Multiple Chronic ConditionsNCT05913206
Understanding Factors in Decision Making for Children With Medical Complexity
A study testing Ambiguity, Complexity and Normalizing language in people with Multiple Chronic Conditions and Children With Medical Complexity, run by University of Utah at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Chronic Conditions, Children With Medical Complexity
- What is being tested?
- Ambiguity, Complexity and Normalizing language
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 831 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2023to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult caregiver of a child with medical complexity
- English- or Spanish-speaking
Who cannot join
- Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Utah
Salt Lake City, Utah, 84114
About this study
Official title: Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity.
Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.
Read the detailed description
Children with medical complexity, their caregivers, and their providers face a multitude of complex, high stakes medical decisions throughout their lifetime. Best practices for the provision of high quality shared decision making in the care of children with medical complexity do not exist. Unique challenges to support decision making for caregivers of children with medical complexity include communication of decision-related risks and benefits and knowledge related to the decision. This study will test the efficacy of various communication techniques in the setting of a simulated patient encounter.
- Being tested
- Ambiguity, Complexity, Normalizing language, Narrative
- Keywords
- Shared decision making, Health communication, Patient- and Family-Centered Care
- 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.
AmbiguityBehavioural
The intervention is a novel communication approach to communicate ambiguity related to the potential risks and benefits associated with clinical decision making for parents and caregivers of children with medical complexity.
ComplexityBehavioural
The intervention is a novel communication approach to communicate complexity related to the potential risks and benefits associated with clinical decision making for parents and caregivers of children with medical complexity.
Normalizing languageBehavioural
The intervention is a novel communication approach to normalize and explain the inherent uncertainty faced by parents of children with medical complexity during clinical decision making.
NarrativeBehavioural
Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No new communication approaches received. |
| Ambiguity only | Experimental | Receive information about ambiguity related to the clinical decision. Receives: Behavioral: Ambiguity |
| Ambiguity and complexity only | Experimental | Receive information about ambiguity and complexity related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Complexity |
| Ambiguity and normalizing only | Experimental | Receive information about ambiguity and normalizing language related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Normalizing language |
| Ambiguity, complexity, and normalizing only | Experimental | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Complexity; Behavioral: Normalizing language |
| Complexity only | Experimental | Receive information about complexity related to the clinical decision. Receives: Behavioral: Complexity |
| Complexity and normalizing only | Experimental | Receive information about complexity and normalizing language related to the clinical decision. Receives: Behavioral: Complexity; Behavioral: Normalizing language |
| Normalizing only | Experimental | Receive information about normalizing language related to the clinical decision. Receives: Behavioral: Normalizing language |
| Narratives only | Experimental | Receive narratives in addition to the control condition. Receives: Behavioral: Narrative |
| Ambiguity and narratives only | Experimental | Receive information about ambiguity and narratives related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Narrative |
| Ambiguity, complexity, and narratives only | Experimental | Receive information about ambiguity, complexity, and narratives related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Complexity; Behavioral: Narrative |
| Ambiguity, normalizing, and narratives only | Experimental | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. Receives: Behavioral: Ambiguity; Behavioral: Normalizing language; Behavioral: Narrative |
| All | Experimental | Receive all new communication approaches Receives: Behavioral: Ambiguity; Behavioral: Complexity; Behavioral: Normalizing language; Behavioral: Narrative |
| Complexity and narratives only | Experimental | Receive information about complexity and narratives related to the clinical decision. Receives: Behavioral: Complexity; Behavioral: Narrative |
| Complexity, normalizing, and narratives only | Experimental | Receive information about complexity, normalizing language, and narratives related to the clinical decision. Receives: Behavioral: Complexity; Behavioral: Normalizing language; Behavioral: Narrative |
| Normalizing and narratives only | Experimental | Receive information about normalizing language and narratives related to the clinical decision. Receives: Behavioral: Normalizing language; Behavioral: Narrative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Readiness
Differences in decision readiness between arms as measured by the validated PrepDM survey measure. The PrepDM is a 10-item (1 to 5 scale) validated survey measure that evaluates a patient's perceived readiness to make a decision with their healthcare provider. The composite score is a mean of all items converted to a scale of 0-100 with higher scores indicating greater decision readiness. PrepDM is widely used to evaluate the effectiveness of decision aids.
Measured: Immediately after reviewing the intervention
Secondary outcomes (3)
Decisional Conflict Scale
Difference in decisional conflict score between arms. The decisional conflict scale is a 16-item (1-5 scale) validated survey measure that evaluates a participant's decisional conflict about a decision that is made and includes five subdomains (uncertainty, informed, values clarity, support, and effective decision). Total and subdomain scores are calculated using a mean composite score and transformed to a scale of 0 to 100 with higher scores indicating higher decisional conflict.
Measured: Immediately after reviewing the intervention
Decision Intent for Treatment
Proportion of participants selecting surgery between the arms.
Measured: Immediately after reviewing the intervention
Knowledge
Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions.
Measured: Immediately after reviewing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start29 Jun 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Sponsor
- Investigators
- Jody L Lin, MD, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913206
- Sponsor's protocol ID
- 00154724
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2023
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 24 Feb 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- Aim 1
- ClinicalTrials.gov ID
- NCT05913206
- Acronym / sponsor ID
- 00154724
- Keywords
- Shared decision making, Health communication, Patient- and Family-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Posted 24 Feb 2026
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 clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity.
Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.
