Clinical trial NCT03354845: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy
Adverse Drug Reaction
Lead sponsor: Bright Vision Hospital
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Cost savings
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of medications
timeFrame: 6 weeks
measure: Change in bowel movement following deprescribing
timeFrame: 6 weeks
measure: Adverse consequences of deprescribing
timeFrame: 6 weeks
measure: Feasibility of implementation
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bright Vision Hospital
name: Charissa Ee (Pharmacist)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.