BACKGROUND AND OBJECTIVES

Consumer home monitors (CHM), which measure vital signs, are popular products marketed to detect airway obstruction and arrhythmia. Yet, they lack evidence of infant death prevention, demonstrate suboptimal accuracy, and may result in false alarms that prompt unnecessary acute care visits. To better understand the hospital utilization and costs of CHM, we characterized emergency department (ED) and hospital encounters associated with CHM use at a children’s hospital.

METHODS

We used structured query language to search the free text of all ED and admission notes between January 2013 and December 2019 to identify clinical documentation discussing CHM use. Two physicians independently reviewed the presence of CHM use and categorized encounter characteristics.

RESULTS

Evidence of CHM use contributed to the presentation of 36 encounters in a sample of over 300 000 encounters, with nearly half occurring in 2019. The leading discharge diagnoses were viral infection (13, 36%), gastroesophageal reflux (8, 22%) and false positive alarm (6, 17%). Median encounter duration was 20 hours (interquartile range: 3 hours to 2 days; max 10.5 days) and median cost of encounters was $2188 (interquartile range: $255 to $7632; max $84 928).

CONCLUSIONS

Although the annual rate of CHM-related encounters was low and did not indicate a major public health burden, for individual families who present to the ED or hospital for concerns related to CHMs, there may be important adverse financial and emotional consequences.

Consumer home monitors (CHM), which measure vital signs and generate alarms for apnea, tachycardia, bradycardia, and/or desaturation, are popular products marketed to detect airway obstruction1  and arrhythmia,2  and are marketed to parents as a safety measure.3  The market for CHMs has grown rapidly, with 1 CHM manufacturer reporting revenue of $49.8 million in 20194  and the global infant CHM market expected to reach $1.9 billion by 2027.5  Yet, the American Academy of Pediatrics discourages CHM use because of lack of evidence of efficacy in preventing infant death.6,7  In contrast to medical-grade monitors prescribed by a provider for use at home, CHMs are marketed as wellness products and have avoided regulation by the US Food and Drug Administration, despite numerous warnings from the US Food and Drug Administration dating as far back as 2016.8  In addition, CHMs have suboptimal accuracy,3  which may result in false alarms that prompt unnecessary acute care visits. Measuring acute care utilization associated with CHM use would inform the understanding and assumed negative public health impact of CHM use at home. The goal of this study was to characterize emergency department (ED) and hospital encounters associated with CHM use at a children’s hospital.

This study was reviewed by the hospital’s institutional review board and determined to meet exemption criteria. We analyzed documentation from all EDs (n = 293 591) and direct hospital admissions (n = 9413) for infants 0 to 12 months between January 1, 2013 and December 31, 2019 (total n = 303 004). Using structured query language and the relational database extract of our electronic health record (Epic, Verona, WI), we searched the free text of all initial ED and direct admission notes to identify clinical documentation in which a CHM keyword was mentioned.

The query was conducted in several phases. First, based on clinical documentation experience, the study team created a preliminary keyword list and queried all ED documentation during the study period. Keywords appeared in 757 encounters by 408 unique patients. Next, a representative sample of note sections was reviewed, (15%, 20 keyword-containing note sections per study year). An additional 10 keywords were identified, yielding an expanded keyword list (Supplemental Information). Using this list, all ED and direct admission documentation during the study period were queried; this query was restricted to infants 0 to 12 months. Keywords appeared in 1103 encounters by 870 unique patients. To further expand keyword capture, a representative sample of notes from different note author roles (ED nurse, provider, etc) were randomly selected and reviewed (15%, 50 notes from each role). This secondary review did not identify additional keywords, indicating the second query had approached maximum sensitivity.9 

Documentation identified by a CHM keyword underwent independent review by 2 physicians. Reviewers categorized documentation of CHM use (documented CHM, no CHM documented, or indeterminate CHM documentation) and listed etiologic diagnoses from a multiple-choice list of common diagnoses. Encounters in which only 1 reviewer confirmed CHM documentation (n = 12) or there were discrepant discharge diagnoses (n = 5) were either discussed by the reviewers or evaluated by a third reviewer. To assure consistent coding, 2 example texts from each category were discussed by the entire study team to create the coding definitions (coding definitions provided in Supplemental Information).

