Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

• ClinicalTrials.gov Identifier: NCT03354845
• Recruitment Status: Unknown
• First Posted: November 28, 2017
• Last Update Posted: November 28, 2017
• Sponsor: Bright Vision Hospital
• Information provided by (Responsible Party): Charissa Ee, Bright Vision Hospital

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
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.

Study Design

• 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

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.
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 [ 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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Bright Vision Hospital

Investigators

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

More Information

Additional Information:

Pharmaceutical Society of Singapore. Polypharmacy in Singapore: The Role of Deprescribing - Pharmacy Week 2015 

National Health System. Deprescribing: a practical guide. May 2015 

Publications of Results:

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.

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.

Other 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.

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.

• Responsible Party: Charissa Ee, Pharmacist, Bright Vision Hospital
• ClinicalTrials.gov Identifier: NCT03354845
• Other Study ID Numbers: 2016/2149
• First Posted: November 28, 2017
• Last Update Posted: November 28, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• 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; Chemically-Induced Disorders