Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial

Background Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. Methods and findings We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers’ competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women–infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69–0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78–1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32–1.77, p = 0.003). There were two major limitations to the study; although a large sample of women–infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided. Conclusion These results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care. Trial registration ISRCTN30829654.


INTRODUCTION
The emcee for the workshop was Mr. Deepak Jha (IMNCI Section, Child Health Division) who started the workshop with chairing of the programme (Dr Bikash Lamichhane, Director, Child Health Division) and chief guest Dr Naresh Pratap KC (Director, Family Health Division) together with delegates from different government and non-government organisations.

PRESENTATIONS
Dr Amrit Pokhrel (IMNCI Section, Child Health Division) started the presentation session with objectives for the workshop. His presentation focused on background of neonatal health and the need for quality improvement (QI) to improve neonatal mortality and ultimately meet Sustainable Development Goals (SDGs). He further stressed that while QI has been initiated by the government, the policy remained poor and steering committees at various levels were largely non-functional.
It was followed by presentation from Dr Alyssa Sharkey (UNICEF ROSA) who presented on international guidelines and World Health Organization (WHO) Quality of Care Framework.
Her presentation focused on standards of care and initiatives taken in different countries bases on those standards. She also provided insights on what is being done in Bangladesh for QI on maternal, neonatal and child health services.
To support the evidence, Mr Abhishek Gurung (Lifeline Nepal) did a short presentation on regional evidence of use of QI for improving maternal and neonatal care. His presentations highlighted some of the QI approaches taken within and outside Nepal to improve neonatal mortality.
Dr Ashish KC (UNICEF) presented on the fundamentals of improving quality of care using QI processes where he highlighted on the Plan, Do, Act and Study (PDSA) model. Moreover, he also detailed on the fundamental steps of QI processes to be implemented for improving quality of newborn care and they would unfold in the successful implementation of the interventions.
He further mentioned that providing equipment doesn't guarantee service availability and service availability doesn't ensure quality of care.
Mr Dipak Raj Chaulagain (Lifeline Nepal) did a presentation on the set of activities to be conducted under the guideline. Three main stages of implementation namely, Inception Phase, Implementation Phase and Sustainability Phase are mentioned in the guidelines with a set of activities listed under them. (Director, FHD) suggested to align the activities of QI done by Management Division (MD) to align with Maternal and Perinatal Death Surveillance and Review (MPDSR) committee which is currently functioning.

Dr Naresh Pratap KC
Dr Binamra (GIZ) gave an example of Japan where quality is a culture and they strive for delivering quality services. Helping Babies Breathe (HBB) did not work in Tanzania because it is a critical skill and people forget if they do not practice it. The scenario is similar here in Nepal too. GIZ started practice sessions in some birthing centres and orient staffs on HBB.
They found that in most of the places, they did not review. The outcomes were good in only those who had kept on practising the skills. He raised the issue of accountability because the training sessions were more like coaching sessions and people did not follow the protocols after the sessions were over.

Dr Karuna Laxmi Shakya (UNICEF) shared her experiences while working in the Family
Health Department (FHD). She reiterated Dr Naresh's suggestions regarding a setup of working committee for quality control in MD and below structures and to avoid duplication of committees through building a common umbrella to incorporate all activities under one belt.
She also highlighted on similar interventions in hospitals in Taplejung and Makwanpur where the focus was more on maternal and child health (MCH). They established a separate hospital improvement committee to focus on MCH issues consisting of medical superintendent (MS), matron, concerned nurses, store, emergency, lab and support staffs. They conducted quarterly review meetings on maternal and neonatal health where they did self-assessments and gap identification. FHD is planning to scale up this process in other districts. Hence, it is necessary to coordinate with other divisions to avoid duplication in the districts. The intervention might be different for tertiary level hospitals due to different scope of work. Dr Bhadra (H4L) also suggested for varying approaches for different level hospitals. He also reiterated the need for social audit and effective data management.
Dr Sheela Verma's comments were regarding lack of quality services despite having all the infrastructures in place. She shared her experience of a similar kind of study conducted in partnership with UNICEF among 12 hospitals. She mentioned that while Mahendranagar had all the equipment and logistics in place, they lacked a paediatrician. But the issue was with the recording of data. They reviewed the charts which had no mention of time of arrival of sick children or other vital information. There is lack of motivation among staffs. The QI tools should be developed taking into consideration all the areas rather than just maternal and newborns. Mr Bhuwan Baral (Care Nepal/SUAAHARA) mentioned that QI is focused more on supply side rather than demand side and suggested that awareness among communities was necessary for better QI implementation.

