Fall in Nursing HomeNCT02863341
Nursing Home Team-Care Deprescribing Study
A study testing Team-care deprescribing with deprescribing guide in people with Fall in Nursing Home and Medication Therapy Management, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall in Nursing Home, Medication Therapy Management
- What is being tested?
- Team-care deprescribing with deprescribing guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Accepted informed consent,
- The healthcare professional is practicing in the involved nursing homes.
- 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.
Who cannot join
- 1) Decline/unable to provide consent.
- For team-care deprescribing study:
- Below the age of 65 years of age,
- Life expectancy of less than 6 months or respite care.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Being tested
- Team-care deprescribing with deprescribing guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-care deprescribing with deprescribing guideOther
Beers criteria 2015, STOPP criteria 2014, drug interaction
| Study group | Role | What they receive |
|---|---|---|
| naive Deprescribing arm | Experimental | Team-based deprescribing practice, Deprescribing Guide Receives: Other: Team-care deprescribing with deprescribing guide |
| naive Wait-list Control arm | No intervention | Not described |
| non-naive Deprescribing arm | Experimental | Team-based deprescribing practice, Deprescribing Guide Receives: Other: Team-care deprescribing with deprescribing guide |
| non-naive Wait-list Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Measured: Change from baseline in FRAT score at 3 months
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Measured: Change from baseline in FRAT score at 6 months
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Measured: Change from baseline in FRAT score at 12 months
Change from baseline in fall rate
Measured: Change from baseline in fall rate at 3 months
Change from baseline in fall rate
Measured: Change from baseline in fall rate at 6 months
Change from baseline in fall rate
Measured: Change from baseline in fall rate at 12 months
Secondary outcomes (13)
Factors affecting deprescribing
Interview questionnaire
Measured: 0 month
Change from baseline in mean number of medications per subject
Measured: Change from baseline in mean number of medications per subject at 3 months
Change from baseline in mean number of medications per subject
Measured: Change from baseline in mean number of medications per subject at 6 months
Change from baseline in mean number of medications per subject
Measured: Change from baseline in mean number of medications per subject at 12 months
Change from baseline in mean medication cost per subject
Measured: Change from baseline in mean medication cost at 3 months
Change from baseline in mean medication cost per subject
Measured: Change from baseline in mean medication cost at 6 months
Change from baseline in mean medication cost per subject
Measured: Change from baseline in mean medication cost at 12 months
Change from baseline in deprescribing intervention acceptance rate
Measured: Change from baseline in deprescribing intervention acceptance rate at 3 months
Change from baseline in deprescribing intervention acceptance rate
Measured: Change from baseline in deprescribing intervention acceptance rate at 6 months
Change from baseline in deprescribing intervention acceptance rate
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline in percentage of DRPs at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fall in Nursing HomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, National Healthcare Group, Singapore
- Responsible party
- Principal investigator, Kua Chong Han, Tan Tock Seng Hospital
- Investigators
- Chong Han Kua, Principal investigator, Monash University/Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863341
- Sponsor's protocol ID
- 2016/00422
- Other IDs
- 2016
- Status last verified
- Apr 2018
- First submitted
- 31 Jul 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
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.
PubMed 28490560
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Home Team-Care Deprescribing Study
- ClinicalTrials.gov ID
- NCT02863341
- Acronym / sponsor ID
- 2016/00422
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Monash University, National Healthcare Group, Singapore
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| naive Deprescribing arm | Experimental | Other: Team-care deprescribing with deprescribing guideTeam-based deprescribing practice, Deprescribing Guide |
| naive Wait-list Control arm | No intervention | – |
| non-naive Deprescribing arm | Experimental | Other: Team-care deprescribing with deprescribing guideTeam-based deprescribing practice, Deprescribing Guide |
| non-naive Wait-list Control arm | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Accepted informed consent,
- The healthcare professional is practicing in the involved nursing homes.
- 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.
Key exclusion criteria (4 listed)
- 1) Decline/unable to provide consent.
- Below the age of 65 years of age,
- Life expectancy of less than 6 months or respite care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-care deprescribing with deprescribing guideBeers criteria 2015, STOPP criteria 2014, drug interaction | Other | naive Deprescribing arm, non-naive Deprescribing arm |
Primary outcome
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Time frame: Change from baseline in FRAT score at 3 months
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Time frame: Change from baseline in FRAT score at 6 months
Change from baseline in Fall Risk Assessment Tool (FRAT) score
Time frame: Change from baseline in FRAT score at 12 months
Change from baseline in fall rate
Time frame: Change from baseline in fall rate at 3 months
Change from baseline in fall rate
Time frame: Change from baseline in fall rate at 6 months
Change from baseline in fall rate
Time frame: Change from baseline in fall rate at 12 months
13 secondary outcomes
Factors affecting deprescribing
Time frame: 0 month
Change from baseline in mean number of medications per subject
Time frame: Change from baseline in mean number of medications per subject at 3 months
Change from baseline in mean number of medications per subject
Time frame: Change from baseline in mean number of medications per subject at 6 months
Change from baseline in mean number of medications per subject
Time frame: Change from baseline in mean number of medications per subject at 12 months
Change from baseline in mean medication cost per subject
Time frame: Change from baseline in mean medication cost at 3 months
Change from baseline in mean medication cost per subject
Time frame: Change from baseline in mean medication cost at 6 months
Change from baseline in mean medication cost per subject
Time frame: Change from baseline in mean medication cost at 12 months
Change from baseline in deprescribing intervention acceptance rate
Time frame: Change from baseline in deprescribing intervention acceptance rate at 3 months
Change from baseline in deprescribing intervention acceptance rate
Time frame: Change from baseline in deprescribing intervention acceptance rate at 6 months
Change from baseline in deprescribing intervention acceptance rate
Time frame: Change from baseline in deprescribing intervention acceptance rate at 12 months
Change from baseline in percentage of drug-related problems (DRPs)
Time frame: Change from baseline in percentage of DRPs at 3 months
Change from baseline in percentage of drug-related problems (DRPs)
Time frame: Change from baseline in percentage of DRPs at 6 months
Change from baseline in percentage of drug-related problems (DRPs)
Time frame: Change from baseline in percentage of DRPs at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 28490560Kua 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Han Kua principal investigator
Monash University/Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-care deprescribing with deprescribing guide in people with Fall in Nursing Home and Medication Therapy Management, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Fall Risk Assessment Tool (FRAT) score (time frame: Change from baseline in FRAT score at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018; AzTrials last refreshed its copy on 27 Oct 2026.