Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial
Phase: NA
Conditions: Pediatric Disorder, Neonatal Disease
Sponsor: University of California, Davis

COVER PAGE 
Official title: Virtual Family-Centered Hospital Rounds in the Neonatal Intensive Care Unit: A 
Cluster Randomized Controlled Trial 
NCT number: NCT05762835 
Document date: 12/07/2022  

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
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1) 
Protocol Title 
Title:  Virtual Family-Centered Rounds in the Neonatal Intensive Care 
Unit: A Randomized Clinical Trial  
Protocol Version Date: 12/5/2022 
2) 
Objectives 
 
The overall objective of this study is to test the efficacy of virtual family-
centered rounds (FCR) compared to standard rounds for NICU patients 
and to conduct an intervention evaluation of the virtual FCR intervention.  
Aim 1: Evaluate the impact of virtual FCR on parental activation and 
wellbeing. The primary outcome will be FCR parent attendance proportion 
(number of round encounters with a parent present – either virtually or in person 
– divided by total number of round encounters). Increased parent FCR 
attendance would increase the delivery of best practice. We will also compare 
parent experience (Child HCAHPS)28 and parent activation (P-PAM)29,30 at 
discharge and parent distress andquality of life at 0, 30, 60, and 90 days from 
discharge between assigned trial arms. Parent wellbeing promotes neonatal 
wellbeing.  
- 
Hypothesis1a: The virtual FCR (intervention) group will have a higher parent 
FCR attendance proportion compared to the standard FCR (control) group. 
- 
Hypotheses1b: Parents of virtual FCR neonates will report (a) better 
experience, (b) higher activation, (c) less distress, and (d) better quality of life 
compared to parents of standard-of-care neonates.  
Aim 2: Evaluate the impact of virtual FCR on neonatal outcomes. We will 
compare breast milk feeding at discharge and 90 days from discharge, growth 
failure,33 medical errors, and NICU length of stay between assigned trial arms.  
- 
Hypotheses2: Virtual FCR neonates will have (a) greater breast milk feeding, 
(b) reduced growth failure, (c) fewer errors, and (d) shortened length of stay 
compared to standard-of-care neonates.  
Aim 3: Conduct a mixed methods evaluation of the virtual FCR intervention. 
We will measure all five RE-AIM dimensions using quantitative (chart review, 
surveys) and qualitative (observations, interviews) methods. Observations will be 
of NICU FCR; interviews will be with intervention arm parents and NICU 
providers. We will use a convergent design and merge data in the analysis and 
reporting phases. 
3) 
Background 
 
Family-centered rounds (FCR) are multidisciplinary bedside rounds for 
hospitalized patients with active engagement by the family.1 FCR provides many 
benefits to patients, families, and providers, including fewer harmful errors, 
shortened hospital stays, reduced parental anxiety, improved family experience, 
and enhanced staff teamwork.2-6 For these reasons, FCR is recognized as a best 
practice for hospitalized children.7,8 However, because active family engagement 
is required, FCR has only been possible for patients whose families can 
physically be at the bedside during hospital rounds. 
In the neonatal intensive care unit (NICU), barriers exist that limit family 
presence at the bedside. Critically ill neonates may be hospitalized for extended 

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
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periods of time.9 Their parents or guardians (“parents” hereafter) often live far 
from the hospital and have travel, financial, work, or childcare constraints that 
limit their ability to be physically present in the NICU.10,11 These barriers are 
particularly challenging for rural and low-income parents.12 NICU parents have 
high rates of depression, anxiety, and post-traumatic stress,13-16 and reduced 
visitation with their infant can exacerbate their depression and inhibit parental-
newborn attachment.14 These parental factors impact the neonate, too. Early 
attachment impacts intelligence and emotional wellbeing later in life.17 Parental 
psychological support and engagement can shorten the NICU hospitalization18 
and facilitate breast milk feeding.19 Breast milk fed infants have improved near-
term (e.g., lower risk of sepsis and improved cognitive development) and long-
term outcomes (e.g., lower risk of hypertension, diabetes, and obesity).20 
Telehealth is a potential solution to mitigate these challenges. Using existing 
secure technology, parents can be virtually present at their neonate’s bedside to 
participate in FCR.21 Prior pediatric and adult research suggests that virtual FCR 
is feasible and meaningful to patients, families, and clinicians.22-25 However, 
these studies had many limitations in sample size, randomization, and outcomes 
measured. Therefore, we propose a rigorous virtual FCR efficacy trial to 
understand the impact of telehealth on neonatal and parental outcomes.  
 
