DeprescribingNCT03713112
Efficacy and Feasibility of De-prescribing Rounds in a Singapore Rehabilitative Hospital- a Pilot Randomized Controlled Trial
A study testing Weekly MDT deprescribing rounds for certain drugs in people with Deprescribing and Multi-disciplinary, run by Bright Vision Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Deprescribing, Multi-disciplinary, Rounds
- What is being tested?
- Weekly MDT deprescribing rounds for certain drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Nov 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Greater or equals to 65 years old
- Newly admitted to rehabilitation or sub-acute disciplines
- Possess 1 or more of the targeted medications
Who cannot join
- Abbreviated mental test less than 7
- No mental capacity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Deprescribing, Multi-disciplinary, Rounds
- Being tested
- Weekly MDT deprescribing rounds for certain drugs
- Keywords
- deprescribe, multi-disciplinary, open label, rounds, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly MDT deprescribing rounds for certain drugsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Weekly MDT deprescribing rounds | Active comparator | Weekly MDT deprescribing rounds for certain drugs will be performed on top of usual care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total daily dose of medication upon discharge from the hospital
Change in total daily dose of medication upon discharge from the hospital
Measured: 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
Cost savings measured in Singapore dollars
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start28 Nov 2018
- Primary completion31 Jul 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DeprescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Vision Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wong Peng Yong, Andrew, MBBS, Principal investigator, Bright Vision Hospital; Singhealth Community Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713112
- Sponsor's protocol ID
- CIRB Ref 2018/2721
- Status last verified
- May 2020
- First submitted
- 12 Oct 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there's no current plans.
Publications
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.
PubMed 11298072Kutner 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.
PubMed 25798575Williams 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.
PubMed 14687321Reeve 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.
PubMed 25385826Frank 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.
PubMed 25183716Wong 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.
PubMed 34674645
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of De-prescribing Rounds in a Singapore Rehabilitative Hospital- a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03713112
- Acronym / sponsor ID
- CIRB Ref 2018/2721
- Conditions
- Deprescribing, Multi-disciplinary, Rounds
- Keywords
- deprescribe, multi-disciplinary, open label, rounds, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Bright Vision HospitalUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Weekly MDT deprescribing rounds | Active comparator | Other: Weekly MDT deprescribing rounds for certain drugsWeekly MDT deprescribing rounds for certain drugs will be performed on top of usual care. |
| 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. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Greater or equals to 65 years old
- Newly admitted to rehabilitation or sub-acute disciplines
- Possess 1 or more of the targeted medications
Key exclusion criteria (2 listed)
- Abbreviated mental test less than 7
- No mental capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Weekly MDT deprescribing rounds |
Primary outcome
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
4 secondary outcomes
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.
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.
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Results publication: PubMed 11298072Roberts 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.
- Results publication: PubMed 25798575Kutner 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.
- Results publication: PubMed 14687321Williams 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.
- Results publication: PubMed 25385826Reeve 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.
- Results publication: PubMed 25183716Frank 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.
- Derived from this study: PubMed 34674645Wong 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.
- Individual participant dataSharing planned: No. there's no current plans.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wong Peng Yong, Andrew, MBBS principal investigator
Bright Vision Hospital; Singhealth Community Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly MDT deprescribing rounds for certain drugs in people with Deprescribing and Multi-disciplinary, run by Bright Vision Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713112, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.