Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Utah
Study ID
NCT07167927
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual care
    Participants receive usual care
  • Experimental: Decision support tool
    Participants receive the novel decision support tool

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Amberly Thai
[email protected]
Tiffany Phan
[email protected]
Tamara Simon, MD, MSPH (PRINCIPAL_INVESTIGATOR)
Lindsay Andras, MD (SUB_INVESTIGATOR)
University of UtahSalt Lake CityUtah84114
Angela Zhu
[email protected]
8016623675
Jody L Lin, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Los Angeles· Los Angeles, CAUniversity of Utah· Salt Lake City, UT

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