Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents

Sponsors

Lead Sponsor: Seattle Children's Hospital

Collaborator: Duke University
University of Utah
Vanderbilt University
Johns Hopkins University
Connecticut Children's Medical Center

Source Seattle Children's Hospital
Brief Summary

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in 500 youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

Detailed Description

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.

Overall Status Not yet recruiting
Start Date November 25, 2020
Completion Date August 2024
Primary Completion Date August 2024
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Post-surgical pain intensity and interference Up to 3 weeks post-surgery
Chronic pain intensity and interference 3 months post-surgery
Secondary Outcome
Measure Time Frame
Change in health-related quality of life Baseline, 3-months post-surgery, 6-months post-surgery
Change in opioid use Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Change in opioid misuse Baseline, 3-months post-surgery, 6-months post-surgery
Change in psychosocial distress Baseline, 3-months post-surgery, 6-months post-surgery
Change in mental health Baseline, 3-months post-surgery, 6-months post-surgery
Change in sleep quality Baseline, 3-months post-surgery, 6-months post-surgery
Change in pain catastrophizing Baseline, 3-months post-surgery
Global pain severity Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Enrollment 500
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: CBT (SurgeryPal)

Description: The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

Intervention Type: Behavioral

Intervention Name: Education

Description: The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

Eligibility

Criteria:

Inclusion Criteria: Teen - 12 to 18 years old at the time of enrollment - Undergoing scheduled spinal fusion surgery (eligible indications: idiopathic scoliosis, juvenile scoliosis, spondylothesis or kyphosis) Parent/Caregiver - Parent or legal guardian of child who meets study criteria Exclusion Criteria: Teen - Does not speak or understand English - Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level) - Does not have access to a smart device (smartphone, iPad or tablet) - Recent psychiatric admission (in the past 30 days) - Severe systemic disease (neuromuscular scoliosis, cancer) - Takes medication daily for treatment of a chronic medical condition (except allergies, asthma, anxiety, depression) - Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery) - Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain) Parent/Caregiver - Does not speak or understand English - Does not have access to a smart device (smartphone, iPad or tablet)

Gender: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Jennifer Rabbitts, MD

Phone: 206-884-1361

Email: [email protected]

Location
Facility: Contact: Investigator: Seattle Children's Hospital Jennifer Rabbitts Jennifer Rabbitts, MD Principal Investigator Tonya Palermo, PhD Principal Investigator
Location Countries

United States

Verification Date

November 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seattle Children's Hospital

Investigator Full Name: Jennifer Rabbitts, MBChB

Investigator Title: Principal Investigator, Anesthesiologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Pre-operative and Post-operative Education intervention

Type: Active Comparator

Description: This arm receives access to Patient Education intervention in the pre- and post-operative phases.

Label: Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention

Type: Experimental

Description: This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

Label: Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)

Type: Experimental

Description: This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

Label: Pre-operative and Post-operative CBT intervention (SurgeryPal)

Type: Experimental

Description: This arm receives access to CBT intervention during the pre-operative and post-operative period.

Acronym SurgeryPal
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Intervention Model Description: Randomized and double-blinded controlled trial of cognitive-behavioral intervention vs education at two phases (pre-operative and post-operative)

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov