NCT07167927 Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
| NCT ID | NCT07167927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Children With Medical Complexity (CMC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-10-21 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision making for neuromuscular scoliosis (NMS). Results from this pilot will inform the design of a future larger effectiveness trial of the decision support tool. Participants will either receive usual care or receive the decision support tool. Researchers will assess the decision made, decision quality, individual affective, cognitive, and behavioral effects, and feasibility and acceptability of tool use. They will also collect potential barriers and facilitators to implementation and feedback about the tool and study design to maximize likelihood of successful deployment of the tool into clinical practice and inform the design of a future trial. The outcomes measures will be used to inform potential effect size estimates to inform a future trial.
Eligibility 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.
Contact & Investigator
Jody Lin, MD, MS
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT07167927 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Children With Medical Complexity (CMC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07167927 currently recruiting?
Yes, NCT07167927 is actively recruiting participants. Contact the research team at angela.zhu@hsc.utah.edu for enrollment information.
Where is the NCT07167927 trial being conducted?
This trial is being conducted at Los Angeles, United States, Salt Lake City, United States.
Who is sponsoring the NCT07167927 clinical trial?
NCT07167927 is sponsored by University of Utah. The principal investigator is Jody Lin, MD, MS at University of Utah. The trial plans to enroll 110 participants.