The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss. Clinical decision support (CDS) displaying NEWT might facilitate its use. Our study’s objective is to determine the effect of CDS displaying NEWT on feeding and health care utilization.
At an hospital involved in NEWT development, we randomly assigned 2682 healthy infants born ≥36 weeks gestation in 2018–2019 either to CDS displaying NEWT with an electronic flag if most recent weight was ≥75th weight loss centile or to a control of usual care with NEWT accessed at clinician discretion. Our primary outcome was feeding type concordant with weight loss, defined as exclusive breastfeeding for those not flagged, exclusive breastfeeding or supplementation for those flagged once, and supplementation for those flagged more than once. Secondary outcomes included inpatient and outpatient utilization in the first 30 days. We used χ2 and Student’s t tests to compare intervention infants with control and to compare trial infants with those born in 2017.
Feeding was concordant with for 1854 (74.5%) trial infants and did not differ between randomized groups (P = .65); concordant feeding was higher for all trial infants than for infants born in 2017 (64.4%; P < .0005). Readmission occurred for 51 (3.8%) CDS infants and 45 (3.4%) control infants (P = .56). Among the 60% of trial infants with outpatient records available, there were 3.5 ± 1.7 visits with no differences between randomized groups (P = .10).
At an hospital involved in NEWT development, CDS displaying NEWT did not alter either feeding or health care utilization compared with discretionary NEWT access.
Initially, after birth, newborns typically lose weight steadily until feeding is well-established. For those exclusively breastfed, weight may not stabilize until 2 to 5 days after delivery.1,2 More pronounced early weight loss is associated with feeding type1–3 as well as with hyperbilirubinemia4–8 and dehydration,9 the 2 most common causes of newborn readmission. To avoid morbidity and preventable readmission, the Academy of Breastfeeding Medicine’s (ABM) supplementation guideline recommends that consideration should be given to supplementary feedings for newborns whose weight loss exceeds the 75th population percentile for hour of age.10
The Newborn Weight Tool (NEWT) is a free, publicly available, Web site that depicts a newborn’s weight loss in the context of normative reference nomograms for weight loss at each hour of age. These nomograms can be used by clinicians to help guide infant feeding decisions. Any clinician can use NEWT in its web-based form by manually entering newborn data, including weight, a process that requires 2 to 3 minutes of clinician effort, including navigation to a browser.
Clinical decision support (CDS) provides clinicians with knowledge and person-specific information in real time. When CDS delivers the right information to the right clinician in the right format through the right channel, and at the right time in the workflow, the ability of a health care organization to achieve targeted goals can be enhanced.11 The Substitutable Medical Applications and Reusable Technologies platform may enhance an institution’s ability to deliver CDS effectively in accordance with these 5 “rights” because it is designed to enable medical applications such as NEWT to run on any electronic health record (EHR) using the openly licensed Health Level Seven standard Fast Health Interoperability Resources. Our team developed CDS using Substitutable Medical Applications and Reusable Technologies on Fast Health Interoperability Resources to interface the NEWT web-based application with the EHR without the need for manual data entry to provide an automatic display of newborn weight in the context of reference norms.
Previous studies of CDS in other clinical domains have revealed variable effectiveness12,13 with ease of use being a major factor.14,15 No previous studies have examined the effect of CDS displaying NEWT or the effect of NEWT use on breastfeeding outcomes. We conducted a randomized controlled trial to compare our CDS displaying NEWT to usual care with NEWT available in a web-based format on the outcomes of newborn feeding and health care utilization. To assess whether the conduct of the trial itself might have impacted outcomes, we used an observational design to compare all trial infants with infants born in 2017, the year before trial initiation.
Methods
In this randomized controlled trial at an academic medical center that had participated in the original development of NEWT, we used the EHR (Epic, Verona, WI) to automatically identify eligible infants born from September 2018 to December 2019 and to randomly assign them to either to CDS or to usual care. A newborn medical record was eligible for randomization if the newborn was >6 hours old, had at least 1 weight documented after birth weight, and had a bed assignment in the newborn nursery. A newborn medical record was ineligible for randomization if the newborn was transferred to the intensive care nursery before randomization. At the time of study activities, all infants born <2200 g or at <36 weeks gestation were transferred to the intensive care nursery; thus, all randomly assigned infants were ≥2200 g and ≥36 weeks gestation. Feeding type was ascertained from discrete fields in the EHR. There were no exclusions by feeding type; 99.2% of study infants were ever breastfed.
