Discussion
The current study was conducted to reduce LONS in a tertiary care teaching hospital NICU using POCQI method to improve central line care bundles' compliance. The study led to a 42% reduction in LONS rates from baseline but no significant reduction in the CLABSI or mortality rates in the study subjects in a VLBW population with central lines in situ.
Compliance to the Central Line Care bundles can be linked to multiple root causes as shown in figure 1. The key factors among them being issues related to processes of care, materials and people-related causes. The QI team used the POCQI method to test a series of change ideas focusing on the root causes as mentioned previously. PDSA cycle 1 was conducted to develop and test the ease of use of the CLABSI bundle handout translated in local language (Hindi) from the existing English version. Feedback was obtained from the NICU staff that Hindi handout was difficult to read and understand as compared with the English. Hence, the team continued to use the English handouts. PDSA cycle 2 was done to test the feasibility of focused group discussions for knowledge enhancement of the NICU staff. It was observed that it was difficult to conduct such sessions every day. Hence, this change idea was adapted to PDSA 3. PDSA cycle 3 consisted of creation of a mobile phone application–based group to increase the number of focused group discussions. A subject-based questionnaire was used to study the effectiveness of this change. There was an increase in the proportion of correct responses from a baseline of 49% to 90%. The change idea was adopted as it was feasible, improved the staff participation and led to an increase in knowledge of NICU staff to CLABSI bundles. Wang et al from China used education, feedback and group discussions to implement the bundle and checklist.28 In PDSA cycles 4 and 5, the QI team created and edited an educational video game consisting of five modules on prevention of hospital-acquired infections. This led to an improvement in participation as well as the behaviour change in the NICU staff. In PDSA cycles 6 and 7, a 3 min video on maintaining asepsis during intravenous fluid administration through central lines was created and subsequently edited by the team. We observed that the audio-visual content developed and tested in PDSA cycles 4–7 enhanced participation and interest in the NICU teams and also led to an increase in their awareness regarding care of central lines. Sinha et al used an educational video similar to our study to educate the NICU staff regarding the sterile fluid administration method.29 Frequent stockouts of essential supplies interfere with routine processes of care and lead to non-adherence to standard guidelines, for example, CLABSI Bundles. In PDSA cycles 8 and 9, we tested and adopted an optimised demand versus supply prediction mechanism to prevent stockout of sterile gowns and size 80/40 mm central lines in the NICU.
Most of the contemporary studies have observed that ensuring compliance to maintenance bundles is the difficult part in the implementation phase.14 15 20 30–32 Improving the central line care bundle compliance is a resource-intense activity and requires intensive monitoring and mentoring for prolonged periods. The challenges of resources being paramount in LMIC settings become the major bottleneck in implementing the said bundle approach more so during sustenance phases .
We conducted a PDSA cycle during phase III of the study as the compliance to central line maintenance bundles in this phase was found to be suboptimal. We initiated weekly group discussions followed by an evaluation regarding central line care for the NICU staff. As a result of this change, we noted an increase in the compliance to maintenance bundle from a mean of 23.3% in phase II to mean of 42.2% in phase III. Intensive monitoring is required to observe central line insertions and ensure sustained compliance to the central line bundles.19–21 28 33 34
Compliance to maintenance bundle is an essential factor in reducing LONS rates in NICU as observed by Kaplan et al.14 NICUs having greater than 90% compliance to maintenance bundle showed nearly 50% reduction in sepsis as compared with those with compliance less than 90%.14 Compliance to maintenance bundles ranged from 65% to 90% in several studies.15 30–34 The compliance to maintenance bundles in an Indian study was lower (60%–69%) as compared with Western studies and showed a decrease in the sustenance phase.20 Interventions in LMIC settings should focus on concurrent improvements directed towards health systems, policies and infrastructure rather than implementing checklists in isolation.35
The change ideas tested and implemented by our team using the PDSA approach led to an improvement in the knowledge of NICU staff which translated into increased compliance to insertion and maintenance bundle. Enhanced compliance to the bundles led to an improvement in the outcome indicators of LONS and CLABSI. The reduction in LONS achieved by our intervention was slightly lower than other studies wherein reduction rates for LONS ranged from 44% to 75.6% in a subset of VLBW neonates.15 16 29 36 A lower rate of reduction seen in our study could have been due to lack of a system-wide implementation at a single setting incorporating minimal interventions over a limited study period.
Contextual factors can significantly affect the study outcomes, as noted by other authors.7 37In our study, presence of factors, for example, an unfavourable nurse, doctor:patient ratio, frequent staff rotation, humid and warm weather favouring microbial proliferation, a higher rate of admissions of extremely low birthweight neonates, survival in phase III and overcrowding may have had affected the effect size unfavourably.
