Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
Primary Purpose
Opioid Dependence, Opioid Use, Pain, Joint
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lucid Lane Therapy Program
Surgical Preparedness Course
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Dependence
Eligibility Criteria
Inclusion Criteria:
- Male or female patients between the ages of 21-90 years old
- Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
- Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
- Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
- Patient is willing to sign a Lucid Lane Client Agreement.
- Patient is willing to sign an informed consent form
Exclusion Criteria:
- Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
- Active suicidal ideations
- Patient is 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 smart phone, tablet, or computer)
- Patients who are in palliative care
- Unable to use English to participate in the consent process, the intervention or study assessments.
- Unable to provide informed consent to participate
Sites / Locations
- Palo Alto Division - VA Palo Alto Health Care SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment
Control
Arm Description
Patients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery. All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Patients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Outcomes
Primary Outcome Measures
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury. They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life. The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
Change in Pain Catastrophizing scale
The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus. It assess rumination, magnification and helplessness. Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time. The scale has a min score of 0 and a max score of 52. A higher score indicates more pain catastrophizing .
Change in Depression Scores
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms. It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks. Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
Change in Anxiety Scores
The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity. Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
Secondary Outcome Measures
Percent tapered off opioid (50% MME)
Full Information
NCT ID
NCT05367050
First Posted
April 22, 2022
Last Updated
May 4, 2022
Sponsor
Lucid Lane, Inc
Collaborators
Stanford University, VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT05367050
Brief Title
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
Official Title
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lucid Lane, Inc
Collaborators
Stanford University, VA Palo Alto Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Opioid Use, Pain, Joint
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Patients participate in the Lucid Lane therapy program including working with a mental health pain coach for up to 4 weeks before surgery and 4 weeks after surgery.
All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients will participate in a a surgery preparedness course provided by the VA before surgery (Standard of Care) and Lucid Lane therapy after surgery
All patients receive therapy provided by Lucid Lane, for 4 weeks after surgery
Intervention Type
Behavioral
Intervention Name(s)
Lucid Lane Therapy Program
Intervention Description
This intervention is designed to aid participants with pre-surgery anxiety management and surgery prep and pain management post-surgery. Participants will be assigned a Lucid Lane pain coach who will utilize mindfulness, cognitive behavioral therapy, group therapy, and mind-body therapies, to accomplish those goals.
Intervention Type
Behavioral
Intervention Name(s)
Surgical Preparedness Course
Intervention Description
This intervention is designed to help the participant prepare for their upcoming surgery. Classes will include discussions around managing chronic pain before surgery, building mental resilience, dealing with the uncertainty of a new diagnosis or treatment plan, questions to ask their anesthesiologist before and on the day of surgery, what to expect during their potential stay at the hospital, and how to optimize their recovery after surgery. Sessions will often include expert doctors who focus on surgery and medical management around it.
Primary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and
Description
The KOOS and HOOS are questionnaires designed to assess short and long-term patient-relevant outcomes following knee/hip injury. They are self-administered and assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee/hip-related quality of life. The scores are normalized on a scale of 0 to 100, where 0 indicates severe problems and 100 indicates no problems.
Time Frame
Up to 4 months
Title
Change in Pain Catastrophizing scale
Description
The Pain catastrophizing scale (PCS) is a self administered, 13-item questionnaire, used to assess a patient's tendency to magnify the threat value of a pain stimulus. It assess rumination, magnification and helplessness. Responses are recorded on a scale of 0-4, where 0 represents absence of the thought and 4 represents the presence of the thought all the time. The scale has a min score of 0 and a max score of 52. A higher score indicates more pain catastrophizing .
Time Frame
Up to 4 months
Title
Change in Depression Scores
Description
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self administered questionnaire used to screen and monitor the severity of depressive symptoms. It inquires about depressive features, that align with the diagnostic and statistical manual of mental disorders, over the course of 2 weeks. Responses are recorded on a scale of 0-3, where 0 represents absence of the symptom and 3 represents its presence nearly every day.
Time Frame
Up to 4 months
Title
Change in Anxiety Scores
Description
The General Anxiety Disorder-7 (GAD-7) is a self administered, 7-item questionnaire used to measure general anxiety disorder and its severity. Responses are recorded on a scale of 0-3, where 0 represents an absence of the symptom and 3 represents presence nearly every day.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Percent tapered off opioid (50% MME)
Time Frame
4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients between the ages of 21-90 years old
Patient is opioid naive i.e hasn't used opioid medication for 30 days prior to surgery
Patient willing to use Lucid Lane program to provide behavioral health support for up to 4 weeks before surgery and 4 weeks after surgery.
Patient is willing to discuss Lucid Lane progress with Palo Alto VA's medical team and prescribing clinicians.
Patient is willing to sign a Lucid Lane Client Agreement.
Patient is willing to sign an informed consent form
Exclusion Criteria:
Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
Active suicidal ideations
Patient is 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 smart phone, tablet, or computer)
Patients who are in palliative care
Unable to use English to participate in the consent process, the intervention or study assessments.
Unable to provide informed consent to participate
Facility Information:
Facility Name
Palo Alto Division - VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle T Harrison, MD
Phone
650-996-6532
Email
kharriso@stanford.edu
First Name & Middle Initial & Last Name & Degree
Nithya Vijayakumar, MS
Phone
6505146117
Email
NVijayakumar@pavir.org
First Name & Middle Initial & Last Name & Degree
Kyle T Harrison, MD
12. IPD Sharing Statement
Learn more about this trial
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
We'll reach out to this number within 24 hrs