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

May 18, 2020 updated by: Bright Vision Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 547530
        • Bright Vision Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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.
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.
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bright Vision Hospital

Investigators

  • Principal Investigator: Wong Peng Yong, Andrew, MBBS, Bright Vision Hospital; Singhealth Community Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIRB Ref 2018/2721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there's no current plans.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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