4) 
Inclusion and Exclusion Criteria 
 
This study is a randomized trial to compare virtual family-centered rounds 
(FCR) to standard FCR for neonatal intensive care unit (NICU) patients. We will 
simultaneously conduct an intervention evaluation of this virtual FCR 
intervention. The unit of randomization is at the subject level (the neonate). The 
site is the UC Davis NICU. To gather necessary data on efficacy outcomes and 
on the 5 dimensions for the intervention evaluation (Reach, Effectiveness, 
Adoption, Implementation, Maintenance), survey data will be collected from the 
subjects’ parent or guardian (referred to as “parent” hereafter), electronic health 
record (EHR) data will be collected from UC Davis, and daily weekday FCR 
observations will be performed. To gather necessary data for the intervention 
evaluation, qualitative interviews will be performed. 
 
- INCLUSION: (NEONATES) Neonates aged <365 days admitted to UC Davis 
neonatal intensive care unit (NICU) during the study period who have one or 
more parent or guardian that self-reports their preferred language to be English. 
This parent must also be non-incarcerated and aged ≥18 years.  
- EXCLUSION: (NEONATES) Age > or = 365 days. Neonates with visitation or 
information restrictions placed by child protective services. Neonates with more 
than one admission during the trial period will be included only on their first 
admission.  
 
- INCLUSION: (QUALITATIVE INTERVIEWS) Parents/guardians of the eligible 
patients (described above) and NICU clinicians (e.g., nurses, physicians). Age 18 
years and older.  
- EXCLUSION: (QUALITATIVE INTERVIEWS) Age less than 18 years. Non-
English speaking.   
 
- INCLUSION: (SURVEY) Parents/guardians of the eligible patients (described 
above). Age 18 years and older.  

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A Randomized Clinical Trial 
 
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- EXCLUSION: (SURVEY) Age less than 18 years. Non-English speaking.   
 
5) 
Study Timelines 
We anticipate this trial will begin ~2/1/2023. We will begin enrolling 
subjects at trial onset. We will enroll subjects (neonates) and assign to 
either the intervention or control arm for 12 months. Each subject 
(neonate) will be included for the duration of their hospitalization. 
We will follow this 12-month period with 1 month of rounding observations 
for data collection. We will also continue to collect surveys at 0, 30, 
60, amd 90 days from discharge. Therefore, survey data collection will 
continue until 16 months from the trial onset.  
Regarding qualitative interviews for the intervention evaluation (Aim 3), 
those will continue for 18 months from the trial onset. 
The estimated date to complete this study is therefore ~8/1/2024. 
6) 
Study Endpoints 
Primary study endpoint is completing 12 months of trial enrollment. 
Secondary study endpoints include (a) completing the 13 months (12 + 1 
month after last enrollment) of daily weekday rounding observations of 
subjects; (b) completing the last survey for the last discharged patient (at 
90 days from discharge); (c) completing qualitative data analysis and 
integration for the mixed methods intervention evaluation.  
7) 
Procedures Involved 
 
OVERVIEW: The overall objective of this study is to conduct a randomized trial 
comparing virtual family-centered rounds (FCR) to standard FCR for NICU 
patients and to conduct an intervention evaluation of the virtual FCR intervention. 
This study protocol involves the UC Davis NICU (n=447 neonates) and uses a 
2:1 intervention-to-control arm ratio. The endpoint of the study includes 
completing the 12-month enrollment (intervention delivery) period plus the 1 
additional month of rounding observation data collection plus the 90-day follow-
up parent survey for neonates discharged home during the study period. Thus a 
16-month total period (12 months + 1 month + 90 days). The end of the 16-month 
period will be when neonates will no longer be assigned to standard FCR 
(control) versus virtual FCR (intervention) and no more neonates will be eligible 
for the study (which occurs at 12 months) followed by completion of the 
additional 1-month rounding observation data collection followed by the last 
survey recruitment invitation (which occurs 90 days following the last eligible 
patient is discharged home to obtain 90-day outcome measures). Hypotheses 
include the following: (1) The virtual FCR (intervention) group will have a higher 
parent FCR attendance proportion compared to the standard FCR (control) 
group; (2) Virtual FCR neonates will have (a) greater breast milk feeding, (b) 
reduced growth failure, (c) fewer medical errors, and (d) shortened length of stay 
compared to standard-of-care neonates; (3) Parents of virtual FCR neonates will 
report (a) better experience, (b) higher activation, (c) less distress, and (d) better 

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
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quality of life compared to parents of standard-of-care neonates. To conduct the 
intervention evaluation, we will apply the 5 dimensions of the RE-AIM framework 
(Reach, Effectiveness, Adoption, Implementation, Maintenance) and use a mixed 
methods approach with a convergent design. Data integration will occur by 
merging data in the analysis and reporting phases.  
 
