Polypharmacy Clinical Trial
— GABA-WHYOfficial title:
GABA-WHY Study: Deprescription of Gabapentinoids in Medical Inpatients
NCT number | NCT04855578 |
Other study ID # | 2021-7353 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 28, 2021 |
Est. completion date | December 7, 2023 |
In this trial, investigators will distribute educational brochures with information about the deprescription of gabapentinoids (gabapentin and pregabalin) to inpatients in five medical wards spread across two tertiary-care hospitals in Montréal, Canada. This intervention will be supplemented by a brief information session for medical staff on the wards. This study aims to evaluate the effectiveness of this combined intervention on increasing gabapentinoid deprescription rates among study participants compared to control following hospital discharge.
Status | Completed |
Enrollment | 160 |
Est. completion date | December 7, 2023 |
Est. primary completion date | December 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - All inpatients 60 years or older admitted to study units who have a gabapentinoid prescription prior to admission Exclusion Criteria: - Less than 60 years of age - Known seizure disorder - Not enrolled in the provincial drug plan (RAMQ) - Opting out of the provincial drug database (Dossier Santé Québec), which will be confirmed with the patient at the time of recruitment - Previous enrollment in the study - Patients expected to die before primary endpoint can be realized (e.g., patients admitted for end-of-life care or prognosis of 3 months or less) - Unable to consent - Major neurocognitive disorder, as determined by a previously established diagnosis or interim diagnosis by the medical staff on the ward of moderate severity or worse - Unable to speak English or French - Insufficient literacy in English or French - No means of contacting patient by phone after discharge (e.g. no valid phone number, traveling, planned discharge to a facility without means of reaching by phone, etc.) |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal General Hospital | Montréal | Quebec |
Canada | Royal Victoria Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop | Proportion of study participants with a gabapentinoid prescription stopped or decreased with intention to stop at the time of follow-up | 8-weeks post-hospital discharge | |
Secondary | Gabapentinoid Dose Reduction Without Intention to Stop | Proportion of study participants with a gabapentinoid dose reduction without intention to stop at the time of follow-up | 8-weeks post-hospital discharge | |
Secondary | Health and Global Function | Assessed by the Patient Reported Outcomes Measurement and Information System (PROMIS) scale v1.2 - Global Health. This scale consists of four questions that are scored from 1 to 5, where higher scores indicate better health and global function. | At study enrollment and 8-weeks post-hospital discharge | |
Secondary | Chronic Pain Intensity | Assessed by the Patient Reported Outcomes Measurement and Information System (PROMIS) scale v2.0 - Pain Intensity 3a. This scale consists of three questions that are scored from 1 to 5, where higher scores indicate higher pain intensity. | At study enrollment and 8-weeks post-hospital discharge | |
Secondary | Cognition | Assessed by the Patient Reported Outcomes Measurement and Information System (PROMIS) scale v2.0 - Cognitive Function - Short Form 6a. This scale consists of six questions that are scored from 1 to 5, where higher scores indicate worse cognition. | At study enrollment and 8-weeks post-hospital discharge | |
Secondary | Initiation of New Pain Medication | Proportion of study participants prescribed a new pain medication at the time of follow-up | 8-weeks post-hospital discharge | |
Secondary | Increase in Doses of Current Pain Medication | Proportion of study participants with an increase in dose of a non-gabapentinoid pain medication at the time of follow-up | 8-weeks post-hospital discharge |
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