DISCUSSION/FEEDBACK ON DRAFT OF IMPLEMENTATION GUIDELINE
Mr Dipak shared a draft of the QI guideline and stressed while neonatal health has been the focus of the government for a long time, two things have always been on debate - • Quality improvement means assuring everything is in place and functioning which will ensure quality of care is maintained. There is nothing new to it and no new intervention is required.
• If quality is required, quality improvement must be focused and should be forwarded as an intervention.
Another debate is regarding the shape of newborn services as to whether it should stay as a part of the broader maternal and neonatal health or that it should be focused as a separate entity and acted accordingly. Having said that, it cannot be conducted as a vertical programme even though extra focus is required to improve the overall status of newborns. CHD has been initiating the effort with a small number of hospitals and while all things cannot be done in a single event, the guideline will act as a reference to achieve quality in the future.
There are three phases as described before:

I. Inception Phase (3 months)
Mentors and internal QI facilitators will be selected in coordination with PSG and MDT at each hospital. At the end of inception phase, the hospital will prepare an on-site plan based on PDSA approach. Then, implementation phase will start together with review, gap findings, refresher trainings for any updates, management of equipment (self or through higher support) and resource mobilisation.

II. Implementation Phase (9 months)
This will include capacity building of health workers on QIC for neonatal care. The QIC process will be implemented together with provision of QI tools. The MDT will review the QI process on a regular basis. Refresher trainings will also be provided to health workers on regular intervals.

III. Sustainability Phase (3 months)
Continuous assessment of activities will be conducted together with review meetings, lesson learning sessions and way forward. The objective is that the hospitals will be able to identify their strengths and weaknesses and be able to sustain accordingly for quality improvement. Dr Bhadra also stressed on community level intervention package. He suggested that district hospitals were different in terms of intervention and they should be managed accordingly.

Mr Parashu Ram Shrestha
Three mentors will be hired who will have extensive experience of working in child health and who will be able to facilitate the QI process from zonal to district hospitals. There will not be a parallel structure and the Perinatal Stakeholders Group (PSG) will be established as a part of the QI committee within the hospital. The need is for a group to be established in every hospital to guide to whole QI process. Dr Sheela and Dr Dhana Raj Aryal shared a common notion regarding duplication of activities and mentioned there already was a working committee called MPDSR above district hospitals. The guidelines have already been developed and we could combine our efforts with that committee for better implementation of our activities.
All participants had a consensus on strengthening existing committee rather than creating a new one. They agreed that a QI committee was necessary to monitor and govern the activities but also insisted on using the existing committees and strengthening them rather than creating a new one. Regarding multidisciplinary team (MDT), they had different views with some agreeing on creating one while others disagreed. Dr Karuna was sceptical if it was the same for district hospitals given the low number of staffs.
Mr Dipak described about the training package for mentors and internal QI facilitators, a seven-day package which was yet to be finalised. After the training, the facilitators will go back to their working stations and start service readiness assessment, with the support from mentors. It will be followed up by equipment availability assessment, procurement and resource mobilisation. This will be done using PDSA model for on-site planning. This whole process will be completed in the inception phase. Dr Binamra had further queries regarding role of internal QI facilitators as to how they will function in the whole process to which Mr Dipak clarified that it was role of the facilitator to do the overall assessment and facilitate the QI process.
The PDSA model is based on the WHO framework and the whole approach will be based on this. The refresher training will also be based on the same model.
All health workers (emergency, delivery room and SNCU/ICU) in the implementing districts will be trained on QIC approach and skills by CHD. Dr Sheela further suggested that the chair of the HDC be oriented on the guidelines for better understanding and ownership. Dr Binamra stated that health workers should be asking for training based on PDSA cycle rather than spoon feeding approach. Dr Ashish clarified that PDSA model is basically about ensuring QI process while refresher trainings are all about ensuring standards. Dr Bhadra supported Dr Ashish's comment mentioning there might be gaps which they identify while working and refresher trainings will be important platforms to address those issues.

Dr Karuna had a query regarding measurement of indicators and how the recording and
reporting system, including feedback was going to work. The intervention is a new one and hence the recording and reporting will not be incorporated in the HMIS/DHIS system. Mr Dipak clarified that there would be register developed which will be used. Besides, the medical recorder/medical record officer will be used for delivery of information from the hospitals to the central level. Dr Bhadra suggested for a coordination between MD and CHD for better data management.
PLAN, make a clear plan for actions targeting a certain problem including assigning who is responsible, a deadline for undertaking the planned action and an expected outcome of the action.
DO, to carry out the planned action; STUDY, to compare the expected outcome of the undertaken action with the result of the action, and; ACT, to reflect and discuss the lessons learnt relating to the action and its outcome including taking decisions on refinements, adjustments or how to support the action to become routine.

REMARKS BY DR BIKASH LAMICHHANE, DIRECTOR, CHD
He insisted that services should now be quality centred rather than quantity and stated that government itself is scaling up activities for newborns through setup of new sick newborn care unit (SNCU)/intensive care unit (ICU) and provision of medicines for under-five children. He urged partners for development of standards for better management and implementation of activities. He also stressed the need for behavioural change and possible ways to bring about change among health workers either through supervision/monitoring or through training.
Furthermore, he suggested that blaming others for issues should stop and everyone should motivate for betterment. Finally, he stressed the need to focus on district and below structures if neonatal deaths are to be reduced and prevent overcrowding in big hospitals.

