Trial Outcomes & Findings for Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds (NCT NCT05618652)
NCT ID: NCT05618652
Last Updated: 2026-06-05
Results Overview
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).
COMPLETED
NA
51 participants
Up to 12 months following the coaching intervention for each arm
2026-06-05
Participant Flow
Aim 1 participants were not considered enrolled.
Participant milestones
| Measure |
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.
|
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.
|
Immediate Intervention Hospitalists
Hospital clinicians who received the intervention immediately.
|
Waitlist Control Hospitalists
Hospital clinicians who received the intervention later.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
4
|
4
|
|
Overall Study
COMPLETED
|
20
|
23
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not collected on Hospitalists.
Baseline characteristics by cohort
| Measure |
Clinician Coaching Control Arm-- Caregivers
n=23 Participants
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.
|
Clinician Coaching Intervention Arm-- Caregivers
n=20 Participants
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.
|
Immediate Intervention Hospitalists
n=4 Participants
Hospital clinicians who received the intervention immediately.
|
Waitlist Control Hospitalists
n=4 Participants
Hospital clinicians who received the intervention later.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤ 24 years
|
3 Participants
n=23 Participants • Data not collected on Hospitalists.
|
6 Participants
n=20 Participants • Data not collected on Hospitalists.
|
—
|
—
|
9 Participants
n=43 Participants • Data not collected on Hospitalists.
|
|
Age, Customized
25-44 years
|
15 Participants
n=23 Participants • Data not collected on Hospitalists.
|
13 Participants
n=20 Participants • Data not collected on Hospitalists.
|
—
|
—
|
28 Participants
n=43 Participants • Data not collected on Hospitalists.
|
|
Age, Customized
≥ 45 years
|
5 Participants
n=23 Participants • Data not collected on Hospitalists.
|
1 Participants
n=20 Participants • Data not collected on Hospitalists.
|
—
|
—
|
6 Participants
n=43 Participants • Data not collected on Hospitalists.
|
|
Sex/Gender, Customized
Gender · Female
|
17 Participants
n=23 Participants
|
19 Participants
n=20 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
43 Participants
n=51 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
4 Participants
n=23 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=51 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to answer
|
2 Participants
n=23 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black or African-American
|
12 Participants
n=23 Participants
|
12 Participants
n=20 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
26 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino(a/e)
|
11 Participants
n=23 Participants
|
8 Participants
n=20 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
0 Participants
n=23 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
20 Participants
n=20 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
51 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Potential participants who were approached for the study.
Outcome measures
| Measure |
All Caregivers
n=64 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=11 Participants
Hospital clinicians
|
|---|---|---|
|
Feasibility Measured by Enrollment Rate of Clinicians and Caregivers
|
43 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsOutcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Feasibility Measured by the Rate of Complete Data Collection by Caregivers
|
22 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsOutcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians
|
4.6 Intervention Elements Per Encounter
Standard Deviation 2.6
|
9.2 Intervention Elements Per Encounter
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Up to 12 months following the coaching intervention for each armThe 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).
Outcome measures
| Measure |
All Caregivers
n=8 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
Hospital clinicians
|
|---|---|---|
|
Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM)
|
4.6 score on a scale
Standard Deviation 0.35
|
—
|
PRIMARY outcome
Timeframe: Up to 12 months following the coaching intervention for each armThe 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).
Outcome measures
| Measure |
All Caregivers
n=8 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
Hospital clinicians
|
|---|---|---|
|
Feasibility Measured by the Feasibility of Intervention Measure (FIM)
|
4.9 score on a scale
Standard Deviation 0.38
|
—
|
PRIMARY outcome
Timeframe: Up to 12 monthsClinician communication behaviors measured via audio-recorded hospital encounters.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Clinician Rapport-building Statements
|
0.0 statements
Interval 0.0 to 1.0
|
1.0 statements
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsClinician communication behaviors measured via audio-recorded hospital encounters.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Clinician Partnership-building Statements
|
2.0 statements
Interval 1.0 to 3.0
|
4.0 statements
Interval 2.5 to 5.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsClinician communication behaviors measured via audio-recorded hospital encounters.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Times Team Interrupted the Caregiver
|
2.0 times
Interval 1.0 to 3.0
|
0.5 times
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsClinician communication behaviors measured via audio-recorded hospital encounters.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Times the Team Praised the Caregiver
|
0.5 times
Interval 0.0 to 1.0
|
2.0 times
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsClinician communication behaviors measured via audio-recorded hospital encounters.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Times the Team Asked Permission
|
1.0 times
Interval 0.0 to 1.0
|
1.0 times
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsSatisfaction was measured with a single item. Response options: 1=Not at all satisfied, 2= A little satisfied, 3= Satisfied, 4=Extremely Satisfied.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Caregiver Satisfaction Measured by Survey
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsTrust 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.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Caregiver Trust in Their Childs Doctors Measured by the Wake Forest Physician Trust Scale
|
4.4 score on a scale
Interval 4.0 to 5.0
|
4.8 score on a scale
Interval 4.8 to 5.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsAll 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.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Hurried
|
4.6 score on a scale
Interval 3.8 to 5.0
|
4.9 score on a scale
Interval 4.3 to 5.0
|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Discrimination
|
5.0 score on a scale
Interval 5.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 5.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsAll 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.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Elicit concern
|
5.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 4.8 to 5.0
|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Results
|
5.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 4.5 to 5.0
|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Shared decision-making
|
4.3 score on a scale
Interval 3.3 to 5.0
|
4.9 score on a scale
Interval 4.3 to 5.0
|
|
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Respect
|
5.0 score on a scale
Interval 4.7 to 5.0
|
5.0 score on a scale
Interval 4.8 to 5.0
|
SECONDARY outcome
Timeframe: 30-60 minutes before and 20-30 minutes after FCRPopulation: Participants with salivary cortisol data collected.
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.
Outcome measures
| Measure |
All Caregivers
n=5 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=7 Participants
Hospital clinicians
|
|---|---|---|
|
Change in Caregiver Salivary Cortisol
|
-18 ng/dL
Interval -41.0 to -11.0
|
-16 ng/dL
Interval -75.0 to 69.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsThe 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.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Number of Caregiver Participatory Behaviors
|
4.5 participatory behaviors
Interval 1.5 to 9.0
|
5.0 participatory behaviors
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsUsing 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.
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Percentage of Caregivers Who Correctly Identify Child's Diagnosis
|
60.9 percentage of caregivers
|
70.0 percentage of caregivers
|
SECONDARY outcome
Timeframe: Up to 30 days after dischargeChild unplanned hospital readmission
Outcome measures
| Measure |
All Caregivers
n=23 Participants
Caregivers of hospitalized children approached for the study
|
Hospitalists
n=20 Participants
Hospital clinicians
|
|---|---|---|
|
Percentage of Participants With Hospital Readmission at 30 Days
|
8.7 percentage of participants
|
10.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 days after dischargeChild unplanned hospital readmission
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 months following the coaching intervention for each armThe 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).
Outcome measures
Outcome data not reported
Adverse Events
Clinician Coaching Control Arm-- Caregivers
Clinician Coaching Intervention Arm-- Caregivers
Immediate Intervention Hospitalists
Waitlist Control Hospitalists
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place