Introduction
Introduced in 2004, the home monitoring programme serves as an early warning system for the fragile population of single ventricle infants discharged home from the hospital. It has been shown to reduce interstage mortality and improve clinical outcomes for this population.Reference Ghanayem, Cava, Jaquiss and Tweddell1–Reference Staehler, Schaeffer and Wasner10 The programme follows infants from hospital discharge after their first surgery as a neonate until their second surgery, between four and six months of age—this interval is referred to as the interstage period.Reference Ghanayem, Hoffman and Mussatto11 Once home, parents keep a log of daily oxygen saturations, heart rates, weights, and feeds in a written journal or electronic monitoring application. They are instructed to contact their clinical team for any red flags, also called breaches, which are clinical changes that can indicate clinical deterioration of the infant.Reference Rudd, Ghanayem and Hill12,Reference Nieves, Uzark, Rudd, Strawn, Schmelzer and Dobrolet13 During this interstage period, there are weekly surveillance communications with the families, care coordination with other services, and general management and support from the team.
In the early years of home monitoring, enrolled infants were primarily diagnosed with hypoplastic left heart syndrome or other single ventricle cardiac lesions who had undergone a Stage I Norwood surgical intervention. They then exited the programme at four to six months of age, when they underwent the second stage of single ventricle palliation, the bidirectional Glenn procedure, and achieved a more stable cardiac physiology. Today, this monitoring is considered a standard of care.Reference Rudd, Ghanayem and Hill12 Recent interventional and surgical innovations, however, have changed the entry and exit points of the programme for many patients.
For the cyanotic infant with ductal-dependent pulmonary blood flow, the use of transcatheter ductal stenting in the cardiac catheterisation lab has become a viable alternative to a surgical shunt and may lead to fewer complications and shorter length of stay.Reference Aggarwal, Petit, Glatz, Goldstein and Qureshi14,Reference Tseng, Truong and Peck15 In one retrospective study, a threefold increase in the use of transcatheter ductal stenting between 2016 and 2021 was observed for infants with ductal-dependent pulmonary blood flow.Reference Valencia, Staffa and Kuntz16 Because of their single ventricle type physiology, these patients are also followed by the home monitoring programme. In addition, a small portion of these patients undergo biventricular repair closer to a year of age and remain in the home monitoring programme until that time. The evolution of intervention strategy and timing has impacted the multifaceted management plan, resulting in the need to evaluate this population of complex infants and their trends of care during the interstage period.
While interstage complexity and mortality are well known for this population, understanding the patterns of care for the primary interstage monitoring team has not been studied. Despite tremendous success of interstage monitoring, operationalisation of these programmes has not been examined. To inform the needs for future patients and their families, we will describe and quantify patterns of care and the required clinical support and management for patients in the home monitoring programme.
Materials and methods
Study design
This was an IRB-approved, single-site, retrospective, descriptive review of infants enrolled in a home monitoring programme from 2010 to 2020 (IRB-P00041067). All neonates with single ventricle cardiac physiology or biventricular shunt-dependent lesions that underwent an initial intervention and exited the programme between January 1, 2010, and December 31, 2020, were eligible for inclusion. Patients were excluded from this study if they did not have an initial intervention, had their first intervention outside of the first 30 days of life, were never discharged home from the acute hospital setting, transferred to another hospital and/or did not stay in the United States for the interstage period.
Study setting
The study took place at a free-standing quaternary care children’s hospital in the northeast United States. The care for children born with CHD takes place within a large heart centre. On average, 35 to 40 infants with single ventricle complex CHD are enrolled in the interstage monitoring programme per year. In the first 10 years of the programme at our centre, the mortality rate decreased from 12% in 2009 to 4.5%.Reference Brown, OBrien and Cohen17 The goals of the programme are to 1) be an early warning system to identify clinical deterioration and 2) optimise growth, targeting average weight gain of 20 to 30g per day. Families receive education prior to discharge from the advanced practice registered nurse and registered dietitian. This training includes 1) use of the infant scale and pulse oximeter, 2) tracking of daily oxygen saturations, weights, and feeds in either the written journal or electronic monitoring app, 3) review of red flags (also called breaches), and most importantly 4) who to contact when these red flags are noted, as a flag can indicate need for prompt evaluation. Once discharged, the advanced practice registered nurse and registered dietitian each speak with the family by phone weekly to assess clinical changes, growth, and nutrition needs and provide general support. Frequent appointments with the paediatrician and cardiologist complement the weekly surveillance calls.
