Clinical Trial

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-03.
Status change: Not Yet Recruiting → Recruiting 2025-12-04
Trial Details
NCT Number NCT07167927
Lead Sponsor University of Utah
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Children With Medical Complexity (CMC), Multiple Chronic Conditions, Neuromuscular Scoliosis, Shared Decision Making, Decision Support Systems, Clinical, Decision Aids
Enrollment 110 participants
Start Date 2025-10-21
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10