Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

NCT07167927 | Recruiting DMC

• 2 other identifiers: IRB_001699301K23AR079778
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

children with medical complexity; shared decision making; values clarification; uncertainty communication; decision support tool

Outcome Measures

Primary Outcomes (1)

• Intention for NMS treatment

  Parent degree of decision preference (1: no surgery-9: surgery)

  Immediately after clinic visit

Secondary Outcomes (19)

• Intention for NMS treatment

  Immediately after clinic visit

• Intention for not delaying treatment

  Immediately after clinic visit

• Knowledge questions

  Immediately after clinic visit

• Acceptability of intervention

  Immediately after clinic visit

• Physician trustworthiness

  Immediately after clinic visit

Other Outcomes (18)

• Barriers and facilitators to implementation

  Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).

• Quality of interpretation

  immediately after clinic visit

• Usability of intervention

  Immediately after clinic visit

Study Arms (2)

Usual care

NO INTERVENTION

Participants receive usual care

Decision support tool

EXPERIMENTAL

Participants receive the novel decision support tool

Behavioral: Decision support tool

Interventions

Decision support tool BEHAVIORAL

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

Decision support tool

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84114, United States

RECRUITING

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jody Lin, MD, MS

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Zhu, BS

CONTACT

801-662-3675; angela.zhu@hsc.utah.edu

Michelle Wilcox

CONTACT

801-581-6410; michelle.o.wilcox@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: pre-intervention crossed over to post-intervention design for provider participants

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)