ASSIGNMENT TO CONTROL VERSUS INTERVENTION: The unit of 
randomization is at the subject (neonate) level. The study statistician will 
generate a random allocation list and employ allocation concealment to assign 
eligible subjects with a 2:1 intervention-to-control arm ratio. During the 12-month 
enrollment (intervention delivery) period, a research coordinator will open the 
sequentially numbered assignments to invite parents of neonates assigned to the 
intervention arm to sign up for virtual FCR. Neonates of parents accepting this 
offer will be considered “subscribed.” For neonates with more than one eligible 
parent, separate subscription invitations will be used for to each parent.  
 
DELIVERY OF INTERVENTION: We will use Extended Care as the software 
interface for virtual FCR. This secure platform meets HIPAA security rules and 
launches from the electronic health record. Parents will use the Extended Care 
application on their personal computer or smart device. The NICU medical team 
will use Extended Care on a computer on wheels with a speaker and camera. 
Virtual FCR will be available for parents of subscribed neonates to attend 
Monday through Friday. For neonates with a subscribed parent, a NICU team 
member will launch an ExtendedCare telehealth visit (“virtual room”) from the 
patient’s Epic chart. From ExtendedCare, a NICU team member will use the 
“invite” feature to invite the subscribed parent(s); the parents then receive a 
message to their email/cell phone that includes their child’s unique Extended 
Care link. The parent(s) can use this link, if desired, to enter the “virtual room.” If 
a parent joins, they will establish the live, bidirectional audio and visual 
connection. FCR will then proceed in usual fashion. Parents can participate in 
virtual FCR as much, or as little, as they choose. They can also participate in 
FCR in person (standard of care) or not participate at all.  
 
QUALITATIVE INTERVIEWS: The stakeholder engagement team members will 
assist with recruitment of the interview participants. Stakeholders or a research 
team member will recruit eligible interview participants. They will hand-deliver a 
flyer to the parents/guardians of eligible patients at the time of [i.e., 2 days before 
the anticipated] hospital discharge. Alternatively, since parents are not often at 
the bedside for in-person recruitment, they will send a secure message from 
StudyPages or make a phone call to invite participants to participate in an 
interview. Non-respondents will be contacted once 7 days later by a research 
coordinator through StudyPages. Clinician (e.g., nurses, physicians) interview 
participants will be identified by stakeholder or research team members. 
Recruitment emails or Secure Chat messages will be sent to the clinicians. 
Repeat email/message outreach will be made to the clinician non-respondents at 
2 and 4 weeks following initial outreach. Participants will receive $50 for 
participating in an interview. Interested participants will have one in-depth 
interview that lasts ~45 minutes. Interviews will be in-person when possible, but 
otherwise by telephone or videoconference. Interviews will be audio recorded, 
transcribed, and reviewed for accuracy by the interviewer. Transcriptions will be 
uploaded into ATLAS.ti. 
 
DELIVERY OF SURVEY: Parents will be invited to complete their first survey at 

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
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the time of [i.e., 2 days before the anticipated] discharge. If a neonate has two 
eligible parents, separate invitations will be sent to each parent. Recruitment will 
occur via giving them a packet at discharge. The packet will contain a recruitment 
letter (flyer), a scannable barcode (to access the survey electronically if 
preferred), a website link (another alternative to access the survey electronically 
if preferred), and a paper version of the survey. Alternatively, since parents are 
not often at the bedside for in-person recruitment, the research assistant will 
send a secure message/email from StudyPages or make a phone call to invite 
participants to participate in an interview. Parents can complete the survey 
themselves or verbally with the research assistant who will directly input verbal 
responses into REDCap. The research assistant will make 3 daily attempts of 
outreach and follow up with non-respondents 7 days later. If a survey is not 
returned within 21 days of discharge, the survey will be considered a non-
response. The survey delivery process from a Secure Chat message/email or 
phone call will occur at 30, 60, and 90 days to administer the subsequent survey 
packets (with 3 daily attempts and follow-up 7 days later and a 21-day response 
time limit). Electronic surveys will be conducted in REDCap. Paper surveys will 
be kept in a locked box in the locked physician workroom until collected by a 
research assistant, who will transfer the data into REDCap and then destroy the 
paper copy. For parents with more than one neonate enrolled in the study (i.e., 
twins/multiples), the parents will only receive one survey packet per child. The 
survey will be sent to the parents at the time that one of their children first 
discharges from the NICU (and each subsequent 30 day period will be based off 
that first child’s discharge date). For subsequent siblings discharged at later 
dates, a research assistant will use StudyPages to message/call parents to 
obtain the responses to (a) questions #1 and 2 of the 30-day survey and (b) 
question #1 of the 90-day survey. These questions relate to the outcomes of (a) 
30-day revisit/readmission and (b) 90-day breastmilk feeding. The research 
assistant will directly input the responses into REDCap.  
 