The CDS intervention consisted of automatically displaying NEWT on the summary page of each infant’s EHR record along with a flag to indicate whether the most recent weight indicated loss ≥75th percentile (Fig 1). The flag included a link to the ABM guideline. No intervention other than the CDS display with a flag was provided by the study. Usual care was optional access through a standard browser to NEWT as a web-based application; the use of NEWT in the usual care group was not part of a standard workflow. Before launch, the UCSF Institutional Review Board (IRB) reviewed the study and determined that it was not human subjects research (17-23249). The IRB determination letter stated, “Based on the information you have provided to us, this is a project that includes program evaluations, quality improvement activities, or other activities that do not require additional IRB oversight according to the federal regulations summarized in 45 CFR 46.102(d).” This study was registered at clinicaltrials.gov (NCT03655314).
Clinical decision support displaying the Newborn Weight Tool with a banner flagging a normal weight loss pattern.
Clinical decision support displaying the Newborn Weight Tool with a banner flagging a normal weight loss pattern.
The primary outcome of this study was feeding concordant with weight loss, defined as exclusive breastfeeding for those not flagged, exclusive breastfeeding or formula supplementation for those flagged once, and formula supplementation for those flagged more than once. Exclusive breastfeeding was defined as breastfeeding or breast milk with no other enteral intake except for vitamins, minerals, and medications throughout the birth hospitalization. Secondary outcomes included length of stay, readmission, outpatient health care utilization, and exclusive breastfeeding. Additional covariables included maternal age and parity and infant sex, gestational age, and race or ethnicity. Data on the above variables were also collected for infants born in 2017 for comparison with the randomized cohort.
With an intention-to-treat approach, we used χ2 testing and Student’s t test to compare groups with respect to dichotomous and continuous outcomes, respectively. To explore whether the study itself had an impact on infant feeding practices, we used χ2 testing to compare feeding outcomes among trial participants with feeding outcomes among infants born in 2017 who met the same eligibility criteria as trial infants. We also conducted an interrupted time series analysis fitting a model allowing for a time trend before the intervention, an immediate change at the time of the intervention, and a modified time trend after the intervention. All statistical analyses were conducted by using Stata/IC 16.1 (Stata Corp., College Station, TX).
Results
Of 2682 newborns, 1346 (50.2%) received the CDS intervention. Demographic and clinical characteristics of the cohort are presented in Table 1.
Baseline Characteristics and Outcomes of Infants by Random Assignment and Trial Participation
| Variable | Clinical Decision Support Intervention, n = 1346 | Control, n = 1336 | Preintervention, n = 2860 | P Value for Pre and PostComparison |
|---|---|---|---|---|
| Vaginal delivery, n (%) | 943 (75.6) | 952 (76.3) | 2161 (77.0) | .40 |
| Gestational age, wk, mean (SD) | 39.4 (1.3) | 39.3 (1.3) | 39.3 (1.8) | .37 |
| Birth wt, g, mean (SD) | 3337 (456) | 3305 (453) | 3318 (475) | .93 |
| Female, n (%) | 651 (48.4) | 724 (54.2) | 1414 (49.4) | .17 |
| Race/ethnicity, n (%) | .15 | |||
| White | 620 (46.1) | 596 (44.6) | 1308 (45.7) | |
| Asian | 331 (24.6) | 333 (24.9) | 354 (12.3) | |
| Hispanic/Latinx | 160 (11.9) | 157 (11.8) | 643 (22,5) | |
| Black | 67 (5.0) | 75 (5.6) | 145 (5.1) | |
