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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Opioid and Benzodiazepine Naive-patients
* Behavioral: Opioid and Benzodiazepine Tolerant-patients


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid and Benzodiazepine Naive-patients<br>Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery | Behavioral: Opioid and Benzodiazepine Naive-patients<br>* Duration of treatment : 1 month Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, Cognitive behavioral therapy(CBT), Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.<br>|
| Experimental: Opioid and Benzodiazepine Tolerant-patients<br>Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery | Behavioral: Opioid and Benzodiazepine Tolerant-patients<br>* Duration of treatment : 6 months Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, CBT, Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that engage and participate in the process | Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled. | 30 days post intervention | 
| Number of patients that engage and participate in the process | Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled. | 90 days post intervention | 
| Number of patients that engage and participate in the process | Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled. | 180 days post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid |  | 30 days post intervention | 
| Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid |  | 90 days post intervention | 
| Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid |  | 180 days post intervention | 
| Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale | 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. | 30 days post intervention | 
| Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9) | 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. | 30 days post intervention | 
| Symptoms as measured by the Edmonton Symptom Assessment System (ESAS) | 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. | 30 days post intervention | 
| Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale | 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. | 90 days post intervention | 
| Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9) | 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. | 90 days post intervention | 
| Well-Being as measured by the Edmonton Symptom Assessment System (ESAS) | 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. | 90 days post intervention | 
| Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale | 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. | 180 days post intervention | 
| Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9) | 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. | 180 days post intervention | 
| Well-Being as measured by the Edmonton Symptom Assessment System (ESAS) | 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. | 180 days post intervention | 
| Quality of life as measured by the Quality of life Score | The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. | 30 days post intervention | 
| Quality of life as measured by the Quality of life Score | The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. | 90 days post intervention | 
| Quality of life as measured by the Quality of life Score | The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. | 180 days post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid taper, post-surgery, behavioral tele-health