medication Therapy Management
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Monash University
name: National Healthcare Group, Singapore
First posted: 2016-08-11
Enrollment: 295
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Fall Risk Assessment Tool (FRAT) score
timeFrame: Change from baseline in FRAT score at 3 months
measure: Change from baseline in Fall Risk Assessment Tool (FRAT) score
timeFrame: Change from baseline in FRAT score at 6 months
measure: Change from baseline in Fall Risk Assessment Tool (FRAT) score
timeFrame: Change from baseline in FRAT score at 12 months
measure: Change from baseline in fall rate
timeFrame: Change from baseline in fall rate at 3 months
measure: Change from baseline in fall rate
timeFrame: Change from baseline in fall rate at 6 months
measure: Change from baseline in fall rate
timeFrame: Change from baseline in fall rate at 12 months
Secondary outcomes:
measure: Factors affecting deprescribing
timeFrame: 0 month
measure: Change from baseline in mean number of medications per subject
timeFrame: Change from baseline in mean number of medications per subject at 3 months
measure: Change from baseline in mean number of medications per subject
timeFrame: Change from baseline in mean number of medications per subject at 6 months
measure: Change from baseline in mean number of medications per subject
timeFrame: Change from baseline in mean number of medications per subject at 12 months
measure: Change from baseline in mean medication cost per subject
timeFrame: Change from baseline in mean medication cost at 3 months
measure: Change from baseline in mean medication cost per subject
timeFrame: Change from baseline in mean medication cost at 6 months
measure: Change from baseline in mean medication cost per subject
timeFrame: Change from baseline in mean medication cost at 12 months
measure: Change from baseline in deprescribing intervention acceptance rate
timeFrame: Change from baseline in deprescribing intervention acceptance rate at 3 months
measure: Change from baseline in deprescribing intervention acceptance rate
timeFrame: Change from baseline in deprescribing intervention acceptance rate at 6 months
measure: Change from baseline in deprescribing intervention acceptance rate
timeFrame: Change from baseline in deprescribing intervention acceptance rate at 12 months
measure: Change from baseline in percentage of drug-related problems (DRPs)
timeFrame: Change from baseline in percentage of DRPs at 3 months
measure: Change from baseline in percentage of drug-related problems (DRPs)
timeFrame: Change from baseline in percentage of DRPs at 6 months
measure: Change from baseline in percentage of drug-related problems (DRPs)
timeFrame: Change from baseline in percentage of DRPs at 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nursing homes
Study officials:
affiliation: Monash University/Tan Tock Seng Hospital
name: Chong Han Kua
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.