| Pacific Islander | 18 (1.3) | 15 (1.1) | 26 (0.9) | |
| N. American/N. Alaskan | 2 (0.2) | 2 (0.2) | 8 (0.3) | |
| Other/Unknown | 148 (11.0) | 158 (11.8) | 376 (13.2) | |
| Maternal age, mean (SD) | 34.1 (4.6) | 34.0 (4.6) | 33.5 (4.8) | <.0005 |
| Maternal primiparity, n (%) | 557 (51.2) | 555 (49.7) | 1321 (46.2) | <.0005 |
| Outcomes | ||||
| Feeding concordant with wt loss, n (%) | 932 (74.9) | 922 (74.1) | 1787 (64.4) | <.0005 |
| Exclusive breastfeeding, n (%) | 1112 (82.7) | 1101 (82.6) | 1930 (67.9) | <.0005 |
| Length of stay during birth hospitalization, d, mean (SD) | 2.4 (0.8) | 2.3 (0.8) | 2.4 (0.9) | .002 |
| Readmission, n (%) | 51 (3.8) | 45 (3.4) | 90 (3.2) | .37 |
| Outpatient visits in the first 30 d | 3.6 (1.7) | 3.4 (1.6) | 3.1 (1.5) | <.0005 |
| Preventive visits in the first 30 d | 1.6 (0.9) | 1.6 (0.0) | 1.4 (0.8) | <.0005 |
| Variable | Clinical Decision Support Intervention, n = 1346 | Control, n = 1336 | Preintervention, n = 2860 | P Value for Pre and PostComparison |
|---|---|---|---|---|
| Vaginal delivery, n (%) | 943 (75.6) | 952 (76.3) | 2161 (77.0) | .40 |
| Gestational age, wk, mean (SD) | 39.4 (1.3) | 39.3 (1.3) | 39.3 (1.8) | .37 |
| Birth wt, g, mean (SD) | 3337 (456) | 3305 (453) | 3318 (475) | .93 |
| Female, n (%) | 651 (48.4) | 724 (54.2) | 1414 (49.4) | .17 |
| Race/ethnicity, n (%) | .15 | |||
| White | 620 (46.1) | 596 (44.6) | 1308 (45.7) | |
| Asian | 331 (24.6) | 333 (24.9) | 354 (12.3) | |
| Hispanic/Latinx | 160 (11.9) | 157 (11.8) | 643 (22,5) | |
| Black | 67 (5.0) | 75 (5.6) | 145 (5.1) | |
| Pacific Islander | 18 (1.3) | 15 (1.1) | 26 (0.9) | |
| N. American/N. Alaskan | 2 (0.2) | 2 (0.2) | 8 (0.3) | |
| Other/Unknown | 148 (11.0) | 158 (11.8) | 376 (13.2) | |
| Maternal age, mean (SD) | 34.1 (4.6) | 34.0 (4.6) | 33.5 (4.8) | <.0005 |
| Maternal primiparity, n (%) | 557 (51.2) | 555 (49.7) | 1321 (46.2) | <.0005 |
| Outcomes | ||||
| Feeding concordant with wt loss, n (%) | 932 (74.9) | 922 (74.1) | 1787 (64.4) | <.0005 |
| Exclusive breastfeeding, n (%) | 1112 (82.7) | 1101 (82.6) | 1930 (67.9) | <.0005 |
| Length of stay during birth hospitalization, d, mean (SD) | 2.4 (0.8) | 2.3 (0.8) | 2.4 (0.9) | .002 |
| Readmission, n (%) | 51 (3.8) | 45 (3.4) | 90 (3.2) | .37 |
| Outpatient visits in the first 30 d | 3.6 (1.7) | 3.4 (1.6) | 3.1 (1.5) | <.0005 |
| Preventive visits in the first 30 d | 1.6 (0.9) | 1.6 (0.0) | 1.4 (0.8) | <.0005 |
SD, standard deviation.
Feeding concordant with weight loss occurred for 932 (74.9%) infants assigned to CDS displaying NEWT and 922 (74.1%) assigned to the control group (P = .65). Readmission occurred for 51 (3.8%) infants assigned to CDS displaying NEWT and 45 (3.4%) assigned to the control group (P = .56). Outpatient utilization also did not differ by treatment assignment. Exclusive breastfeeding during the birth hospitalization occurred for 1112 (82.7%) infants randomly assigned to CDS displaying NEWT and 1101 (82.6%) in the control group (P = .96).
Using χ2 analysis to compare all trial infants with 2860 infants born in 2017 before trial initiation who would have met trial eligibility criteria, feeding concordant with weight loss occurred less commonly for those born in 2017 than for trial newborns. Among those born in 2017, 1787 (64.4%) were fed concordant with weight loss, whereas, among trial newborns, 1854 (74.5%) were fed concordant with weight loss (P < .0005). Similarly, the proportion breastfeeding exclusively was lower among those born in 2017 than among trial newborns; 1930 (67.9%) infants born in 2017 breastfed exclusively, whereas 2213 (82.6%) trial infants breastfed exclusively (P < .0005). The relationship between year of birth and feeding method obtained through interrupted time series analysis is depicted in Fig 2.
