Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Conditions
Keywords
Opioid taper, post-surgery, behavioral tele-health
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.
Interventions
BEHAVIORALOpioid 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.
BEHAVIORALOpioid 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients that engage and participate in the process | 30 days post intervention | Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9) | 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. |
| Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid | 30 days post intervention | — |
| Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9) | 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. |
| Well-Being as measured by the Edmonton Symptom Assessment System (ESAS) | 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. |
| Quality of life as measured by the Quality of life Score | 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. |
| Symptoms as measured by the Edmonton Symptom Assessment System (ESAS) | 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. |
Countries
United States
Outcome results
None listed