Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 831
- 试验地点
- 2
- 主要终点
- Decision Readiness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and the investigator team will be blinded to which condition the participant is randomized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult caregiver of a child with medical complexity
- •English- or Spanish-speaking
排除标准
- •Child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.
研究组 & 干预措施
Ambiguity only
Receive information about ambiguity related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity and complexity only
Receive information about ambiguity and complexity related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Normalizing and narratives only
Receive information about normalizing language and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
Control
No new communication approaches received.
Ambiguity and complexity only
Receive information about ambiguity and complexity related to the clinical decision.
干预措施: Complexity (Behavioral)
Ambiguity and normalizing only
Receive information about ambiguity and normalizing language related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity and normalizing only
Receive information about ambiguity and normalizing language related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
干预措施: Complexity (Behavioral)
Ambiguity, complexity, and normalizing only
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Complexity only
Receive information about complexity related to the clinical decision.
干预措施: Complexity (Behavioral)
Complexity and normalizing only
Receive information about complexity and normalizing language related to the clinical decision.
干预措施: Complexity (Behavioral)
Complexity and normalizing only
Receive information about complexity and normalizing language related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Normalizing only
Receive information about normalizing language related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Narratives only
Receive narratives in addition to the control condition.
干预措施: Narrative (Behavioral)
Ambiguity and narratives only
Receive information about ambiguity and narratives related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity and narratives only
Receive information about ambiguity and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
干预措施: Complexity (Behavioral)
Ambiguity, complexity, and narratives only
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
干预措施: Ambiguity (Behavioral)
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Ambiguity, normalizing, and narratives only
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
All
Receive all new communication approaches
干预措施: Ambiguity (Behavioral)
All
Receive all new communication approaches
干预措施: Complexity (Behavioral)
All
Receive all new communication approaches
干预措施: Normalizing language (Behavioral)
All
Receive all new communication approaches
干预措施: Narrative (Behavioral)
Complexity and narratives only
Receive information about complexity and narratives related to the clinical decision.
干预措施: Complexity (Behavioral)
Complexity and narratives only
Receive information about complexity and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
干预措施: Complexity (Behavioral)
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
干预措施: Normalizing language (Behavioral)
Complexity, normalizing, and narratives only
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
干预措施: Narrative (Behavioral)
Normalizing and narratives only
Receive information about normalizing language and narratives related to the clinical decision.
干预措施: Normalizing language (Behavioral)
结局指标
主要结局
Decision Readiness
时间窗: 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.
次要结局
- Knowledge(Immediately after reviewing the intervention)
- Decisional Conflict Scale(Immediately after reviewing the intervention)
- Decision Intent for Treatment(Immediately after reviewing the intervention)