Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids Clinical Trial
Official title:
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
| Verified date | February 2022 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | January 1, 2022 |
| Est. primary completion date | January 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid | 30 days post intervention | ||
| Secondary | Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid | 90 days post intervention | ||
| Secondary | Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid | 180 days post intervention | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |