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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No new communication approaches received. | |
| Ambiguity only | Experimental | Receive information about ambiguity related to the clinical decision. |
|
| Ambiguity and complexity only | Experimental | Receive information about ambiguity and complexity related to the clinical decision. |
|
| Ambiguity and normalizing only | Experimental | Receive information about ambiguity and normalizing language related to the clinical decision. |
|
| Ambiguity, complexity, and normalizing only | Experimental | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. |
|
| Complexity only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambiguity | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jody L Lin, MD, MS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Utah |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No new communication approaches received. |
| FG001 | Narratives Only | Receive narratives in addition to the control condition. |
| FG002 | Normalizing Only | Receive information about normalizing language related to the clinical decision. |
| FG003 | Normalizing and Narratives Only | Receive information about normalizing language and narratives related to the clinical decision. |
| FG004 | Complexity Only | Receive information about complexity related to the clinical decision. |
| FG005 | Complexity and Narratives Only | Receive information about complexity and narratives related to the clinical decision. |
| FG006 | Complexity and Normalizing Only | Receive information about complexity and normalizing language related to the clinical decision. |
| FG007 | Complexity, Normalizing, and Narratives Only | Receive information about complexity, normalizing language, and narratives related to the clinical decision. |
| FG008 | Ambiguity Only | Receive information about ambiguity related to the clinical decision. |
| FG009 | Ambiguity and Narratives Only | Receive information about ambiguity and narratives related to the clinical decision. |
| FG010 | Ambiguity and Normalizing Only | Receive information about ambiguity and normalizing language related to the clinical decision. |
| FG011 | Ambiguity, Normalizing, and Narratives Only | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. |
| FG012 | Ambiguity and Complexity Only | Receive information about ambiguity and complexity related to the clinical decision. |
| FG013 | Ambiguity, Complexity, and Narratives Only | Receive information about ambiguity, complexity, and narratives related to the clinical decision. |
| FG014 | Ambiguity, Complexity, and Normalizing Only | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. |
| FG015 | All Communication Approaches | Receive all new communication approaches |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No new communication approaches received. |
| BG001 | Ambiguity Only | Receive information about ambiguity related to the clinical decision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately after reviewing the intervention |
|
Throughout the duration of recruitment and data collection, approximately 1 day.
This study was an online factorial experiment of a simulated patient encounter. Thus, participants were not at risk for any health outcomes for their own care or the care of their child.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No new communication approaches received. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Lin | University of Utah | 801-662-3645 | jody.lin@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2025 | Sep 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2025 | Sep 26, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2025 | Sep 26, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062525 | Narrative Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants and the investigator team will be blinded to which condition the participant is randomized.
| Experimental |
Receive information about complexity related to the clinical decision. |
|
| Complexity and normalizing only | Experimental | Receive information about complexity and normalizing language related to the clinical decision. |
|
| Normalizing only | Experimental | Receive information about normalizing language related to the clinical decision. |
|
| Narratives only | Experimental | Receive narratives in addition to the control condition. |
|
| Ambiguity and narratives only | Experimental | Receive information about ambiguity and narratives related to the clinical decision. |
|
| Ambiguity, complexity, and narratives only | Experimental | Receive information about ambiguity, complexity, and narratives related to the clinical decision. |
|
| Ambiguity, normalizing, and narratives only | Experimental | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. |
