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The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Virtual Family-Centered Rounds [FCR]) | Experimental | Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR. |
|
| Control (Usual Care) | No Intervention | Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual family-centered rounds (FCR) | Behavioral | Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Parent FCR Attendance | Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83. | Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Experience | Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience). | Day 0 (post-NICU discharge) |
| Family-Centered Care |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Growth Velocity | Continuous variable. Measure/Tool: Sex-specific Fenton growth charts. Calculate change in Z-score divided by number of days in the NICU. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Adverse Events and Errors |
Enrolling family units (which consists of INFANTS and PARENTS [SURVEYS]):
INFANT Inclusion
INFANT Exclusion
PARENTS [SURVEYS] Inclusion
PARENTS [SURVEYS] Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Rosenthal, MD, MAS | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Regents of the University of California, Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37194089 | Derived | Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial. Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x. | |
| 37131689 |
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Family units enrolled and randomized. At time of enrollment, the number of infants was known, but the number of parents was unknown (because at that time did not know if family units had 1 vs. 2 parents/guardians). Enrolled 486 families (514 infants).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (Virtual Family-Centered Rounds [FCR]) | Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR. Virtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). |
| FG001 | Control (Usual Care) | Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall # baseline participants is 322 intervention families (342 infants, 242 P1s, 188 P2s = 772 total) & 160 control families (168 infants, 119 P1s, 100 P2s = 387 total). Each family consisted of different #s of infants (e.g., twins) and different #s of parents (i.e., 1 to 2 parents/guardians per family) participants.
Baseline data includes (a) enrolled infants plus (b) parents.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention (Virtual Family-Centered Rounds [FCR]) | Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR. Virtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Each family consisted of different #s of infants (e.g., twins/other multiples) and different #s of parents (i.e., 1 to 2 parents/guardians per family) participants. At time of randomization, the number of infants was known, but the number of parents was unknown (because at that time did not know if family units had 1 vs. 2 parents/guardians). |
| 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 | Parent FCR Attendance | Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83. | Posted | Mean | 95% Confidence Interval | proportion of encounters | Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days) |
|
13 months
Adverse event data were collected and monitored for infant participants only. Adverse events were not assessed or recorded for parent participants as part of the study's safety monitoring.
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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 (Virtual Family-Centered Rounds [FCR]) | Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR. Virtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Rosenthal | University of California at 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 | Dec 7, 2022 | May 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey) |
| Day 0 (post-NICU discharge) |
| Parent Activation | Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey) | Day 0 (post-NICU discharge) |
| Parent Health-related Quality of Life | Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey) | Day 0/30/60/90 (post-NICU discharge) |
| NICU Length of Stay | Unit of measure: days in NICU. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Breastmilk Feeding | Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days). | Day 0/90 (post-NICU discharge) |
| Postnatal Growth Failure (Dichotomous) | Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Postnatal Growth Failure (Categorical) | Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record. | Day 0 (post-NICU discharge) |
Include the rates of harmful errors, non-harmful errors, and overall errors (harmful errors plus non-harmful errors). Obtained via review of data from electronic health record, incident report system, and solicited reports. Two neonatologists, blinded to the study arm, will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion.
| Day 0 (post-NICU discharge) |
| 30-day Revisit | Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey. | Day 30 (post-NICU discharge) |
| 30-day Readmission | Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey. | Day 30 (post-NICU discharge) |
| Temperature Instability | Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Central Line-associated Bloodstream Infection | Dichotomous variable defined as any occurrence during the NICU hospitalization of a laboratory-confirmed bacterial or viral bloodstream infection that develops with a central line in place and is not related to an infection at another site. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Central Line Days | Number of days among the total number of NICU days that the infant has an umbilical catheter or one or more central lines in place. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Antibiotic Days | Number of days among the total number of NICU days that the infant receives intramuscular or intravascular antibacterial or antifungal agents. Obtained from electronic health record. | Day 0 (post-NICU discharge) |
| Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial. Res Sq [Preprint]. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1. |
| BG001 | Control (Usual Care) | Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | The overall number of baseline participants includes all individuals enrolled in the study (infants and their parents). Each baseline row reports data from a specific sub-population: infants, Parent 1s, and Parent 2s. The number analyzed in each row reflects the actual number of participants in that subgroup only. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Parent participants included those with unknown sex | Count of Participants | Participants |
|
| Race (NIH/OMB) | 510 (infants) + 361 (parent 1) + 288 (parent 2) = 1159 total | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Intervention (Virtual Family-Centered Rounds [FCR]) | Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR. Virtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care. The NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s). |
| OG001 | Control (Usual Care) | Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR. |
|
|
| Secondary | Parent Experience | Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience). | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Secondary | Family-Centered Care | Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey) | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Secondary | Parent Activation | Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey) | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Secondary | Parent Health-related Quality of Life | Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey) | Not Posted | Day 0/30/60/90 (post-NICU discharge) | Participants |
| Secondary | NICU Length of Stay | Unit of measure: days in NICU. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Secondary | Breastmilk Feeding | Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days). | Not Posted | Day 0/90 (post-NICU discharge) | Participants |
| Secondary | Postnatal Growth Failure (Dichotomous) | Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Secondary | Postnatal Growth Failure (Categorical) | Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline </=0.8 SD), mild (>0.8 and </=1.2 SD), moderate (>1.2 and </=2 SD), or severe (>2 SD). Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | Neonatal Growth Velocity | Continuous variable. Measure/Tool: Sex-specific Fenton growth charts. Calculate change in Z-score divided by number of days in the NICU. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | Adverse Events and Errors | Include the rates of harmful errors, non-harmful errors, and overall errors (harmful errors plus non-harmful errors). Obtained via review of data from electronic health record, incident report system, and solicited reports. Two neonatologists, blinded to the study arm, will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | 30-day Revisit | Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey. | Not Posted | Day 30 (post-NICU discharge) | Participants |
| Other Pre-specified | 30-day Readmission | Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey. | Not Posted | Day 30 (post-NICU discharge) | Participants |
| Other Pre-specified | Temperature Instability | Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | Central Line-associated Bloodstream Infection | Dichotomous variable defined as any occurrence during the NICU hospitalization of a laboratory-confirmed bacterial or viral bloodstream infection that develops with a central line in place and is not related to an infection at another site. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | Central Line Days | Number of days among the total number of NICU days that the infant has an umbilical catheter or one or more central lines in place. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| Other Pre-specified | Antibiotic Days | Number of days among the total number of NICU days that the infant receives intramuscular or intravascular antibacterial or antifungal agents. Obtained from electronic health record. | Not Posted | Day 0 (post-NICU discharge) | Participants |
| 13 |
| 342 |
| 0 |
| 342 |
| 0 |
| 342 |
| EG001 | Control (Usual Care) | Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR. | 6 | 168 | 0 | 168 | 0 | 168 |
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| Male |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|