GABA-WHY Study: Deprescription of Gabapentinoids in Medical Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inpatients 60 years or older admitted to study units who have a gabapentinoid prescription prior to admission
排除标准
- •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.)
结局指标
主要结局
Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop
时间窗: 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
次要结局
- Gabapentinoid Dose Reduction Without Intention to Stop(8-weeks post-hospital discharge)
- Cognition(At study enrollment and 8-weeks post-hospital discharge)
- Health and Global Function(At study enrollment and 8-weeks post-hospital discharge)
- Chronic Pain Intensity(At study enrollment and 8-weeks post-hospital discharge)
- Initiation of New Pain Medication(8-weeks post-hospital discharge)
- Increase in Doses of Current Pain Medication(8-weeks post-hospital discharge)
研究者
Emily McDonald
Dr. Emily McDonald, Associate Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre