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Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

NCT ID: NCT03354845

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-05

Study Completion Date

2018-01-31

Brief Summary

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Deprescribing is a systematic method of withdrawing potentially inappropriate or unnecessary medications and is warranted in the elderly due to the high prevalence of polypharmacy. In particular, symptomatic control medications, such as acid suppressants, laxatives and painkillers, are frequently prescribed and continued, though such medications are rarely needed on a long-term basis.

Therefore, the study objectives were to determine the cost savings, effects and feasibility of implementing a systematic process of deprescribing medications for symptomatic management, namely, acid suppressants, laxatives, analgesics, and antiemetics.

Detailed Description

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Deprescribing is a systematic process of identifying and withdrawing drugs, which are potentially or currently causing more harm than benefit to patients, based on each individual patient's condition, treatment goals and level of functioning. Deprescribing needs to be patient-centric with shared decision-making between patients or caregivers and the multidisciplinary care team. Five distinct steps of deprescribing have been elucidated, and they comprise: 1) performing a comprehensive patient medical/medication history; 2) considering the overall risk and appropriateness of drugs; 3) assessing possibility of and planning drug discontinuation; 4) initiating and documenting drug discontinuation; and 5) monitoring effects and providing patient support.

Deprescribing is necessary in elderly aged 65 years and above due to the higher prevalence of polypharmacy and unnecessary and inappropriate medication use, compared to younger age groups. In Singapore, statistics from an acute restructured hospital in 2013 showed that 50 percent or more of inpatients were discharged with at least five chronic medications.

The discontinuation of medications has been trialled in earlier studies without causing significant adverse effects or symptom recurrence. Positive outcomes demonstrated include enhanced cognition, improved health and reduced falls. However, it is necessary to investigate the effects and feasibility of deprescribing in the present local setting, where healthcare perceptions, and associations between medication discontinuation and patient clinical outcomes may be different from other studied populations.

Therefore, this randomized controlled intervention study was conducted in a community hospital in Singapore to determine the cost savings, effects and feasibility of implementing a systematic process of deprescribing medications for symptomatic management, namely, acid suppressants, laxatives, analgesics, and antiemetics.

Conditions

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Polypharmacy Adverse Drug Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was conducted as an open trial with two parallel groups. A total of 200 patients were randomized to an intervention (deprescribing) or control (usual care) group in a 1:1 ratio. Randomization of patients was performed after recruitment by an independent administrator using GraphPad randomization sequence software ©2017. Doctors were free to make any changes to patients' medication regimens as they wished in both groups.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Group assignment was made known to the pharmacists and doctors involved in the deprescribing study intervention. However, patients were not aware of which group they had been assigned to.

Study Groups

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Control (usual care) group

In the control group, doctors maintained the usual practice of medication review, altering and discontinuing medications as necessary, without receiving deprescribing recommendations from pharmacists.

Group Type NO_INTERVENTION

No interventions assigned to this group

Deprescribing intervention group

The five-step patient-centred deprescribing process was utilized in the intervention group.

Group Type OTHER

Deprescribing intervention

Intervention Type OTHER

Pharmacists assessed the appropriateness of target symptomatic medications and potential for discontinuation. After discussion with pharmacists and consideration of patients' and caregivers' preferences regarding discontinuation or dose reduction, doctors would deprescribe these symptomatic medications. Symptom recurrence, adverse drug withdrawal events (ADWEs), and the need for drug re-initiation or initiation of new symptomatic control medications after deprescribing were monitored and documented in the 1st, 2nd and 6th weeks.

Interventions

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Deprescribing intervention

Pharmacists assessed the appropriateness of target symptomatic medications and potential for discontinuation. After discussion with pharmacists and consideration of patients' and caregivers' preferences regarding discontinuation or dose reduction, doctors would deprescribe these symptomatic medications. Symptom recurrence, adverse drug withdrawal events (ADWEs), and the need for drug re-initiation or initiation of new symptomatic control medications after deprescribing were monitored and documented in the 1st, 2nd and 6th weeks.

Intervention Type OTHER

Other Intervention Names

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Systematic deprescribing Deprescribing algorithm Five-step patient-centred deprescribing process

Eligibility Criteria

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Inclusion Criteria

* All patients, regardless of age, who were on at least one of the following target symptomatic control medications for deprescribing: acid suppressants/proton pump inhibitors (PPIs), laxatives, analgesics (paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), codeine, tramadol) and antiemetics

Exclusion Criteria

* Patients with terminal illness or cancer and patients with documented clinically significant dementia and had no accompanying caregiver
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bright Vision Hospital

OTHER

Sponsor Role lead

Responsible Party

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Charissa Ee

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charissa Ee (Pharmacist)

Role: PRINCIPAL_INVESTIGATOR

Bright Vision Hospital

References

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Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.

Reference Type BACKGROUND
PMID: 25798731 (View on PubMed)

Reeve E, Shakib S, Hendrix I, Roberts MS, Wiese MD. Review of deprescribing processes and development of an evidence-based, patient-centred deprescribing process. Br J Clin Pharmacol. 2014 Oct;78(4):738-47. doi: 10.1111/bcp.12386.

Reference Type BACKGROUND
PMID: 24661192 (View on PubMed)

Garfinkel D, Zur-Gil S, Ben-Israel J. The war against polypharmacy: a new cost-effective geriatric-palliative approach for improving drug therapy in disabled elderly people. Isr Med Assoc J. 2007 Jun;9(6):430-4.

Reference Type RESULT
PMID: 17642388 (View on PubMed)

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.

Reference Type RESULT
PMID: 25385826 (View on PubMed)

Related Links

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http://www.derbyshiremedicinesmanagement.nhs.uk/assets/Clinical_Guidelines/clinical_guidelines_front_page/Deprescribing.pdf

National Health System. Deprescribing: a practical guide. May 2015

Other Identifiers

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2016/2149

Identifier Type: -

Identifier Source: org_study_id