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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2022

Interventions

  • Behavioral: Opioid and Benzodiazepine Naive-patients
    • 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.
  • Behavioral: Opioid and Benzodiazepine Tolerant-patients
    • 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.

Arms, Groups and Cohorts

  • Experimental: Opioid and Benzodiazepine Naive-patients
    • Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery
  • Experimental: Opioid and Benzodiazepine Tolerant-patients
    • Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients that engage and participate in the process
    • Time Frame: 30 days post intervention
    • Engagement and participation are defined as patient’s commitment for 1 hour a week as scheduled.
  • Number of patients that engage and participate in the process
    • Time Frame: 90 days post intervention
    • Engagement and participation are defined as patient’s commitment for 1 hour a week as scheduled.
  • Number of patients that engage and participate in the process
    • Time Frame: 180 days post intervention
    • Engagement and participation are defined as patient’s commitment for 1 hour a week as scheduled.

Secondary Measures

  • Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
    • Time Frame: 30 days post intervention
  • Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
    • Time Frame: 90 days post intervention
  • Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
    • Time Frame: 180 days post intervention
  • Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
    • Time Frame: 30 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)
    • Time Frame: 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.
  • Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
    • Time Frame: 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 Generalized Anxiety Disorder 7-item (GAD-7) scale
    • Time Frame: 90 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 Patient Health Questionnaire 9 (PHQ-9)
    • Time Frame: 90 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)
    • Time Frame: 90 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 Generalized Anxiety Disorder 7-item (GAD-7) scale
    • Time Frame: 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 Patient Health Questionnaire 9 (PHQ-9)
    • Time Frame: 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)
    • Time Frame: 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.
  • Quality of life as measured by the Quality of life Score
    • Time Frame: 30 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.
  • Quality of life as measured by the Quality of life Score
    • Time Frame: 90 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.
  • Quality of life as measured by the Quality of life Score
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Evan Pivalizza, Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Evan G Pivalizza, MD, Principal Investigator, The University of Texas Health Science Center, Houston

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