Encounters with documented CHM use were further evaluated by 2 physician reviewers to classify the role of CHM (primary cause of visit, secondary role, no role, or indeterminate) and categorize the discharge diagnoses. In cases where CHM was determined to play a primary or secondary role, clinical characteristics and measures of resource utilization were abstracted. Costs were extracted from the Pediatric Health Information System database (Children’s Hospital Association, Lenexa, Kansas), an administrative database with deidentified information from 50 US tertiary care pediatric hospitals. The Pediatric Health Information System data include standardized wage-index-adjusted charges by department (room and board, pharmacy, laboratory, clinical, supply, and imaging) and cost-to-charge ratios. Treatment costs were estimated as wage-index-adjusted charges multiplied by the corresponding cost-to-charge ratio, inflated to 2019 US dollars using the Medical Services component of the Consumer Price Index.

Among the ED and direct admission encounters for infants 0 to 12 months old during the study period (n = 303 004), keyword queries identified 1103 potentially CHM-related encounters. Review confirmed documentation of CHM use in 39 cases (Fig 1). In 36 encounters by 34 unique patients, CHM had a primary (n = 25, 69%) or secondary role (n = 11, 31%) in prompting the visit. Encounters mentioning CHM increased over the study period, more than doubling in the final year of the study (2019) compared with the prior year.

FIGURE 1

Confirmed documentation of CHM.

FIGURE 1

Confirmed documentation of CHM.

Close modal

All patients were under the age of 9 months at time of initial presentation (Table 1), with majority of presentations occurring within the first 3 months of life (n = 24, 67%). Over half of patients (n = 18, 53%) were born either preterm (<37 weeks; 8 patients, 24%) or early term (37 weeks to 38 weeks 6 days; 10 patients, 29%) per consensus definitions by multiple professional organizations.10  Most patients (n = 27, 79%) were non-Hispanic White, and all had English-speaking caretakers.

TABLE 1

Clinical and Sociodemographic Characteristics of Patients with CHM-Related Presentations (n = 34 patients across 36 encounters)

Characteristicsn (%)
Age at presentationa  
 0 through 30 d 9 (25) 
 31 d through 3 mo 15 (42) 
 4 mo through 9 mo 12 (33) 
Gestational age  
 Preterm (<37 wk) 8 (24) 
 Early term (37 wk to 38 wk 6 d) 10 (29) 
 Full term (≥39 wk) 15 (44) 
 Unable to verifyb 1 (3) 
Sex  
 Male 19 (56) 
 Female 15 (44) 
Race and ethnicity  
 Non-Hispanic White 27 (79) 
 Non-Hispanic Black 3 (9) 
 Declined 1 (3) 
 Non-Hispanic or Latino other 2 (6) 
 Hispanic or Latino 1(3) 
Caregiver’s preferred language  
 English 34 (100) 
Birth historyc  
 No complications 21 (62) 
 Complicated perinatal historyc 13 (38) 
Characteristicsn (%)
Age at presentationa  
 0 through 30 d 9 (25) 
 31 d through 3 mo 15 (42) 
 4 mo through 9 mo 12 (33) 
Gestational age  
 Preterm (<37 wk) 8 (24) 
 Early term (37 wk to 38 wk 6 d) 10 (29) 
 Full term (≥39 wk) 15 (44) 
 Unable to verifyb 1 (3) 
Sex  
 Male 19 (56) 
 Female 15 (44) 
Race and ethnicity  
 Non-Hispanic White 27 (79) 
 Non-Hispanic Black 3 (9) 
 Declined 1 (3) 
 Non-Hispanic or Latino other 2 (6) 
 Hispanic or Latino 1(3) 
Caregiver’s preferred language  
 English 34 (100) 
Birth historyc  
 No complications 21 (62) 
 Complicated perinatal historyc 13 (38) 
a

n = 36 in this category because 2 patients each presented twice.

b

Patient was noted to be “full term,” but no gestational age was documented.

c

Documented perinatal complications in encounter notes or birth history section (eg, required resuscitation, NICU stay, or emergency caesarian section for nonreassuring fetal heart tones).

Most encounters were initiated in the ED (29, 80%) as opposed to direct admission (7, 20%). Median length of stay (LOS) for ED-only encounters was 2.8 hours (interquartile range [IQR]: 2.2–4.2 hours). Patients admitted through the ED had a median hospital LOS of 1.4 days (IQR: 1.2–4.2 days; max 1.1 weeks). Median LOS was longer among direct admissions at 2.3 days (IQR: 1.5 days–5.6 days; max 1.5 weeks).

