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, Houston150 enrolled

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

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

Interventions

Opioid and Benzodiazepine Naive-patientsBEHAVIORAL

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.

Opioid and Benzodiazepine Tolerant-patientsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 180 days post intervention

Secondary Outcomes

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

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.

Time frame: 30 days post intervention

Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)

Data from ClinicalTrials.gov

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