Decision support tool to help families choose spinal surgery for children with neuromuscular scoliosis
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis - Aims 2 and 3
This pilot will test a decision support tool designed to help parents, children, and doctors make clearer choices about spinal surgery for children with neuromuscular scoliosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT07167927 on ClinicalTrials.gov |
What this trial studies
This pilot hybrid type I efficacy/implementation trial will compare usual care to use of a newly developed decision support tool during surgical consultations for pediatric neuromuscular scoliosis at two academic centers. Parent-child dyads (ages 8–21) and participating surgeons will receive the tool or usual care in English or Spanish and researchers will track the treatment chosen, measures of decision quality, and short-term affective, cognitive, and behavioral outcomes. The study will also collect feasibility, acceptability, and implementation barriers and facilitators from families and clinicians. Findings will inform effect size estimates, refinements to the tool, and the design of a larger effectiveness trial.
Who should consider this trial
Good fit: Parent–child dyads where the child is 8–21 years old with neuromuscular scoliosis (excluding Duchenne/Becker muscular dystrophy) coming for a surgical consultation and who speak English or Spanish are ideal candidates.
Not a fit: Children under 8, those with Duchenne or Becker muscular dystrophy, or families not facing a surgical decision are unlikely to benefit from this tool.
Why it matters
Potential benefit: If successful, the tool could reduce decisional uncertainty and help families make treatment choices that better match their values and expectations.
How similar studies have performed: Shared decision making tools and decision aids have improved decision quality in other surgical and chronic-care settings, but this application for pediatric neuromuscular scoliosis is novel and builds on only preliminary formative work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Parent-child dyads of children with neuromuscular scoliosis who speak English and Spanish. * Child is between ages 8-21 years of age and they are coming into the pediatric orthopaedic surgery clinic for consultation about potential surgery for NMS. * NMS is defined as having neurologic impairment (NI) and scoliosis using relevant ICD-9 or ICD-10 codes from Feudtner, et al. 2014 or Berry, et al. 2012. or a qualifying diagnosis per the Pediatric Spine Study Group definition of NMS. * All pediatric orthopaedic surgeons and neurosurgeons who treat neuromuscular scoliosis at our study sites will be eligible participants. Exclusion criteria: * Families whose child with NMS is less than 8 years of age at time of orthopaedic consultation because surgery at a younger age usually indicates an atypical case. * Children with the diagnosis of Duchenne's or Becker's muscular dystrophy due to potential disease modifying therapies that may alter curve progression.
Where this trial is running
Los Angeles, California and 1 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Jody Lin, MD, MS — University of Utah
- Study coordinator: Angela Zhu, BS
- Email: angela.zhu@hsc.utah.edu
- Phone: 801-662-3675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.