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Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

Sponsor
Bright Vision Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03354845
Collaborator
(none)
200
Enrollment
2
Arms
21.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Deprescribing intervention
 N/A

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.

Study Design

Study Type:
Interventional
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.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 :
Apr 5, 2016
Actual Primary Completion Date :
Feb 21, 2017
Anticipated Study Completion Date :
Jan 31, 2018

Arms and Interventions

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.
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cost savings [6 weeks]

      Reduction in the cost of one month of medications

    Secondary Outcome Measures

    1. Number of medications [6 weeks]

      Reduction in the total number of medications

    2. Change in bowel movement following deprescribing [6 weeks]

      Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)

    3. Adverse consequences of deprescribing [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 [6 weeks]

      Time required to complete the deprescribing process and the limitations and challenges encountered

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bright Vision Hospital

    Investigators

    • Principal Investigator: Charissa Ee (Pharmacist), Bright Vision Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Charissa Ee, Pharmacist, Bright Vision Hospital
    ClinicalTrials.gov Identifier:
    NCT03354845
    Other Study ID Numbers:
    • 2016/2149
    First Posted:
    Nov 28, 2017
    Last Update Posted:
    Nov 28, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Nov 28, 2017