Data collection
We abstracted demographic and clinical data from the electronic medical record to create a description of the index admission and subsequent interstage period. The index admission was the initial admission during which the first staged intervention took place. In most cases, this was a Stage I Norwood operation, but it could also be other surgical or catheter interventions for infants with single ventricle physiology or biventricular CHD with ductal-dependent pulmonary blood flow. For the index admission, this data included cardiac diagnosis, prematurity, comorbidities, initial intervention type, and length of hospital stay.
The interstage period started on the date of discharge from the index admission. Exit from the home monitoring programme was the date of the Stage 2 or bidirectional Glenn surgery (or in some cases biventricular surgery), transfer to the transplant team, death, or per discussion with the primary cardiologist. Outcomes of interest were the number and frequency of emergency department visits only (i.e. no associated admission), unplanned hospital admissions, early cardiac catheterisation due to a breach, surgical interventions (cardiac and non-cardiac), and mortality (occurrence of death during the interstage period).
To describe current patterns of care provided by the designated home monitoring advanced practice registered nurse and registered dietitian, patient progress notes from 2019 and 2020 were abstracted from the electronic medical record. Variables that were collected from these encounters included the date of communication, the amount of time spent per encounter, the content of the note, and the author. Encounters were stratified into three themes: 1) Clinical Management (assessment of infant’s condition via review of oxygen saturations, heart rates, weights, and feeds with subsequent management modifications to address changes in their condition); 2) Care Escalation (response to changes in the infant’s condition); and 3) Care Coordination (communication with other care providers to provide appropriate responses to changes in the infant’s condition) (Figure 1). The three themes for each communication were assigned a level of care, either standard/routine or advanced/complex.
Patterns of care during the interstage period.

Figure 1. Long description
A table comparing standard and advanced levels of care for infants in a home monitoring program. The table has three main sections: Clinical Management, Care Escalation, and Care Coordination. Each section is divided into two columns: Standard/Routine Level of Care and Advanced/Complex Level of Care. Clinical Management includes assessment of the infant’s condition via review of oxygen saturations, heart rates, weights, and feeds, with subsequent changes in medication, formula, calorie or volume adjustments, and graduation calls. Advanced/Complex Level of Care includes more frequent communication, engagement of multiple additional strategies for persistent difficulty with oral intake or weight gain, and RD pre-discharge teaching for non-English speakers. Care Escalation includes responses to changes in the infant’s condition, with Standard/Routine Level of Care involving continued monitoring, review of App data, and education with family, while Advanced/Complex Level of Care involves clinic visits, ED visits, hospital admission, and communication with VNA, PCP, cardiologist, or Case Management. Care Coordination includes communication with other care providers, with Standard/Routine Level of Care involving notes sent for routine review and HMP/RD pre-discharge coordination, and Advanced/Complex Level of Care involving verbal/additional written communication and new care coordination with ancillary services.
Because language barriers adversely impact clinical processes and outcomes, professional interpreters provided through the hospital contracted service were used for every encounter for parents with limited English proficiency.Reference Goenka18 It is recognised that language barriers complicate the delivery of care and increase the nurse’s stress and workload.Reference Gerchow, Burka, Miner and Squires19 Errors in medical interpretation are common.Reference Flores, Laws and Mayo20,Reference Flores, Abreu, Barone, Bachur and Lin21 Furthermore, patients with limited English proficiency have a higher 30-day risk of readmission.Reference Squires, Ma, Miner, Feldman, Jacobs and Jones22 Given the critical nature of accurate assessment and the increased workload, communications with limited English proficiency families were assigned an Advanced/Complex level of care for the two themes, clinical management and care escalation.
After the assignment of the level of care for the three themes of each encounter, a 10% confirmatory check of the data was then conducted, with a 92% reliability result.
Study data were collected and managed using REDCap, hosted at our institution.Reference Harris, Taylor, Thielke, Payne, Gonzalez and Conde23,Reference Harris, Taylor and Minor24 REDCap (Research Electronic Data Capture) is a secure, web-based software that supports data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) a track record for data and export procedures; 3) automated export procedures for data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.Reference Harris, Taylor, Thielke, Payne, Gonzalez and Conde23,Reference Harris, Taylor and Minor24
Analysis
Data were extracted from the cardiology home monitoring REDCap database and the patient’s electronic medical record. Any records with more than 20% data missing were excluded from the study. Summary statistics were performed for sample demographic, clinical, and surgical characteristics, interstage events, and patterns of care, which included means, standard deviations, medians, and ranges for continuous variables, and counts and percentages for categorical variables. Analyses for this study were supported using SPSS 29.
