Children With Medical Complexity (CMC)NCT07167927
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis
A study testing Decision support tool in people with Children With Medical Complexity (CMC) and Multiple Chronic Conditions, run by University of Utah at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Children With Medical Complexity (CMC), Multiple Chronic Conditions, Neuromuscular Scoliosis
- What is being tested?
- Decision support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Amberly Thai, amthai@chla.usc.edu
Tiffany Phan, tphan@chla.usc.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84114
Angela Zhu, 8016623675, angela.zhu@hsc.utah.edu
Jody L Lin, MD, MS
About this study
Official title: Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis - Aims 2 and 3
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.
Read the detailed description
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.
- Conditions
- Children With Medical Complexity (CMC), Multiple Chronic Conditions, Neuromuscular Scoliosis, Shared Decision Making, Decision Support Systems, Clinical, Decision Aids
- Being tested
- Decision support tool
- Keywords
- children with medical complexity, shared decision making, values clarification, uncertainty communication, decision support tool
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision support toolBehavioural
Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants receive usual care |
| Decision support tool | Experimental | Participants receive the novel decision support tool Receives: Behavioral: Decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention for NMS treatment
Parent degree of decision preference (1: no surgery-9: surgery)
Measured: Immediately after clinic visit
Secondary outcomes (19)
Intention for NMS treatment
Parent's desired treatment option: Binary (1- surgery, 0- no surgery)
Measured: Immediately after clinic visit
Intention for not delaying treatment
For parents who select surgery, the intention of treatment timing.
Measured: Immediately after clinic visit
Knowledge questions
Parent's response to five decision-related knowledge questions, scored as total answered correctly
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after clinic visit
Acceptability of Intervention- Qualitative
Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after clinic visit
Feasibility of Intervention- Qualitative
Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants.
Measured: 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.
Measured: 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
Measured: During clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start21 Oct 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Medical Complexity (CMC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- pre-intervention crossed over to post-intervention design for provider participants
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Jody Lin, University of Utah
- Investigators
- Jody Lin, MD, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167927
- Sponsor's protocol ID
- IRB_00169930
- Other IDs
- 1K23AR079778
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis - Aims 2 and 3
- ClinicalTrials.gov ID
- NCT07167927
- Acronym / sponsor ID
- IRB_00169930
- Conditions
- Children With Medical Complexity (CMC), Multiple Chronic Conditions, Neuromuscular Scoliosis, Shared Decision Making, Decision Support Systems, Clinical, Decision Aids
- Keywords
- children with medical complexity, shared decision making, values clarification, uncertainty communication, decision support tool
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre-intervention crossed over to post-intervention design for provider participants
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants receive usual care |
| Decision support tool | Experimental | Behavioral: Decision support toolParticipants receive the novel decision support tool |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision support toolDecision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis | Behavioural | Decision support tool |
Primary outcome
Intention for NMS treatment
Time frame: Immediately after clinic visit
Parent degree of decision preference (1: no surgery-9: surgery)
19 secondary outcomes
Intention for NMS treatment
Time frame: Immediately after clinic visit
Intention for not delaying treatment
Time frame: Immediately after clinic visit
Knowledge questions
Time frame: Immediately after clinic visit
Acceptability of intervention
Time frame: Immediately after clinic visit
Physician trustworthiness
Time frame: Immediately after clinic visit
Feasibility of intervention
Time frame: Immediately after clinic visit
Risk perception
Time frame: Immediately after clinic visit
Decision conflict
Time frame: Immediately after clinic visit
Decision readiness
Time frame: Immediately after clinic visit
Acceptability of Intervention- Qualitative
Time frame: Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers).
Worry
Time frame: Immediately after clinic visit
Quality of shared decision making
Time frame: Immediately after clinic visit
Decisional self-efficacy
Time frame: Immediately after clinic visit
preference concordance for parents
Time frame: Immediately after clinic visit
Appropriateness of intervention
Time frame: Immediately after clinic visit
Preference concordance between parents and providers
Time frame: Immediately after clinic visit
Feasibility of Intervention- Qualitative
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
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
Time frame: During clinic visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jody Lin, MD, MS principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision support tool in people with Children With Medical Complexity (CMC) and Multiple Chronic Conditions, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Zhu, BS (801-662-3675, angela.zhu@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention for NMS treatment (time frame: Immediately after clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.