There was a decline in mean CLABSI rates across phase I, II by 45%, and III a 36.4% reduction compared with phase I. These reductions were not statistically significant. The possible reasons for a slower decline in the CLABSI rates in our study population are complex to understand. We tried to reduce CLABSI using the same approach to minimise LONS, that is, by trying to improve the compliance to the adapted version of the central line care bundles. The compliance to maintenance bundle in our research was suboptimal and could have contributed to a lower reduction in CLABSI rates. The bundles used in various studies for CLABSI prevention are difficult to compare with our study due to a difference in method and techniques.15 16 18 19 37 38 Studies from China, India and Pakistan have reported a much higher reduction in CLABSI rates than our study. A study conducted on 110 VLBW neonates in China28 by Wang et al, using central line bundle guidelines and a standard checklist, achieved a significant reduction in central line infections from 10 to 2.2 infections/1000 catheter days. In another study from India which included 1565 term and late preterm neonates, an 89% reduction in CLABSI and 41% reduction in mortality (both statistically significant) was demonstrated.20 Using evidence-based interventions, CLABSI prevention package and nurse empowerment, a tertiary care NICU in Pakistan reduced CLABSI rates across all admitted neonates regardless of gestational age by 70%.21 This study intervention was conducted in a resource-replete setting of Aga Khan University with a very favourable nurse:patient ratio and NICU staffing pattern. None of these studies has evaluated the reduction in CLABSI rates in VLBW neonates as has been done in our study. This per se can explain the lower reductions in CLABSI observed by us. It is reported that reducing CLABSI in VLBW and ELBW neonates are very challenging.37 In a meta-analysis by Payne et al in 2017 on the use of care bundles to reduce CLABSI in neonatal units, a subgroup analysis on VLBW neonates was conducted, revealing an insignificant reduction in CLABSI rate, a finding in conformity with our observations.39 In addition, it brings forth the importance of a skilled workforce, an essential prerequisite for any successful quality improvement initiative, the need for larger sample size, more interventions and more stringent diagnostic facilities that are often not available in LMIC settings.
Our study did not show any effect on mortality indicators of the study population. Some studies using QI methods for improving compliance to CLABSI bundle have shown mixed results, showing no significant reduction in mortality21 36 40 in contrast to others18 20 who have showed a substantial reduction in mortality rates. Mortality in VLBW neonates could be due to multiple causes like extreme prematurity, asphyxia, severe RDS, IVH, BPD, PPHN and pulmonary haemorrhage.41 To demonstrate the effect of a single intervention on reduction of mortality in a VLBW subset would require a much larger sample size. This can be achieved through a QI collaborative study design with an extended sustenance phase.
There were a few strengths of the study. Our study was done in a LMIC setting in an exclusive cohort of VLBW babies with central lines in situ. The study applied the POCQI methodology to address the problem of LONS among such VLBW neonates by implementing and improving compliance to central line care bundles. The study reports data on compliance with central line care bundles, including compliance with individual components and reports on a sustenance period of 6 months.
Our study had a few limitations. The study was undertaken in a single setting with a limited sample size over a fixed period. A collaborative study design would have yielded a more significant impact and understanding on the effectiveness of POCQI in reducing LONS and CLABSI in VLBW neonates in LMIC settings and is increasingly being regarded as the need of the hour in such settings.42 A single investigator did the measurements of compliance and data recording. However, this limitation was turned to an advantage as it led to a lack of inter-observer variability and ensured high-quality data capture. Hence, only a limited number of central line insertions and maintenance checklists could be checked for compliance with potential observation bias in the study. There was a periodic rotation of resident doctors and an influx of new nurses who were yet to be trained, which caused periodic fluctuations in the study’s asepsis protocols. The organisation of induction sessions addressed this as a standard unit policy. We could not study the impact of the bundle elements' components on the outcomes, cost-effectiveness of implementing checklists, balancing measures, and long-term impact on growth and neurodevelopment.
The study has good generalisability for similar settings as the POCQI methodology has proven to be a useful tool to achieve improvements in processes and outcomes of care in resource-constrained settings.22 23 POCQI can seed regional QI collaboratives across LMIC settings using QI to improve compliance to evidence-based bundles, thus catalysing better infection control in busy NICUs.15 16 33 34 38 Studying more extended sustenance periods, cost–benefit analysis of implementing checklists and the impact of individual interventions of bundles could be included in future study designs. Each NICU could form its bundle by selecting the best interventions from such studies relevant to their context for better infection control practices in the units.43 44 The newer changes in healthcare guidelines and evidence-based interventions could be included as part of the nursing curriculum.45
To conclude, the POCQI method is a useful and simple tool to improve healthcare personnel’s compliance with evidence-based guidelines in resource-limited settings. It can aid in reduction of NICU infection rates and could be scaled up across similar settings after contextual adaptations.