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Efficacy and Feasibility of De-prescribing Rounds in a Singapore Rehabilitative Hospital- a Pilot Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03713112
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bright Vision Hospital

Brief Summary:
This open-labelled randomized control trial will be conducted in a Singapore Rehabilitation Hospital to investigate the efficacy, cost-reduction, safety and feasibility of a weekly deprescribing multi-disciplinary inpatient deprescribing round up to 28 days post discharge.

Condition or disease Intervention/treatment Phase
Deprescribing Multi-disciplinary Rounds Other: Weekly MDT deprescribing rounds for certain drugs Not Applicable

Detailed Description:

ABSTRACT BACKGROUND: Deprescribing has been effective and safe in reducing polypharmacy and morbidity (e.g. fall), especially amongst elderly. However, little has been studied about the efficacy of a regular multidisciplinary round in deprescribing predefined medications in Singapore rehabilitative hospitals.

AIM: This study aims to evaluating the effects of a weekly multidisciplinary team(MDT) de-prescribing round on the reduction on total daily dose, cost of medications, its safety and feasibility in a Singapore rehabilitative hospital.

Methods: A total of 260 newly admitted patients will be randomised to a de-prescribing intervention (n= 130) or control (usual care) group (n= 130), using GraphPad randomization sequence software ©2017. The 5 steps of deprescribing process will be used and the targets of deprescribing are Beer's list of potentially inappropriate medications (AGS 2015 version), predetermined supplements and symptomatic medications. Predetermined medications were deprescribed following initial MDT assessment, discussion with attending doctors and consideration of patients' preferences regarding discontinuation or dose reduction. Total daily dose reduction, cost and side effects of deprescribing were monitored on admission day 14, 28, discharge day and post-discharge day 28. Time required for such rounds are also measured.

IMPACT: Once proven successful, this effective model of deprescribing could safely help to cut down caregiver's medicine administrative burden, improve compliance and reduce national healthcare cost. This model could also be easily replicated in all Singapore rehabilitative hospitals.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The 2 arms of rehabilitative and/or subacute care patients consist of the intervention arm (receiving weekly multidisciplinary rounds up to the point of discharge, using 5 steps of deprescribing at the bedside, targeted to deprescribe selected medications [Beers' List of inappropriate Medications 2015; selected supplements and selected symptomatic medications]) and control arm (receving usual care)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Feasibility of De-prescribing Rounds in a Singapore Rehabilitative Hospital- a Pilot Randomized Controlled Trial
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Weekly MDT deprescribing rounds
Weekly MDT deprescribing rounds for certain drugs will be performed on top of usual care.
Other: Weekly MDT deprescribing rounds for certain drugs
  • Weekly deprescribing round (from randomization to day of discharge)
  • Conducted by a multidisciplinary team (non-ward doctors, pharmacist, ward nurse)
  • Using the 5 steps of de-prescribing
  • De-prescribing targets:

    1. Beer's list of potentially inappropriate medications (American Geriatric Society 2015 version)
    2. Supplements of questionable benefits (glucosamine, chondroitin, vitamin B complex and multivitamins)
    3. Symptomatic medications (laxatives, gastro-protectives, painkillers, anti-emetics and steroid creams) (Standardized verbal script to initiate de-prescribing by the team)
  • On top of usual care

No Intervention: Control (Usual Care)

Usual Care includes the following:

  • De-prescribing at the discretion of the ward doctors
  • Initial medication reconciliation by pharmacist on admission
  • Ward rounds to be conducted 3 weekdays per week for rehabilitative patients and daily on weekdays for sub-acute patients.



Primary Outcome Measures :
  1. Change in total daily dose of medication upon discharge from the hospital [ Time Frame: During the patient's inpatient stay (this will be measured on the day of discharge, usually ranging between 21 to 49 days upon inpatient admission) ]
    Change in total daily dose of medication upon discharge from the hospital


Secondary Outcome Measures :
  1. Cost savings measured in Singapore dollars [ Time Frame: These outcomes will be measured on days 14, 28 of inpatient admission, the day of inpatient discharge (*this is usually between 21 to 49 days after admission) and day 28 post discharge. Overall timeframe ranges between 49 to 77days after admission. ]
    Cost savings measured in Singapore dollars

  2. Number of participants with side effects from deprescribing [ Time Frame: These outcomes will be measured on days 14, 28 of inpatient admission, the day of inpatient discharge (*this is usually between 21 to 49 days after admission) and day 28 post discharge. Overall timeframe ranges between 49 to 77days after admission. ]
    Number of participants with side effects from deprescribing (i.e. recurrence of medical indications or symptoms; withdrawal effects of deprescribing; reinstating the same medications or substituting another medication, hospitalization and death)

  3. feasibility of intervention in terms of time taken, measured in minutes. [ Time Frame: During the patient's inpatient stay (this will be measured on the day of discharge, usually ranging between 21 to 49 days upon inpatient admission) ]
    The feasibility of implementation of intervention will also be determined through the time required to complete the de-prescribing process, measured in minutes.

  4. feasibility of intervention in terms of ease at which the rounds are conducted (descriptive) [ Time Frame: During the patient's inpatient stay (this will be measured on the day of discharge, usually ranging between 21 to 49 days upon inpatient admission) ]
    The feasibility of implementation of intervention will also be determined through limitations and challenges encountered, as documented by the multidisciplinary team.



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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Greater or equals to 65 years old
  • Newly admitted to rehabilitation or sub-acute disciplines
  • Possess 1 or more of the targeted medications

Exclusion Criteria:

  • Abbreviated mental test less than 7
  • No mental capacity

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): NCT03713112


Contacts
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Contact: Wong Peng Yong, Andrew, MBBS 62485755 ext 5749 med10056@yahoo.co.uk
Contact: Belinda Soh Qimin 62485755 ext 5275 belinda.soh@bvh.org.sg

Locations
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Singapore
Bright Vision Hospital Recruiting
Singapore, Singapore, 547530
Contact: Wong Peng Yong, Andrew, MBBS    62485755 ext 5749    med10056@yahoo.co.uk   
Contact: Belinda Soh Qimin    62485755    belinda.soh@bvh.org.sg   
Sub-Investigator: Charissa Ann Ee Jia Ming         
Sub-Investigator: Tan Wanting         
Sub-Investigator: Low Lian Leng, MBBS         
Principal Investigator: Wong Peng Yong, Andrew, MBBS         
Sponsors and Collaborators
Bright Vision Hospital
Investigators
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Principal Investigator: Wong Peng Yong, Andrew, MBBS Bright Vision Hospital; Singhealth Community Hospitals

Additional Information:
Publications of Results:

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Responsible Party: Bright Vision Hospital
ClinicalTrials.gov Identifier: NCT03713112     History of Changes
Other Study ID Numbers: CIRB Ref 2018/2721
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there's no current plans.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bright Vision Hospital:
deprescribe
multi-disciplinary
open label
rounds
randomised controlled trial