NCT03713112

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

October 12, 2018

Last Update Submit

May 18, 2020

Conditions

Keywords

deprescribemulti-disciplinaryopen labelroundsrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in total daily dose of medication upon discharge from the hospital

    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 Outcomes (4)

  • 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

    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.

    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)

    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)

Study Arms (2)

Weekly MDT deprescribing rounds

ACTIVE COMPARATOR

Weekly MDT deprescribing rounds for certain drugs will be performed on top of usual care.

Other: Weekly MDT deprescribing rounds for certain drugs

Control (Usual Care)

NO INTERVENTION

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.

Interventions

* 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

Weekly MDT deprescribing rounds

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Abbreviated mental test less than 7
  • No mental capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bright Vision Hospital

Singapore, 547530, Singapore

Location

Related Publications (6)

  • Roberts MS, Stokes JA, King MA, Lynne TA, Purdie DM, Glasziou PP, Wilson DA, McCarthy ST, Brooks GE, de Looze FJ, Del Mar CB. Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes. Br J Clin Pharmacol. 2001 Mar;51(3):257-65. doi: 10.1046/j.1365-2125.2001.00347.x.

  • Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.

  • Williams ME, Pulliam CC, Hunter R, Johnson TM, Owens JE, Kincaid J, Porter C, Koch G. The short-term effect of interdisciplinary medication review on function and cost in ambulatory elderly people. J Am Geriatr Soc. 2004 Jan;52(1):93-8. doi: 10.1111/j.1532-5415.2004.52016.x.

  • Reeve E, Andrews JM, Wiese MD, Hendrix I, Roberts MS, Shakib S. Feasibility of a patient-centered deprescribing process to reduce inappropriate use of proton pump inhibitors. Ann Pharmacother. 2015 Jan;49(1):29-38. doi: 10.1177/1060028014558290. Epub 2014 Nov 10.

  • Frank C, Weir E. Deprescribing for older patients. CMAJ. 2014 Dec 9;186(18):1369-76. doi: 10.1503/cmaj.131873. Epub 2014 Sep 2. No abstract available.

  • Wong APY, Ting TW, Charissa EJM, Boon TW, Heng KY, Leng LL. Feasibility & Efficacy of Deprescribing rounds in a Singapore rehabilitative hospital- a randomised controlled trial. BMC Geriatr. 2021 Oct 21;21(1):584. doi: 10.1186/s12877-021-02507-0.

Study Officials

  • Wong Peng Yong, Andrew, MBBS

    Bright Vision Hospital; Singhealth Community Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 19, 2018

Study Start

November 28, 2018

Primary Completion

July 31, 2019

Study Completion

June 30, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

there's no current plans.

Locations