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, Houston1 site in 1 country150 target enrollmentAugust 7, 2020

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 150
Locations: 1
Primary Endpoint: Number of patients that engage and participate in the process
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 7, 2020

End Date

January 1, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Evan Pivalizza

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Outcomes

Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale(180 days post intervention)
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)(30 days post intervention)
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)
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)
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)(180 days post intervention)
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)(180 days post intervention)