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Completed

NCT Number: NCT04787692

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.

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Key information

Conditions

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

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opioid and Benzodiazepine Naive-patients

Behavioral

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-patients

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid

    Time frame: 30 days post intervention

  2. Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid

    Time frame: 90 days post intervention

  3. Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid

    Time frame: 180 days post intervention

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.