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Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354845
Recruitment Status : Unknown
Verified November 2017 by Charissa Ee, Bright Vision Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Charissa Ee, Bright Vision Hospital

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.


Condition or disease Intervention/treatment Phase
Polypharmacy Adverse Drug Reaction Other: Deprescribing intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Other
Official Title: Deprescribing of Symptomatic Medications in Patients Receiving Rehabilitative or Subacute Care
Actual Study Start Date : April 5, 2016
Actual Primary Completion Date : February 21, 2017
Estimated Study Completion Date : January 31, 2018

Arm Intervention/treatment
No Intervention: 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.
Deprescribing intervention group
The five-step patient-centred deprescribing process was utilized in the intervention group.
Other: 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.
Other Names:
  • Systematic deprescribing
  • Deprescribing algorithm
  • Five-step patient-centred deprescribing process




Primary Outcome Measures :
  1. Cost savings [ Time Frame: 6 weeks ]
    Reduction in the cost of one month of medications


Secondary Outcome Measures :
  1. Number of medications [ Time Frame: 6 weeks ]
    Reduction in the total number of medications

  2. Change in bowel movement following deprescribing [ Time Frame: 6 weeks ]
    Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)

  3. Adverse consequences of deprescribing [ Time Frame: 6 weeks ]
    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

  4. Feasibility of implementation [ Time Frame: 6 weeks ]
    Time required to complete the deprescribing process and the limitations and challenges encountered



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354845


Sponsors and Collaborators
Bright Vision Hospital
Investigators
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Principal Investigator: Charissa Ee (Pharmacist) Bright Vision Hospital
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Charissa Ee, Pharmacist, Bright Vision Hospital
ClinicalTrials.gov Identifier: NCT03354845    
Other Study ID Numbers: 2016/2149
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders