ClinicalTrials.gg
CompletedNCT05913206Updated Feb 24, 2026Results posted

Understanding Factors in Decision Making for Children With Medical Complexity

An interventional study of Ambiguity and Complexity in Multiple Chronic Conditions and Children With Medical Complexity, sponsored by University of Utah. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by University of Utah · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
831
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Multiple Chronic Conditions
  • Children With Medical Complexity

Keywords

  • Shared decision making
  • Health communication
  • Patient- and Family-Centered Care
03

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's enrollment of 831 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult caregiver of a child with medical complexity
  • English- or Spanish-speaking

Exclusion criteria

Exclusion Criteria:

  • Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
831 participants (actual)

Study arms

  • No intervention
    Control

    No new communication approaches received.

  • Experimental
    Ambiguity only

    Receive information about ambiguity related to the clinical decision.

    Behavioral: Ambiguity

  • Experimental
    Ambiguity and complexity only

    Receive information about ambiguity and complexity related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Complexity

  • Experimental
    Ambiguity and normalizing only

    Receive information about ambiguity and normalizing language related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Normalizing language

  • Experimental
    Ambiguity, complexity, and normalizing only

    Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Complexity · Behavioral: Normalizing language

  • Experimental
    Complexity only

    Receive information about complexity related to the clinical decision.

    Behavioral: Complexity

  • Experimental
    Complexity and normalizing only

    Receive information about complexity and normalizing language related to the clinical decision.

    Behavioral: Complexity · Behavioral: Normalizing language

  • Experimental
    Normalizing only

    Receive information about normalizing language related to the clinical decision.

    Behavioral: Normalizing language

  • Experimental
    Narratives only

    Receive narratives in addition to the control condition.

    Behavioral: Narrative

  • Experimental
    Ambiguity and narratives only

    Receive information about ambiguity and narratives related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Narrative

  • Experimental
    Ambiguity, complexity, and narratives only

    Receive information about ambiguity, complexity, and narratives related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Complexity · Behavioral: Narrative

  • Experimental
    Ambiguity, normalizing, and narratives only

    Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.

    Behavioral: Ambiguity · Behavioral: Normalizing language · Behavioral: Narrative

  • Experimental
    All

    Receive all new communication approaches

    Behavioral: Ambiguity · Behavioral: Complexity · Behavioral: Normalizing language · Behavioral: Narrative

  • Experimental
    Complexity and narratives only

    Receive information about complexity and narratives related to the clinical decision.

    Behavioral: Complexity · Behavioral: Narrative

  • Experimental
    Complexity, normalizing, and narratives only

    Receive information about complexity, normalizing language, and narratives related to the clinical decision.

    Behavioral: Complexity · Behavioral: Normalizing language · Behavioral: Narrative

  • Experimental
    Normalizing and narratives only

    Receive information about normalizing language and narratives related to the clinical decision.

    Behavioral: Normalizing language · Behavioral: Narrative

Interventions

  • BehavioralAmbiguity

    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.

  • BehavioralComplexity

    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.

  • BehavioralNormalizing language

    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.

  • BehavioralNarrative

    Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after reviewing the intervention

Secondary outcomes

  1. 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.

    Time frame: Immediately after reviewing the intervention

  2. Decision Intent for Treatment

    Proportion of participants selecting surgery between the arms.

    Time frame: Immediately after reviewing the intervention

  3. Knowledge

    Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions.

    Time frame: Immediately after reviewing the intervention

07

Results

Posted Feb 24, 2026

Participant flow

Participant flow — Overall Study
MilestoneControlNarratives OnlyNormalizing OnlyNormalizing and Narratives OnlyComplexity OnlyComplexity and Narratives OnlyComplexity and Normalizing OnlyComplexity, Normalizing, and Narratives OnlyAmbiguity OnlyAmbiguity and Narratives OnlyAmbiguity and Normalizing OnlyAmbiguity, Normalizing, and Narratives OnlyAmbiguity and Complexity OnlyAmbiguity, Complexity, and Narratives OnlyAmbiguity, Complexity, and Normalizing OnlyAll Communication Approaches
Started53505250515152495251535850535353
Completed51454947484849475045485647515052
Not completed2533333226523231

Outcome measures

PrimaryDecision 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.

Time frame:
Immediately after reviewing the intervention
Reported as:
Mean · score on a scale
Decision Readiness
score on a scaleControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communication Approaches
Decision Readiness77.3 ± 17.179.1 ± 18.679.1 ± 15.478.5 ± 23.282.3 ± 12.980.5 ± 14.272.8 ± 19.677.3 ± 17.976.2 ± 17.578.5 ± 18.079.4 ± 17.782.3 ± 15.280.3 ± 16.280.2 ± 17.375.6 ± 20.180.2 ± 15.2
SecondaryDecisional 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.

Time frame:
Immediately after reviewing the intervention
Reported as:
Mean · score on a scale
Decisional Conflict Scale
score on a scaleControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communication Approaches
Decisional Conflict Scale30.7 ± 19.736.5 ± 24.532.9 ± 21.428.1 ± 23.526.0 ± 18.031.3 ± 19.234.8 ± 25.630.4 ± 22.437.0 ± 24.229.4 ± 17.327.5 ± 22.630.5 ± 23.228.8 ± 22.229.8 ± 23.426.8 ± 22.427.0 ± 21.7
SecondaryDecision Intent for Treatment

Proportion of participants selecting surgery between the arms.

