Recruiting

Behavioral Tele-health

Sponsor:

Lucid Lane, Inc

Code:

NCT05367050

Conditions

Opioid Dependence

Opioid Use

Pain, Joint

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Lucid Lane Therapy Program

Surgical Preparedness Course

Study Details

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.

Conditions

Opioid Dependence

Opioid Use

Pain, Joint

Study ID

NCT05367050

Start date

May 4, 2021

Status verified date

May, 2022

Completion date

Apr, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

103 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Treatment

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

active comparator: Control

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

Interventions

Lucid Lane Therapy Program

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.

Surgical Preparedness Course

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

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) or Hip Injury and Osteoarthritis Outcome Score (HOOS) and [ Time Frame: Up to 4 months ]
  • Change in Pain Catastrophizing scale [ Time Frame: Up to 4 months ]
  • Change in Depression Scores [ Time Frame: Up to 4 months ]
  • Change in Anxiety Scores [ Time Frame: Up to 4 months ]

Central Contacts and Locations

Locations

Palo Alto Division - VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kyle T Harrison, MD

650-996-6532kharriso@stanford.edu

Nithya Vijayakumar, MS

6505146117NVijayakumar@pavir.org

Principal Investigator:

Kyle T Harrison, MD

More Information

Sponsor

Lucid Lane, Inc

Last update posted

May 10, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lucid Lane, Inc on 2022-05-10.