With improving access to facility-based neonatal care (FBNC), an increasing number of preterm neonates are surviving in India and new challenges are emerging about their ongoing care.\[[@ref1]\] Such a major challenge is ensuring the survival of preterm neonates with intact and optimal neurosensory abilities. Retinopathy of prematurity (ROP) is one of the important conditions which endangers intact survival, and which needs to be detected in a timely manner and treated promptly, if severe. ROP is also amenable to primary prevention by improving adherence to evidence-based clinical care practices in hospitalized sick preterm neonates.\[[@ref2][@ref3]\] Improved access to FBNC does not, however, ensure adherence to best practices, and thus a quality-improvement and assurance system needs to be put in place to prevent the consequences of suboptimal clinical care. The recent expansion of neonatal care services in many low- and middle-income countries, coupled with suboptimal care is leading to an increasing number of infants with stage 4 and 5 ROP being seen by ophthalmologists, including India.\[[@ref4][@ref5]\]

ROP is not only among the commonest causes of acquired blindness in children but is also an excellent indicator of the quality of care provided to preterm neonates in a healthcare facility. Risk factors for ROP include unmonitored and unnecessary oxygen administration, sepsis, poor nutrition, and exposure to blood products.\[[@ref3]\] Therefore, interventions aimed at reducing ROP are likely to impact many aspects of neonatal healthcare resulting in improved rates of intact survival without abnormal neurological outcomes. The hypothesis of the Madhya Pradesh-quality improvement (MP-QI) project is that among preterm neonates admitted in SCNUs (*population*), implementation of a need-based intervention package comprising evidence-informed practices targeting healthcare providers (nurses, doctors, coordinators) to improve their capacity and skills for providing clinical care as well as undertaking QI activities (*intervention*), would improve neonatal survival without severe ROP (*outcome*) compared with current quality of care and competencies (*control*). To test this hypothesis, we developed a theory of change \[[Fig. 1](#F1){ref-type="fig"}\] which formed the basis of the package of interventions. The current article presents the development of the theory of change and the study protocol to test this theory of change.

![Theory of change](IJO-68-115-g001){#F1}

Methods {#sec1-2}
=======

This before-and-after study is being undertaken in three district hospitals and a medical college in the state of Madhya Pradesh, India. Madhya Pradesh was one of the four states selected for the ROP project supported by Queen Elizabeth Diamond Jubilee Trust (2013--1019) following a situational analysis.

The study has three main objectives. Firstly, to assess baseline levels of knowledge, skills, attitudes, and practices of SCNU healthcare personnel, state SCNU coordinators, and child health consultants about clinical care pathways which are likely to reduce the risk of severe ROP, to assess their problem solving and QI skills, and the awareness of parents regarding the need for ROP screening and potential therapy. Secondly, to formulate pilot test and finalize a package of interventions (consisting of educational materials \[webinars and videos\], protocols/guidelines, simulation-based training, standard operating procedures, advocacy tools for policy change, collaborative quality-improvement network) to improve knowledge, skills, attitudes and practices of SCNU coordinators, child health consultants, and SCNU healthcare workers in abovementioned domains. Lastly, to evaluate the effectiveness of this package of interventions in improving knowledge, skills, attitudes and practices of the health care professionals identified above; increasing awareness of parents regarding the need for ROP screening and potential therapy; improving clinical practices related to risk of ROP and ultimately, increasing the survival of preterm infants without severe ROP.

For objective 1, the needs assessment was undertaken by the coordinating centers (PGIMER, Chandigarh, GMCH Chandigarh, and AIIMS New Delhi) in the four facilities outlined above. For objective 2, a learning package was developed by the coordinating centers which was tested in the SCNUs used for objective 1. (website for free access to the learning package: <https://www.pretermcare-eliminatingrop.com>.) For the development of QI collaborative, network data were collected from the participating SCNUs and coordinating centers through an app developed specifically for this purpose. POCQI tool developed in collaboration with World Health Organization South-East Asia Reginal Office (WHO-SEARO) was used for imparting training for QI projects ([www.pocqi.org](www.pocqi.org) and <http://workbook.pocqi.org/>) For objective 3, the study unit consisted of a teaching institution as the hub and three SCNUs as the spokes, with the intention that the teaching institution would mentor the SCNUs and help implement the educational and QI packages.

For objectives 1 and 2, participants included medical officers or consultants employed in the state child health program with responsibilities pertaining to SCNU; pediatricians, medical officers, and nurses working in SCNUs. For objective 3, data were collected from neonates who fulfilled criteria for ROP screening as per guidelines of the Government of India.

[Table 1](#T1){ref-type="table"} presents the methods of data collection for the formative component of the study. [Table 2](#T2){ref-type="table"} presents the outcomes relevant to each specific objective of the study.