Time series analysis comparing infant feeding concordance between trial infants and infants born the year before the trial.
Time series analysis comparing infant feeding concordance between trial infants and infants born the year before the trial.
Discussion
In this study of infants born at a single medical center with a high prevalence of exclusive breastfeeding, CDS did not increase the prevalence of either feeding concordant with weight loss or exclusive breastfeeding compared with the access of NEWT online at clinician discretion. In addition, CDS did not impact inpatient or outpatient utilization compared with the access of NEWT online at clinician discretion. Of note, however, in a post hoc analysis, all infants enrolled in the trial had a substantially better concordance of feeding with weight loss and substantially better rates of exclusive breastfeeding than historical controls born the year before the trial launch. One possible explanation for the observed results is that intermittent presentation to clinicians of CDS displaying NEWT could have potentially impacted feeding outcomes independent of individual random assignment. It is possible that intermittent presentation of CDS displaying NEWT promoted clinician learning that was carried forward from 1 encounter to another so that clinicians viewing randomly assigned CDS gained information that influenced future clinical management of all infants. It is also possible that concurrent trends unrelated to the NEWT CDS were responsible for the difference in outcomes over time, especially because of clinician awareness of NEWT and ABM guidelines was likely high at the enrolling institution that participated in NEWT development.
Existing literature clearly reveals that the effectiveness of CDS varies based on a clinical decision support design and clinician alert fatigue.13–16 Although repetitive CDS presentation may lead to clinician alert fatigue, it is possible that, in our study, intermittent CDS presentation led to ongoing clinical learning while avoiding alert fatigue. To our knowledge, no previous studies have tested the effectiveness of intermittent CDS presentation compared with universal CDS presentation, but such investigation might be informative.
Our study had several important limitations. First, NEWT is publicly available at www.newbornweight.org, and clinicians were able to access NEWT online for both intervention and control infants. Although familiarity with NEWT and online use of NEWT were not assessed in this study, enrollment occurred at an academic hospital that had participated in NEWT development, so clinician familiarity with NEWT was likely high. Because our study did not collect data regarding NEWT usage in the control group, our results describe only the effect of CDS displaying NEWT and do not directly address the question of whether NEWT usage is effective. Second, our study tested CDS using a format in which NEWT appeared as a sidebar with a flag for weight loss ≥75th percentile. It is not known whether a different display or flag design might affect the impact of CDS displaying NEWT on patient outcomes. Third, as noted above, temporal trends may have introduced confounding into our pre- and postanalyses comparing trial participants to infants born in 2017. A variety of breastfeeding promotion efforts have been ongoing at the enrolling hospital and across the state over the past decade and likely contributed to the observed increase in exclusive breastfeeding rates. Thus, the results of our time series analysis do not preclude the need for additional research to determine the effects of intermittent presentation of CDS to clinicians. Other potential study limitations include the use of administrative data for outcome assessment, incomplete outcome assessment from infants born at the study hospital who received follow-up elsewhere after discharge, and lack of data on clinician characteristics such as level of training, years of experience, or familiarity with NEWT online. These factors may have impacted our results.
Overall, our study revealed that, although CDS alone did not alter feeding practices or health care utilization, providing CDS displaying NEWT is feasible and consistent with improved overall clinical outcomes. It is possible that intermittent display of CDS displaying NEWT may be an effective approach to guiding provider behavior. Additional work is needed to determine the most effective methods of clinical decision support regarding feeding practices.
This study has been registered at www.clinicaltrials.gov (identifier NCT03655314).
FUNDING: This publication was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF-CTSI Grant Number UL1 TR001872. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. The funder did not participate in the work. Funded by the National Institutes of Health (NIH).
CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no potential conflicts of interest relevant to this article to disclose.
Dr Flaherman conceptualized and designed this study, analyzed and interpreted the data and drafted the manuscript; Mr Robinson and Ms Creasman contributed to study design and acquisition, participated in the analysis and interpretation of data, and critically revised the manuscript for important intellectual content; Drs McCulloch and Paul contributed to data analysis and critically revised the manuscript for important intellectual content; Dr Pletcher contributed to study design, analyzed and interpreted the data, and critically revised the manuscript for important intellectual content; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Comments