Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.

Not Applicable

Completed

• Conditions: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids

• Registration Number: NCT04787692
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-07
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients that engage and participate in the process	180 days post intervention	Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.

Secondary Outcome Measures

Name	Time	Method
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale	180 days post intervention	The Generalized Anxiety Disorder 7-item (GAD-7) scale has 7 questions each ranging in score from 0-3, with a higher score indicating a worse outcome.
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)	30 days post intervention	The Patient Health Questionnaire 9 (PHQ-9) consists of 10 questions with a total score ranging form 1 to 27, with a higher score indicating greater depression.
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	The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
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	The Edmonton Symptom Assessment System consists of 10 questions, each question ranging from 0-10, with a higher score indicating a worse outcome. The ESAS rates the intensity of common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)	180 days post intervention	The Patient Health Questionnaire 9 (PHQ-9) consists of 10 questions with a total score ranging form 1 to 27, with a higher score indicating greater depression.
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)	180 days post intervention	The Edmonton Symptom Assessment System consists of 10 questions, each question ranging from 0-10, with a higher score indicating a worse outcome. The ESAS rates the intensity of common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States