Trial Outcomes & Findings for Nurse-To-Family Telehealth (NCT NCT05593900)

NCT ID: NCT05593900

Last Updated: 2025-01-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

291 participants

Primary outcome timeframe

Day 0

Results posted on

2025-01-14

Participant Flow

The unit of randomization was the community emergency department (ED). Rationale for randomizing at the ED level was that it decreased contamination in comparison to randomization at the patient level. We used constrained randomization to better balance the intervention and control arms with respect to ED-to-children's hospital distance and pediatric transfer volume. Participants were grouped as families, with one child participant and one parent participant per family.

Unit of analysis: community emergency department

Participant milestones

Participant milestones
Measure	Intervention Among the families who presented to one of the three emergency departments randomized to the intervention arm, parents had the option to use telehealth to virtually connect with the nurse before transfer ("Nurse-to-Family Video Chat"). Thus the intervention was having the option to use the telehealth innovation in addition to usual care. The decision to use telehealth in this trial was encouraged in the intervention arm but remained optional; no nurse or parent was required to use telehealth. Nurse-to-Family Video Chat: A Nurse-To-Family Video Chat was offered to parents/guardians to virtually connect with their post-transfer nurse; this intervention was changing the behavior of how providers deliver healthcare and how parents/guardians engage in their child's care.	Control Among the families who present to one of the three emergency departments randomized to the control arm, they will receive standard of care (which is not having the option to use the Nurse-to-Family intervention).
Overall Study STARTED	154 3	78 3
Overall Study Parents	77 3	39 3
Overall Study Children	77 3	39 3
Overall Study COMPLETED	154 3	78 3
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

19 participants had unknown sex

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 0

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

Outcome measures

Outcome measures
Measure	Intervention n=154 Participants Parents have the option to use telehealth to virtually connect with the nurse before transfer 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.	Control n=78 Participants Standard of care
Assignment Adherence	4 Participants	76 Participants

SECONDARY outcome

Timeframe: Day 0

Population: Telehealth connection was initiated among 4 intervention arm participants. This measure was not applicable for the Control arm.

Whether or not a telehealth connection was initiated prior to patient's arrival to UC Davis hospital. Time of telehealth initiation, if applicable, was obtained from the ExtendedCare (telehealth platform) reporting system. Time of patient arrival was obtained from the electronic health record.

Outcome measures

Outcome measures
Measure	Intervention n=4 Participants Parents have the option to use telehealth to virtually connect with the nurse before transfer 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.	Control Standard of care
Fidelity: Percentage of Telehealth Initiated Before Arrival	4 Participants	—

SECONDARY outcome

Timeframe: Day 0

Population: Surveys sent to one parent/guardian per family.

Percentage of completed surveys among eligible respondents

Outcome measures

Outcome measures
Measure	Intervention n=77 Participants Parents have the option to use telehealth to virtually connect with the nurse before transfer 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.	Control n=39 Participants Standard of care
Survey Completion Rate (%)	81.8 percentage of completed surveys Interval 71.4 to 89.7	87.2 percentage of completed surveys Interval 72.6 to 95.7

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Rosenthal

University of California Davis

Phone: 9167344719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention n=77 Participants Parents have the option to use telehealth to virtually connect with the nurse before transfer 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.	Control n=39 Participants Standard of care	Total n=116 Participants Total of all reporting groups
Age, Continuous Children	5.6 years STANDARD_DEVIATION 5.4 • n=77 Participants	5.2 years STANDARD_DEVIATION 5.7 • n=39 Participants	5.4 years STANDARD_DEVIATION 5.5 • n=116 Participants
Age, Continuous Parents	34.7 years STANDARD_DEVIATION 9.0 • n=77 Participants	34.7 years STANDARD_DEVIATION 8.0 • n=39 Participants	34.7 years STANDARD_DEVIATION 8.6 • n=116 Participants
Sex: Female, Male Children · Female	26 Participants n=77 Participants • 19 participants had unknown sex	21 Participants n=39 Participants • 19 participants had unknown sex	47 Participants n=116 Participants • 19 participants had unknown sex
Sex: Female, Male Children · Male	51 Participants n=77 Participants • 19 participants had unknown sex	18 Participants n=39 Participants • 19 participants had unknown sex	69 Participants n=116 Participants • 19 participants had unknown sex
Sex: Female, Male Parents · Female	54 Participants n=63 Participants • 19 participants had unknown sex	24 Participants n=34 Participants • 19 participants had unknown sex	78 Participants n=97 Participants • 19 participants had unknown sex
Sex: Female, Male Parents · Male	9 Participants n=63 Participants • 19 participants had unknown sex	10 Participants n=34 Participants • 19 participants had unknown sex	19 Participants n=97 Participants • 19 participants had unknown sex
Ethnicity (NIH/OMB) Children · Hispanic or Latino	6 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	11 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	17 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Ethnicity (NIH/OMB) Children · Not Hispanic or Latino	57 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	15 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	72 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Ethnicity (NIH/OMB) Children · Unknown or Not Reported	14 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	13 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	27 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Ethnicity (NIH/OMB) Parents · Hispanic or Latino	14 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	13 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	27 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Ethnicity (NIH/OMB) Parents · Not Hispanic or Latino	48 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	20 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	68 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Ethnicity (NIH/OMB) Parents · Unknown or Not Reported	15 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	6 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	21 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · American Indian or Alaska Native	0 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · Asian	1 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	1 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · Native Hawaiian or Other Pacific Islander	1 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	1 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · Black or African American	3 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	2 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	5 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · White	19 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	3 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	22 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · More than one race	2 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	2 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Children · Unknown or Not Reported	51 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	34 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	85 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · American Indian or Alaska Native	3 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	0 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	3 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · Asian	3 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	7 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	10 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · Native Hawaiian or Other Pacific Islander	2 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	1 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	3 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · Black or African American	5 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	6 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	11 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · White	36 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	9 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	45 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · More than one race	7 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	2 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	9 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.
Race (NIH/OMB) Parents · Unknown or Not Reported	21 Participants n=77 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	14 Participants n=39 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.	35 Participants n=116 Participants • Overall Number of Baseline Participants is presented separately by Children and by Parents.