DATA COLLECTION: Data collection will include daily weekday virtual FCR 
observations; parent surveys; and review of the EHR, incident reports, and 
helpdesk technical issues log. Outcomes (for Aims 1-3) will include the following: 
FCR parent attendance proportion (captured using weekday rounding 
observations), length of stay (captured using EHR data), breast milk feeding 
initiation and breast milk feeding at discharge (captured using EHR data) and at 
90 days after discharge (captures via parent via parent/guardian survey), growth 
failure and growth velocity (captured using EHR data), time to first social work 
contact (captured using EHR data), temperature instability (captured from an 
existy NICU quality dataset), feeding difficulty (captured from an existy NICU 
quality dataset), central line-associated bloodstream infection (captured from an 
existy NICU quality dataset), central line days (captured from an existy NICU 
quality dataset), antibiotics days (captured from an existy NICU quality dataset), 
medical errors (captured using data from EHR, incident reporting system, and 
solicited reports), 30-day revisit and readmission (captured via EHR and survey) 
parent experience and family-centered care (captured via parent/guardian survey 
at discharge), parent activation (captured via parent/guardian survey at 
discharge), parent distress: depression and anxiety (captured via parent/guardian 
survey at 0, 30, 60, 90 days from discharge), parent sleep (captured via 
parent/guardian survey at 0, 30, 60, 90 days from discharge), and parent quality 
of life (captured via parent/guardian survey at 0, 30, 60, 90 days from discharge).  
 
RE-AIM (Aim 3) implementation evaluation data collection will include the 

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
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following: subscribed vs. not subscribed parents among intervention-arm parents, 
heterogeneity of intervention effects (interactions between neonate/parent 
characteristics and the intervention effect), virtual FCR attempts with technical 
issues (sounds, video, other), trial-related 24/7 helpdesk line calls, ExtendedCare 
wait time when parent(s) join, ExtendedCare connection time, device model (e.g., 
iPhone, Android, etc.) that parent uses to connect to the ExtendedCare visit, 
interruptions requiring a break in rounds due to a delivery or new admission, and 
virtual FCR use with NICU parents post-trial (maintenance). 
 
Data will be collected from both the intervention and control arm subjects. The 
EHR access for data collection will only occur in a retrospective fashion. The 
interaction with the control arm group parents will therefore include an invitation 
via letter (flyer) to participate in the surveys. The obeservtions of FCR will be 
conducted by either a research team member or a NICU team member who 
already participates in FCR as part of clinical care. The information being 
recorded from the observations is whether or not parent(s) are present at FCR, 
and if so, what type of attendance (in person vs. virtual).   
 
8) 
Data and/or Specimen Management and Confidentiality 
☒ I understand that if this study involves the use of  the UC Davis Health 
Electronic Health Record (EMR/EPIC) also contains the clinical data for 
Marshall Medical Center (MMC). I understand that MMC patient data 
cannot be accessed for research purposes and that I must take the 
necessary steps to ensure that MMC data is not accessed, used, or 
disclosed for UC Davis Health research purposes. 
☐ I undersand that if this study involves use of UC Davis students’ 
educational records (including records in the PI’s own possession such as 
course exams/assignments), I must consult with the Registrar’s office to 
see if all requirements of the Family Educational Rights and Privacy Act 
(FERPA) are satisfied.   
 
