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

Deprescribing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03713112
• Other study ID #: CIRB Ref 2018/2721
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Bright Vision Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: June 30, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Deprescribing
• Multi-disciplinary
• Rounds

Intervention

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: 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

Locations

Country	Name	City	State
Singapore	Bright Vision Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bright Vision Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

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. Review. — View Citation

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, Ogunse — View Citation

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 — View Citation

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; — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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)
Secondary	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)

External Links

•   Ee et al, Effectiveness and feasibility of deprescribing of symptomatic medications in a Singapore rehabilitation hospital; DOI: 10.1177/2010105818782006 journals.sagepub.com/home/psh