###### 

Method of information collection for the formative phase (objective 1)

  Participants                                                                         Information to be collected                                                        Methods
  ------------------------------------------------------------------------------------ ---------------------------------------------------------------------------------- -------------------------------------------------------
  State Ministry; NHM                                                                  Priorities in newborn health                                                       Key informant interviews
  Mechanisms or processes for QI                                                                                                                                          
  New policies on the horizon                                                                                                                                             
  State SCNU coordinator/ child health consultants                                     Role in/approaches to QI in the state                                              One to one in-depth interview Web-based questionnaire
  Main challenges                                                                                                                                                         
  Limitations in current training of SCNU staff                                                                                                                           
  Priorities for training and capacity building                                                                                                                           
  Attitude towards creating a QI nurse in each SCNU                                                                                                                       
  Potential role of a QI nurse                                                                                                                                            
  Characteristics of an ideal QI nurse                                                                                                                                    
  Knowledge assessment in leadership and QI methodology                                                                                                                   
  Senior nurses in SCNU                                                                The support they receive from state SCNU coordinator and hospital administration   One to one in-depth interview
  Training nurses have received                                                                                                                                           
  Staff turnover/attrition                                                                                                                                                
  In-service training for themselves and other nurses                                                                                                                     
  Main challenges in the SCNU                                                                                                                                             
  Approaches currently followed to improving quality                                                                                                                      
  Roles of nurses and doctors and how they complement each other                                                                                                          
  Equipment and whether it is functioning                                                                                                                                 
  Attitude towards creating a QI nurse in this SCNU                                                                                                                       
  Potential role of a QI nurse                                                                                                                                            
  Willingness for staff to be trained                                                                                                                                     
  Priorities for capacity building among staff                                                                                                                            
  Knowledge assessment in leadership and QI methodology                                                                                                                   
  Nurses                                                                               Pre-service and in-service training                                                Questionnaire; case studies
  Current knowledge about the care of preterm infants                                                                                                                     
  How long they have worked on the SCNU                                                                                                                                   
  How they access information to improve their work                                                                                                                       
  Access to the internet and on-line materials and attitudes towards online learning                                                                                      
  Satisfaction with their work                                                         Focussed group discussions                                                         
  Challenges they face in their work                                                                                                                                      
  Freedom to make decisions and act on them                                                                                                                               
  Use of clinical care protocols                                                                                                                                          
  How they currently gain knowledge and skills                                                                                                                            
  How problems are managed in the SCNU                                                                                                                                    
  Attitudes concerning knowledge and skills of the doctors                                                                                                                
  Response to the idea of a QI nurse                                                                                                                                      
  Attitudes towards mothers                                                                                                                                               
  Areas they would like training in                                                                                                                                       
  Current skills and practices e.g., handwashing, setting alarms                       OSCE and observation                                                               
  Current knowledge in various domains of preterm neonatal care                        Questionnaire                                                                      
  Doctors                                                                              Satisfaction with their work                                                       One to one in-depth interview; case studies
  Challenges they face in their work                                                                                                                                      
  Who makes decisions about patient care                                                                                                                                  
  How problems are managed in the SCNU                                                                                                                                    
  Their role in training nurses                                                                                                                                           
  Attitudes concerning knowledge and skills of the nurses                                                                                                                 
  Attitudes towards mothers                                                                                                                                               
  Attitude towards creating a QI nurse in this SCNU                                                                                                                       
  Potential role of a QI nurse                                                                                                                                            
  Current knowledge in various domains of preterm neonatal care                        Questionnaire                                                                      
  Current skills and practices e.g., handwashing, wearing gloves, use of antibiotics   OSCE and observation                                                               
  Parents                                                                              What they know about ROP                                                           Questionnaire
  Their attitudes towards helping to provide care for their infant                                                                                                        
  Barriers they face in spending time in the NICU                                                                                                                         

OSCE=Objective structured clinical examination, QI=Quality improvement

###### 

Study outcomes

  Objectives                                                                                                                                         Outcomes
  -------------------------------------------------------------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------
  Objective 1                                                                                                                                        Needs of healthcare personnel for improving their clinical and QI skills
  Knowledge of barriers in improving practices of healthcare personnel                                                                               
  Needs of SCNU coordinators/child health consultants for improving their skills                                                                     
  Objective 2                                                                                                                                        Learning package for improving managerial and leadership skills of healthcare personnel
  Learning package for improving knowledge of healthcare personnel in core clinical care areas of preterm neonates                                   
  Skill-labs in mentoring institutes for improving skills of healthcare personnel                                                                    
  Dissemination material to improve awareness of parents, health system administrators and the general public regarding retinopathy of prematurity   
  Collaborative QI network for chosen states and voluntary institutions                                                                              
  Objective 3                                                                                                                                        Knowledge, attitude, skills, and practices of the target group
  The proportion of admitted neonates receiving antibiotics for ≥5 days Incidence of probable/proven sepsis                                          
  The proportion of neonates on oxygen who are being optimally monitored by a pulse oximeter                                                         
  The proportion of neonates on exclusive breast milk feeding at discharge                                                                           
  The proportion of neonates receiving a blood transfusion                                                                                           
  The proportion of eligible mothers receiving antenatal steroids                                                                                    
  The proportion of eligible neonates identified for ROP screening                                                                                   
  The proportion of eligible neonates screened for ROP                                                                                               
  The proportion of neonates survived without severe ROP                                                                                             

Approval was obtained from the ethics committees of the respective institutions and written informed consent was obtained from healthcare providers (for objective 1 and 2) and either parent of preterm neonates (for objective 3).

