Understanding Factors in Decision Making for Children With Medical Complexity
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
1 other identifier
interventional
831
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2024
CompletedResults Posted
Study results publicly available
February 24, 2026
CompletedFebruary 24, 2026
February 1, 2026
1.2 years
June 12, 2023
August 29, 2025
February 20, 2026
Conditions
Keywords
Outcome Measures
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.
Immediately after reviewing the intervention
Secondary Outcomes (3)
Decisional Conflict Scale
Immediately after reviewing the intervention
Decision Intent for Treatment
Immediately after reviewing the intervention
Knowledge
Immediately after reviewing the intervention
Study Arms (16)
Control
NO INTERVENTIONNo new communication approaches received.
Ambiguity only
EXPERIMENTALReceive information about ambiguity related to the clinical decision.
Ambiguity and complexity only
EXPERIMENTALReceive information about ambiguity and complexity related to the clinical decision.
Ambiguity and normalizing only
EXPERIMENTALReceive information about ambiguity and normalizing language related to the clinical decision.
Ambiguity, complexity, and normalizing only
EXPERIMENTALReceive information about ambiguity, complexity, and normalizing language related to the clinical decision.
Complexity only
EXPERIMENTALReceive information about complexity related to the clinical decision.
Complexity and normalizing only
EXPERIMENTALReceive information about complexity and normalizing language related to the clinical decision.
Normalizing only
EXPERIMENTALReceive information about normalizing language related to the clinical decision.
Narratives only
EXPERIMENTALReceive narratives in addition to the control condition.
Ambiguity and narratives only
EXPERIMENTALReceive information about ambiguity and narratives related to the clinical decision.
Ambiguity, complexity, and narratives only
EXPERIMENTALReceive information about ambiguity, complexity, and narratives related to the clinical decision.
Ambiguity, normalizing, and narratives only
EXPERIMENTALReceive information about ambiguity, normalizing language, and narratives related to the clinical decision.
All
EXPERIMENTALReceive all new communication approaches
Complexity and narratives only
EXPERIMENTALReceive information about complexity and narratives related to the clinical decision.
Complexity, normalizing, and narratives only
EXPERIMENTALReceive information about complexity, normalizing language, and narratives related to the clinical decision.
Normalizing and narratives only
EXPERIMENTALReceive information about normalizing language and narratives related to the clinical decision.
Interventions
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.
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.
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.
Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Eligibility Criteria
You may qualify if:
- Adult caregiver of a child with medical complexity
- English- or Spanish-speaking
You may not qualify if:
- Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Children's Hospital Los Angelescollaborator
Study Sites (2)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of Utah
Salt Lake City, Utah, 84114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jody Lin
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Jody L Lin, MD, MS
University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and the investigator team will be blinded to which condition the participant is randomized.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2023
First Posted
June 22, 2023
Study Start
June 29, 2023
Primary Completion
August 29, 2024
Study Completion
August 29, 2024
Last Updated
February 24, 2026
Results First Posted
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share