Hospitalism in Children, Post Traumatic Stress Disorder
Conditions
Brief summary
Development and pilot testing of a clinician coaching communication intervention to improve communication between medical teams and caregivers (parents, family members) of children in the hospital. Our team is specifically focused on improving partnership, respect, and collaboration with Black and Latinx caregivers of children in the hospital by incorporating elements from trauma-informed care and racial equity into a communication intervention. The investigators will explore the impact of this intervention on communication quality, caregiver trust, caregiver satisfaction, and hospital readmissions.
Detailed description
When admitted to the hospital, Black and Latino(a/x) children are at greater risk of medical errors, surgical complications, longer, more-costly hospital stays, and mortality compared to White children. Although many factors play a role, poor clinician communication likely contributes to these disparities in health outcomes. Across settings, including our preliminary work in the inpatient pediatric environment, Black and Latino(a/x) patients have been shown to experience worse communication quality as evidenced by less patient and family-centered, empathic, and respectful communication as compared to White patients. Poor communication can make the hospital stay more stressful for caregivers, with implications for caregiver and child health and recovery from illness. While prior experiences of discrimination and trauma can negatively affect clinician-caregiver communication, current best practices in clinician communication fail to incorporate equity and trauma-informed principles. In this study the investigators will test the feasibility, acceptability, and preliminary efficacy of a pilot randomized waitlist control trial of an equity focused and trauma-informed clinician coaching communication intervention that aims to teach clinicians skills to improve communication in areas where inequities are known to exist (i.e. respect, partnership) and incorporate principles of equity (i.e affirmation) and trauma-informed care. To do this, first the investigators will co-develop and refine a clinician coaching communication intervention with iterative feedback from Black and Latino(a/x) caregivers as well as clinicians of children in the hospital. Second, the investigators will examine the feasibility, acceptability and preliminary efficacy of the intervention. The investigators will randomize 10 clinicians to an intervention or waitlist group; clinicians in the intervention group will receive the intervention immediately, while clinicians in the waitlist group will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The investigators will assess the feasibility of recruiting and collecting data as well as acceptability of the intervention by clinicians. The investigators will explore preliminary efficacy for the effect of the intervention on communication, caregiver satisfaction, caregiver trust, and hospital readmissions.
Interventions
BEHAVIORALEquity Focused and Trauma-Informed Communication Intervention
Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.
Sponsors
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and their caregivers will not know whether their clinical team has received or not yet received the communication intervention. Additionally, team members who assess outcomes (coding of audio-recorded transcripts) will be blinded to the clinical team intervention status.
Intervention model description
The investigators will test the intervention in a randomized pilot with intervention and waitlist control arms. Half the clinical teams will receive the clinician communication intervention immediately upon enrollment and half will receive the intervention after 6 months. The investigators will assess recruitment, enrollment, and data collection feasibility as well as intervention fidelity to evaluate feasibility of implementation and skill uptake using audio-recordings of rounds. The investigators will develop a semi-structured interview and survey to assess acceptability as well as facilitators/barriers to implementation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility criteria for caregivers: * Adults (18 years of age or older) * Proficient in English or Spanish * Capable of providing informed consent * Identified as a primary caregiver (parent or guardian) of a hospitalized Black or Latino(a/x) child on the general pediatrics team. * We will exclude caregivers of children undergoing evaluation for child abuse/neglect or other cases in which the medical team believes family-centered rounds are not appropriate. Eligibility criteria for clinicians: * pediatric attending physicians who provide hospital care to children at Duke Children's Hospital. * Capable of providing informed consent * We will exclude clinicians who do not provide hospital care to children on the general pediatrics team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Measured by Enrollment Rate of Clinicians and Caregivers | Up to 12 months | — |
| Feasibility Measured by the Rate of Complete Data Collection by Caregivers | Up to 12 months | — |
| Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians | Up to 12 months | — |
| Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM) | Up to 12 months following the coaching intervention for each arm | The AIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree). The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great acceptability. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group). |
| Feasibility Measured by the Feasibility of Intervention Measure (FIM) | Up to 12 months following the coaching intervention for each arm | The FIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree). The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great feasibility. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group). |
| Number of Clinician Rapport-building Statements | Up to 12 months | Clinician communication behaviors measured via audio-recorded hospital encounters. |
| Number of Clinician Partnership-building Statements | Up to 12 months | Clinician communication behaviors measured via audio-recorded hospital encounters. |
| Number of Times Team Interrupted the Caregiver | Up to 12 months | Clinician communication behaviors measured via audio-recorded hospital encounters. |
| Number of Times the Team Praised the Caregiver | Up to 12 months | Clinician communication behaviors measured via audio-recorded hospital encounters. |
| Number of Times the Team Asked Permission | Up to 12 months | Clinician communication behaviors measured via audio-recorded hospital encounters. |
| Caregiver Satisfaction Measured by Survey | Up to 12 months | Satisfaction was measured with a single item. Response options: 1=Not at all satisfied, 2= A little satisfied, 3= Satisfied, 4=Extremely Satisfied. |
| Caregiver Trust in Their Childs Doctors Measured by the Wake Forest Physician Trust Scale | Up to 12 months | Trust was measured using a validated 5-item measure, the Wake Forest Physician Trust Scale. Responses to each item were a 5-point Likert scale, which was averaged together for these analyses for a total score range of 1 to 5, where a higher score indicates greater trust. |
| Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18) | Up to 12 months | All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged, not summed). Domains of hurried and discrimination were reverse coded so that higher scores represented better communication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Salivary Cortisol | 30-60 minutes before and 20-30 minutes after FCR | The investigators will assess for reductions in caregiver salivary cortisol following interactions with clinical teams. The investigators will collect saliva samples from caregivers at two time points: 30-60 minutes before and 20-30 minutes after family-centered rounds (FCR). The investigators anticipate lower salivary cortisol levels in the intervention compared to control arm at 20-30 minutes following FCR. The investigators will also compare differences in the change in cortisol from before and after FCR for each caregiver; the investigators hypothesize caregivers in the intervention arm will have a smaller change from baseline following FCR. |
| Number of Caregiver Participatory Behaviors | Up to 12 months | The investigators will measure caregiver participation during clinical encounters by counting the number of times caregivers (1) ask a question, (2) state a preference and (3) express an emotion per clinician encounter. These three behaviors will be summed together and analyzed in aggregate as a count of caregiver participatory behaviors. |
| Percentage of Caregivers Who Correctly Identify Child's Diagnosis | Up to 12 months | Using validated approach described by Lion et al. the caregiver description of "the main condition child was admitted for" will be compared to the diagnoses listed by the child's doctors in the electronic health record. |
| Percentage of Participants With Hospital Readmission at 30 Days | Up to 30 days after discharge | Child unplanned hospital readmission |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria M. Parente, MD
Duke University
Participant flow
Pre-assignment details
Aim 1 participants were not considered enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized ≤ 24 years | 9 Participants |
| Age, Customized 25-44 years | 28 Participants |
| Age, Customized ≥ 45 years | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino(a/e) | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black or African-American | 26 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 0 Participants |
| Region of Enrollment United States | 51 Participants |
| Sex/Gender, Customized Gender Female | 17 Participants |
| Sex/Gender, Customized Gender Male | 6 Participants |
| Sex/Gender, Customized Gender Prefer not to answer | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 20 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 23 | 0 / 20 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 | 0 / 4 | 0 / 4 |
Outcome results
None listed