A Quality Improvement Intervention to Decrease Hypothermia in the Delivery Room Using a Checklist.

INTRODUCTION: Premature babies are at increased risk of hypothermia, core body temperature <97°F. Delivery room environment may contribute and lead to complications. The objective was to reduce hypothermia in babies <32 weeks of gestation in the delivery room to <40% using a checklist and sustain it for 6 months.
METHODS: We created a delivery room checklist in 2012. Chart review established a baseline rate of hypothermia (<97°F). The team analyzed the checklist's effect on hypothermia from 2012 to 2018 and utilized numerous interventions to maintain compliance. Chi-square test and Fisher's exact test analyzed hypothermia and hyperthermia as a balancing measure. All calculations performed in SAS 9.3.
RESULTS: The checklist reduced hypothermia from a baseline of 50% in 2011 (n = 104) to 33% in 2012 (n = 106). In 2013, the proportion of hypothermia slightly increased to 36% (n = 81). The year 2014 brought larger drift, and proportion of hypothermia increased to 44% (n = 117). In 2015, we reinforced the use of the checklist and proportion of hypothermia improved to 36% (n = 99). Further interventions through 2018 decreased hypothermia further to 14% to achieve statistical significance.
CONCLUSIONS: A checklist is a simple tool that may yield beneficial changes in practice and helped to decrease the proportion of neonatal hypothermia.

INTRODUCTION

Hypothermia is a complication of prematurity that results in increased morbidity and mortality. It may lead to unwanted outcomes, such as hypoglycemia, acidosis, neurological deficits, intraventricular hemorrhage, and longer hospital stays.[1-4] One study demonstrated an increase in mortality of 28% with every decrease of 1°C in core body temperature.[5]

Premature newborns are susceptible to hypothermia for various reasons. Gestational age and birth weight are inversely related to its development.[1] Evaporative heat loss, a lesser amount of subcutaneous fat, and immature neurological function result in increased susceptibility. Premature newborns are unable to shiver, hindering effective thermogenesis.[6] Evaporative, conductive, radiant, and convective heat loss occur simultaneously.[5] As a result, premature newborns require extra measures to maintain body temperature. Interventions incorporated into routine resuscitation measures (radiant warmers, plastic bags/wraps, heated transport incubators) decrease the incidence of neonatal hypothermia and improve neonatal survival.[4,5,7] However, hypothermia remains an all too common global problem, especially in resource-deprived regions.[8,9]

Checklists have long been adopted for use by the aviation industry to ensure safety.[10] Checklists serve as useful tools in healthcare for reducing medical errors that lead to morbidity and mortality.[11] One study by Berenholtz et al[12] in the intensive care unit at John Hopkins Hospital demonstrated that checklists decreased the incidence of central line–associated infection as well as improved patient care and communication. The World Health Organization incorporated this concept in 2006 into their Surgical Safety Checklist and Guidelines for Safe Surgery.[13] The Safety Checklist significantly reduced morbidity and mortality in a multicenter study.[14] In addition to reducing medical error and near misses, checklists ensure adherence to updated clinical practice guidelines.[15,16]

This quality improvement (QI) effort devised a delivery room checklist to decrease hypothermic admission temperatures for premature newborns admitted to the neonatal intensive care unit (NICU). Our SMART aim was “to decrease the incidence of hypothermia in babies born at <32 weeks estimated gestational age (EGA) by 25% from a 2011 baseline of 50% to <40% by December 2012 and sustain for 6 months.”

METHODS

Context

NYU Winthrop Hospital (NYU-WH) is a suburban tertiary care academic hospital in Mineola, New York, with an accredited residency training program in general pediatrics. NYU-WH is also a Children’s Medical Center and designated regional perinatal center with over 4,800 newborn deliveries per year. A level 4 forty-five–bed NICU receives approximately 700 admissions per year, approximately 100 are born at < 32 weeks of gestation. A QI initiative began in 2012 when staff recognized that 50% of all NICU admissions for babies born at <32 weeks EGA had hypothermic rectal temperatures <97°F upon admission to the NICU.[4] This finding is significantly different from the average proportion of hypothermia of 25% seen by the Vermont Oxford Network, an international NICU database.

