Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
Overview
- Phase
- Not Applicable
- Intervention
- Ambiguity
- Conditions
- Multiple Chronic Conditions
- Sponsor
- University of Utah
- Enrollment
- 831
- Locations
- 2
- Primary Endpoint
- Decision Readiness
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Ambiguity only
Receive information about ambiguity related to the clinical decision.
Intervention: Ambiguity
Ambiguity and complexity only
Receive information about ambiguity and complexity related to the clinical decision.
Intervention: Ambiguity
Normalizing and narratives only
Receive information about normalizing language and narratives related to the clinical decision.
Intervention: Narrative
Control
No new communication approaches received.
Ambiguity and complexity only
Receive information about ambiguity and complexity related to the clinical decision.
Intervention: Complexity
Ambiguity and normalizing only
Receive information about ambiguity and normalizing language related to the clinical decision.
Intervention: Ambiguity
Ambiguity and normalizing only
Receive information about ambiguity and normalizing language related to the clinical decision.
Intervention: Normalizing language
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
Intervention: Ambiguity
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
Intervention: Complexity
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
Intervention: Normalizing language
Complexity only
Receive information about complexity related to the clinical decision.
Intervention: Complexity
Complexity and normalizing only
Receive information about complexity and normalizing language related to the clinical decision.
Intervention: Complexity
Complexity and normalizing only
Receive information about complexity and normalizing language related to the clinical decision.
Intervention: Normalizing language
Normalizing only
Receive information about normalizing language related to the clinical decision.
Intervention: Normalizing language
Narratives only
Receive narratives in addition to the control condition.
Intervention: Narrative
Ambiguity and narratives only
Receive information about ambiguity and narratives related to the clinical decision.
Intervention: Ambiguity
Ambiguity and narratives only
Receive information about ambiguity and narratives related to the clinical decision.
Intervention: Narrative
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
Intervention: Ambiguity
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
Intervention: Complexity
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
Intervention: Narrative
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
Intervention: Ambiguity
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
Intervention: Normalizing language
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
Intervention: Narrative
All
Receive all new communication approaches
Intervention: Ambiguity
All
Receive all new communication approaches
Intervention: Complexity
All
Receive all new communication approaches
Intervention: Normalizing language
All
Receive all new communication approaches
Intervention: Narrative
Complexity and narratives only
Receive information about complexity and narratives related to the clinical decision.
Intervention: Complexity
Complexity and narratives only
Receive information about complexity and narratives related to the clinical decision.
Intervention: Narrative
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
Intervention: Complexity
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
Intervention: Normalizing language
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
Intervention: Narrative
Normalizing and narratives only
Receive information about normalizing language and narratives related to the clinical decision.
Intervention: Normalizing language
Outcomes
Primary Outcomes
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
- Knowledge(Immediately after reviewing the intervention)
- Decisional Conflict Scale(Immediately after reviewing the intervention)
- Decision Intent for Treatment(Immediately after reviewing the intervention)