Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients
Primary Purpose
Polypharmacy, Adverse Drug Reaction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deprescribing intervention
Sponsored by
About this trial
This is an interventional other trial for Polypharmacy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control (usual care) group
Deprescribing intervention group
Arm Description
In the control group, doctors maintained the usual practice of medication review, altering and discontinuing medications as necessary, without receiving deprescribing recommendations from pharmacists.
The five-step patient-centred deprescribing process was utilized in the intervention group.
Outcomes
Primary Outcome Measures
Cost savings
Reduction in the cost of one month of medications
Secondary Outcome Measures
Number of medications
Reduction in the total number of medications
Change in bowel movement following deprescribing
Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)
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
Feasibility of implementation
Time required to complete the deprescribing process and the limitations and challenges encountered
Full Information
NCT ID
NCT03354845
First Posted
November 22, 2017
Last Updated
November 22, 2017
Sponsor
Bright Vision Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03354845
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
January 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bright Vision Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypharmacy, Adverse Drug Reaction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (usual care) group
Arm Type
No Intervention
Arm Description
In the control group, doctors maintained the usual practice of medication review, altering and discontinuing medications as necessary, without receiving deprescribing recommendations from pharmacists.
Arm Title
Deprescribing intervention group
Arm Type
Other
Arm Description
The five-step patient-centred deprescribing process was utilized in the intervention group.
Intervention Type
Other
Intervention Name(s)
Deprescribing intervention
Other Intervention Name(s)
Systematic deprescribing, Deprescribing algorithm, Five-step patient-centred deprescribing process
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost savings
Description
Reduction in the cost of one month of medications
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of medications
Description
Reduction in the total number of medications
Time Frame
6 weeks
Title
Change in bowel movement following deprescribing
Description
Adverse effect of constipation indicated by no bowel movement in the past two days (BNO ≥2/7)
Time Frame
6 weeks
Title
Adverse consequences of deprescribing
Description
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
Title
Feasibility of implementation
Description
Time required to complete the deprescribing process and the limitations and challenges encountered
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charissa Ee (Pharmacist)
Organizational Affiliation
Bright Vision Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25798731
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.
Results Reference
background
PubMed Identifier
24661192
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.
Results Reference
background
PubMed Identifier
17642388
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.
Results Reference
result
PubMed Identifier
25385826
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.
Results Reference
result
Links:
URL
https://www.pss.org.sg/sites/default/files/PW/PW15/polypharmacy-deprescribing_position_statement.pdf
Description
Pharmaceutical Society of Singapore. Polypharmacy in Singapore: The Role of Deprescribing - Pharmacy Week 2015
URL
http://www.derbyshiremedicinesmanagement.nhs.uk/assets/Clinical_Guidelines/clinical_guidelines_front_page/Deprescribing.pdf
Description
National Health System. Deprescribing: a practical guide. May 2015
Learn more about this trial
Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients
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