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Understanding Factors in Decision Making for Children With Medical Complexity

Primary Purpose

Multiple Chronic Conditions, Children With Medical Complexity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambiguity
Complexity
Normalizing language
Narrative
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Chronic Conditions focused on measuring Shared decision making, Health communication, Patient- and Family-Centered Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Ambiguity only

Ambiguity and complexity only

Ambiguity and normalizing only

Ambiguity, complexity, and normalizing only

Complexity only

Complexity and normalizing only

Normalizing only

Narratives only

Ambiguity and narratives only

Ambiguity, complexity, and narratives only

Ambiguity, normalizing, and narratives only

All

Complexity and narratives only

Complexity, normalizing, and narratives only

Normalizing and narratives only

Arm Description

No new communication approaches received.

Receive information about ambiguity related to the clinical decision.

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

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

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

Receive information about complexity related to the clinical decision.

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

Receive information about normalizing language related to the clinical decision.

Receive narratives in addition to the control condition.

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

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

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

Receive all new communication approaches

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Decision intent for treatment
Proportion of participants selecting surgery between the arms.
Knowledge
Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions.

Full Information

First Posted
June 12, 2023
Last Updated
October 6, 2023
Sponsor
University of Utah
Collaborators
Children's Hospital Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05913206
Brief Title
Understanding Factors in Decision Making for Children With Medical Complexity
Official Title
Developing an Innovative Decision Support Tool for Pediatric Neuromuscular Scoliosis- Aim 1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
Children's Hospital Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions, Children With Medical Complexity
Keywords
Shared decision making, Health communication, Patient- and Family-Centered Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
Participants and the investigator team will be blinded to which condition the participant is randomized.
Allocation
Randomized
Enrollment
736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No new communication approaches received.
Arm Title
Ambiguity only
Arm Type
Experimental
Arm Description
Receive information about ambiguity related to the clinical decision.
Arm Title
Ambiguity and complexity only
Arm Type
Experimental
Arm Description
Receive information about ambiguity and complexity related to the clinical decision.
Arm Title
Ambiguity and normalizing only
Arm Type
Experimental
Arm Description
Receive information about ambiguity and normalizing language related to the clinical decision.
Arm Title
Ambiguity, complexity, and normalizing only
Arm Type
Experimental
Arm Description
Receive information about ambiguity, complexity, and normalizing language related to the clinical decision.
Arm Title
Complexity only
Arm Type
Experimental
Arm Description
Receive information about complexity related to the clinical decision.
Arm Title
Complexity and normalizing only
Arm Type
Experimental
Arm Description
Receive information about complexity and normalizing language related to the clinical decision.
Arm Title
Normalizing only
Arm Type
Experimental
Arm Description
Receive information about normalizing language related to the clinical decision.
Arm Title
Narratives only
Arm Type
Experimental
Arm Description
Receive narratives in addition to the control condition.
Arm Title
Ambiguity and narratives only
Arm Type
Experimental
Arm Description
Receive information about ambiguity and narratives related to the clinical decision.
Arm Title
Ambiguity, complexity, and narratives only
Arm Type
Experimental
Arm Description
Receive information about ambiguity, complexity, and narratives related to the clinical decision.
Arm Title
Ambiguity, normalizing, and narratives only
Arm Type
Experimental
Arm Description
Receive information about ambiguity, normalizing language, and narratives related to the clinical decision.
Arm Title
All
Arm Type
Experimental
Arm Description
Receive all new communication approaches
Arm Title
Complexity and narratives only
Arm Type
Experimental
Arm Description
Receive information about complexity and narratives related to the clinical decision.
Arm Title
Complexity, normalizing, and narratives only
Arm Type
Experimental
Arm Description
Receive information about complexity, normalizing language, and narratives related to the clinical decision.
Arm Title
Normalizing and narratives only
Arm Type
Experimental
Arm Description
Receive information about normalizing language and narratives related to the clinical decision.
Intervention Type
Behavioral
Intervention Name(s)
Ambiguity
Intervention Description
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
Intervention Name(s)
Complexity
Intervention Description
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
Intervention Name(s)
Normalizing language
Intervention Description
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
Intervention Name(s)
Narrative
Intervention Description
Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Primary Outcome Measure Information:
Title
Decision readiness
Description
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.
Time Frame
Immediately after reviewing the intervention
Secondary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
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.
Time Frame
Immediately after reviewing the intervention
Title
Decision intent for treatment
Description
Proportion of participants selecting surgery between the arms.
Time Frame
Immediately after reviewing the intervention
Title
Knowledge
Description
Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions.
Time Frame
Immediately after reviewing the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Zhu
Phone
8016623675
Email
angela.zhu@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Wilcox
Phone
8015816410
Email
michelle.o.wilcox@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jody L Lin, MD, MS
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Vega
Phone
323-229-7434
Email
jovega@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Amberly Thai
Phone
323-327-3501
Email
amthai@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Tamara Simon
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Zhu
Phone
801-662-3675
Email
angela.zhu@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jody L Lin, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Understanding Factors in Decision Making for Children With Medical Complexity

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