Live-born deliveries at NYU-WH are graded on a progressive acuity scale from level 1 to level 3, with the delivery of a baby born at 32 weeks of gestation or less designated as a level 3. One NICU attending, 1 NICU advanced practitioner, 1 pediatric resident, and 1 NICU nurse in addition to 2 Labor and Delivery nurses, 1 to 2 obstetric attending physicians, and 1 obstetric resident comprise the team typically present at a level 3 delivery.

Stakeholders of the project included neonatologists, pediatric residents, advanced practitioners, and registered nurses working in the NICU and Labor and Delivery staff. The partnership between the Pediatrics and the Obstetrics and Gynecology departments facilitated its implementation. The overall goal was to reduce hypothermia and preventable harm for premature newborns.

Establishment of Baseline Data

Retrospective chart review established a baseline proportion of hypothermia of 50% of all babies born at gestational age <32 weeks admitted to the NYU-WH NICU.

Measures

The primary outcome measure was the proportion of hypothermia (core temperature <97°F) among babies less than 32 weeks EGA admitted to the NICU. The team designated the proportion of babies <32 weeks EGA admitted with hyperthermia, or core temperature ≥100.4°F as the balancing measure. The team also tracked individual defective checklist components (ie, specific components of the checklist that were not followed or documented) among all cumulative checklist components throughout the project as a process measure.

Interventions

A multidisciplinary process improvement team composed of attending neonatologists and obstetricians, house staff, nurses (NICU, Labor, and Delivery), and quality specialists formed. The team created a 10-item Delivery Room Checklist to standardize the process for preventing hypothermia in the delivery room. The checklist outlined specific instructions for preparing the delivery room for the birth of a baby born at less than 32 weeks gestation (Table 1). It included routine practices as dictated by Neonatal Resuscitation Program in addition to actions the team felt would positively impact outcome measure.[4] For instance, despite the common practice of using polyethylene bags for only babies born before 30 weeks of gestation (at that time), the polyethylene bag was to be used regardless of gestational age. With collaboration from the Obstetrics department, delivery room thermostats in the operating rooms for cesarean sections were set to 75°F upon notification of an impending delivery.[17] The checklist included documentation of operating room temperatures at the time of birth. NICU staff measured rectal temperatures upon admission to the NICU (within 30 minutes of birth) to ensure quick delivery of care shown to be beneficial to the survival of premature newborns.[18,19] Any staff member present at the delivery could complete the checklist.

Table 1.

Delivery Room Checklist to Prevent Hypothermia

The team brainstormed to define strategies to drive frontline buy-in, resulting in the Key Driver Diagram (Fig. 1).

Fig. 1.

Key Driver Diagram.

Implementation of Checklist (April 2012)

The first major intervention of education built provider knowledge and engaged the frontline in fostering a teamwork effort. The team educated NICU staff, labor and delivery staff, and house officers on complications of hypothermia and how to properly use the checklist. The official roll-out date for checklist implementation occurred in April 2012. To reinforce knowledge and encourage reliability, monthly reminders, recurring focus group discussions, and just-in-time educational coaching followed checklist roll-out.

Visual tools displayed in delivery rooms reminded the frontline staff to use the checklist. The team audited and analyzed reliability to checklist components. De-briefing sessions addressed gaps and opportunities. The checklist and corresponding interventions served as the primary approaches for preventing hypothermia at the time.

Improving Checklist Accessibility (January 2013)

Staff identified access to the checklist (physical location) as a barrier to timely completion. During the initial year of intervention, we located checklists in only 1 location in the NICU. Investigators placed them in several more convenient locations, namely in the delivery rooms themselves and in different areas of the NICU (house staff office and advance practitioner office). During focus group discussions, staff agreed that this made accessing the checklists easier.

Data Sharing with Frontline (June 2013)

The team presented data from the first 12 months of implementation to all NICU and Labor and Delivery staff in addition to the proportion of hypothermia at NYU-WUH as compared with Vermont Oxford Network.

Addressing Practice Drift (August 2014)

The team noted a drift in reliability in the second and third quarters of 2014. We stepped in to again reinforce the importance of the checklist and its beneficial effects via data sharing with appropriate staff. Monthly focus groups switched to weekly. Staff huddle discussions at each change of shift included the checklist in daily safety discussion.

Simulation (2015)

An increased emphasis on the appropriate steps taken to prevent hypothermia occurred at mock codes attended by residents, nurses, attending physicians, and advanced practitioners.