|
| All | Experimental | Receive all new communication approaches |
|
| Complexity and narratives only | Experimental | Receive information about complexity and narratives related to the clinical decision. |
|
| Complexity, normalizing, and narratives only | Experimental | Receive information about complexity, normalizing language, and narratives related to the clinical decision. |
|
| Normalizing and narratives only | Experimental | Receive information about normalizing language and narratives related to the clinical decision. |
|
| Complexity | 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 | 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 | Behavioral | Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity. |
|
| Immediately after reviewing the intervention |
| Decision Intent for Treatment | Proportion of participants selecting surgery between the arms. | Immediately after reviewing the intervention |
| 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 |
| Salt Lake City |
| Utah |
| 84114 |
| United States |
| BG002 | Complexity Only | Receive information about complexity related to the clinical decision. |
| BG003 | Ambiguity and Complexity Only | Receive information about ambiguity and complexity related to the clinical decision. |
| BG004 | Normalizing Only | Receive information about normalizing language related to the clinical decision. |
| BG005 | Ambiguity and Normalizing Only | Receive information about ambiguity and normalizing language related to the clinical decision. |
| BG006 | Complexity and Normalizing Only | Receive information about complexity and normalizing language related to the clinical decision. |
| BG007 | Ambiguity, Complexity, and Normalizing Only | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. |
| BG008 | Narratives Only | Receive narratives in addition to the control condition. |
| BG009 | Ambiguity and Narratives Only | Receive information about ambiguity and narratives related to the clinical decision. |
| BG010 | Complexity and Narratives Only | Receive information about complexity and narratives related to the clinical decision. |
| BG011 | Ambiguity, Complexity, and Narratives Only | Receive information about ambiguity, complexity, and narratives related to the clinical decision. |
| BG012 | Normalizing and Narratives Only | Receive information about normalizing language and narratives related to the clinical decision. |
| BG013 | Ambiguity, Normalizing, and Narratives Only | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. |
| BG014 | Complexity, Normalizing, and Narratives Only | Receive information about complexity, normalizing language, and narratives related to the clinical decision. |
| BG015 | All Communciation Approaches | Receive all new communication approaches |
| BG016 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Child age | age of child with medical complexity | Mean | Standard Deviation | years |
|
| Language preference | Preference for English or Spanish language | Count of Participants | Participants | No |
|
| type of insurance coverage | Count of Participants | Participants | No |
|
| technology dependene | if a child had technology dependence | Count of Participants | Participants | No |
|
| neurodevelopmental impairment | whether a child had neurodevelopmental impairment | Count of Participants | Participants | No |
|
| neuromuscular scoliosis | presence of neuromuscular scoliosis | Count of Participants | Participants | No |
|
| readability assessment of video | 3 Likert-scale items assessing readability of the video on a 10-point scale of 1=not at all to 10=completely | Mean | Standard Deviation | units on a scale |
|
| Intolerance of uncertainty | The IUS-12 is a validated 12-item survey measure that evaluates the participant's intolerance of uncertainty. The scale is split into two subdomains: prospective anxiety and inhibitory anxiety. Each item is rated on a 5-point Likert scale and a composite score is calculated by summing all item responses for a composite score on a scale of 12-60 with higher scores reflecting greater difficulty coping with uncertain situations. | Mean | Standard Deviation | units on a scale |
|
| tolerance of uncertainty | two unique items on tolerance of uncertainty, each scored individually: Item 1: In general, I want to know all the information even if it's scary. (range: 1- strongly agree to 4- strongly disagree) Item 2: In general, are you a person who wants to wait or do everything? (range: 1-wait to 5-do everything) | Mean | Standard Deviation | units on a scale |
|
| trust in information | 5 items, each scored individually on a range of 1-not at all to 4- a lot. Preamble: In general, how much would you trust information about health or medical topics from each of the following?
