Trends in and Documentation of Refusal of Common Routine Newborn Interventions: 2013–2019

The study was performed in a single large health system in the Northeast consisting of 5 well newborn units. At the time of the study, of the 5 newborn units, 1 unit was located at the tertiary academic medical center, and 4 were at affiliated community hospital sites. The delivery volume at the tertiary academic medical center is ∼4500 deliveries a year. At the 4 affiliated community hospitals, the annual delivery volume is ∼5000 combined. Each delivery site has an ED affiliated with the hospital. The ED at the tertiary academic medical center is staffed primarily by pediatric clinicians, and the EDs at the community hospitals are staffed with a mix of pediatric and adult clinicians. The network of EDs within the health system provides a large catchment area for patients and families across the state.

All hospitals are on the same electronic medical record system (EPIC, Verona, WI), and administration of IM vitamin K, ocular prophylaxis, and HBV by the labor and delivery or postpartum nurse is documented in the medication administration record (MAR) per a standardized protocol across all well newborn units in the health system. IM vitamin K and ocular prophylaxis is administered routinely to all newborns shortly after birth unless the parent explicitly states that they do not want these interventions for their newborn (opt out). Parents who refuse IM vitamin K or ocular prophylaxis are asked to sign a refusal form after counseling by the clinician and the form is uploaded into the infant’s medical record. In our experience, omission of IM vitamin K or ocular prophylaxis because of an error is a rare event because of required nursing documentation and the refusal form. Before administration of HBV, verbal consent is obtained by the nurse or clinician from the parent (opt in).

For the purposes of this study, invasive procedures occurring during the birth hospitalization included any procedure with a risk for bleeding, including male circumcision, lumbar puncture, suturing a laceration, or frenotomy. There is no standardized process by which provision of IM vitamin K is confirmed before doing an invasive procedure. During the birth hospitalization, the majority of infants are seen by in-house hospitalists, and the remainder are seen by community clinicians. Most circumcisions are performed by obstetricians and a smaller proportion are performed by pediatricians. Clinicians use templated notes that have been customized over time between provider groups and sites, such that there are many note types in circulation, and, during the study period, none included information about vitamin K, ocular prophylaxis, and HBV administration, unless manually entered by the clinician. After discharge, the PCP identified by the parents receives an electronically faxed copy of the infant’s discharge summary with details of the infant’s birth hospitalization.

We performed a chart review of otherwise healthy newborns admitted to the well newborn units in our single large health system to determine the frequency of refusal of IM vitamin K, ocular prophylaxis, and HBV by a parent over a 7-year period. Our information technology team provided a data set that included whether IM vitamin K, ocular prophylaxis, and HBV were documented in the MAR and additional demographics (mother’s age, infant’s sex, infant’s race and ethnicity, insurance, gestational age, and type of delivery) for livebirths ≥35 weeks admitted to the well newborn units between 2013 and 2019. For infants who did not have IM vitamin K, ocular prophylaxis, or HBV documented in the MAR, notes were reviewed in each chart for documentation of refusal by clinician. Nursing notes were reviewed to confirm refusals.

We reviewed charts of infants who did not receive IM vitamin K for any invasive procedures done in the birth hospitalization and for documentation of IM vitamin K refusal in the admission and/or discharge notes. Charts of infants who did not receive IM vitamin K during the study period were also reviewed for visits to the ED in our single large health system for bleeding in the first 6 months of life and documentation of the absence of IM vitamin K prophylaxis during those visits.

We report the frequency of refusal of IM vitamin K, ocular prophylaxis, and HBV vaccine by year for all sites combined. We performed χ² analysis for differences across demographic variables between infants who did and did not receive IM vitamin K. We also performed χ² analysis for differences in refusal rates of IM vitamin K, ocular prophylaxis, and HBV vaccine by year. We report the frequency of documentation of IM vitamin K refusal in the admission and discharge notes by clinicians, ED visits for bleeding in the first 6 months of life, and invasive procedures done without IM vitamin K prophylaxis in the birth hospitalization. Analysis was performed by using SPSS version 26 (IBM SPSS Statistics, IBM Corporation). Institutional review board approval was obtained before study initiation.