Revised SMART Aim and Increased Transparency (2016)

The favorable results from 2012 to 2015 pleased the investigators, and so the team reevaluated our SMART aim to: “To further decrease the incidence of hypothermia in babies born at <32 weeks EGA from a baseline of 37% to <25% by December 2016 and sustain for 6 months.” New interventions were employed to accomplish this. Checklist data became part of the discussion during monthly Town Hall-style meetings with NICU staff. The team displayed a “Days Since Last Hypothermic Event” in the NICU for full transparency with parents and families. New resident house staff members joined the team after original resident members graduated.

Data Analysis

The team designated a core body temperature cutoff of 97°F (<97°F versus ≥97°F). The proportion of hypothermia and hyperthermia were analyzed using chi-square test and Fisher’s exact test as appropriate. Bonferroni adjustments were performed to adjust for multiple comparisons, one for each observation year (7 in total) with the alpha level adjusted to 0.007 (0.05/7). Relative risks and 95% confidence intervals were calculated for each pair-wise comparison. The team used Minitab 18 software to produce statistical process control charts of ongoing data points. SAS 9.4 (SAS Institute Inc., Cary, N.C.) performed all analyses.

Ethical Considerations

There were no ethical concerns or conflicts of interest in our initiative. As it did not affect human subjects, NYU Winthrop’s Institutional Review Board did not require full review and approval.

RESULTS

The baseline period consisted of 104 babies in 2011. Of the 107 babies born in 2012, 34 had rectal temperatures <97°F on admission. The rate of hypothermia decreased from 50% in 2011 to 33% in 2012. Data analysis using chi-square test revealed a significant difference (P value = 0.013; RR, 0.66; 95% CI, 0.47–0.92) between the baseline and study period data (Table 2).

Table 2.

Hypothermia Pair-wise Comparison, 2011–2018

In 2013, of the 88 babies born at <32 weeks of gestation and admitted to the NICU, 31 had hypothermic admission temperatures. The difference between 2011 and 2013 again showed no significance [from 50% to 36%, P value = 0.058 (RR, 0.73; 95% CI, 0.52–1.02)].

After 2 years in practice, however, there was a process drift from January 2014 until August 2014. The proportion of hypothermia increased from 36% to approximately 44% (51/117). With new interventions, the proportion of hypothermia decreased back to 36% in 2015 (35/99).

A control p-chart of the data from 2012 to 2018 (Fig. 2) shows the first centerline shift indicating a decline in the mean proportion of hypothermia of 37.47% for those observation years and a significant P value of < 0.001.

Fig. 2.

Proportion of hypothermia, 2012–2018.

Reliability to checklist components saw an initial decrease in defective components after initial education period (Fig. 3). Reliability subsequently hovered around the mean centerline for the majority of 2013 to 2015.

Fig. 3.

Number of defective checklist components, 2012–2018.

When comparing individual observation years to the baseline and incorporating Bonferroni corrections for all years, statistical significance was not reached until 2016. P chart data from 2016 to 2018 display yet another mean centerline shift with the proportion of hypothermia decreasing further to a mean of 14% from 37% (P value < 0.001).

Although the number of hyperthermic (core temperature ≥100.4°F) babies did increase after the introduction of the checklist, the balancing measure of hyperthermia showed no statistically significant results (P value < 0.0007; Table 3).

Table 3.

Hyperthermia as Balancing Measure, 2011–2018

DISCUSSION

The checklist and subsequent interventions successfully decreased overall rates of hypothermia for preterm babies born at 32 weeks gestational age or less from a baseline of 50% to proportions exceeding the goal of <40%. The team achieved sustainability for subsequent years with numerous ongoing efforts, including continued use of the checklist. This result can support the benefit and effectiveness of incorporating checklists to achieve desired outcome measures and reduce potential complications.

The initial intervention of education increased staff knowledge on hypothermia and its potentially detrimental effects. The checklist itself and instructions for use were explicitly described. This baseline of education supported by monthly reminders, focus group discussions, and just-in-time coaching achieved a dramatic decrease in the rate of hypothermia from 50% to 33% in the initial year of the project.

Further interventions followed in subsequent years and thus, as a further intervention, they were placed in multiple areas of the NICU and delivery rooms.