Results
Index admission
Between 2010 and 2020, 334 infants in the home monitoring programme met the inclusion criteria for this study. Demographic and clinical characteristics are summarised in Table 1. Hypoplastic left heart syndrome and its variants made up half of the patients (n = 168). Eight percent (n = 25) were premature (gestational age < 37 weeks). Twelve percent (n = 38) had heterotaxy syndrome, and almost 10% had a genetic syndrome (other than heterotaxy syndrome) or anomaly (n = 32). Fifty-five percent of patients (n = 185) underwent a Stage I Norwood as their initial intervention. Thirty percent (n = 102) had some other surgical intervention and were considered to have staged single ventricle physiology. Thirty-three patients (10%) had a patent ductus arteriosus stent placed in the cardiac catheterisation lab as their initial intervention. Lastly, 31 (9%) of the patients’ families had limited English proficiency. The median length of the index admission was 32 (5–191) days for all patients. There was minimal difference in the median length of stay for the 268 patients from 2010 to 2018 (33, 5–139 days) and the 66 patients from 2019 to 2020 (31, 5–191 days).
Index admission and interstage events (n = 334 patients)

Table 1. Long description
A table summarizing index admission and interstage events for 334 patients. The table has 25 rows and 2 columns. The columns are labeled ‘Index admissions’ and ‘Frequency (%)’. The rows are grouped into several categories: Diagnosis, Co-morbidities, Initial intervention, Non-English speaking, Interstage events, Admissions, Interstage catheterisations and surgeries, and Interstage mortality. Each row lists a specific condition, intervention, or event along with its frequency percentage. Notable entries include Hypoplastic left heart syndrome and variants with a frequency of 50.3 percent, Stage 1 Norwood with a frequency of 55.4 percent, and Interstage mortality with a frequency of 4.5 percent.
In the 2019–2020 subset of patients used to examine patterns of care, characteristics of the index admission were similar to the earlier 2010–2018 cohort, with a few notable exceptions. Twenty-nine percent of the patients during this time had a ductal-dependent cyanotic cardiac lesion compared to 11% for the first eight years of patients. Fourteen percent of patients from 2019 to 2020 were premature compared to 6% of patients from 2010 to 2018. Fifteen percent of patients from 2019 to 2020 had a genetic syndrome or abnormality compared to 8% for the early cohort. Finally, 38% of patients between 2019 and 2020 underwent placement of a patent ductus arteriosus stent as their initial intervention compared to 3% from 2010 to 2018.
Significant interstage events
Significant interstage events are also outlined in Table 1. Mortality during the interstage period was 15 patients or 4.5%. Seventy-six patients (23%) had at least one visit to the emergency department that was not associated with admission. Almost two-thirds of the patients (n = 210, 63%) had an unplanned admission to the hospital. Most patients (n = 282, 84%) had a cardiac catheterisation, and 88 patients (26%) had an early catheterisation due to a red flag. Ten patients (3%) underwent cardiac surgery, and 27 (8%) had undergone non-cardiac surgery. The median length of the interstage period was 118 days (3–458) for all patients in this study. The median duration of the interstage period was slightly higher for the later 2019–2020 group (122 days, 3–358) compared to the earlier 2010–2018 cohort (116 days, 3–458).
In the 2019–2020 subset of patients used to examine patterns of care, interstage events were similar to the earlier 2010 to 2018 cohort, with two exceptions. Fifty-five percent of patients from 2019 to 2020 had at least one planned admission compared to 30% in the earlier 2010–2018 group. A higher percentage of patients in the latter group (33%) underwent an early cardiac catheterisation due to a breach compared to 25% in the 2010–2018 group.
Interstage encounters with the home monitoring team
Encounter types were evaluated by looking at three themes: Clinical Management, Care Escalation, and Care Coordination. For each theme, the encounter was assigned a standard or advanced level of care (Figure 1). For the 1,421 encounters, 17% (n = 247) required an advanced level of clinical management; 17% (n = 247) required an advanced level of care escalation; and 6% (n = 85) required an advanced level of care coordination.
