Children With Medical Complexity, Multiple Chronic Conditions
Conditions
Keywords
Shared decision making, Health communication, Patient- and Family-Centered Care
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.
Interventions
BEHAVIORALAmbiguity
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.
BEHAVIORALComplexity
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.
BEHAVIORALNormalizing 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.
BEHAVIORALNarrative
Parent and caregiver narratives about their decision making experiences for the care of their child with medical complexity.
Sponsors
University of Utah
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and the investigator team will be blinded to which condition the participant is randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Readiness | Immediately after reviewing the intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Immediately after reviewing the intervention | 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 | Immediately after reviewing the intervention | Proportion of participants selecting surgery between the arms. |
| Knowledge | Immediately after reviewing the intervention | Difference in mean score of total knowledge questions answered correctly between arms. The score will be calculated from 5 knowledge questions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJody L Lin, MD, MS
University of Utah
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 10.3 |
| Child age | 9 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Health literacy | 10.1 units on a scale STANDARD_DEVIATION 1.6 |
| Hope | 39.6 units on a scale STANDARD_DEVIATION 5.7 |
| Intolerance of uncertainty | 29.4 units on a scale STANDARD_DEVIATION 7.5 |
| Language preference English | 42 Participants |
| Language preference Spanish | 6 Participants |
| neurodevelopmental impairment Absent | 24 Participants |
| neurodevelopmental impairment Decline to answer | 3 Participants |
| neurodevelopmental impairment Present | 16 Participants |
| neuromuscular scoliosis Absent | 40 Participants |
| neuromuscular scoliosis I don't know | 5 Participants |
| neuromuscular scoliosis Missing | 3 Participants |
| neuromuscular scoliosis Present | 4 Participants |
| Numeracy | 4.2 units on a scale STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 20 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race Other | 11 Participants |
| Race/Ethnicity, Customized Race Two or more races | 3 Participants |
| Race/Ethnicity, Customized Race White | 34 Participants |
| readability assessment of video How believable was the story? | 8.3 units on a scale STANDARD_DEVIATION 1.5 |
| readability assessment of video How clear was the story? | 8.6 units on a scale STANDARD_DEVIATION 1.7 |
| readability assessment of video How confusing did you find the story? | 3.3 units on a scale STANDARD_DEVIATION 2.3 |
| Risk taking behavior | 1.8 units on a scale STANDARD_DEVIATION 0.6 |
| Sex/Gender, Customized Female | 41 Participants |
| Sex/Gender, Customized Male | 101 Participants |
| Sex/Gender, Customized Missing | 2 Participants |
| Sex/Gender, Customized Other | 0 Participants |
| technology dependene Decline to answer | 56 Participants |
| technology dependene Not technology dependent | 275 Participants |
| technology dependene Technology dependent | 25 Participants |
| tolerance of uncertainty Item 1 | 1.1 units on a scale STANDARD_DEVIATION 0.5 |
| tolerance of uncertainty Item 2 | 3.8 units on a scale STANDARD_DEVIATION 1 |
| trust in information Item 1 | 3.7 units on a scale STANDARD_DEVIATION 0.4 |
| trust in information Item 2 | 2.6 units on a scale STANDARD_DEVIATION 0.7 |
| trust in information Item 3 | 2.6 units on a scale STANDARD_DEVIATION 0.8 |
| trust in information Item 4 | 2.5 units on a scale STANDARD_DEVIATION 0.8 |
| trust in information Item 5 | 2.3 units on a scale STANDARD_DEVIATION 1 |
| type of insurance coverage Don't know | 13 Participants |
| type of insurance coverage Medicaid | 386 Participants |
| type of insurance coverage Medicare | 91 Participants |
| type of insurance coverage Other | 4 Participants |
| type of insurance coverage Private | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 45 | 0 / 49 | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 49 | 0 / 47 | 0 / 50 | 0 / 45 | 0 / 48 | 0 / 56 | 0 / 47 | 0 / 51 | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 0 / 51 | 0 / 45 | 0 / 49 | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 49 | 0 / 47 | 0 / 50 | 0 / 45 | 0 / 48 | 0 / 56 | 0 / 47 | 0 / 51 | 0 / 50 | 0 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 45 | 0 / 49 | 0 / 47 | 0 / 48 | 0 / 48 | 0 / 49 | 0 / 47 | 0 / 50 | 0 / 45 | 0 / 48 | 0 / 56 | 0 / 47 | 0 / 51 | 0 / 50 | 0 / 52 |
Outcome results
None listed