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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Deprescribing, Multi-disciplinary, Rounds

Intervention / Treatment
-----------------
* Other: Weekly MDT deprescribing rounds for certain drugs


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly MDT deprescribing rounds<br>Weekly MDT deprescribing rounds for certain drugs will be performed on top of usual care. | Other: Weekly MDT deprescribing rounds for certain drugs<br>* 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: Beer's list of potentially inappropriate medications (American Geriatric Society 2015 version) Supplements of questionable benefits (glucosamine, chondroitin, vitamin B complex and multivitamins) 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<br>|
| No Intervention: Control (Usual Care)<br>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 | 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 | 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 | 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. | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deprescribe, multi-disciplinary, open label, rounds, randomised controlled trial