During 2019 and 2020, there were a total of 1,421 encounters for 68 patients. Sixty-six percent (n = 932) of these were with the registered dietitian, and 34% (n = 489) were with the advanced practice registered nurse. Fourteen percent (n = 204) of the encounters required an interpreter. Encounter types were broken down into five categories. Pre-discharge teaching or communication accounted for 7% (n = 105) of the encounters. Outpatient communication made up the majority of encounters at 82.5% (n = 1172). Voicemail communications were included if there was a review of the patient’s data entered in the electronic app. This was 4.5% (n = 64) of outpatient encounters. Four percent (n = 52) were encounters documenting exit or graduation from the programme. Additionally, 2% (n = 28) of communications were miscellaneous encounters.
The median documented length of all encounters was six minutes, with an IQR of four to 15 minutes. Encounters using an interpreter required twice as much time (median value of 10 minutes) as encounters without an interpreter (median value of 5 minutes) with p < 0.001 between the two groups (Table 2).
Encounters using an interpreter

Table 2. Long description
A table comparing encounters with and without an interpreter. The table has 12 rows and 8 columns. The columns are labeled ‘Interpreter needed’, ‘No (n = 1217)’, ‘n’, ‘%’, ‘Yes (n = 204)’, ‘n’, and ‘%’. The rows are labeled ‘Performed by’, ‘Registered dietitian’, ‘Advanced practice registered nurse’, ‘Encounter type’, ‘Pre-discharge teaching or communication’, ‘Outpatient communication’, ‘Voicemail’, ‘Graduation’, and ‘Other’. The table also includes a section for ‘Time (minutes)’ with columns for ‘Mean (Min, Max)’, ‘Median (IQR)’, and ‘p value’. Row-wise data: Row 1: Performed by. Row 2: Registered dietitian, 786, 64.6, 146, 71.6. Row 3: Advanced practice registered nurse, 431, 35.4, 58, 28.4. Row 4: Encounter type. Row 5: Pre-discharge teaching or communication, 93, 7.6, 12, 5.9. Row 6: Outpatient communication, 992, 81.5, 180, 88.2. Row 7: Voicmail, 59, 4.8, 5, 2.5. Row 8: Graduation, 45, 3.7, 7, 3.4. Row 9: Other, 28, 2.3, 0, 0. Row 10: Interpreter needed. Row 11: Time (minutes), 10.54 (2, 75), 12.63 (2, 60), 0.042, 5 (4, 15), 10 (6, 15), <0.001.
Discussion
Information generated from this study describes an infant population with single ventricle physiology that is fragile and complex. At birth, they undergo complex surgical and catheter interventions. They often experience a prolonged recovery and are vulnerable to multiple complications. Due to their age and tenuous circulation after the first staged intervention, these infants’ clinical status can deteriorate rapidly. Upon discharge home, the home monitoring programme provides a safety net and early warning system for the infants and their families.
This retrospective review of the first 10 years of our programme describes the array of complex lesions and types of initial staged procedures followed at home with interstage monitoring. Patient characteristics in the cohort are similar to other studies; however, until recently, most studies have looked primarily at home monitoring for patients who have undergone a Stage I Norwood (BTTS or Sano) or solely a modified BTTS as their first staged intervention.Reference Petit, Fraser, Mattamal, Slesnick, Cephus and Ocampo2,Reference Rudd, Frommelt and Tweddell4–Reference Oster, Ehrlich and King6,Reference Gardner, Mercer-Rosa and Faerber9 For infants with ductal-dependent lesions, the initial staging approach has evolved, and a greater number of patients are undergoing catheterisation for placement of a patent ductus arteriosus stent as their initial intervention. These patients typically have a shorter length of stay after this intervention compared to surgical patients and are thus followed at home for a longer period. Our data did not reflect a shorter length of stay, possibly related to the relatively recent increase in the use of this approach in this study’s cohort. Additionally, with an IQR of 91 to 246 days, there are a number of patients who continue to be followed by the programme well beyond six months of age.
In the 2019–2020 subset of patients used to examine patterns of care, many characteristics of the index admission were similar to the earlier 2010–2018 cohort. Notable exceptions were a higher percentage of ductal-dependent lesions, prematurity, and genetic syndrome/abnormalities in the 2019–2020 patient group compared to 2010–2018. The reason for these differences is likely multifactorial including changes in treatment approaches and intervention options for more complex infants. Given the increase in ductal-dependent lesions and prematurity, as well as recent procedural advances, it follows that there was an increase in the percentage of patients (38%) who underwent placement of a patent ductus arteriosus stent as their initial intervention compared to the earlier cohort (3%).