Of 67 750 livebirths ≥35 weeks' gestational age admitted to 5 well newborn units in our single large health system over a 7-year period (2013 through 2019), 283 (0.4%) infants did not receive IM vitamin K, 1645 (2.4%) did not receive ocular prophylaxis, and 7551 (11.1%) did not receive HBV before discharge from the birth hospitalization.

Characteristics of our patient population and results of χ² analysis are shown in Table 1. We observed statistically significant differences between infants who did not receive IM vitamin K, compared with infants who did receive IM vitamin K with respect to the mother’s age, infant sex, infant race and ethnicity, and delivery type (P < .05). Infants who did not receive IM vitamin K were also more likely to not receive HBV, ocular prophylaxis, or both (P < .0001).

Trends in receipt of IM vitamin K, ocular prophylaxis and HBV by year are shown in Fig 1. In the χ² analysis there was an overall observed trend in increasing refusal of IM vitamin K (P < .05) and decreasing refusal of birth dose HBV (P < .0001) over time but no significant overall trend in ocular prophylaxis refusal over time (P > .05).

Of 283 infants who did not receive IM vitamin K, the refusal was documented by clinicians in the admission note and discharge summary in 152 (53.7%) and 141 (49.8%) of charts, respectively. Of 283 infants, 17 (6.0%) infants who did not have IM vitamin K administration documented in the MAR had an invasive procedure before hospital discharge. This included circumcision (n = 12), frenotomy (n = 4), and a lumbar puncture (n = 1). There were no bleeding complications, additional interventions, or further evaluations documented after the procedures.

Of 283 infants who did not receive IM vitamin K, 30 (10.6%) were seen in the ED within our single large health system in the first 6 months of life. There were no reports of VKDB. Four infants were evaluated for bleeding or potential for intracranial bleeding in the first 6 months of life: specifically, bloody stool at 8 weeks (n = 1), fall evaluation at 5 days and 4 months of life (n = 2), and evaluation for irritability at 3 weeks of life (n = 1). The infant with bloody stool was admitted to the inpatient pediatric unit for observation and discharged the next day. A total of 3 of the 4 infants were discharged from the ED after observation; no additional imaging or testing was performed. There was no documentation about absent IM vitamin K prophylaxis or risk for VKDB in any of these cases from the ED or inpatient unit.

Although the rates of IM vitamin K and ocular prophylaxis refusal have not increased dramatically over time in our institution, the lack of a significant decrease in refusal rates is notable. This suggests that in our local and state community, there is a small but steady group of expectant parents who remain skeptical. We did not find data on trends in IM vitamin K and ocular prophylaxis refusal in US hospitals reported in the literature to compare our findings with. Overall, refusal rates of IM vitamin K and ocular prophylaxis were similar to refusal rates reported in other studies in the United States.²  Uptake of the birth dose HBV in our institution was higher than the national average of 71.1% in 2016.⁸  Our findings are similar to national trends in the United States, with increasing rates of HBV coverage over recent years.⁹  The reason for this observation in our study is unclear and warrants further study.

Factors associated with the refusal of routine newborn interventions have been reported previously.²  With our findings, we confirm many of these factors still remain, including the increased likelihood that parents who refuse IM vitamin K are more likely to also refuse ocular prophylaxis and HBV.²  This suggests that some parents may have concerns about the entire bundle of standard newborn interventions. Conversely, investigators in Michigan reported that parents who declined 1 routine newborn intervention were not necessarily more likely to decline others.⁶  Investigators suspected that, for some parents in the local community, refusals were more tied to the immediate postdelivery period rather than long-term hesitation toward vaccines and other preventive measures.⁶  Why parents chose to refuse routine newborn interventions is out of the scope of this article, but one major reason for refusal is parents wanting fewer interventions to mimic a more naturalistic approach to their newborn’s care,^10,11  and this may explain the bundled refusals, in part. Characteristics of parents who tend to refuse IM vitamin K (white race; age: >30 years) are important with regards to targeting education and continuing to understand and address the hesitation in these specific groups of mothers.

