Recruiting

Decision Support Tool

Sponsor:

University of Utah

Code:

NCT07167927

Conditions

Children With Medical Complexity (CMC)

Multiple Chronic Conditions

Neuromuscular Scoliosis

Shared Decision Making

Decision Support Systems, Clinical

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Decision support tool

Study Details

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

Children With Medical Complexity (CMC)

Multiple Chronic Conditions

Neuromuscular Scoliosis

Shared Decision Making

Decision Support Systems, Clinical

Study ID

NCT07167927

Start date

Oct 21, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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 Becker's muscular dystrophy due to potential disease modifying therapies that may alter curve progression.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual care

Participants receive usual care

experimental: Decision support tool

Participants receive the novel decision support tool

Interventions

Decision support tool

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

Primary outcome measure

  • Intention for NMS treatment [ Time Frame: Immediately after clinic visit ]

Central Contacts and Locations

Central contacts

Angela Zhu, BS

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

Michelle Wilcox

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

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Amberly Thai

amthai@chla.usc.edu

Tiffany Phan

tphan@chla.usc.edu

Principal Investigator:

Tamara Simon, MD, MSPH

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84114

Contacts

Angela Zhu

8016623675angela.zhu@hsc.utah.edu

Principal Investigator:

Jody L Lin, MD, MS

More Information

Sponsor

University of Utah

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-10.