Understanding Factors in Decision Making for Children with Medical Complexity
- Conditions
- Multiple Chronic ConditionsChildren with Medical Complexity
- Interventions
- Behavioral: AmbiguityBehavioral: NarrativeBehavioral: ComplexityBehavioral: Normalizing language
- Registration Number
- NCT05913206
- Lead Sponsor
- University of Utah
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 826
- Adult caregiver of a child with medical complexity
- English- or Spanish-speaking
- Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Ambiguity, complexity, and normalizing only Complexity Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. Ambiguity only Ambiguity Receive information about ambiguity related to the clinical decision. Ambiguity and complexity only Ambiguity Receive information about ambiguity and complexity related to the clinical decision. Ambiguity and normalizing only Normalizing language Receive information about ambiguity and normalizing language related to the clinical decision. Ambiguity, complexity, and normalizing only Ambiguity Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. Ambiguity, complexity, and normalizing only Normalizing language Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. Complexity only Complexity Receive information about complexity related to the clinical decision. Narratives only Narrative Receive narratives in addition to the control condition. Ambiguity and narratives only Ambiguity Receive information about ambiguity and narratives related to the clinical decision. Ambiguity and normalizing only Ambiguity Receive information about ambiguity and normalizing language related to the clinical decision. Complexity and normalizing only Normalizing language Receive information about complexity and normalizing language related to the clinical decision. Ambiguity, complexity, and narratives only Narrative Receive information about ambiguity, complexity, and narratives related to the clinical decision. All Complexity Receive all new communication approaches All Normalizing language Receive all new communication approaches Normalizing and narratives only Normalizing language Receive information about normalizing language and narratives related to the clinical decision. Ambiguity and complexity only Complexity Receive information about ambiguity and complexity related to the clinical decision. Complexity and normalizing only Complexity Receive information about complexity and normalizing language related to the clinical decision. Ambiguity, complexity, and narratives only Ambiguity Receive information about ambiguity, complexity, and narratives related to the clinical decision. Ambiguity, complexity, and narratives only Complexity Receive information about ambiguity, complexity, and narratives related to the clinical decision. Complexity, normalizing, and narratives only Complexity Receive information about complexity, normalizing language, and narratives related to the clinical decision. Normalizing only Normalizing language Receive information about normalizing language related to the clinical decision. Ambiguity, normalizing, and narratives only Narrative Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. Ambiguity and narratives only Narrative Receive information about ambiguity and narratives related to the clinical decision. Ambiguity, normalizing, and narratives only Normalizing language Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. Complexity and narratives only Narrative Receive information about complexity and narratives related to the clinical decision. Ambiguity, normalizing, and narratives only Ambiguity Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. All Ambiguity Receive all new communication approaches All Narrative Receive all new communication approaches Complexity and narratives only Complexity Receive information about complexity and narratives related to the clinical decision. Complexity, normalizing, and narratives only Normalizing language Receive information about complexity, normalizing language, and narratives related to the clinical decision. Complexity, normalizing, and narratives only Narrative Receive information about complexity, normalizing language, and narratives related to the clinical decision. Normalizing and narratives only Narrative Receive information about normalizing language and narratives related to the clinical decision.
- Primary Outcome Measures
Name Time Method Decision readiness 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 Outcome Measures
Name Time Method Decision intent for treatment Immediately after reviewing the intervention Proportion of participants selecting surgery between the arms.
Knowledge 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.
Decisional Conflict Scale 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.
Trial Locations
- Locations (2)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States