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Status unknownNCT03354845Updated Nov 28, 2017

Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

An interventional study of Deprescribing intervention in Polypharmacy and Adverse Drug Reaction, sponsored by Bright Vision Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Bright Vision Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Polypharmacy
  • Adverse Drug Reaction
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Patients with terminal illness or cancer and patients with documented clinically significant dementia and had no accompanying caregiver
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • 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

Interventions

  • OtherDeprescribing 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.

    Also known as: Systematic deprescribing, Deprescribing algorithm, Five-step patient-centred deprescribing process

05

What researchers measure

Primary outcomes

  1. Cost savings

    Reduction in the cost of one month of medications

    Time frame: 6 weeks

Secondary outcomes

  1. Number of medications

    Reduction in the total number of medications

    Time frame: 6 weeks

  2. Change in bowel movement following deprescribing

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

    Time frame: 6 weeks

  3. 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

    Time frame: 6 weeks

  4. Feasibility of implementation

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

    Time frame: 6 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 25798731 ↗
  • 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. PubMed 24661192 ↗
  • 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. PubMed 17642388 ↗
  • 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. PubMed 25385826 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03354845
Lead sponsor
Bright Vision Hospital
Responsible party
Charissa Ee (Pharmacist, Bright Vision Hospital) — Principal investigator
First posted
Nov 28, 2017
Start date
Apr 5, 2016
Primary completion
Feb 21, 2017
Completion
Jan 31, 2018 (estimated)
Last update
Nov 28, 2017

Study contacts

Charissa Ee (Pharmacist)
principal investigator · Bright Vision Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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