Nursing Home Team-Care Deprescribing Study

• Sponsor: Tan Tock Seng Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02863341
• Collaborator: Monash University (Other), National Healthcare Group, Singapore (Other)
• Enrollment: 295
• Location: 1
• Arms: 4
• Duration (Months): 17
• Patients Per Site Per Month: 17.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fall in Nursing Home; Medication Therapy Management	Other: Team-care deprescribing with deprescribing guide	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 295 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Nursing Home Team-Care Deprescribing Study
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in Fall Risk Assessment Tool (FRAT) score [Change from baseline in FRAT score at 3 months]

2. Change from baseline in Fall Risk Assessment Tool (FRAT) score [Change from baseline in FRAT score at 6 months]

3. Change from baseline in Fall Risk Assessment Tool (FRAT) score [Change from baseline in FRAT score at 12 months]

4. Change from baseline in fall rate [Change from baseline in fall rate at 3 months]

5. Change from baseline in fall rate [Change from baseline in fall rate at 6 months]

6. Change from baseline in fall rate [Change from baseline in fall rate at 12 months]

Secondary Outcome Measures

1. Factors affecting deprescribing [0 month]

   Interview questionnaire

2. Change from baseline in mean number of medications per subject [Change from baseline in mean number of medications per subject at 3 months]

3. Change from baseline in mean number of medications per subject [Change from baseline in mean number of medications per subject at 6 months]

4. Change from baseline in mean number of medications per subject [Change from baseline in mean number of medications per subject at 12 months]

5. Change from baseline in mean medication cost per subject [Change from baseline in mean medication cost at 3 months]

6. Change from baseline in mean medication cost per subject [Change from baseline in mean medication cost at 6 months]

7. Change from baseline in mean medication cost per subject [Change from baseline in mean medication cost at 12 months]

8. Change from baseline in deprescribing intervention acceptance rate [Change from baseline in deprescribing intervention acceptance rate at 3 months]

9. Change from baseline in deprescribing intervention acceptance rate [Change from baseline in deprescribing intervention acceptance rate at 6 months]

10. Change from baseline in deprescribing intervention acceptance rate [Change from baseline in deprescribing intervention acceptance rate at 12 months]

11. Change from baseline in percentage of drug-related problems (DRPs) [Change from baseline in percentage of DRPs at 3 months]

    Medication review form (Hepler/Strand DRP classification system)

12. Change from baseline in percentage of drug-related problems (DRPs) [Change from baseline in percentage of DRPs at 6 months]

    Medication review form (Hepler/Strand DRP classification system)

13. Change from baseline in percentage of drug-related problems (DRPs) [Change from baseline in percentage of DRPs at 12 months]

    Medication review form (Hepler/Strand DRP classification system)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nursing homes	Singapore		Singapore

Sponsors and Collaborators

• Tan Tock Seng Hospital
• Monash University
• National Healthcare Group, Singapore

Investigators

• Principal Investigator: Chong Han Kua, Monash University/Tan Tock Seng Hospital

Study Documents (Full-Text)

• Study Protocol - Mar 17, 2017

More Information

Publications

None provided.

• Responsible Party: Kua Chong Han, PhD Intern, Tan Tock Seng Hospital
• ClinicalTrials.gov Identifier: NCT02863341
• Other Study ID Numbers: 2016/00422
• First Posted: Aug 11, 2016
• Last Update Posted: Apr 5, 2018
• Last Verified: Apr 1, 2018

Study Results

No Results Posted as of Apr 5, 2018