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Nursing Home Team-Care Deprescribing Study

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ClinicalTrials.gov Identifier: NCT02863341
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Monash University
National Healthcare Group, Singapore
Information provided by (Responsible Party):
Kua Chong Han, Tan Tock Seng Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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



Primary Outcome Measures :
  1. Change from baseline in Fall Risk Assessment Tool (FRAT) score [ Time Frame: Change from baseline in FRAT score at 3 months ]
  2. Change from baseline in Fall Risk Assessment Tool (FRAT) score [ Time Frame: Change from baseline in FRAT score at 6 months ]
  3. Change from baseline in Fall Risk Assessment Tool (FRAT) score [ Time Frame: Change from baseline in FRAT score at 12 months ]
  4. Change from baseline in fall rate [ Time Frame: Change from baseline in fall rate at 3 months ]
  5. Change from baseline in fall rate [ Time Frame: Change from baseline in fall rate at 6 months ]
  6. Change from baseline in fall rate [ Time Frame: Change from baseline in fall rate at 12 months ]

Secondary Outcome Measures :
  1. Factors affecting deprescribing [ Time Frame: 0 month ]
    Interview questionnaire

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Change from baseline in mean medication cost per subject [ Time Frame: Change from baseline in mean medication cost at 3 months ]
  6. Change from baseline in mean medication cost per subject [ Time Frame: Change from baseline in mean medication cost at 6 months ]
  7. Change from baseline in mean medication cost per subject [ Time Frame: Change from baseline in mean medication cost at 12 months ]
  8. Change from baseline in deprescribing intervention acceptance rate [ Time Frame: Change from baseline in deprescribing intervention acceptance rate at 3 months ]
  9. Change from baseline in deprescribing intervention acceptance rate [ Time Frame: Change from baseline in deprescribing intervention acceptance rate at 6 months ]
  10. Change from baseline in deprescribing intervention acceptance rate [ Time Frame: Change from baseline in deprescribing intervention acceptance rate at 12 months ]
  11. Change from baseline in percentage of drug-related problems (DRPs) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change from baseline in percentage of DRPs at 12 months ]
    Medication review form (Hepler/Strand DRP classification system)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863341


Locations
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Singapore
Nursing homes
Singapore, Singapore
Sponsors and Collaborators
Tan Tock Seng Hospital
Monash University
National Healthcare Group, Singapore
Investigators
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Principal Investigator: Chong Han Kua Monash University/Tan Tock Seng Hospital
  Study Documents (Full-Text)

Documents provided by Kua Chong Han, Tan Tock Seng Hospital:
Study Protocol  [PDF] March 17, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kua Chong Han, PhD Intern, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT02863341     History of Changes
Other Study ID Numbers: 2016/00422
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018