Understanding Factors in Decision Making for Children With Medical Complexity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Chronic Conditions, Children With Medical Complexity

Intervention / Treatment
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* Behavioral: Ambiguity
* Behavioral: Complexity
* Behavioral: Normalizing language
* Behavioral: Narrative


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 
| Decision intent for treatment | Proportion of participants selecting surgery between the arms. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient- and Family-Centered Care, Shared decision making, Health communication