Time frame:
Immediately after reviewing the intervention
Reported as:
Count of participants · Participants
Decision Intent for Treatment
ParticipantsControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communication Approaches
No surgery79985107756316535
Surgery44403738433840434038444937514446
Missing0121102001114001
SecondaryKnowledge

Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions.

Time frame:
Immediately after reviewing the intervention
Reported as:
Mean · proportion of correct answers
Knowledge
proportion of correct answersControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communication Approaches
Knowledge0.9 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.10.8 ± 0.20.8 ± 0.20.7 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.20.8 ± 0.2

Adverse events

Collected over Throughout the duration of recruitment and data collection, approximately 1 day.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control0/51 (0%)0/51 (0%)0/51 (0%)
Narratives Only0/45 (0%)0/45 (0%)0/45 (0%)
Normalizing Only0/49 (0%)0/49 (0%)0/49 (0%)
Normalizing and Narratives Only0/47 (0%)0/47 (0%)0/47 (0%)
Complexity Only0/48 (0%)0/48 (0%)0/48 (0%)
Complexity and Narratives Only0/48 (0%)0/48 (0%)0/48 (0%)
Complexity and Normalizing Only0/49 (0%)0/49 (0%)0/49 (0%)
Complexity, Normalizing, and Narratives Only0/47 (0%)0/47 (0%)0/47 (0%)
Ambiguity Only0/50 (0%)0/50 (0%)0/50 (0%)
Ambiguity and Narratives Only0/45 (0%)0/45 (0%)0/45 (0%)
Ambiguity and Normalizing Only0/48 (0%)0/48 (0%)0/48 (0%)
Ambiguity, Normalizing, and Narratives Only0/56 (0%)0/56 (0%)0/56 (0%)
Ambiguity and Complexity Only0/47 (0%)0/47 (0%)0/47 (0%)
Ambiguity, Complexity, and Narratives Only0/51 (0%)0/51 (0%)0/51 (0%)
Ambiguity, Complexity, and Normalizing Only0/50 (0%)0/50 (0%)0/50 (0%)
All Communication Approaches0/52 (0%)0/52 (0%)0/52 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Mean39.3 ± 8.538.3 ± 8.137.9 ± 7.138.7 ± 6.836.8 ± 7.238.8 ± 9.836.0 ± 7.338.1 ± 10.435.9 ± 8.235.7 ± 7.137.2 ± 8.837.3 ± 8.538.5 ± 8.338.8 ± 9.739.4 ± 9.137.0 ± 10.337.8 ± 8.5
Sex/Gender, Customized
Sex/Gender, Customized(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Female44444139354436433942384437443741648
Male446593104529771088101
Other00010000000000001
Missing321251331110322333
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Hispanic or Latino20191919201920202018212020252022322
Not Hispanic or Latino31312928292929302527273127312730461
Unknown or Not Reported00000000000000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Race — American Indian or Alaskan Native111111121220211220
Race — Asian221122322211211126
Race — Black322121313202142332
Race — Native Hawaiian or Other Pacific Islander112001110011110112
Race — Other99991071110881110911911151
Race — Two or more races312433122204131234
Race — White32343131313329322929333331353332508
Child age
Child age(years)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Mean9 ± 5.27.3 ± 5.57.9 ± 5.28.4 ± 68.3 ± 5.78.5 ± 66.5 ± 5.28.1 ± 5.77.6 ± 5.28.1 ± 57.2 ± 6.37.1 ± 5.38.6 ± 5.67.6 ± 5.58.6 ± 5.77.6 ± 5.87.9 ± 5.6
Language preference
Language preference(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
English46454242444142423837394639464046675
Spanish55655778789581076108
type of insurance coverage
type of insurance coverage(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Don't know002103010021001213
Medicaid19282819212923232023252929272122386
Medicare282625767648748991
Private22202417171624161817152111191617290
Other854457321263546671
technology dependene
technology dependene(Participants)ControlAmbiguity OnlyComplexity OnlyAmbiguity and Complexity OnlyNormalizing OnlyAmbiguity and Normalizing OnlyComplexity and Normalizing OnlyAmbiguity, Complexity, and Normalizing OnlyNarratives OnlyAmbiguity and Narratives OnlyComplexity and Narratives OnlyAmbiguity, Complexity, and Narratives OnlyNormalizing and Narratives OnlyAmbiguity, Normalizing, and Narratives OnlyComplexity, Normalizing, and Narratives OnlyAll Communciation ApproachesTotal
Technology dependent26262525273831302926282828342625452
Not technology dependent2321191519813141314172015201925275
Decline to answer234732563533422256

10 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • University of Utah
    Salt Lake City, Utah 84114, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Aug 2024, 14 months.

Results were first posted in Feb 2026, 1 year 5 months after primary completion.

Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 14 months is below that.

Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.

Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2023
First posted
Jun 22, 2023
StartActual
Jun 29, 2023
Primary completionActual
Aug 29, 2024
CompletionActual
Aug 29, 2024
Results first posted
Feb 24, 2026
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05913206
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jun 29, 2023
Primary completion
Aug 29, 2024
Completion
Aug 29, 2024
Results posted
Feb 24, 2026
Last update
Feb 24, 2026

Study contacts

Jody L Lin, MD, MS
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion