Back to resultsImpact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Primary Purpose
Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid and Benzodiazepine Naive-patients
Opioid and Benzodiazepine Tolerant-patients
Sponsored by
About this trial
This is an interventional treatment trial for Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids focused on measuring Opioid taper, post-surgery, behavioral tele-health
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.
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Opioid and Benzodiazepine Naive-patients
Opioid and Benzodiazepine Tolerant-patients
Arm Description
Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery
Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04787692
First Posted
March 3, 2021
Last Updated
February 3, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04787692
Brief Title
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Official Title
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Keywords
Opioid taper, post-surgery, behavioral tele-health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opioid and Benzodiazepine Naive-patients
Arm Type
Experimental
Arm Description
Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery
Arm Title
Opioid and Benzodiazepine Tolerant-patients
Arm Type
Experimental
Arm Description
Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery
Intervention Type
Behavioral
Intervention Name(s)
Opioid and Benzodiazepine Naive-patients
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Opioid and Benzodiazepine Tolerant-patients
Intervention Description
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 Outcome Measure Information:
Title
Number of patients that engage and participate in the process
Description
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Time Frame
30 days post intervention
Title
Number of patients that engage and participate in the process
Description
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Time Frame
90 days post intervention
Title
Number of patients that engage and participate in the process
Description
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Time Frame
180 days post intervention
Secondary Outcome Measure Information:
Title
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Time Frame
30 days post intervention
Title
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Time Frame
90 days post intervention
Title
Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
Time Frame
180 days post intervention
Title
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
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
Title
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)
Description
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.
Time Frame
30 days post intervention
Title
Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
Description
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.
Time Frame
30 days post intervention
Title
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
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
90 days post intervention
Title
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Description
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.
Time Frame
90 days post intervention
Title
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Description
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.
Time Frame
90 days post intervention
Title
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
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
180 days post intervention
Title
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Description
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.
Time Frame
180 days post intervention
Title
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Description
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.
Time Frame
180 days post intervention
Title
Quality of life as measured by the Quality of life Score
Description
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Time Frame
30 days post intervention
Title
Quality of life as measured by the Quality of life Score
Description
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Time Frame
90 days post intervention
Title
Quality of life as measured by the Quality of life Score
Description
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Time Frame
180 days post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan G Pivalizza, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
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