NCT05593900

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

October 18, 2022

Results QC Date

April 18, 2024

Last Update Submit

January 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assignment Adherence

    Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed

    Day 0

Secondary Outcomes (2)

  • Fidelity: Percentage of Telehealth Initiated Before Arrival

    Day 0

  • Survey Completion Rate (%)

    Day 0

Other Outcomes (5)

  • Family-Centered Care

    Day 0

  • Family Experience

    Day 0

  • Parent Acute Stress

    Day 0

  • +2 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Parents have the option to use telehealth to virtually connect with the nurse before transfer

Behavioral: Nurse-to-Family Video Chat

Control

NO INTERVENTION

Standard of care

Interventions

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.

Intervention

Eligibility Criteria

Age8 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • does not have an English-speaking adult parent/guardian at the bedside
  • For parent surveys --
  • are parents/guardians of the eligible patients (described above)
  • are age 18 years and older
  • are English-speaking
  • are age less than 18 years
  • have a preferred language that is other than English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Rosenthal JL, Hoyt-Austin AE, Ketchersid A, Sanders A, Harper TA, Tancredi DJ, Young HM, Romano PS, Marcin JP. Nurse-to-family telehealth for pediatric transfers: protocol for a feasibility and pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2023 Apr 11;9(1):57. doi: 10.1186/s40814-023-01292-4.

Results Point of Contact

Title
Jennifer Rosenthal
Organization
University of California Davis

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 26, 2022

Study Start

January 3, 2023

Primary Completion

July 2, 2023

Study Completion

July 23, 2023

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Locations