Understanding Factors in Decision Making for Children With Medical Complexity

Multiple Chronic Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913206
• Other study ID #: 00154724
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: June 2028

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: Angela Zhu
• Phone: 8016623675
• Email: angela.zhu[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 736
• Est. completion date: June 2028
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Children With Medical Complexity
• Chronic Disease
• Multiple Chronic Conditions

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Decision intent for treatment	Proportion of participants selecting surgery between the arms.	Immediately after reviewing the intervention
Secondary	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