Patients were hospitalized in 20 (56%) encounters including 8 ICU admissions. As summarized in Table 2 and listed for each patient in the Supplemental Table 3, evaluation included laboratory testing in 16 encounters (44%), procedures (eg, EKG or 4-channel pneumogram) in 18 encounters (50%), and radiographic studies in 15 encounters (42%). In 3 encounters the infant received a neonatal sepsis evaluation; none were diagnosed with invasive bacterial infection. The leading discharge diagnoses were viral infection (13, 36%), gastroesophageal reflux (8, 22%), and false positive alarm (6, 17%). Diagnoses for the 8 ICU admissions included supraventricular tachycardia (2, 25%), viral infections (5, 63%), and fall or trauma (1, 13%). In both admissions for supraventricular tachycardia, the infants appeared well before the CHM alarm but became symptomatic with poor feeding, inconsolability, and a dusky appearance shortly after the alarm. Both infants converted to sinus rhythm with adenosine and were ultimately discharged on oral propranolol. Other potentially life-threatening presentations included an infant whose CHM alarm activated following an unwitnessed fall and an infant who was ultimately diagnosed with interstitial lung disease.

TABLE 2

Resource Utilization in Encounters Related to CHM Use (n = 36)

Resourcen (%)
Role of CHM total 36 (100) 
 Primary 25 (69) 
 Secondary 11 (31) 
Year of presentation total 36 (100) 
 2013 0 (0) 
 2014 2 (6) 
 2015 1 (3) 
 2016 4 (11) 
 2017 7 (19) 
 2018 7 (19) 
 2019 15 (42) 
Encounter types total 36 (100) 
 ED 29 (80) 
 Direct admissions 7 (20) 
Hospital admissionsb, % of total CHM encounters 20 (56) 
 ED admission to hospital ward 9 (25) 
 ED admission to intensive care (including NICU) 4 (11) 
 Direct admission to hospital ward 3 (8) 
 Direct admission to intensive care (including NICU) 4 (11) 
Laboratory testinga total 16 (44) 
 Phlebotomy 11 (31) 
 Respiratory viral testing 9 (25) 
 Cerebrospinal fluid analysis 3 (8) 
 Urine studies 3 (8) 
Proceduresa total 18 (50) 
 EKG 13 (36) 
 4-channel pneumogram 3 (8) 
 Lumbar puncture 2 (6) 
 Sleep study 1 (3) 
 pH probe 1 (3) 
Imaging studiesa total 15 (42) 
 Radiograph 13 (36) 
 ECHO 3 (8) 
 CT 2 (6) 
 Head ultrasound 3 (8) 
 Upper gastrointestinal contrast study 1 (3) 
Discharge diagnosisb  
 Viral infection 13 (36) 
 GERD or GER 8 (22) 
 False positive alarm 6 (17) 
 BRUE or ALTE 2 (6) 
 SVT 2 (6) 
 Viral infection and GERD or GER 1 (3) 
 Interstitial lung disease 1 (3) 
 Trauma or fall 1 (3) 
 Hypothermia 1 (3) 
 Abnormal movements 1 (3) 
Resourcen (%)
Role of CHM total 36 (100) 
 Primary 25 (69) 
 Secondary 11 (31) 
Year of presentation total 36 (100) 
 2013 0 (0) 
 2014 2 (6) 
 2015 1 (3) 
 2016 4 (11) 
 2017 7 (19) 
 2018 7 (19) 
 2019 15 (42) 
Encounter types total 36 (100) 
 ED 29 (80) 
 Direct admissions 7 (20) 
Hospital admissionsb, % of total CHM encounters 20 (56) 
 ED admission to hospital ward 9 (25) 
 ED admission to intensive care (including NICU) 4 (11) 
 Direct admission to hospital ward 3 (8) 
 Direct admission to intensive care (including NICU) 4 (11) 
Laboratory testinga total 16 (44) 
 Phlebotomy 11 (31) 
 Respiratory viral testing 9 (25) 
 Cerebrospinal fluid analysis 3 (8) 
 Urine studies 3 (8) 
Proceduresa total 18 (50) 
 EKG 13 (36) 
 4-channel pneumogram 3 (8) 
 Lumbar puncture 2 (6) 
 Sleep study 1 (3) 
 pH probe 1 (3) 
Imaging studiesa total 15 (42) 
 Radiograph 13 (36) 
 ECHO 3 (8) 
 CT 2 (6) 
 Head ultrasound 3 (8) 
 Upper gastrointestinal contrast study 1 (3) 
Discharge diagnosisb  
 Viral infection 13 (36) 
 GERD or GER 8 (22) 
 False positive alarm 6 (17) 
 BRUE or ALTE 2 (6) 
 SVT 2 (6) 
 Viral infection and GERD or GER 1 (3) 
 Interstitial lung disease 1 (3) 
 Trauma or fall 1 (3) 
 Hypothermia 1 (3) 
 Abnormal movements 1 (3) 

