Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery (SurgeryPal)

Seattle Children's Healthcare System

Status: Completed

Conditions: Juvenile; Scoliosis; Spondylolisthesis; Scoliosis; Adolescence; Scoliosis;Congenital; Scoliosis Idiopathic; Kyphosis

Treatments: Behavioral: CBT (SurgeryPal); Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04637802

UH3HD102038

Details and patient eligibility

About

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 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).

Full 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.

Enrollment: 433 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Teen

• 12 to 18 years old at the time of enrollment
• Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis 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; Teens can borrow an iPad from the study team if one is available)
• Recent psychiatric admission (in the past 30 days)
• Severe systemic disease (neuromuscular scoliosis, cancer)
• On a regular treatment regimen for a severe chronic medical condition
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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433 participants in 4 patient groups

Pre-operative and Post-operative Education intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Education

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

Experimental group

Description:

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

Treatment:

Behavioral: Education

Behavioral: CBT (SurgeryPal)

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

Experimental group

Description:

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

Treatment:

Behavioral: Education

Behavioral: CBT (SurgeryPal)

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

Experimental group

Description:

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

Treatment:

Behavioral: CBT (SurgeryPal)