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Completed

NCT Number: NCT05913206

Understanding Factors in Decision Making for Children With Medical Complexity

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.

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Key information

Conditions

Multiple Chronic Conditions Children with Medical Complexity Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambiguity

Behavioral

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.

Complexity

Behavioral

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 language

Behavioral

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.

Narrative

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Decisional Conflict Scale

    Time frame: Immediately after reviewing the intervention

    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.

  2. Decision Intent for Treatment

    Time frame: Immediately after reviewing the intervention

    Proportion of participants selecting surgery between the arms.

  3. Knowledge

    Time frame: Immediately after reviewing the intervention

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Children's Hospital Los Angeles

Registry information

Official study title

Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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