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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05593900
Other study ID # 1062184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date July 23, 2023

Study information

Verified date August 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be a pilot test of using telehealth to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date July 23, 2023
Est. primary completion date July 2, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Days and older
Eligibility Inclusion Criteria: Children who: - are aged 8 days to <=18 years - present to a participating community hospital ED - are accepted for inter-facility transfer to UC Davis - are assigned to UC Davis unit D10, D7, or T6 - have an English-speaking adult parent/guardian at the bedside Exclusion Criteria: - does not have an English-speaking adult parent/guardian at the bedside For parent surveys -- Inclusion Criteria: - are parents/guardians of the eligible patients (described above) - are age 18 years and older - are English-speaking Exclusion Criteria: - are age less than 18 years - have a preferred language that is other than English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nurse-to-Family Video Chat
A Nurse-To-Family Video Chat will be offered to parents/guardians to virtually connect with their post-transfer nurse; this intervention is changing the behavior of how providers deliver healthcare and how parents/guardians engage in their child's care.

Locations

Country Name City State
United States University of California Davis Medical Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Family-Centered Care Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE) Day 0
Other Family Experience Unit of measure: mean score Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) 2 items measuring overall experience Day 0
Other Parent Acute Stress Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety Day 0
Other Parent Distress Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety Day 30
Other Change in level of care Unit of measure: Proportion of subjects with change in level of care among eligible subjects.
subjects
- Definition: (chart review dichotomous outcome) Switching from an acute care unit or service to an intensive care unit or service, and vice versa.
Day 0
Primary Assignment adherence Proportion of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed Day 0
Secondary Fidelity: Launch prior to patient arrival Whether or not telehealth connection was initiated prior to patient's arrival to UC Davis Day 0
Secondary Survey response rates Proportion of completed surveys among eligible respondents Day 0/Day 30
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