An interventional study of Decision support tool in Children With Medical Complexity (CMC), Multiple Chronic Conditions and Neuromuscular Scoliosis, sponsored by University of Utah. Recruiting at 2 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Utah · Not applicable, Interventional, and Health services research
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.
Neuromuscular scoliosis (NMS) can result in severe disability for children. Non-operative management including bracing and physical therapy minimally slows scoliosis progression, but operative management with posterior spinal fusion (PSF) carries high risks of morbidity and mortality in part due to the multiple comorbid conditions seen in children with NMS. Decisions like PSF that have no clear best treatment option are best served by shared decision making (SDM). SDM is a collaborative process where patients, parents, and providers share their knowledge, preferences, and values to reach treatment plan agreement. Our prior qualitative study creating a framework of SDM for children with multiple comorbid conditions like children with NMS found that parents face immense decision related uncertainty that often goes unacknowledged by providers and that parents and providers struggle with identifying and communicating family preferences and values that are important for treatment decision making. Our prior work has identified optimal methods to communicate uncertainty and identified the preferences and values parents of children with NMS have when it comes to treatment decision making for NMS. This study will pilot test a decision support tool that contains these elements.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's planned enrollment of 110 is below the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
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Exclusion criteria:
Participants receive usual care
Participants receive the novel decision support tool
Behavioral: Decision support tool
Decision 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)
Time frame: Immediately after clinic visit
Intention for NMS treatment
Parent's desired treatment option: Binary (1- surgery, 0- no surgery)
Time frame: Immediately after clinic visit
Intention for not delaying treatment
For parents who select surgery, the intention of treatment timing.
Time frame: Immediately after clinic visit
Knowledge questions
Parent's response to five decision-related knowledge questions, scored as total answered correctly
Time frame: Immediately after clinic visit
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.
Time frame: Immediately after clinic visit
Physician trustworthiness
The Dugan Physician Trust Scale is a validated 5-item survey measure to assess the participant's trust in their physician. Each item is rated on a 5-point Likert scale and one item is reverse coded before all items are summed to create a composite score. Higher scores indicate stronger trust in the physician.
Time frame: Immediately after clinic visit
Feasibility of intervention
Measured by the validated Feasibility of Intervention Measure. 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.
Time frame: Immediately after clinic visit
Risk perception
2 unique items on perception of risk related to decision, scored individually. Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher perceived decision-related risk.
Time frame: Immediately after clinic visit
Decision conflict
Decisional conflict scale and 2 unique decision conflict items (individual items scored individually). Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher decisional conflict.
Time frame: Immediately after clinic visit
Decision readiness
Preparation for Decision Making (PrepDM): The PrepDM scale is a validated 10-item survey measure that evaluates the participant's perception of how helpful their clinic visit was in preparing them to make the decision. Each item is rated on a 5-point Likert scale, and scores are standardized to a 0-100 scale, with higher scores indicating greater perceived readiness for decision-making.
Time frame: Immediately after clinic visit
Acceptability of Intervention- Qualitative
Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants.
Time frame: Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).
Worry
Consists of 3 unique items to assess the participant's level of worry related to decision making. Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher levels of decision-related worry.
Time frame: Immediately after clinic visit
Quality of shared decision making
Quantitatively via the 9-item SDM-Q-9 (parent) and SDM-Q-Doc (provider) surveys. Each item is rated on a 6-point Likert scale. The total score is standardized to a scale from 0 to 100, with higher scores indicating greater perceived involvement in decision-making.
Time frame: Immediately after clinic visit
Decisional self-efficacy
The Decisional Self-Efficacy Scale is a validated 11-item survey measure that evaluates the participant's ability to make informed health-related decisions. Items are rated on a 5-point Likert scale and scores are standardized to a 0-100 scale, with higher scores reflecting greater decisional self-efficacy.
Time frame: Immediately after clinic visit
preference concordance for parents
Compare parent self-rated top three values/preferences driving decision making with decision they chose for consistency of decision with values/preferences. Will be scored based on number of values (out of 3) that match the treatment option selected.
Time frame: Immediately after clinic visit
Appropriateness of intervention
Measured quantitatively by the validated Appropriateness of Intervention Measure. 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.
Time frame: Immediately after clinic visit
Preference concordance between parents and providers
Correlation between top three parent preferences and values for decision identified by parents and by providers, calculated via a kappa score.
Time frame: Immediately after clinic visit
Feasibility of Intervention- Qualitative
Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants.
Time frame: Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).
Appropriateness of Intervention- Qualitative
Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants.
Time frame: Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).
Quality of shared decision making- qualitative
Using the DEEP-SDM coding scheme on video- and audio-recorded clinical encounters
Time frame: During clinic visit
Barriers and facilitators to implementation
Qualitative analysis of interviews and focus groups from intervention group participants using the CFIR
Time frame: Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).
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.
Time frame: immediately after clinic visit
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.
Time frame: Immediately after clinic visit
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.
Time frame: Immediately after clinic visit
Tool use
Metadata on tool interaction, inputs, and use
Time frame: End of study, approximately 18 months after first enrollment.
Severe pneumonia
Chart review of medical records to count number of admissions for pneumonia.
Time frame: Within 18 months of clinic visit
Readability
Consists of 2 unique items to assess how clearly the intervention is presented. Each item is rated on a 5-point Likert scale. The items will be scored individually. Only parent participants assigned to the intervention group will answer these items.
Time frame: Immediately after the clinic visit
provider preferences and values for decision making
provider free response of top three reasons for decisiion that was made
Time frame: immediately after clinic visit
parent preferences and values
selection of top three parent preferences and values for decision making from a list of options including a free response "other" field; asked to parent/patient participants and provider participants
Time frame: immediately after visit
Quality of interpretation
Qualitative analysis of quality of interpretation captured on video-recordings of clinic visits.
Time frame: During clinic visit
Decision adherence
Chart review of medical records to assess adherence to decision made.
Time frame: Within 18 months after clinic visit.
Pain symptoms
Chart review of patient record for changes in pain symptoms related to scoliosis. Options include: worsened, unchanged, improved, not mentioned.
Time frame: Within 18 months of clinic visit
Surgical outcomes
Chart review of medical records to assess for presence surgical outcomes: minor complications, major complications.
Time frame: Within 18 months of clinic visit
Sitting comfort
Chart review of patient record for changes in sitting comfort symptoms related to scoliosis. Options include: worsened, unchanged, improved, not mentioned.
Time frame: Within 18 months of clinic visit
ICU length of stay
For those who undergo surgery, the days the patient spent in the ICU after surgery
Time frame: Within 18 months of clinic visit
Total length of stay
For those who undergo surgery, the days the patient spent in the the hospital after surgery
Time frame: Within 18 months of clinic visit
Length of ventilation
For those who undergo surgery, the days the patient spent on mechanical ventilation (if not ventilated at baseline) or days spent on higher than normal mechanical ventilation settings (if ventilated at baseline).
Time frame: Within 18 months of clinic visit
Pneumonia hospital days
Chart review of medical records to count number of days admitted for pneumonia.
Time frame: Within 18 months of clinic visit
Plan to share: No
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