| Mean | Standard Deviation | units on a scale |
|
| Health literacy | Chew health literacy scale; 3-item measure on a Likert scale (0-never to 4-always) with summary composite outcome score ranging 0-12. Higher score indicates higher health literacy. | Mean | Standard Deviation | units on a scale |
|
| Numeracy | subjective numeracy scale: 8-item measure on a Likert-based scale (1-6) with a mean composite outcome score ranging from 1-6, with higher scores indicating higher numeracy. Q7 is reverse-coded (6-1). | Mean | Standard Deviation | units on a scale |
|
| Risk taking behavior | DOSPERT: 8-item Likert-based scale measuring likelihood to engage in risk taking behavior ranging from 1-very unlikely to 5-very likely. Mean composite outcome with higher scores indicating higher risk taking behavior. | Mean | Standard Deviation | units on a scale |
|
| Hope | Herth Hope Index: 12-items on a Likert scale (1-strongly disagree to 4-strongly agree). Summary composite outcome with reverse scaling for items hhi3, hhi6 with a range of 12-48. Higher scores indicate higher hope. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Complexity Only | Receive information about complexity related to the clinical decision. |
| OG003 | Ambiguity and Complexity Only | Receive information about ambiguity and complexity related to the clinical decision. |
| OG004 | Normalizing Only | Receive information about normalizing language related to the clinical decision. |
| OG005 | Ambiguity and Normalizing Only | Receive information about ambiguity and normalizing language related to the clinical decision. |
| OG006 | Complexity and Normalizing Only | Receive information about complexity and normalizing language related to the clinical decision. |
| OG007 | Ambiguity, Complexity, and Normalizing Only | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. |
| OG008 | Narratives Only | Receive narratives in addition to the control condition. |
| OG009 | Ambiguity and Narratives Only | Receive information about ambiguity and narratives related to the clinical decision. |
| OG010 | Complexity and Narratives Only | Receive information about complexity and narratives related to the clinical decision. |
| OG011 | Ambiguity, Complexity, and Narratives Only | Receive information about ambiguity, complexity, and narratives related to the clinical decision. |
| OG012 | Normalizing and Narratives Only | Receive information about normalizing language and narratives related to the clinical decision. |
| OG013 | Ambiguity, Normalizing, and Narratives Only | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. |
| OG014 | Complexity, Normalizing, and Narratives Only | Receive information about complexity, normalizing language, and narratives related to the clinical decision. |
| OG015 | All Communication Approaches | Receive all new communication approaches |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately after reviewing the intervention |
|
|
|
| Secondary | Decision Intent for Treatment | Proportion of participants selecting surgery between the arms. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | proportion of correct answers | Immediately after reviewing the intervention |
|
|
|
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Narratives Only | Receive narratives in addition to the control condition. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG002 | Normalizing Only | Receive information about normalizing language related to the clinical decision. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG003 | Normalizing and Narratives Only | Receive information about normalizing language and narratives related to the clinical decision. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG004 | Complexity Only | Receive information about complexity related to the clinical decision. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG005 | Complexity and Narratives Only | Receive information about complexity and narratives related to the clinical decision. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG006 | Complexity and Normalizing Only | Receive information about complexity and normalizing language related to the clinical decision. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG007 | Complexity, Normalizing, and Narratives Only | Receive information about complexity, normalizing language, and narratives related to the clinical decision. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG008 | Ambiguity Only | Receive information about ambiguity related to the clinical decision. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG009 | Ambiguity and Narratives Only | Receive information about ambiguity and narratives related to the clinical decision. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG010 | Ambiguity and Normalizing Only | Receive information about ambiguity and normalizing language related to the clinical decision. | 0 | 48 | 0 | 48 | 0 | 48 |
| EG011 | Ambiguity, Normalizing, and Narratives Only | Receive information about ambiguity, normalizing language, and narratives related to the clinical decision. | 0 | 56 | 0 | 56 | 0 | 56 |
| EG012 | Ambiguity and Complexity Only | Receive information about ambiguity and complexity related to the clinical decision. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG013 | Ambiguity, Complexity, and Narratives Only | Receive information about ambiguity, complexity, and narratives related to the clinical decision. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG014 | Ambiguity, Complexity, and Normalizing Only | Receive information about ambiguity, complexity, and normalizing language related to the clinical decision. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG015 | All Communication Approaches | Receive all new communication approaches | 0 | 52 | 0 | 52 | 0 | 52 |
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| Surgery |
|
| Missing |
|