Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
NCT07167927 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-12-05
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
- Decision Aids
Interventions
- BEHAVIORAL
-
Decision support tool
Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH - lead OTHER
Principal Investigators
-
Jody Lin, MD, MS · University of Utah
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 8 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-21
- Primary Completion
- 2027-01-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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