Understanding Factors in Decision Making for Children with Medical Complexity

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Multiple Chronic Conditions; Children with Medical Complexity

Treatments: Behavioral: Ambiguity; Behavioral: Normalizing language; Behavioral: Narrative; Behavioral: Complexity

Study type: Interventional

Funder types: Other

Identifiers

NCT05913206

00154724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 826 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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826 participants in 16 patient groups

Control

No Intervention group

Description:

No new communication approaches received.

Ambiguity only

Experimental group

Description:

Receive information about ambiguity related to the clinical decision.

Treatment:

Behavioral: Ambiguity

Ambiguity and complexity only

Experimental group

Description:

Receive information about ambiguity and complexity related to the clinical decision.

Treatment:

Behavioral: Complexity

Behavioral: Ambiguity

Ambiguity and normalizing only

Experimental group

Description:

Receive information about ambiguity and normalizing language related to the clinical decision.

Treatment:

Behavioral: Normalizing language

Behavioral: Ambiguity

Ambiguity, complexity, and normalizing only

Experimental group

Description:

Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.

Treatment:

Behavioral: Complexity

Behavioral: Normalizing language

Behavioral: Ambiguity

Complexity only

Experimental group

Description:

Receive information about complexity related to the clinical decision.

Treatment:

Behavioral: Complexity

Complexity and normalizing only

Experimental group

Description:

Receive information about complexity and normalizing language related to the clinical decision.

Treatment:

Behavioral: Complexity

Behavioral: Normalizing language

Normalizing only

Experimental group

Description:

Receive information about normalizing language related to the clinical decision.

Treatment:

Behavioral: Normalizing language

Narratives only

Experimental group

Description:

Receive narratives in addition to the control condition.

Treatment:

Behavioral: Narrative

Ambiguity and narratives only

Experimental group

Description:

Receive information about ambiguity and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Ambiguity

Ambiguity, complexity, and narratives only

Experimental group

Description:

Receive information about ambiguity, complexity, and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Complexity

Behavioral: Ambiguity

Ambiguity, normalizing, and narratives only

Experimental group

Description:

Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Normalizing language

Behavioral: Ambiguity

All

Experimental group

Description:

Receive all new communication approaches

Treatment:

Behavioral: Narrative

Behavioral: Complexity

Behavioral: Normalizing language

Behavioral: Ambiguity

Complexity and narratives only

Experimental group

Description:

Receive information about complexity and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Complexity

Complexity, normalizing, and narratives only

Experimental group

Description:

Receive information about complexity, normalizing language, and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Complexity

Behavioral: Normalizing language

Normalizing and narratives only

Experimental group

Description:

Receive information about normalizing language and narratives related to the clinical decision.

Treatment:

Behavioral: Narrative

Behavioral: Normalizing language