DATA ANALYSIS: We will analyze subject data according to their assigned 
group (intervention vs. control). We will use descriptive statistics to summarize 
subject-level characteristics. We will compare neonatal and parental 
characteristics between study arms using Pearson’s Chi-square test for 
categorical variables, t-test for normally distributed continuous variables, and 
nonparametric equality-of-medians test for non-normally distributed continuous 
variables. Generalized linear models will be used to estimate effect sizes and to 
test hypotheses for study outcomes, using a binary indicator for intervention 
assignment as the independent variable of interest and including a parsimonious 
set of demographic and clinical characteristics as covariates. We will analyze all 
available data and anticipate high data completion rates, based on our pilot trial. 
We will conduct sensitivity analyses using multiple imputation approaches for 
missing data to complement the primary analysis.  
 
SAMPLE SIZE: We specified effect sizes of interest for all the trial outcomes and 
determined the necessary sample size to satisfy each. The sample size 
estimation that satisfies length of stay requirements also satisfies requirements 
for all other outcomes of interest, except for medical errors (which are rare and 

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thus this outcome will be considered exploratory. Outcome distributional 
assumptions were based on data from our pilot trial or other relevant literature. 
Pilot trial baseline mean log transformed length of stay +/- standard deviation 
(SD) was 3.0 +/- 1.0 days. Minimally clinically important differences (MCID) were 
based on the literature when available or via consensus opinion elicited from 
NICU clinicians we consulted. For the length of stay outcome, experts specified 
that a 25% reduction in geometric mean length of stay was of interest. A 
randomized sample of 447 neonates (298 intervention, 149 control) subject to 
4% attrition in each arm yields a sufficient sample size (429 neonates) to provide 
80% power (under two-sided testing, alpha=5%) to detect this MCID. This 
estimated attrition is based on 4 of 110 randomized subjects in the pilot trial 
being excluded from final analysis (e.g., child protective visitation restrictions 
placed after randomization). Parent-reported outcomes assume a survey 
response rate of 75% (thus n=321 parents). Note: Regarding sample size for the 
interviews, we anticipate interviewing ~15 parents, ~10 nurses, and ~10 
physicians. Consistent with standard qualitative methods, we will continue to 
sample interview participants until we reach thematic saturation, thus we cannot 
specificy a priori the exact number of interviewees.  
 
All virtual FCR encounters will occur using an application platform that is 
approved by Information Technology at UC Davis Health System as meeting 
HIPAA and HITECH data security requirements. The only telehealth 
communication that will occur will be through the HIPAA-compliant application. 
No telehealth encounter will be recorded or stored in any way. 
Participants will decide to what extent they want to participate in the 
interviews and surveys. There will be no personal or intrusive questions. In all 
steps of this pilot study, the risk of loss of confidentiality is very low given the 
measures described above to protect PHI.  
Only trained UC Davis professionals will work directly with interview and 
survey participants. All verbal communication with interview participants will 
occur in private locations to protect the confidentiality of the material being 
discussed. Review of the interview recordings will take place in UC Davis private 
offices. Digital audio recordings will be stored using number identification that will 
be kept on a password-protected computer. The risk of loss of confidentiality is 
extremely low and is minimized by not including identifiable information in the 
fieldnotes as well as de-identifying the transcription data. Notes and 
transcriptions will be maintained in a locked cabinet in a locked UC Davis private 
office. 
Only study personnel will have access to the study materials. The 
knowledge gained from this study will be disseminated in such forms as 
manuscripts and conference presentations; this disseminated information will 
contain no identifying information.  
The possibility of any adverse effects on participants as result of the study 
intervention is minimal given the intervention (virtual FCR in the NICU) is a 
method of communication that has been demonstrated in prior research (a pilot 
trial) to improve care quality without causing harm. The difference for this present 
trial is that it is powered for hypothesis testing and includes additional outcome 
measures.  
A Data Safety Monitoring Plan with an Independent Monitoring Committee 
will be used for this study to provide additional protection. The Independent 
Monitoring Committee will meet to independently review outcomes on a quarterly 
basis, and as needed based on any reported complications. Safety information 
will be collected by reviewing charts. The safety monitoring will begin when the 

