Hospitalism in ChildrenEFTINCT05618652
Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds
A study testing Equity Focused and Trauma-Informed Communication Intervention in people with Hospitalism in Children and Post Traumatic Stress Disorder, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospitalism in Children, Post Traumatic Stress Disorder
- What is being tested?
- Equity Focused and Trauma-Informed Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 29 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Sustem
Durham, North Carolina, 27710
About this study
Official title: Development and Pilot Testing of an Equity-focused and Trauma-informed Communication Intervention During Family-centered Rounds
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.
Read the 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.
- Being tested
- Equity Focused and Trauma-Informed Communication Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equity Focused and Trauma-Informed Communication InterventionBehavioural
Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Coaching Immediate Intervention Arm-- Caregivers | Active comparator | 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. Receives: Behavioral: Equity Focused and Trauma-Informed Communication Intervention |
| Clinician Coaching Wait-List Control Arm-- Caregivers | Other | Clinicians in the wait-list control arm will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The clinicians randomized the control arm will undergo didactics and feedback once their pre-intervention audio-recordings are complete.
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. Receives: Behavioral: Equity Focused and Trauma-Informed Communication Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measured by Enrollment Rate of Clinicians and Caregivers
Measured: Up to 12 months
Feasibility Measured by the Rate of Complete Data Collection by Caregivers
Measured: Up to 12 months
Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians
Measured: Up to 12 months
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).
Measured: Up to 12 months following the coaching intervention for each arm
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).
Measured: Up to 12 months following the coaching intervention for each arm
Number of Clinician Rapport-building Statements
Clinician communication behaviors measured via audio-recorded hospital encounters.
Measured: Up to 12 months
Number of Clinician Partnership-building Statements
Clinician communication behaviors measured via audio-recorded hospital encounters.
Measured: Up to 12 months
Number of Times Team Interrupted the Caregiver
Clinician communication behaviors measured via audio-recorded hospital encounters.
Measured: Up to 12 months
Number of Times the Team Praised the Caregiver
Clinician communication behaviors measured via audio-recorded hospital encounters.
Measured: Up to 12 months
Number of Times the Team Asked Permission
Clinician communication behaviors measured via audio-recorded hospital encounters.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Secondary outcomes (4)
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.
Measured: 30-60 minutes before and 20-30 minutes after FCR
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Percentage of Participants With Hospital Readmission at 30 Days
Child unplanned hospital readmission
Measured: Up to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Feb 2024
- Primary completion29 Mar 2025
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hospitalism in ChildrenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Victoria M. Parente, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618652
- Sponsor's protocol ID
- Pro00111356
- Other IDs
- 1K23MD018433
- Acronym
- EFTI
- Status last verified
- May 2026
- First submitted
- 25 Oct 2022
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be available to individuals on the Institutional Review Board protocol. We will share study protocol documents including intervention didactic materials and outcome measure assessments.
Publications
Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available.
PubMed 35411380Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831.
PubMed 35696195Parente V, Stark A, Key-Solle M, Olsen M, Sanders LL, Bartlett KW, Pollak KI. Caregiver Inclusivity and Empowerment During Family-Centered Rounds. Hosp Pediatr. 2022 Feb 1;12(2):e72-e77. doi: 10.1542/hpeds.2021-006034.
PubMed 35079809
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of an Equity-focused and Trauma-informed Communication Intervention During Family-centered Rounds
- ClinicalTrials.gov ID
- NCT05618652
- Acronym / sponsor ID
- EFTI / Pro00111356
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinician Coaching Immediate Intervention Arm-- Caregivers | Active comparator | Behavioral: Equity Focused and Trauma-Informed Communication InterventionClinicians 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. |
| Clinician Coaching Wait-List Control Arm-- Caregivers | Other | Behavioral: Equity Focused and Trauma-Informed Communication InterventionClinicians in the wait-list control arm will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The clinicians randomized the control arm will undergo didactics and feedback once their pre-intervention audio-recordings are complete. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equity Focused and Trauma-Informed Communication InterventionClinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters. | Behavioural | Clinician Coaching Immediate Intervention Arm-- Caregivers, Clinician Coaching Wait-List Control Arm-- Caregivers |
Primary outcome
Feasibility Measured by Enrollment Rate of Clinicians and Caregivers
Time frame: Up to 12 months
Feasibility Measured by the Rate of Complete Data Collection by Caregivers
Time frame: Up to 12 months
Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians
Time frame: Up to 12 months
Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM)
Time frame: 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)
Time frame: 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
Time frame: Up to 12 months
Clinician communication behaviors measured via audio-recorded hospital encounters.
Number of Clinician Partnership-building Statements
Time frame: Up to 12 months
Clinician communication behaviors measured via audio-recorded hospital encounters.
Number of Times Team Interrupted the Caregiver
Time frame: Up to 12 months
Clinician communication behaviors measured via audio-recorded hospital encounters.
Number of Times the Team Praised the Caregiver
Time frame: Up to 12 months
Clinician communication behaviors measured via audio-recorded hospital encounters.
Number of Times the Team Asked Permission
Time frame: Up to 12 months
Clinician communication behaviors measured via audio-recorded hospital encounters.
Caregiver Satisfaction Measured by Survey
Time frame: 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
Time frame: 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)
Time frame: 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.
Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)
Time frame: 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). Lower scores represent better communication.
4 secondary outcomes
Change in Caregiver Salivary Cortisol
Time frame: 30-60 minutes before and 20-30 minutes after FCR
Number of Caregiver Participatory Behaviors
Time frame: Up to 12 months
Percentage of Caregivers Who Correctly Identify Child's Diagnosis
Time frame: Up to 12 months
Percentage of Participants With Hospital Readmission at 30 Days
Time frame: Up to 30 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35411380Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available.
- Results publication: PubMed 35696195Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831.
- Results publication: PubMed 35079809Parente V, Stark A, Key-Solle M, Olsen M, Sanders LL, Bartlett KW, Pollak KI. Caregiver Inclusivity and Empowerment During Family-Centered Rounds. Hosp Pediatr. 2022 Feb 1;12(2):e72-e77. doi: 10.1542/hpeds.2021-006034.
- Individual participant dataSharing planned: No. Data will only be available to individuals on the Institutional Review Board protocol. We will share study protocol documents including intervention didactic materials and outcome measure assessments.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria M. Parente, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equity Focused and Trauma-Informed Communication Intervention in people with Hospitalism in Children and Post Traumatic Stress Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Measured by Enrollment Rate of Clinicians and Caregivers (time frame: Up to 12 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05618652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.