Pediatric Disorder
Conditions
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.
Interventions
BEHAVIORALNurse-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.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assignment Adherence | Day 0 | Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity: Percentage of Telehealth Initiated Before Arrival | Day 0 | 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. |
| Survey Completion Rate (%) | Day 0 | Percentage of completed surveys among eligible respondents |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parent Distress | Day 30 | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety |
| Family-Centered Care | Day 0 | Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE) |
| Change in Level of Care | Day 0 | Unit of measure: Percentage 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. |
| Family Experience | Day 0 | Unit of measure: mean score Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) 2 items measuring overall experience |
| Parent Acute Stress | Day 0 | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 77 |
| Control Standard of care | 39 |
| Total | 116 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous Children | 5.6 years STANDARD_DEVIATION 5.4 | 5.2 years STANDARD_DEVIATION 5.7 | 5.4 years STANDARD_DEVIATION 5.5 |
| Age, Continuous Parents | 34.7 years STANDARD_DEVIATION 9 | 34.7 years STANDARD_DEVIATION 8 | 34.7 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 6 Participants | 11 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 57 Participants | 15 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Parents Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Parents Not Hispanic or Latino | 48 Participants | 20 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Parents Unknown or Not Reported | 15 Participants | 6 Participants | 21 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Children Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Children Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Children More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 51 Participants | 34 Participants | 85 Participants |
| Race (NIH/OMB) Children White | 19 Participants | 3 Participants | 22 Participants |
| Race (NIH/OMB) Parents American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Parents Asian | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) Parents Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) Parents More than one race | 7 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Parents Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Parents Unknown or Not Reported | 21 Participants | 14 Participants | 35 Participants |
| Race (NIH/OMB) Parents White | 36 Participants | 9 Participants | 45 Participants |
| Sex: Female, Male Children Female | 26 Participants | 21 Participants | 47 Participants |
| Sex: Female, Male Children Male | 51 Participants | 18 Participants | 69 Participants |
| Sex: Female, Male Parents Female | 54 Participants | 24 Participants | 78 Participants |
| Sex: Female, Male Parents Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 39 |
| other Total, other adverse events | 0 / 77 | 0 / 39 |
| serious Total, serious adverse events | 0 / 77 | 0 / 39 |
Outcome results
Primary
Assignment Adherence
Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Assignment Adherence | 4 Participants |
| Control | Assignment Adherence | 76 Participants |
Secondary
Fidelity: Percentage of Telehealth Initiated Before Arrival
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.
Time frame: Day 0
Population: Telehealth connection was initiated among 4 intervention arm participants. This measure was not applicable for the Control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Fidelity: Percentage of Telehealth Initiated Before Arrival | 4 Participants |
Secondary
Survey Completion Rate (%)
Percentage of completed surveys among eligible respondents
Time frame: Day 0
Population: Surveys sent to one parent/guardian per family.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Survey Completion Rate (%) | 81.8 percentage of completed surveys |
| Control | Survey Completion Rate (%) | 87.2 percentage of completed surveys |
Other Pre-specified
Change in Level of Care
Unit of measure: Percentage 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.
Time frame: Day 0
Other Pre-specified
Family-Centered Care
Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE)
Time frame: Day 0
Other Pre-specified
Family Experience
Unit of measure: mean score Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) 2 items measuring overall experience
Time frame: Day 0
Other Pre-specified
Parent Acute Stress
Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety
Time frame: Day 0
Other Pre-specified
Parent Distress
Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety
Time frame: Day 30