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A Randomized Clinical Trial 
 
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trial enrollment begins. The Independent Monitoring Committee will complete 
quarterly reports detailing the study progress, any adverse events, and any 
protocol deviations. The details are as follows: 
• 
Definition: An adverse event is any untoward medical occurrence in a 
subject during participation in the study. An adverse finding can include a 
sign, symptom, abnormal assessment, abnormal occurrence, or any 
combination of these. A serious adverse event is any adverse event that 
results in one or more of the following outcomes: death, a life-threatening 
event, inpatient hospitalization or prolongation of existing hospitalization, 
a persistent or significant disability or incapacity, or an important medical 
event based upon appropriate medical judgment.  
• 
Classification: Adverse events will be labeled according to severity, 
which is based on their impact on the neonate. An adverse event will be 
termed “mild” if it does not have a major impact on the neonate, 
“moderate” if it causes the neonate some minor inconvenience, and 
“severe” if it causes a substantial disruption to the neonate’s well-being.  
• 
Attribution Scale: Adverse events will be categorized according to the 
likelihood that they are related to the study intervention. Specifically, they 
will be labeled definitely unrelated, definitely related, probably related, or 
possibly related to the study intervention. 
• 
Adverse Event Reporting: Adverse events will be collected by the PI and 
forwarded immediately to the Independent Monitoring Committee. 
Events determined to be unanticipated, serious, and possibly related to 
the study intervention will be reported to the appropriate monitoring 
agencies, including the UC Davis IRB and the funding agency, within 10 
days. Adverse events that are determined to be unrelated problems will 
be reported per IRB policy at the time of continuing review.  
To conduct the intervention evalution that includes the RE-AIM dimensions, all 
eligible subjects will be included in the data collection process. Their data will be 
kept in secure REDCap databases containing only their study ID, and the link to 
their study ID and MRN will be kept in the “Participant Log” that is stored on a 
secure Excel database stored on the secure UC Davis servers.  
This study is evaluating a systems-level intervention; a system-level intervention 
means that we are doing an intervention on how we deliver healthcare. In other 
words, our intervention is a test of change to the healthcare system. In this case, 
the system is how we deliver family-centered rounds. The study team will not be 
able to determine the feasibility and implementation of the pilot project without 
collecting the implementation data on all patients. It is important that we collect 
data on all eligible subjects, because we want to ensure that we include 
gathering data from underserved populations in order to learn how to better 
provide them with clinical services that meet/address their unique needs. This 
aspect is particularly relevant for telehealth interventions, whereby the ditigal 
divide is potentially designing/deliverying telehealth services that do not serve 
diverse populations. It is therefore important to have all of our diverse groups 
represented in our data in order to conduct our comprehensive intervention 
evaluation (Aim 3). We recognize the limitation that our survey-based outcomes 
(for Aims 1 and 2) will only gather data from those who complete the survey, and 
thus the conclusions from survey-based data will only be generalizable to similar 
populations as those represented in those surveys. However, our other outcomes 
(that rely on FCR observations and review of the EHR, incident reports, and 

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helpdesk technical issues log) will include all our subjects – and thus represent 
diverse groups. 
Since this is a systems-level intervention, only collecting data on consented 
patients will provide Aim 3 (intervention evaluation) results that are biased and 
therefore not useful. We cannot understand how to refine and deliver our 
telehealth intervention (and thus improve this clinical service line) without having 
data on all eligible patients. Although we will need to collect data on every 
patient, the family members in the intervention group can choose if and how 
much to use the intervention (they can decide to never provide their cell phone 
number and to never use telehealth for FCR). 
We will be using StudyPages, a secure web-based application developed by the 
UCD CTSC to maintain communication with study participants. All study 
personnel involved in this proposed project have received Human Subjects 
Protection and HIPAA education. 
 
9) 
Data and/or Specimen Banking 
N/A 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
There is potential minimal risk. There is potential loss of confidentiality; 
however, for all data, only study personnel will have access to these materials. 
Although the research coordinator will view identifiable information from the 
health records, the data downloaded from REDCap to be used for analysis will all 
be de-identified. All data will be destroyed 7 years after completion of the study. 
There is no risk to data security with regards to letting the parents use their 
personal device/computer to conduct virtual FCR, because the telehealth 
connection requires the download and use of the HIPAA-compliant application, 
Extended Care. This telehealth application platform to be used will be a secure 
platform that meets HIPAA and HITECH data security requirements. Therefore, 
since the telehealth intervention in this pilot trial will use a secure telehealth 
application to conduct virtual FCR, the communication will be secure. In this 
study, virtual FCR will only proceed using the HIPAA compliant application, since 
the videoconference connection is established through the HIPAA compliant 
application. No aspects of the virtual FCR encounter will be recorded nor stored 
in any way.  
There are no anticipated risks to patients with regards to assignment to the 
intervention (virtual FCR). The intervention places no pressure on clinicians to 
alter clinical management. Rather, the intervention assigns the use of telehealth 
as an additional mode of communication to enhance the in person standards of 
FCR.  
The alternative to virtual FCR is standard in person FCR or to not attend 
rounds at all. The benefits of in person FCR are not needing to communicate 
using a technology interface. However, the risks of in person FCR include the 
inability of the family to be able to physically be in the NICU during rounds, and 
thus to participate in FCR at all. 
For the qualitative interview participants, there is potential minimal risk. 
Parents (or clinicians) might experience distress discussing their experiences 
during the NICU hospitalization of their child. However, this research team has 
previously conducted qualitative interviews with NICU parents who were asked to 

