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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Parents have the option to use telehealth to virtually connect with the nurse before transfer |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-to-Family Video Chat | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assignment Adherence | Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Family-Centered Care | Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE) | Day 0 |
| Family Experience | Unit of measure: mean score Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) 2 items measuring overall experience |
Inclusion Criteria:
Children who:
Exclusion Criteria:
For parent surveys --
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37041600 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall # of baseline participants is 77 intervention families & 39 control families. Each family consisted of 2 participants: a pediatric patient (child) and their parent/guardian. Thus, total # of participants was 154 intervention & 78 control.
Baseline data includes data of (a) enrolled pediatric patients plus (b) the parent. Data collection used electronic health record (for pediatric patient data) and parent surveys (for parent data). Parent baseline data unknown if survey not completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assignment Adherence | Percentage of eligible patients for whom the protocol assignment (telehealth vs standard of care) was followed | Posted | Count of Participants | Participants | Day 0 |
|
6 months
Minimal risk intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Rosenthal | University of California Davis | 9167344719 | rosenthal@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2022 | Apr 18, 2024 | Prot_SAP_000.pdf |
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|
| Survey Completion Rate (%) | Percentage of completed surveys among eligible respondents | Day 0 |
| Day 0 |
| Parent Acute Stress | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety | Day 0 |
| Parent Distress | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety | Day 30 |
| 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. | Day 0 |
| BG001 | Control | Standard of care |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 19 participants had unknown sex | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Overall Number of Baseline Participants is presented separately by Children and by Parents. | Count of Participants | Participants |
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| Race (NIH/OMB) | Overall Number of Baseline Participants is presented separately by Children and by Parents. | Count of Participants | Participants |
|
|
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| 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. | Telehealth connection was initiated among 4 intervention arm participants. This measure was not applicable for the Control arm. | Posted | Count of Participants | Participants | Day 0 |
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| Secondary | Survey Completion Rate (%) | Percentage of completed surveys among eligible respondents | Surveys sent to one parent/guardian per family. | Posted | Mean | 95% Confidence Interval | percentage of completed surveys | Day 0 |
|
|
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| Other Pre-specified | Family-Centered Care | Unit of measure: mean score Measure/Tool: Family-Centered Care Experience (FACCE) | Not Posted | Day 0 | Participants |
| 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 | Not Posted | Day 0 | Participants |
| Other Pre-specified | Parent Acute Stress | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety | Not Posted | Day 0 | Participants |
| Other Pre-specified | Parent Distress | Unit of measure: mean score Measure/Tool: (parent-reported survey) PROMIS 7-item Emotional Distress: Anxiety | Not Posted | Day 30 | Participants |
| 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. | Not Posted | Day 0 | Participants |
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Control | Standard of care | 0 | 39 | 0 | 39 | 0 | 39 |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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