The checklist yielded favorable results over time with common cause variation occurring throughout the observation period (Fig. 3). There were 3 points of unfavorable special cause variation noted in the starting years of the project in 2012 and 2013 and again in 2016. Reasons for these variations remain unclear to the QI team. However, we suspect that 2 transitions to an electronic medical record during the observation period—one at the end of 2012 and yet another at the start of 2016—played significant roles. The team addressed the drifts with interventions of more frequent reminders; focus groups made weekly, incorporation of the checklist into shift safety huddles, and simulation exercises.

Beginning in 2016, another centerline shift in the proportion of hypothermia (Fig. 2) coincided with an improvement of defective checklist components indicated by 5 points below the centerline mean in a descending trend (Fig. 3). The intervention used during this time were inclusion in monthly Town Hall style meetings with NICU and OB staff and a posting of “Days of Last Hypothermic Event” in the NICU. New house staff members also brought a renewed enthusiasm to the project.

As the team learned the hard way, initial buy-in from frontline staff and success is not enough to maintain process reliability over extended periods of time. The run chart of defective checklist components displays common cause variation throughout the observation period that ultimately resulted in a favorable decreasing trend from 2016 onward.

At times, staff did not utilize the checklist or did not complete them despite reeducation and reminders. Reasons for this are likely multifactorial. The delivery or clinical condition of a preterm baby may have been too critical to allow staff to prioritize the checklist. Although we did not distribute a formal survey to elicit staff’s perception of the checklist, we often overheard staff discussing the time spent utilizing the checklist unfavorably; this is not uncommon when compared with quality initiatives at other institutions.[20]

Several actions on the checklist remained underutilized. Before 2016, staff least complied with using polyethylene bags to reduce evaporative heat loss, especially for babies born between 30 and 32 weeks.[21] Since the revision of the Neonatal Resuscitation Program guidelines (seventh edition) published in 2016, the recommendation for use in infants with gestational age less than 32 weeks is currently standard practice.[4] This change is potentially confounding and may contribute to the improvement in the proportion of hypothermia that was observed beginning in 2016.

Collaboration with the Obstetrics department allowed for placement of visual reminders and the checklists themselves in operating rooms as well as setting thermostats to 75°F. Unfortunately, this ideal room temperature remained unattainable a large proportion of the time from 2012 to 2018 (39%). Most of the completed checklists showed that, despite thermostat adjustment, time often did not allow for the rooms to reach 75°F. This failure was especially true for emergent deliveries. Two of the patients delivered vaginally; labor room thermostats were only adjusted for cesarean deliveries.

With regard to hyperthermia, the lack of statistical significance of data from 2012 to 2018 as compared with 2011, illustrates that the increase in the proportion of hyperthermia is not necessarily a direct effect of the checklist. Rather, it is possibly random variation. A look into the proportion of hyperthermia before 2011 would be helpful.

Limitations

This project was conducted at a single institution and may or may not be generalizable to other pediatric hospitals. Baseline data (Fig. 2) are composed of only 4 data points. However, the proportion of hypothermia was elicited from the medical record software used at the time which the authors trust as accurate. Clinical and maternal factors that influence newborn thermogenesis and may contribute to confounding (ie, maternal fever, chorioamnionitis) are not accounted for on the checklist. There was a disparity between operating rooms and labor and delivery rooms; only operating room temperatures were set to 75°F.

CONCLUDING SUMMARY AND NEXT STEPS

Compliance with checklists may improve clinical outcomes and other industries outside of healthcare.[15,16,20] This QI initiative supports the idea that successful implementation of a checklist with multiple interventions for enforcement may achieve desired outcome measures. Use of the checklist continues as it yielded highly desirable and sustainable results over some years. Several publications recently demonstrated the benefits of utilizing checklists and/or bundles in a delivery room setting to attain optimal outcomes, namely DeMauro[22] in 2013 and Pinheiro[23] in 2014.

Education is an important first step in any QI project. However, it is simply not enough, given the overturning nature of residency programs and ever-changing house staff members. Compliance and process reliability is of utmost importance but is challenging when trying to influence a change in long-standing behaviors. Collaboration with stakeholders from other departments may strengthen any initiative that targets modifications in the protocol or clinical practice. Staff and all appropriate personnel should be reminded, reeducated, and peer-coached regularly to maintain cooperation.

Next steps include incorporation into yet another electronic medical record system launching in August 2019 with a built-in prompt to mandate completion.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.