Understanding Factors in Decision Making for Children With Medical Complexity

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.

Study Overview

• Status: Completed
• Conditions: Multiple Chronic Conditions; Children With Medical Complexity
• Intervention / Treatment: Behavioral: Ambiguity; Behavioral: Complexity; Behavioral: Normalizing language; Behavioral: Narrative

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 Type: Interventional
• Enrollment (Actual): 831
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No new communication approaches received.
Experimental: Ambiguity only; Receive information about ambiguity related to the clinical decision.	Behavioral: Ambiguity; 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.
Experimental: Ambiguity and complexity only; Receive information about ambiguity and complexity related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: 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.
Experimental: Ambiguity and normalizing only; Receive information about ambiguity and normalizing language related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: Normalizing 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.
Experimental: Ambiguity, complexity, and normalizing only; Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: 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.; Behavioral: Normalizing 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.
Experimental: Complexity only; Receive information about complexity related to the clinical decision.	Behavioral: 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.
Experimental: Complexity and normalizing only; Receive information about complexity and normalizing language related to the clinical decision.	Behavioral: 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.; Behavioral: Normalizing 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.
Experimental: Normalizing only; Receive information about normalizing language related to the clinical decision.	Behavioral: Normalizing 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.
Experimental: Narratives only; Receive narratives in addition to the control condition.	Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Ambiguity and narratives only; Receive information about ambiguity and narratives related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Ambiguity, complexity, and narratives only; Receive information about ambiguity, complexity, and narratives related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Ambiguity, normalizing, and narratives only; Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.	Behavioral: Ambiguity; 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.; Behavioral: Normalizing 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: All; Receive all new communication approaches	Behavioral: Ambiguity; 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.; Behavioral: 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.; Behavioral: Normalizing 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Complexity and narratives only; Receive information about complexity and narratives related to the clinical decision.	Behavioral: 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Complexity, normalizing, and narratives only; Receive information about complexity, normalizing language, and narratives related to the clinical decision.	Behavioral: 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.; Behavioral: Normalizing 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Experimental: Normalizing and narratives only; Receive information about normalizing language and narratives related to the clinical decision.	Behavioral: Normalizing 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.; Behavioral: Narrative; Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Immediately after reviewing the intervention
Decision Intent for Treatment	Proportion of participants selecting surgery between the arms.	Immediately after reviewing the intervention

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Jody L Lin, MD, MS, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): August 29, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Shared decision making; Health communication; Patient- and Family-Centered Care
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Multiple Chronic Conditions; Psychotherapy; Behavioral Disciplines and Activities; Narrative Therapy
• Other Study ID Numbers: 00154724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No