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A Randomized Clinical Trial 
 
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reflect on their experiences when their child was hospitalized. In these interviews, 
informants did not report or demonstrate any distress. It is thus unlikely that such 
distress will occur with the proposed study. There exists a minimal risk of loss of 
confidentiality. 
 
11) Withdrawal of Subjects 
 
Subjects will only be withdawn if they no longer meet inclusion criteria. For 
example, this might occur if a neonate (subject) is enrolled but then has a CPS 
placement of visitor restrictions. At that point, we will inform the recruited parents, 
if applicable, that they no longer meet criteria to participate in the trial. This 
circumstance would be no different than their routine care, since a CPS 
restriction would prohibit them from joining FCR; so we would similarly restrict 
then form joining virtual FCR. 
Families randomized to use the intervention can choose to use or not use 
the intervention as they see fit, and it will not impact their participation in the 
study. Families will be free to choose to complete or not complete the surveys 
the week of discharge. 
 
12) Risks to Subjects 
There is potential loss of confidentiality; however, for all data, only 
study personnel will have access to these materials. Although the 
research coordinator will view identifiable information from the health 
records, the data downloaded from REDCap to be used for analysis will 
all be de-identified. All data will be destroyed 7 years after completion of 
the study 
 
13) Potential Benefits to Subjects 
It is possible that families who have the intervention available to them find benefit 
in being able to participate in family-centered rounds while not being present in 
the NICU.  
 
14) Multi-Site Research 
N/A 
15) Community-Based Participatory Research 
N/A 
16) Sharing of Results with Subjects 
Results will not be shared with subjects. Summary of findings will be 
reported in the form of manuscripts and presentations at scientific 
meetings. 

PROTOCOL TITLE: Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: 
A Randomized Clinical Trial 
 
Page 11 of 11 
 
HRP-503-PTOTOCOL TEMPLATE-General 
 
 
Template Revision: January 17, 2020 
17) Prior Approvals 
N/A 
18) Provisions to Protect the Privacy Interests of Subjects 
 
All information will be kept in secure REDCap or Excel databases and the only 
link between the patient and the REDCap will be a Study ID. We will use a 
“Participant Log” excel file to store data that links the Study ID with the subject. 
This log will include the following information: Study ID, patient name, MRN, 
CSN, intervention vs. control arm, admit date, enrolled date, parent identify (e.g., 
“mom”), parent cell/email preferred contact, subscription status, and disposition. 
This “Participant Log” will be stored on the secure UC Davis server. 
Families will be free to use the intervention if/when it works for them. Families 
randomized to the intervention can opt out of using it entirely, with no penalty to 
them or their child. Families are free to answer (or not answer) the surveys the 
week of discharge and at 30, 60, and 90 days after discharge, with no penalty to 
them or their child. 
Only members of the research team will have access to the data.  
 
19) Compensation for Research-Related Injury 
N/A 
20) Economic Burden to Subjects 
N/A 
21) Drugs or Devices 
N/A 
22) Review Requirements 
        Are there any contractual obligations or other considerations that 
require IRB review of this research, or review at intervals other 
than those required by the Common Rule or FDA? If yes, check 
box: 
 