Detailed description
Children with medical complexity, their caregivers, and their providers face a multitude of complex, high stakes medical decisions throughout their lifetime. Best practices for the provision of high quality shared decision making in the care of children with medical complexity do not exist. Unique challenges to support decision making for caregivers of children with medical complexity include communication of decision-related risks and benefits and knowledge related to the decision. This study will test the efficacy of various communication techniques in the setting of a simulated patient encounter.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No new communication approaches received. |
| Ambiguity only | Experimental | Behavioral: AmbiguityReceive information about ambiguity related to the clinical decision. |
| Ambiguity and complexity only | Experimental | Behavioral: Ambiguity, Behavioral: ComplexityReceive information about ambiguity and complexity related to the clinical decision. |
| Ambiguity and normalizing only | Experimental | Behavioral: Ambiguity, Behavioral: Normalizing languageReceive information about ambiguity and normalizing language related to the clinical decision. |
| Ambiguity, complexity, and normalizing only | Experimental | Behavioral: Ambiguity, Behavioral: Complexity, Behavioral: Normalizing languageReceive information about ambiguity, complexity, and normalizing language related to the clinical decision. |
| Complexity only | Experimental | Behavioral: ComplexityReceive information about complexity related to the clinical decision. |
| Complexity and normalizing only | Experimental | Behavioral: Complexity, Behavioral: Normalizing languageReceive information about complexity and normalizing language related to the clinical decision. |
| Normalizing only | Experimental | Behavioral: Normalizing languageReceive information about normalizing language related to the clinical decision. |
| Narratives only | Experimental | Behavioral: NarrativeReceive narratives in addition to the control condition. |
| Ambiguity and narratives only | Experimental | Behavioral: Ambiguity, Behavioral: NarrativeReceive information about ambiguity and narratives related to the clinical decision. |
| Ambiguity, complexity, and narratives only | Experimental | Behavioral: Ambiguity, Behavioral: Complexity, Behavioral: NarrativeReceive information about ambiguity, complexity, and narratives related to the clinical decision. |
| Ambiguity, normalizing, and narratives only | Experimental | Behavioral: Ambiguity, Behavioral: Normalizing language, Behavioral: NarrativeReceive information about ambiguity, normalizing language, and narratives related to the clinical decision. |
| All | Experimental | Behavioral: Ambiguity, Behavioral: Complexity, Behavioral: Normalizing language, Behavioral: NarrativeReceive all new communication approaches |
| Complexity and narratives only | Experimental | Behavioral: Complexity, Behavioral: NarrativeReceive information about complexity and narratives related to the clinical decision. |
| Complexity, normalizing, and narratives only | Experimental | Behavioral: Complexity, Behavioral: Normalizing language, Behavioral: NarrativeReceive information about complexity, normalizing language, and narratives related to the clinical decision. |
| Normalizing and narratives only | Experimental | Behavioral: Normalizing language, Behavioral: NarrativeReceive information about normalizing language and narratives related to the clinical decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult caregiver of a child with medical complexity
- English- or Spanish-speaking
Key exclusion criteria (1 listed)
- Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
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 |
|---|---|---|
| AmbiguityThe intervention is a novel communication approach to communicate ambiguity related to the potential risks and benefits associated with clinical decision making for parents and caregivers of children with medical complexity. | Behavioural | All, Ambiguity and complexity only, Ambiguity and narratives only, Ambiguity and normalizing only, Ambiguity only, Ambiguity, complexity, and narratives only, Ambiguity, complexity, and normalizing only, Ambiguity, normalizing, and narratives only |
| ComplexityThe intervention is a novel communication approach to communicate complexity related to the potential risks and benefits associated with clinical decision making for parents and caregivers of children with medical complexity. | Behavioural | All, Ambiguity and complexity only, Ambiguity, complexity, and narratives only, Ambiguity, complexity, and normalizing only, Complexity and narratives only, Complexity and normalizing only, Complexity only, Complexity, normalizing, and narratives only |
| Normalizing languageThe intervention is a novel communication approach to normalize and explain the inherent uncertainty faced by parents of children with medical complexity during clinical decision making. | Behavioural | All, Ambiguity and normalizing only, Ambiguity, complexity, and normalizing only, Ambiguity, normalizing, and narratives only, Complexity and normalizing only, Complexity, normalizing, and narratives only, Normalizing and narratives only, Normalizing only |
| NarrativeParent and caregiver narratives about their decision making experiences for the care of their child with medical complexity. | Behavioural | All, Ambiguity and narratives only, Ambiguity, complexity, and narratives only, Ambiguity, normalizing, and narratives only, Complexity and narratives only, Complexity, normalizing, and narratives only, Narratives only, Normalizing and narratives only |
Primary outcome
Decision Readiness
Time frame: Immediately after reviewing the intervention
Differences in decision readiness between arms as measured by the validated PrepDM survey measure. The PrepDM is a 10-item (1 to 5 scale) validated survey measure that evaluates a patient's perceived readiness to make a decision with their healthcare provider. The composite score is a mean of all items converted to a scale of 0-100 with higher scores indicating greater decision readiness. PrepDM is widely used to evaluate the effectiveness of decision aids.
3 secondary outcomes
Decisional Conflict Scale
Time frame: Immediately after reviewing the intervention
Decision Intent for Treatment
Time frame: Immediately after reviewing the intervention
Knowledge
Time frame: Immediately after reviewing the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Jody L 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 Ambiguity, Complexity and Normalizing language in people with Multiple Chronic Conditions and Children With Medical Complexity, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 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?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Readiness (time frame: Immediately after reviewing the intervention). 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 24 Feb 2026.