Deprescription of Gabapentinoids in Medical Inpatients (GABA-WHY)

January 26, 2024 updated by: Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

GABA-WHY Study: Deprescription of Gabapentinoids in Medical Inpatients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gabapentinoids, which include gabapentin and pregabalin, are antiepileptic drugs that have been approved by the FDA and Health Canada for the treatment of postherpetic neuralgia, with pregabalin also approved for the treatment of diabetic neuropathy, fibromyalgia, and spinal cord injury-associated neuropathic pain. Despite a small number of approved indications, gabapentinoid prescription has increased substantially in recent years. The majority of new prescriptions are off-label for the treatment of multiple chronic pain conditions, such as osteoarthritis, chronic lower back pain, sciatica, and cancer-related pain.

A 2013 Cochrane review found reasonably good evidence for the use of both drugs in postherpetic neuralgia and painful diabetic neuropathy, as well as evidence supporting pregabalin use for the treatment of fibromyalgia and central neuropathic pain. However, there was either evidence against, or a lack of evidence for the efficacy of gabapentinoids in other chronic pain conditions. Furthermore, beneficial effects were associated with high risk of multiple adverse effects, including sedation, xerostomia, lower extremity edema, and traumatic falls in older adults.

In a recent study of inpatients at a tertiary-care hospital in Montréal, Canada between 2013 and 2017, 1 in 8 patients had a gabapentinoid prescription on admission, only 17% of which were for an FDA-approved indications. Gabapentinoid users had more comorbidities than non-users and were more likely to be co-prescribed opioids, which is concerning given previous evidence of increased opioid-related death with gabapentinoid co-prescriptions. Given their high prevalence of off-label use, their many adverse effects, and their frequent use among multimorbid patients who are vulnerable to these adverse effects, gabapentinoids are an ideal target for deprescription.

Patient education through the distribution of educational brochures is an effective method of promoting deprescription. A brochure specific to gabapentinoids is available on the Canadian Deprescribing Network website. This brochure contains a self-assessment of knowledge of the risks of gabapentinoids, provides information on the benefits and potential harms of use, presents safer treatment alternatives, and proposes a tapering regimen using an illustrated calendar, with instructions to contact a healthcare provider prior to discontinuation or tapering. This brochure aims to improve safe and successful deprescription by promoting patient motivation and self-capacity, and by encouraging patients to meet with their healthcare providers to create opportunities for deprescription.

In previous studies, a similar brochure was found effective in promoting benzodiazepine deprescription. In the Eliminating Medications through Patient Ownership of End Results (EMPOWER) trial, the distribution of educational brochures to 303 community-dwelling older adults who were chronically taking benzodiazepines resulted in a 27% discontinuation rate at 6 months, compared to a 5% discontinuation rate in the control group. The EMPOWER trial inspired a subsequent study in which the same brochure was distributed to medical inpatients at a tertiary-care hospital in Montreal, Canada. A total of 50 patients received the brochure while hospitalized, and 64% of those patients had discontinued benzodiazepines at 30 days-post discharge. This result was significantly higher than the hospital's historical deprescription rate of 21%. The higher deprescription rate associated with the intervention in this study compared to the EMPOWER trial highlights the importance of using hospital admissions as an opportunity for deprescription. Thus, the aim of this trial is to assess the efficacy of an educational brochure about gabapentinoids in improving gabapentinoid deprescription among elderly inpatients after discharge.

This study will follow a prospective controlled before and after study design involving five medical units across two centres: the McGill University Health Centre Glen Site (Royal Victoria Hospital) and the Montreal General Hospital. The sample size of the study is 160 participants, with 80 participants in the control group and 80 participants in the intervention group. The sample size was calculated to detect a 20% absolute increase in deprescription within the intervention group. Each study unit will act as its own control. The study will begin in the control period on all study units, until the pre-specified target of 80 control participants are enrolled. Once the enrolment of the 80 control participants has been completed, all study units will simultaneously transition to the intervention period. The intervention period will be completed once the pre-specified target number of 80 intervention participants is reached. Recruitment is expected to last approximately 10 months, with 16 patients enrolled per month. This rate of enrolment is based on previous study data regarding the prevalence of admitted gabapentinoid users and historical admission statistics from the study units, and assumes a study participation refusal rate of 15%.

During the control period, enrolled patients admitted to the medical ward will receive a pharmacy medication reconciliation as part of usual medical care. Although they will be informed that the goal of the trial is to evaluate medications and changes after discharge, participants will not be told that gabapentinoids are specifically being targeted. Additionally, medical staff will not receive specific information about the trial, or particular instructions related to deprescription.

During the intervention period, enrolled patients will receive an educational brochure about the risks of chronic gabapentinoid use and how to safely discontinue use. The educational brochure is written using a sixth-grade vocabulary and has been validated in both English and French for comprehension among individuals with and without mild cognitive impairment. Additionally, an educational session detailing purpose of the study and the risks of gabapentinoid prescription will be delivered to medical staff and residents on each study unit. The educational session will include a presentation by the chief of the medical service at the monthly teaching rounds, and an electronic message sent to all physicians on the medical service. The session will also include a brief overview of the brochure.

Follow-up questionnaires will be administered at 8 weeks after hospital discharge by telephone. The questionnaire will collect information regarding demographic changes, gabapentinoid deprescription, use of other pain medications, withdrawal symptoms, global functioning, pain control, and cognition.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital
      • Montréal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-weeks post-hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-weeks post-hospital discharge
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.
At study enrollment and 8-weeks post-hospital discharge
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.
At study enrollment and 8-weeks post-hospital discharge
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.
At study enrollment and 8-weeks post-hospital discharge
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
8-weeks post-hospital discharge
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
8-weeks post-hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Emily G McDonald, MD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Actual)

December 7, 2023

Study Completion (Actual)

December 7, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-7353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available in an anonymized format by emailing the primary investigator

IPD Sharing Time Frame

One year following the primary publication

IPD Sharing Access Criteria

Non-industry researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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