Neonatal Disease, Pediatric Disorder
Conditions
Keywords
Pediatrics, Neonatal Intensive Care Units, Neonate, Clinical Trial, Telemedicine, Patient-Centered Care, Patient Reported Outcome Measures
Brief summary
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.
Interventions
BEHAVIORALVirtual 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).
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Enrolling family units (which consists of INFANTS and PARENTS \[SURVEYS\]): INFANT Inclusion * Infants aged less than 365 days who are admitted to the NICU * Have at least one adult parent or guardian with English proficiency INFANT Exclusion * Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information * Infants with a previous NICU admission (and enrollment) during the trial period PARENTS \[SURVEYS\] Inclusion * Parents/guardians of the eligible infants (described above) * Age 18 years and older PARENTS \[SURVEYS\] Exclusion * Age less than 18 years * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent FCR Attendance | Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Experience | Day 0 (post-NICU discharge) | Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience). |
| Family-Centered Care | Day 0 (post-NICU discharge) | Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey) |
| Parent Activation | Day 0 (post-NICU discharge) | Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey) |
| Parent Health-related Quality of Life | Day 0/30/60/90 (post-NICU discharge) | Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey) |
| NICU Length of Stay | Day 0 (post-NICU discharge) | Unit of measure: days in NICU. Obtained from electronic health record. |
| Breastmilk Feeding | Day 0/90 (post-NICU discharge) | 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). |
| Postnatal Growth Failure (Dichotomous) | Day 0 (post-NICU discharge) | 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. |
| Postnatal Growth Failure (Categorical) | Day 0 (post-NICU discharge) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Errors | 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. |
| 30-day Revisit | Day 30 (post-NICU discharge) | Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey. |
| 30-day Readmission | Day 30 (post-NICU discharge) | Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey. |
| Temperature Instability | Day 0 (post-NICU discharge) | Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record. |
| Central Line-associated Bloodstream Infection | Day 0 (post-NICU discharge) | 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. |
| Central Line Days | Day 0 (post-NICU discharge) | 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. |
| Antibiotic Days | Day 0 (post-NICU discharge) | 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. |
| Neonatal Growth Velocity | Day 0 (post-NICU discharge) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 772 |
| 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. | 387 |
| Total | 1,159 |
Baseline characteristics
| Characteristic | Total | Intervention (Virtual Family-Centered Rounds [FCR]) | Control (Usual Care) |
|---|---|---|---|
| Age, Categorical Participants <=18 years | 510 Participants | 342 Participants | 168 Participants |
| Age, Categorical Participants >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Participants Between 18 and 65 years | 649 Participants | 430 Participants | 219 Participants |
| Age, Continuous Infants | 0.01 years STANDARD_DEVIATION 0.04 | 0.01 years STANDARD_DEVIATION 0.05 | 0.01 years STANDARD_DEVIATION 0.04 |
| Age, Continuous Parent 1 | 31.3 years STANDARD_DEVIATION 5.8 | 31.1 years STANDARD_DEVIATION 6 | 31.7 years STANDARD_DEVIATION 5.6 |
| Age, Continuous Parent 2 | 33.8 years STANDARD_DEVIATION 7.3 | 33.5 years STANDARD_DEVIATION 7.3 | 34.3 years STANDARD_DEVIATION 7.3 |
| Race (NIH/OMB) Infant American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Infant Asian | 45 Participants | 27 Participants | 18 Participants |
| Race (NIH/OMB) Infant Black or African American | 46 Participants | 36 Participants | 10 Participants |
| Race (NIH/OMB) Infant More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infant Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Infant Unknown or Not Reported | 214 Participants | 138 Participants | 76 Participants |
| Race (NIH/OMB) Infant White | 199 Participants | 138 Participants | 61 Participants |
| Race (NIH/OMB) Parent 1 American Indian or Alaska Native | 13 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) Parent 1 Asian | 44 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) Parent 1 Black or African American | 34 Participants | 27 Participants | 7 Participants |
| Race (NIH/OMB) Parent 1 More than one race | 31 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) Parent 1 Native Hawaiian or Other Pacific Islander | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Parent 1 Unknown or Not Reported | 66 Participants | 46 Participants | 20 Participants |
| Race (NIH/OMB) Parent 1 White | 165 Participants | 103 Participants | 62 Participants |
| Race (NIH/OMB) Parent 2 American Indian or Alaska Native | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Parent 2 Asian | 36 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) Parent 2 Black or African American | 21 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Parent 2 More than one race | 24 Participants | 19 Participants | 5 Participants |
| Race (NIH/OMB) Parent 2 Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Parent 2 Unknown or Not Reported | 52 Participants | 36 Participants | 16 Participants |
| Race (NIH/OMB) Parent 2 White | 145 Participants | 89 Participants | 56 Participants |
| Region of Enrollment United States | 1159 participants | 772 participants | 387 participants |
| Sex: Female, Male Infant Female | 222 Participants | 154 Participants | 68 Participants |
| Sex: Female, Male Infant Male | 288 Participants | 188 Participants | 100 Participants |
| Sex: Female, Male Parent 1 Female | 358 Participants | 240 Participants | 118 Participants |
| Sex: Female, Male Parent 1 Male | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Parent 2 Female | 14 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Parent 2 Male | 274 Participants | 177 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 342 | 6 / 168 |
| other Total, other adverse events | 0 / 342 | 0 / 168 |
| serious Total, serious adverse events | 0 / 342 | 0 / 168 |
Outcome results
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.
Time frame: Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention (Virtual Family-Centered Rounds [FCR]) | Parent FCR Attendance | 0.56 proportion of encounters |
| Control (Usual Care) | Parent FCR Attendance | 0.12 proportion of encounters |
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).
Time frame: Day 0/90 (post-NICU discharge)
Secondary
Family-Centered Care
Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Time frame: Day 0 (post-NICU discharge)
Secondary
NICU Length of Stay
Unit of measure: days in NICU. Obtained from electronic health record.
Time frame: Day 0 (post-NICU discharge)
Secondary
Parent Activation
Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Time frame: Day 0 (post-NICU discharge)
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).
Time frame: Day 0 (post-NICU discharge)
Secondary
Parent Health-related Quality of Life
Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Time frame: Day 0/30/60/90 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
Other Pre-specified
30-day Readmission
Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.
Time frame: Day 30 (post-NICU discharge)
Other Pre-specified
30-day Revisit
Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.
Time frame: Day 30 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)
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.
Time frame: Day 0 (post-NICU discharge)