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

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 Overview

• Status: Completed
• Conditions: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
• Intervention / Treatment: Behavioral: Opioid and Benzodiazepine Naive-patients; Behavioral: Opioid and Benzodiazepine Tolerant-patients

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Opioid and Benzodiazepine Naive-patients; Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery	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.
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Evan G Pivalizza, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 7, 2020
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (ACTUAL): March 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: post-surgery; Opioid taper; behavioral tele-health
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: HSC-MS-20-0549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No