 Yes 
 
 No 
 

 
STATISTICAL ANALYSIS PLAN 
Statistical methods for primary and secondary outcomes 
Our primary analysis strategy will analyze all available data from participating family 
units and their members, with groups defined according to the randomized assignment 
(intervention versus control) for that family unit. We will use graphical and analytical descriptive 
statistics to summarize infant, parent, and family unit characteristics. We will use methods for 
clustered survey data to adjust confidence intervals for family units with multiple parental 
respondents. We will not use cluster-adjusted confidence intervals for family units with multiple 
infants unless the mean number of infants per family unit unexpectedly exceeds 1.10. 
We will use generalized linear models to estimate intervention effect sizes and 
confidence intervals and to test hypotheses for outcomes. Independent variables will include a 
binary indicator for intervention assignment along with a parsimonious set of subject 
characteristics as covariates (parent age, race, ethnicity, gender, education, transportation 
security, marital status, other children dependents, digital literacy score). We will specify the 
generalized linear mixed models as linear, logistic, or Poisson regressions, according to the 
outcome type. Random effects will be specified to accommodate the multilevel structure of the 
data and the nesting of longitudinal measurements, when applicable, within parents and the 
nesting of parents and infants within family units. 
To account for increased exposure among subjects with longer neonatal intensive care 
unit (NICU) stays when analyzing the primary outcome, we will use Poisson regression to 
compare rates for the family-centered rounds (FCR) parent attendance outcome between 
intervention vs. control group subjects, using the numerator for this outcome as the dependent 
variable and using the logarithm of the denominator as an offset term. We will also use Poisson 

 
regression for analyzing the error rate outcomes, with the offset being the logarithm of the number 
of days in the NICU. The exponentiation of the Poisson regression coefficient for the treatment 
indicator will thus represent an adjusted between-arm rate ratio for FCR parent attendance. 
For parent experience and family-centered care, we will use the top-box scoring method 
and assess intervention effects on the individual items as well as on the summary scores. For 
parent health-related quality of life (HRQOL), we will similarly assess the intervention effects on 
the PedsQL™ Family Impact Module 36 items, eight subscales, and summary scores (overall 
total score, Parent HRQOL Summary score, and Family Functioning Summary score). To 
accommodate the longitudinal data collection for the HRQOL outcomes, we will use generalized 
linear mixed models that include main effects for time, study arm, and the interaction, to estimate 
timepoint-specific intervention effects. We will also evaluate the effect of the intervention on the 
remaining outcomes.  
Interim analyses  
Interim analyses will not be conducted during this trial. 
Methods for additional analyses (e.g. subgroup analyses)  
We will conduct mediation analysis to evaluate relationships between parent activation 
and the other secondary and exploratory outcomes. We will also evaluate relationships between 
FCR attendance and the other outcomes. For example, the intervention effect on HRQOL may be 
mediated by FCR attendance with a dose-response relationship. Thus, if we find a positive 
intervention effect on HRQOL, we will explore FCR attendance mediation using similar 
methods. We anticipate that the intervention effect on the following outcomes will be mediated 
by FCR attendance with a dose-response relationship: parent experience, family-centered care, 
parent activation, parent HRQOL, length of stay, and breastmilk feeding.  

 
We will explore heterogeneity of the treatment effects, using rigorous analyses based on 
including interaction terms for the candidate effect modifier and the intervention effect term(s). 
Candidate effect modifiers will include residence-to-NICU distance, neighborhood health 
conditions, parent race and ethnicity, parent transportation security, other children dependents, 
parent computer/smart device access, parent internet access, and parent digital literacy score. For 
these terms, each will be evaluated without correction for multiple discovery. Other candidate 
effect modifiers will be evaluated as part of a comprehensive examination of intervention effects 
and for these, we will control the false discovery rate at 10%. 
We will decompose the FCR parent attendance outcome measure by the type of 
attendance to separate the in-person and virtual components. We will explore the type of 
attendance as an outcome variable and as a predictor of the secondary outcomes. We will include 
a statistical exploration within the intervention arm for whether higher virtual FCR attendance is 
associated with differences in in-person FCR attendance. Additionally, we will fit regression 
models for each secondary outcome that simultaneously include measures of both virtual and in-
person FCR attendance, allowing us to assess and compare whether the incremental benefits of 
higher FCR attendance are similar between both types of attendance.  
Methods in analysis to handle protocol non-adherence and any statistical methods to 
handle missing data 
The primary analysis strategy – a modified intention-to-treat analysis – differs from 
intention-to-treat only in that it will not require replacing missing data with imputed values. This 
‘complete-case’ analysis strategy assumes that missingness is at random. Sensitivity analysis 
using multiple imputation will be performed to assess the potential impacts of nonignorable 
missingness and alternative approaches for handling infants whose disposition is not to the home 

 
and thus for whom the outcome may not be as applicable. In particular, for the few infants who 
transfer to another unit or hospital, the parent-reported outcomes and the 30-day 
revisit/readmission outcomes are of limited applicability. Our modified intention-to-treat analysis 
will include these subjects, but alternative analysis that excludes such outcomes from infants not 
discharged to home would be warranted. We will also estimate alternative treatment effects, such 
as per-protocol and as-treated.