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

NCT ID: NCT05367050

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2023-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Lucid Lane Therapy Program

Intervention Type: BEHAVIORAL

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.

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

Group Type: ACTIVE_COMPARATOR

Lucid Lane Therapy Program

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Lucid Lane, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Palo Alto Division - VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Kyle T Harrison, MD

Role: primary

kharriso@stanford.edu

650-996-6532

Nithya Vijayakumar, MS

Role: backup

NVijayakumar@pavir.org

6505146117

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

56984

Identifier Type: -

Identifier Source: org_study_id