Pediatric Disorder Clinical Trial
Official title:
Nurse-to-Family Telehealth for Pediatric Transfers: A Randomized Controlled Pilot Trial
| 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 |
| Verified date | August 2023 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California Davis Medical Center | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis |
United States,
| 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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