A lack of documentation of refusals during the birth hospitalization can affect transitions of care (ToCs), ongoing counseling of hesitant parents, and, in the case of IM vitamin K refusal, follow-up care, especially when presenting with bleeding to the ED. From literature on vaccine hesitancy, health care professionals are an important, trusted, informative, and reliable source of information for parents, and face to face communication is one of the most effective strategies to mitigate hesitancy.¹²  In addition, reopening nonconfrontational dialogue and continuing to discuss the risks and benefits of immunization during subsequent patient encounters can help.¹³ 

Communication of refusals during ToCs and clear documentation in the electronic medical record (EMR) have implications for patient safety¹⁴  Barriers to ToCs in an ED setting can include “limited knowledge of patient’s history and preexisting conditions.”¹⁵  Clear documentation in the EMR can provide important information to alert a clinician to consider VKDB in the differential of an infant with bleeding who did not receive IM vitamin K prophylaxis. Of infants who did not receive IM vitamin K in our study, 10% were seen in an ED in our delivery network. A few infants were evaluated for bleeding and risk for intracranial bleeding after a fall, without mention of the risk for VKDB in the absence of prophylaxis.

Procedures done during the birth hospitalization in infants without documentation of IM vitamin K warrant further investigation. It may be that the combination of high delivery volume and wellness bias contributes to the lack of awareness. Although bleeding after a frenotomy is rare, this procedure is an opportunity to discuss IM vitamin K refusal. Given the rarity of both VKDB and IM vitamin K refusal, it is important to maintain a high index of suspicion.

We identified the following problems with documentation of refusals in the birth hospitalization: (1) inconsistent documentation of refusal after discharge, (2) inconsistency between admission and discharge documentation, and (3) differences in note templates and content of notes between clinicians. In response to our findings, we collaborated with our information technology group to prepopulate IM vitamin K, ocular prophylaxis, and HBV administration into the discharge note template from the MAR to improve documentation for the PCP and other clinicians. We also provided education to our hospitalist group to add refusal of IM vitamin K to the problem list in the EMR. Documentation of IM vitamin K administration into procedure notes or as part of the preprocedure time-out process could create another important opportunity to discuss IM vitamin K refusal.

Our study is limited to the population in our single large health system in the Northeast. We reviewed ED visits of infants delivered in our health system in the first 6 months of life, but we do not know how many parents sought care for their infant outside of our single large health system and may have missed additional cases of bleeding as a result. It is possible that IM vitamin K, ocular prophylaxis, and HBV may have been administered but not documented, resulting in an overestimation of refusal rates. The rate of vitamin K refusal was consistent with national data, so the likelihood of overestimation is low. Our data set was not stratified by birth hospital; therefore, we did not perform a subanalysis to assess the differences in trends and refusals by site or compare results by tertiary and community site. We did not capture refusal rates, documentation, and ED visits in infants born outside of the hospital.

To our knowledge, this is the first study to report temporal trends in parental refusals of 3 routine newborn interventions. Refusals during the birth hospitalization can be distressing to hospitalists and staff and take significant amount of rounding time to address and counsel parents. Although refusals remain infrequent, at least in our institution, there appears to be an uptick in refusal of IM vitamin K, and, therefore, more infants are at risk for VKDB, compared with previous years. In the absence of national surveillance of VKDB, clinicians have to remain vigilant about VKDB. The low frequency of IM vitamin K refusal and low probability of VKDB are added challenges. One opportunity is clear communication through documentation after discharge from the birth hospitalization as well as documentation during invasive procedures and when assessing an infant in an emergency setting <6 months of age with potential bleeding. Touch points with the health care system (specifically, the birth hospitalization, an invasive procedure, and ED visits) also serve as opportunities to continue the conversation with hesitant parents.