Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid and Benzodiazepine Naive-patients | Experimental | Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery |
|
| Opioid and Benzodiazepine Tolerant-patients | Experimental | Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 180 days post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid | 30 days post intervention | |
| Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid | 90 days post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Evan G Pivalizza, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37645940 | Derived | Hussain M, Norgeot B, Zaafran A, Stark J, Caridi J, Fenoy A, Pivalizza E. Virtual transitional pain service delivered via telehealth is effective in preventing new and persistent opioid use amongst post-surgical spine patients. medRxiv [Preprint]. 2023 Aug 20:2023.08.18.23294272. doi: 10.1101/2023.08.18.23294272. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 | 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. | 30 days post intervention |
| 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. | 30 days post intervention |
| 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. | 30 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. | 90 days post intervention |
| 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. | 90 days post intervention |
| 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. | 90 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. | 180 days post intervention |
| 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. | 180 days post intervention |
| 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. | 180 days post intervention |
| 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. | 30 days post intervention |
| 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. | 90 days post intervention |
| 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. | 180 days post intervention |
| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided