Understanding Factors in Decision Making for Children with Medical Complexity

NCT ID: NCT05913206

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

826 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-29

Study Completion Date

2024-08-29

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.

Conditions

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Multiple Chronic Conditions Children with Medical Complexity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
Participants and the investigator team will be blinded to which condition the participant is randomized.

Study Groups

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Control

No new communication approaches received.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ambiguity only

Receive information about ambiguity related to the clinical decision.

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Ambiguity and complexity only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Complexity

Intervention Type BEHAVIORAL

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.

Ambiguity and normalizing only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Ambiguity, complexity, and normalizing only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Complexity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Complexity only

Receive information about complexity related to the clinical decision.

Group Type EXPERIMENTAL

Complexity

Intervention Type BEHAVIORAL

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.

Complexity and normalizing only

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

Group Type EXPERIMENTAL

Complexity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Normalizing only

Receive information about normalizing language related to the clinical decision.

Group Type EXPERIMENTAL

Normalizing language

Intervention Type BEHAVIORAL

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.

Narratives only

Receive narratives in addition to the control condition.

Group Type EXPERIMENTAL

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Ambiguity and narratives only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Ambiguity, complexity, and narratives only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Complexity

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Ambiguity, normalizing, and narratives only

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

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

All

Receive all new communication approaches

Group Type EXPERIMENTAL

Ambiguity

Intervention Type BEHAVIORAL

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.

Complexity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Complexity and narratives only

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

Group Type EXPERIMENTAL

Complexity

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Complexity, normalizing, and narratives only

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

Group Type EXPERIMENTAL

Complexity

Intervention Type BEHAVIORAL

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.

Normalizing language

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Normalizing and narratives only

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

Group Type EXPERIMENTAL

Normalizing language

Intervention Type BEHAVIORAL

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.

Narrative

Intervention Type BEHAVIORAL

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Interventions

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Ambiguity

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.

Intervention Type BEHAVIORAL

Complexity

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.

Intervention Type BEHAVIORAL

Normalizing language

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.

Intervention Type BEHAVIORAL

Narrative

Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jody L Lin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00154724

Identifier Type: -

Identifier Source: org_study_id

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