In terms of interstage events from 2019 to 2020, it also follows that if there are more patients with a patent ductus arteriosus stent as the initial intervention, then there is also an increase in planned admissions and early catheterisation due to a breach during the interstage period. Balloon angioplasty with or without stenting is a common reintervention within six months of the initial intervention.Reference Valencia, Staffa and Kuntz16 At our facility, there is a two-pronged follow-up approach to management of the patient with a patent ductus arteriosus stent once discharged home. One is the daily SpO2 check at home that is a pillar of the home monitoring programme. Two is scheduling the patient for a planned catheterisation approximately eight weeks after discharge. A greater number of patients with a patent ductus arteriosus stent as the initial intervention leads to more planned admissions and early catheterisation due to a breach.
Novel in this study is the description of provider-parent encounters. These encounters comprise three aspects—Clinical Management, Care Escalation, and Care Coordination—and two levels of care, standard and advanced. The specialised and experienced advanced practice registered nurse and registered dietitian monitor patients at home during the interstage period, and most encounters were assessed at a standard level of care. Length of encounter as an indicator for level of care was not used, as this was not uniformly measured by the advanced practice registered nurse and registered dietitian. Standardising reporting of length of encounter moving forward would assist in recognition of the level of care, with subsequent assignment of appropriate team support when encounters trend at an advanced level of care.
Using the newly developed Patterns of Care framework, more than 75% of encounters were assessed at a “standard level of care.” Review of encounters showed there were isolated advanced level of care occurrences when there were acute changes requiring an emergency room visit or unplanned admission.
Much of the time, a standard level of care is sufficient—for example, advancing calories, close monitoring, providing newborn support, and general care management. At times, the encounter requires more complex escalation, such as organising an unplanned higher level of care (e.g. clinic appointment, emergency room visit or hospital admission), and/or utilising additional clinical providers or resources. For families with limited English proficiency, however, every encounter requires a professional interpreter and sufficient time to clarify and confirm information, parent concerns, and management changes. These encounters necessitate more time which is both clinically and statistically significant. Using the metric of time to quantify clinical workload significance supports the complex level of care assigned to encounters with families with limited English proficiency.
Regardless of their defect, intervention type, or length of hospital stay, when the single ventricle infant is discharged from the hospital, this indicates a clinical level of stability to be home. However, these infants have a known tenuous physiology during the interstage period, and their clinical status can change quickly. The home monitoring team, collaborating with the cardiologist and paediatrician, serves as the safety net to support families navigating this complexity at home. Future work should compare interstage events rates and encounter complexity between patients with a surgical intervention and patients with PDA stent placement as their initial intervention. This would in turn help inform the question as to whether these two groups of patient types carry the same risk during the interstage period and thus help better target surveillance, support, and resources.
Further areas to explore include the role of digital monitoring programmes and other resources in bridging language challenges. Using the Pattern of Care framework, a standardised documentation can be applied, facilitating early identification of vulnerabilities and opportunities to improve the monitoring of medically complex infants. As there is a growing demand to manage and monitor other complex patient populations at home, it is important to understand the support and resources required to do this. Future work to stratify characteristics of the index admission (e.g. length of stay, defect, intervention type) and frequency and timing of encounters with advanced level of care during the interstage period could further inform the use of home monitoring programme support and resources. Limitations of this study include the inherent nature of a single-centre retrospective review. Home monitoring programmes are organised differently from facility to facility, and the results from our centre may not necessarily be generalisable to other centres.
The advanced practice registered nurse-led interstage home monitoring programme supports an increasingly complex and fragile population of single ventricle infants and their families at home. Using the newly developed Patterns of Care framework, more than 75% of encounters were assessed to be “standard level of care.” Encounters with limited English proficiency families were designated an advanced level of care. The statistically significant metric of time for these encounters validates this designation. Valuable next steps would include a comparison of interstage encounter complexity and frequency between patients who undergo a Stage I Norwood and patients who undergo placement of a PDA stent.
Acknowledgements
We would like to acknowledge Dr Mary Poyner Reed and the Nursing Science Fellowship for their support and guidance, as well as Elizabeth Cove for her assistance with data retrieval, and Dr Hangying She for her assistance with data analysis.
Financial support
This project was funded by the Inquiry Investment Drives Evidence into Action Grant from Boston Children’s Hospital, grant number 90324.
Competing interests
None.