Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery

Not Applicable

• Conditions: Pain, Joint; Opioid Dependence; Opioid Use
• Interventions: Behavioral: Lucid Lane Therapy Program; Behavioral: Surgical Preparedness Course

• Registration Number: NCT05367050
• Lead Sponsor: Lucid Lane, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2022-04-22
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-10
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Lucid Lane Therapy Program	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
Control	Surgical Preparedness Course	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
Treatment	Lucid Lane Therapy Program	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

Primary Outcome Measures

Name	Time	Method
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and	Up to 4 months	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 Depression Scores	Up to 4 months	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 Pain Catastrophizing scale	Up to 4 months	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 Anxiety Scores	Up to 4 months	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

Name	Time	Method
Percent tapered off opioid (50% MME)	4 weeks after surgery

Trial Locations

Locations (1)

Palo Alto Division - VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States