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.
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.
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.
Crossover
Decision support tool
BehavioralDecision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis
Intention for NMS treatment
Parent degree of decision preference (1: no surgery-9: surgery)
Intention for NMS treatment
Parent's desired treatment option: Binary (1- surgery, 0- no surgery)
Intention for not delaying treatment
For parents who select surgery, the intention of treatment timing.
Knowledge questions
Parent's response to five decision-related knowledge questions, scored as total answered correctly
Acceptability of intervention
Measured quantitatively by the validated Acceptability of Intervention Measure for caregivers in the intervention group. The scale consists of 4 items rated on a 5-point Likert scale. A mean score is created with a higher score indicating higher acceptability.
Barriers and facilitators to implementation
Qualitative analysis of interviews and focus groups from intervention group participants using the CFIR
Quality of interpretation
5-item survey questions based on Napoles 2015 and qualitative analysis of recorded clinic visits to assess quality of interpretation. The first item assesses the type and need for interpretation, with participants selecting from 7 categories. If an interpreter was used, participants will then answer 4 additional items about the quality of interpretation for the visit. Each of these subsequent items is rated on a 5-point Likert scale (1-poor to 5-excellent). A mean composite outcome of the completed items is used to calculate overall quality.
Usability of intervention
System Usability Scale (SUS): The SUS is a validated 10-item survey measure that evaluates the perceived usability of the intervention. Items are rated on a 5-point Likert scale and scores are calculated by converting responses to a 0-100 scale, with higher scores indicating better usability. Only parent participants assigned to the intervention group will answer this measure.
Mental load of intervention
NASA Task Load Index (NASA-TLX): The NASA-TLX is a validated measure used to assess the perceived mental workload of using the intervention. It consists of 6-items to measure 6 core dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated on a scale from 0 to 100, and scores are combined to produce an overall workload score. Higher scores indicate greater perceived workload. Only parent participants assigned to the intervention group will answer this measure.
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University of Utah
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
