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Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

Primary Purpose

Polypharmacy, Adverse Drug Reaction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deprescribing intervention
Sponsored by
Bright Vision Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Polypharmacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Control (usual care) group

    Deprescribing intervention group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Cost savings
    Reduction in the cost of one month of medications

    Secondary Outcome Measures

    Number of medications
    Reduction in the total number of medications
    Change in bowel movement following deprescribing
    Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)
    Adverse consequences of deprescribing
    Symptom recurrence, adverse drug withdrawal events (ADWEs), and the need for deprescribed medications to be restarted or initiation of new symptomatic control medications after deprescribing
    Feasibility of implementation
    Time required to complete the deprescribing process and the limitations and challenges encountered

    Full Information

    First Posted
    November 22, 2017
    Last Updated
    November 22, 2017
    Sponsor
    Bright Vision Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03354845
    Brief Title
    Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients
    Official Title
    Deprescribing of Symptomatic Medications in Patients Receiving Rehabilitative or Subacute Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 5, 2016 (Actual)
    Primary Completion Date
    February 21, 2017 (Actual)
    Study Completion Date
    January 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bright Vision Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polypharmacy, Adverse Drug Reaction

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control (usual care) group
    Arm Type
    No Intervention
    Arm Description
    In the control group, doctors maintained the usual practice of medication review, altering and discontinuing medications as necessary, without receiving deprescribing recommendations from pharmacists.
    Arm Title
    Deprescribing intervention group
    Arm Type
    Other
    Arm Description
    The five-step patient-centred deprescribing process was utilized in the intervention group.
    Intervention Type
    Other
    Intervention Name(s)
    Deprescribing intervention
    Other Intervention Name(s)
    Systematic deprescribing, Deprescribing algorithm, Five-step patient-centred deprescribing process
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Cost savings
    Description
    Reduction in the cost of one month of medications
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Number of medications
    Description
    Reduction in the total number of medications
    Time Frame
    6 weeks
    Title
    Change in bowel movement following deprescribing
    Description
    Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)
    Time Frame
    6 weeks
    Title
    Adverse consequences of deprescribing
    Description
    Symptom recurrence, adverse drug withdrawal events (ADWEs), and the need for deprescribed medications to be restarted or initiation of new symptomatic control medications after deprescribing
    Time Frame
    6 weeks
    Title
    Feasibility of implementation
    Description
    Time required to complete the deprescribing process and the limitations and challenges encountered
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charissa Ee (Pharmacist)
    Organizational Affiliation
    Bright Vision Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25798731
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24661192
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17642388
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25385826
    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 Nov 10.
    Results Reference
    result
    Links:
    URL
    https://www.pss.org.sg/sites/default/files/PW/PW15/polypharmacy-deprescribing_position_statement.pdf
    Description
    Pharmaceutical Society of Singapore. Polypharmacy in Singapore: The Role of Deprescribing - Pharmacy Week 2015
    URL
    http://www.derbyshiremedicinesmanagement.nhs.uk/assets/Clinical_Guidelines/clinical_guidelines_front_page/Deprescribing.pdf
    Description
    National Health System. Deprescribing: a practical guide. May 2015

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    Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

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