Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

NCT ID: NCT07167927

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-21
• Study Completion Date: 2027-03-31

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.

Detailed Description

Neuromuscular scoliosis (NMS) can result in severe disability for children. Non-operative management including bracing and physical therapy minimally slows scoliosis progression, but operative management with posterior spinal fusion (PSF) carries high risks of morbidity and mortality in part due to the multiple comorbid conditions seen in children with NMS. Decisions like PSF that have no clear best treatment option are best served by shared decision making (SDM). SDM is a collaborative process where patients, parents, and providers share their knowledge, preferences, and values to reach treatment plan agreement. Our prior qualitative study creating a framework of SDM for children with multiple comorbid conditions like children with NMS found that parents face immense decision related uncertainty that often goes unacknowledged by providers and that parents and providers struggle with identifying and communicating family preferences and values that are important for treatment decision making. Our prior work has identified optimal methods to communicate uncertainty and identified the preferences and values parents of children with NMS have when it comes to treatment decision making for NMS. This study will pilot test a decision support tool that contains these elements.

Conditions

Children With Medical Complexity (CMC); Multiple Chronic Conditions; Neuromuscular Scoliosis; Shared Decision Making; Decision Support Systems, Clinical; Decision Aids

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

Participants receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Decision support tool

Participants receive the novel decision support tool

Group Type: EXPERIMENTAL

Decision support tool

Intervention Type: BEHAVIORAL

Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis

Interventions

Decision support tool

Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jody Lin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jody Lin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angela Zhu, BS

Role: CONTACT

angela.zhu@hsc.utah.edu

801-662-3675

Michelle Wilcox

Role: CONTACT

michelle.o.wilcox@hsc.utah.edu

801-581-6410

Facility Contacts

Amberly Thai

Role: primary

amthai@chla.usc.edu

Tiffany Phan

Role: backup

tphan@chla.usc.edu

Angela Zhu

Role: primary

angela.zhu@hsc.utah.edu

8016623675

Other Identifiers

1K23AR079778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00169930

Identifier Type: -

Identifier Source: org_study_id