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Deprescription of Gabapentinoids in Medical Inpatients (GABA-WHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855578
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polypharmacy Gabapentin Pregabalin Other: In-Hopsital Patient Educational Brochure Other: Physician Education about Gabapentinoid Prescription Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Prospective before-and-after study involving five medical wards at two health centres. All wards will start in the control phase and enrolled participants will receive standard therapy. Once the pre-specified target of a 80 participants have been enrolled, all five wards will simultaneously transition into the intervention phase. All subsequently enrolled participants will receive the intervention until another 80 participants are enrolled. The control and intervention phases are expected to take approximately 5 months each.
Masking: Single (Investigator)
Masking Description:

It is impossible to blind physicians or study participants. However, medical staff on study units will not be told that gabapentinoids are being targeted by the trial until after the control period has ended. The rationale is that prior knowledge of the goal may bias medical staff in favour of gabapentinoid deprescription. Similarly, participants recruited during the control period will not be told that gabapentinoids are targeted. Since medical staff work in multiple study units in a given year, all units will transition from the control phase to the intervention phase simultaneously to prevent contamination between the control and intervention group.

It is impossible to blind outcome assessors at the time of follow-up. Undue influence on the investigator by outcome assessors will be mitigated through the use of a standardized survey that do not depend on the judgement of outcome assessors. Additionally, patient data will be anonymized with a unique identifier prior to analysis.

Primary Purpose: Supportive Care
Official Title: GABA-WHY Study: Deprescription of Gabapentinoids in Medical Inpatients
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
No Intervention: Usual Medical Care
During the control period, patients admitted to the study sites who qualify for the trial will receive a pharmacy medication reconciliation as part of usual medical care. Study participants will be informed that the goal of the trial is to evaluate medication use and medication changes after discharge, but they will not be informed that gabapentinoids are specifically being targeted. Medical staff will not receive specific information about the trial, or particular instructions with regards to deprescription during the control period.
Experimental: In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription
During the intervention period, patients admitted to the study sites who qualify for the trial will receive an in-hospital educational brochure. Additionally, the medical team will attend an educational session about gabapentinoid prescription.
Other: In-Hopsital Patient Educational Brochure
The participant's medication list will be identified from the pharmacy database and validated with the participant's best possible medication history taken at time of admission by a pharmacist. Eligibility will be confirmed by the participant's treating medical team with support from the study investigators. Participants who are enrolled during the intervention phase will receive an educational brochure about the risks of chronic gabapentinoid use, and about how to safely discontinue use. The brochure is written using a sixth-grade vocabulary and has been validated in both English and French for comprehension and readability, including for people with mild cognitive impairment.

Other: Physician Education about Gabapentinoid Prescription
An educational session about the purpose of the study and risks of gabapentinoid prescription will be delivered to physicians (staff and medical residents) on each study unit at both sites during the intervention period. The educational session will include a presentation by the chief of the medical service at the monthly teaching rounds, and an electronic message will be sent to all physicians on the medical service. Physicians will also be presented a brief overview of the educational brochure.




Primary Outcome Measures :
  1. Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop [ Time Frame: 8-weeks post-hospital discharge ]
    Proportion of study participants with a gabapentinoid prescription stopped or decreased with intention to stop at the time of follow-up


Secondary Outcome Measures :
  1. Gabapentinoid Dose Reduction Without Intention to Stop [ Time Frame: 8-weeks post-hospital discharge ]
    Proportion of study participants with a gabapentinoid dose reduction without intention to stop at the time of follow-up

  2. Health and Global Function [ Time Frame: At study enrollment and 8-weeks post-hospital discharge ]
    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.

  3. Chronic Pain Intensity [ Time Frame: At study enrollment and 8-weeks post-hospital discharge ]
    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.

  4. Cognition [ Time Frame: At study enrollment and 8-weeks post-hospital discharge ]
    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.

  5. Initiation of New Pain Medication [ Time Frame: 8-weeks post-hospital discharge ]
    Proportion of study participants prescribed a new pain medication at the time of follow-up

  6. Increase in Doses of Current Pain Medication [ Time Frame: 8-weeks post-hospital discharge ]
    Proportion of study participants with an increase in dose of a non-gabapentinoid pain medication at the time of follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855578


Contacts
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Contact: Emily G McDonald, MD, MSc 514-494-1934 ext 48488 emily.mcdonald@mcgill.ca

Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Emily McDonald         
Royal Victoria Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Emily G McDonald, MD, MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily McDonald, Dr. Emily McDonald, Associate Professor of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04855578    
Other Study ID Numbers: 2021-7353
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available in an anonymized format by emailing the primary investigator
Time Frame: One year following the primary publication
Access Criteria: Non-industry researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Polypharmacy
Deprescribing
Gabapentin
Pregabalin
Medication Stewardship
High-Value Healthcare
Empowerment
Shared Decision-Making
Adverse Drug Reaction
Elderly
Frailty