| Primary | Feasibility Measured by Enrollment Rate of Clinicians and Caregivers | | Potential participants who were approached for the study. | Posted | | Count of Participants | | Participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | All Caregivers | Caregivers of hospitalized children approached for the study | | OG001 | Hospitalists | |
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| Primary | Feasibility Measured by the Rate of Complete Data Collection by Caregivers | | | Posted | | Count of Participants | | Participants | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm - Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm - Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians | | | Posted | | Mean | Standard Deviation | Intervention Elements Per Encounter | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM) | 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). | | Posted | | Mean | Standard Deviation | score on a scale | | Up to 12 months following the coaching intervention for each arm | | | | ID | Title | Description |
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| OG000 | Hospitalists | |
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| Primary | Feasibility Measured by the Feasibility of Intervention Measure (FIM) | 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). | | Posted | | Mean | Standard Deviation | score on a scale | | Up to 12 months following the coaching intervention for each arm | | | | ID | Title | Description |
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| OG000 | Hospitalists | |
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| Primary | Number of Clinician Rapport-building Statements | Clinician communication behaviors measured via audio-recorded hospital encounters. | | Posted | | Median | Inter-Quartile Range | statements | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Number of Clinician Partnership-building Statements | Clinician communication behaviors measured via audio-recorded hospital encounters. | | Posted | | Median | Inter-Quartile Range | statements | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Number of Times Team Interrupted the Caregiver | Clinician communication behaviors measured via audio-recorded hospital encounters. | | Posted | | Median | Inter-Quartile Range | times | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Number of Times the Team Praised the Caregiver | Clinician communication behaviors measured via audio-recorded hospital encounters. | | Posted | | Median | Inter-Quartile Range | times | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Number of Times the Team Asked Permission | Clinician communication behaviors measured via audio-recorded hospital encounters. | | Posted | | Median | Inter-Quartile Range | times | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Caregiver Satisfaction Measured by Survey | Satisfaction was measured with a single item. Response options: 1=Not at all satisfied, 2= A little satisfied, 3= Satisfied, 4=Extremely Satisfied. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Caregiver Trust in Their Childs Doctors Measured by the Wake Forest Physician Trust Scale | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18) | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Primary | Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18) | 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). Lower scores represent better communication. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Secondary | Change in Caregiver Salivary Cortisol | 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. | Participants with salivary cortisol data collected. | Posted | | Median | Inter-Quartile Range | ng/dL | | 30-60 minutes before and 20-30 minutes after FCR | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Secondary | Number of Caregiver Participatory Behaviors | 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. | | Posted | | Median | Inter-Quartile Range | participatory behaviors | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Secondary | Percentage of Caregivers Who Correctly Identify Child's Diagnosis | 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. | | Posted | | Number | | percentage of caregivers | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Secondary | Percentage of Participants With Hospital Readmission at 30 Days | Child unplanned hospital readmission | | Posted | | Number | | percentage of participants | | Up to 30 days after discharge | | | | ID | Title | Description |
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| OG000 | Clinician Coaching Control Arm-- Caregivers | Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | | OG001 | Clinician Coaching Intervention Arm-- Caregivers | Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm. Equity Focused and Trauma-Informed Communication Intervention: Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. |
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| Other Pre-specified | Percentage of Participants With Hospital Readmission at 90 Days | Child unplanned hospital readmission | | Not Posted | | | | | | Up to 90 days after discharge | | Participants | | | | |
| Other Pre-specified | Appropriateness Measured by the Intervention Appropriateness Measure (IAM) | The IAM 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 appropriateness. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group). | | Not Posted | | | | | | Up to 12 months following the coaching intervention for each arm | | Participants | | | | |