ALTE, apparent life threatening event; BRUE, brief, resolved unexplained event; GER, gastroesophageal reflux; GERD, gastroesophageal reflux disease; SVT, supraventricular tachycardia.

a

Totals may exceed 100% because of some patients receiving multiple tests, procedures, and imaging studies.

b

Totals may not equal 100% because of rounding.

Cost information was available for 35 encounters. Median cost for ED only visits was $233 (IQR: $118–$384; max $1510). Median costs were higher among direct admissions ($11 675, IQR: $3453–$26 254) compared with ED-initiated admissions ($6593, IQR: $3124–$21 721).

Using a rigorous EHR note text-mining approach, we identified CHM use contributing to 36 ED visits or direct admissions in a sample of over 300 000 encounters during a 7 year period. The rate of CHM-related encounters rose over time and occurred primarily in predominately non-Hispanic White infants with English-speaking caregivers. Hospital admission rates and resource utilization were high in CHM-related encounters, particularly among direct admissions. Therefore, even though the overall annual rate of CHM-related encounters was low and did not indicate a major public health burden, for individual families who present to the ED or hospital for concerns related to CHMs, there may be important adverse financial and emotional consequences.

This study has several important limitations. First, we do not know the extent of CHM use in this hospital’s catchment area or the proportion of monitor users in the catchment area that would present to this hospital with CHM-related concerns. Therefore, we cannot calculate population-based utilization rates. Second, notes are imperfect reflections of encounters. It is possible that some of the notes categorized as “indeterminate” might have been CHM-related. There may also be encounters instigated by CHM alarms in which CHMs were not discussed in documentation. However, we attempted to be expansive in our keyword search methodology, and no additional keywords were identified after a second iteration of the keyword search. The observed increase in CHM-related encounters over time also mirrors increasing sales of these devices, suggesting our methodology reflects CHM use patterns. Third, further research is needed to understand the effect of CHM on families (who may experience relief or anxiety associated with CHM use), and the challenges CHM pose to outpatient pediatricians.

In conclusion, while the overall hospital resource utilization burden of CHM was low, it is increasing over time. When patients presented for monitor-related concerns, resource utilization and hospital cost for the individual patient was high. Potentially actionable diagnoses were sometimes made, consistent with a prior report.2  It is unknown whether there would have been clinically important health impacts to these patients in the absence of CHM use or if they represent a form of overdiagnosis. While there are other compelling reasons for pediatricians to recommend against using CHM, the use of these products does not appear to be a frequent cause of ED or hospital visits in our catchment area.

FUNDING: This project was supported in part by grant number R18HS026620 from the Agency for Healthcare Research and Quality. The Agency for Healthcare Research and Quality had no role in the design or conduct of the study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.

CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest to disclose.

Dr Craig designed and conceptualized the study, conducted the analyses, and reviewed and revised the manuscript; Dr Rasooly participated in data collection and analysis and drafted the initial manuscript; Dr Kern-Goldberger participated in data collection and reviewed and revised the manuscript; Drs Luo, Mai, and Muthu participated in study design, created and implemented data queries, participated in data collection, and critically reviewed the manuscript; Drs Beus, Faulkenberry, and Herchline participated in data collection and review and critically reviewed the manuscript; Ms Brent participated in study design and oversaw data collection; Dr Bonafide designed and conceptualized the study, oversaw data collection, participated in data analysis, and critically reviewed the manuscript; and all authors approved the final manuscript as submitted.

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Supplementary data