NCT04787692已完成不适用
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年8月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of patients that engage and participate in the process
研究概览
简要总结
The purpose of this study is to examine the safety, acceptability, and feasibility of a controlled taper off of opioids and/or benzodiazepines, with the use of behavioral health tele-health based therapy services, in the perioperative patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative benzodiazepines opioid dependence (daily use of opioids or benzodiazepines preoperatively) (Naive: No Meds 30 Days Prior to surgery,Opioid tolerant/dependant: Use of Meds on Most Days For 1 or more months prior to surgery)
- •Subject willing to use Lucid Lane program to provide behavioral health support perioperative period up to 6 months post-op for tolerant opioid/benzo users
- •Subject is willing to discuss Lucid Lane progress with the University of Texas Health Science Center(UTHealth) perioperative team and prescribing clinicians
- •Subject is willing to sign a Lucid Lane Client Agreement
- •Willing to sign an informed consent
排除标准
- •Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
- •Active suicidal ideations
- •Patients on methadone or buprenorphine for treatment of opioid use disorder (i.e. for treatment of addiction, and not for treatment of pain)
- •Patient unwilling to use or not possessing access to a device that allows for video visits (e.g. a smartphone, tablet, or computer)
- •Patients who are on palliative care
- •Insufficient ability to use English to participate in the consent process, the intervention or study assessments.
- •Insufficient ability to provide informed consent to participate
- •If the patient misses more than 2 lucid lane sessions per week, the staff will be immediately notified by Lucid Lane.
结局指标
主要结局
Number of patients that engage and participate in the process
时间窗: 180 days post intervention
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
次要结局
- Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale(180 days post intervention)
- Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)(30 days post intervention)
- Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid(90 days post intervention)
- Quality of life as measured by the Quality of life Score(180 days post intervention)
- Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid(180 days post intervention)
- Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)(30 days post intervention)
- Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)(180 days post intervention)
- Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)(180 days post intervention)
研究者
Evan Pivalizza
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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