GROUP WORK AND DISCUSSION
The participants were then divided into two groups for discussion and feedback on the draft of implementation guideline and any other issues that might be seen. incentives. Dr Ashish further clarified incentivising did not always work and it was more about social recognition and responsibility. It was more about motivation and positive thinking. He also mentioned that it was an evidence-based approach and it had been thoroughly reviewed and implemented in many countries. Despite that, the sustainability would still be a challenge.

Facilitator -Dipak Raj Chaulagain
Dr Ashish presented hospital based study showing misclassification and low reporting of data.
He also pointed the flaw in our review system where we do death review rather than process review (unpublished data). He insisted that the whole review should be based on QI process.
The monitoring will be based on process indicators to ensure the clinical performance should be good. That should ultimately lead to survival status. This will be channelled through checklists provided to the hospitals where the staffs will fill in the forms to ensure the process is done and the outcome of the child will be written. The whole information will be displayed on the dashboard daily to ensure services are delivered. The facilitator will then check whether the process is fulfilled and quality is assured.
He then described about the eight dimensions mentioned in the WHO Standards Guideline for further clarification. Having said that, Dr Hemanta insisted on bringing aboard Health Management Information System (HMIS) citing reasons of data not being reported from bigger hospitals. Dr Ashish clarified by saying while the register is developed and will be used for recording, there is no assurance if it is going to work due to which it will take some time before it can be incorporated in the system.

PROCEEDINGS OF DAY II (March 16, 2017)
The second day continued with group discussions from earlier day. The consensus was that where there is a QI committee, the existing committee (MPDSR) will be used. Dr Bikash said the while the committee would give it a formal shape, the facilitator would be the one who would be working for the whole implementation process. He also said that the committee should be a legitimate one. It is necessary for authenticity. However, Dr Sheelu Adhikari (USAID) suggested the committee be formed at the earnest rather than waiting for governing bodies to form due to delay in implementation. She further said that while the MD did have a guideline, it has not been accelerated yet so this intervention can go ahead with the formation through the medical superintendent. Dr Bikash also agreed to her views. Besides, there is no formal guideline at the zonal and regional level so this can be a breakthrough into formalising one. Endorsement would however be necessary so coordination and meetings with MD and Curative Division would be important.
There was further discussion regarding availability of MPDSR committees in zonal and regional hospitals and consensus was developed to use the same committees to act as perinatal stakeholders' group (PSG). There will be two teams -

QI Committee Internal Teams
Internal QI Facilitator There is need for a vertical and horizontal communication to show that quality is an issue. The issues will be raised by the facilitator and managed by the QI Committee. Dr Bikash raised the issue of human resources being critical to implementation of QI process together with sustainability. Citing such reasons, he suggested the intervention to be flexible and not time bound. Dr Ashish also described about checklists which will be developed to help facilitators and staffs with timely identification of issues and deal accordingly. The registers will be kept in separate wards and they will be helpful in monitoring progress over time. There are evidences of it being helpful in developing skills and self-assessment through skills checks.
CHD will provide a two-day update on clinical standards to health workers.
Dr Sheelu had further issues regarding use of new QI tools and suggested to use the tools developed by MD to which Dr Ashish cleared mentioning the same will be used and developed.
He further stated that the whole idea was to focus on QI process rather than clinical outcomes.
The whole thing will be reviewed through process audit rather than outcome audit. Dr Sheelu also suggested that the review/evaluation process should be simultaneously rather than on a linear basis to which everyone agreed. One of the potential risks is the staff turnover which also needs to be addressed. Dr Bikash also suggested for another meeting of relevant stakeholders (MD, CHD, FHD, LMD, Curative Division, PHAMED and other partners) for update and way forward.

RISKS AND SOLUTIONS
One of prime issues raised was who would be the secretary of the committee for this implementation process. In previous committees, the medical recorder/medical record officer is usually the secretary. The group had some discussions regarding scope of work and decided that the committee guidelines and protocols should be followed to avoid any clashes in the future. Some of the participants had different opinions regarding medical recorders as they may not adhere to guidelines citing extra work. Dr Sheelu shared her previous experiences where the medical recorders did not adhere in MPDSR meetings. The consensus was that while the records would be kept by the medical recorders, facilitators will be the one guiding the process.
The intervention is not trying to build a new structure rather strengthen the existing one. The two-day workshop was formally closed by Dr Amrit Pokhrel on behalf of CHD. Capacity building of health workers on using QI tools and provision of QI tools Implementation of PDSA cycle to improve quality of care and QI processes Periodic review on implementation of plan in each delivery unit (PDSA)

FINAL CONSENSUS MODEL OF QUALITY IMPROVEMENT FOR STANDARD NEONATAL CARE IN HOSPITALS OF NEPAL
Continuous assessment on quality of newborn care and QI process implementation