Results {#sec1-3}
=======

Five main target clinical areas were identified in the theory of change for improvement which could impact preterm survival without severe ROP. These areas included good control of oxygen, less exposure to blood products, good nutritional status, less systemic infections, and good developmentally supportive care. Good control of oxygen included steps to improve methods of oxygen administration and monitoring and optimizing the use of continuous airway pressure (CPAP) and surfactant. Strategies to reduce exposure to blood products included less blood sampling, policy to restrict the use of blood products and effective use of phototherapy. Strategies to improve nutritional status included early initiation and rapid advancement of enteral feeding with breastmilk. Various strategies were planned to improve aseptic techniques at the time of birth and during hospital admission to reduce systemic infections. Prevention of hypothermia, kangaroo mother care, pain control and less noise, and light exposure were strategies to improve developmental care, with greater involvement of parents in the care of their preterm baby during the hospital stay.

[Table 3](#T3){ref-type="table"} enlists the QI projects conducted in the SNCUs during the study. [Fig. 2](#F2){ref-type="fig"} presents an example of a successful QI project. At present, data collected during the project are being analyzed to evaluate the effectiveness of the intervention package on the study outcomes.

###### 

Quality improvement projects conducted during the project

  Site                                                                                                                            Project
  ------------------------------------------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------
  Sehore                                                                                                                          Early initiation of enteral feed in neonates admitted to SCNU Decrease oxygen consumption from 8-10 cylinders per day to 3-4 cylinders per day over 8 weeks
  Rationalizing oxygen therapy in neonates admitted to SCNU                                                                       
  An increasing percentage of babies breastfed within 1 h of birth in babies born at the district hospital                        
  Increasing proportion neonates undergoing KMC in SCNU                                                                           
  Bhopal                                                                                                                          Increasing the rate of initiation of feeds in eligible low-birth-weight newborns within 24 h of admission in SCNU
  Increasing temperature monitoring in neonates admitted in postnatal wards                                                       
  Increasing KMC rates in stable neonates transferred to postnatal wards                                                          
  Reducing excess oxygen administration among neonates at the time of admission by increasing the use of pulse oximetry in SCNU   
  Increasing duration of KMC in postnatal wards                                                                                   
  Dhar                                                                                                                            Decreasing the use of antibiotics in sick newborn babies admitted in SCNU
  Prevention of hypothermia at admission to SCNU                                                                                  
  Increasing the duration of KMC in admitted neonates                                                                             
  Ujjain                                                                                                                          Rationalizing the initiation of antibiotics in SCNU
  Decreasing irrational use of oxygen in newborns admitted in SCNU                                                                
  Increase the proportion of neonates undergoing KMC                                                                              
  Other SCNUs                                                                                                                     Improving the rational use of antibiotic in SCNU
  Reducing inappropriate use of oxygen by standardizing its initiation among neonates admitted in SCNU                            
  Increasing the use of EBM for feeding of neonates admitted in SCNU Vidisha                                                      
  Increasing early initiation of BF in C-section mothers at SCNU Mandsaur                                                         
  Increasing feed initiation within 24 h of admission at SCNU Betul                                                               
  Improving hand hygiene compliance in Gwalior NICU                                                                               
  Improve hepatitis B vaccine coverage at Medical College, Sagar                                                                  
  Increasing KMC duration at SCNU, Vidisha                                                                                        
  Reducing hypothermia at admission at SCNU Datia                                                                                 
  Early enteral nutrition initiation at SCNU, Indore                                                                              
  Increasing KMC duration at SCNU Rewa                                                                                            
  Increasing skin-to-skin contact in stable neonates born by normal vaginal delivery at SCNU Jabalpur                             

![Example of a quality improvement project](IJO-68-115-g002){#F2}

Discussion {#sec1-4}
==========

This study was planned to improve the survival of preterm neonates without sight-threatening ROP. The interventions used in the study are based on two important evidence-based approaches. Firstly, it has been recognized that although healthcare workers in resource-limited settings have suboptimal knowledge and skills about preterm care, the latter cannot be improved by continuing medical education or skill training alone.\[[@ref6]\] System barriers which preclude the application of evidence-based practices need to be overcome along with improvement in knowledge and skills.\[[@ref7]\] Therefore, the interventions in this study have components of improving the capacity of healthcare workers and their teams in both clinical and QI domains. Secondly, it has been recognized that risk factors for ROP in preterm neonates cared for resource-limited settings are different from those in reported from well-resourced countries.\[[@ref3][@ref8][@ref9][@ref10]\] Unmonitored and unnecessary use of oxygen therapy and a high incidence of infection are two important risk factors identified in low- and middle-income countries. As a result, ROP is often observed in heavier and relatively mature preterm neonates.\[[@ref11]\] Therefore, improvement strategies to decrease the incidence of ROP need to focus on improving context-specific risk factors and health systems.

We have used both in-person contact and e-learning approaches to reach many healthcare providers in the target hospitals. While in-person two-way interaction is an important component of adult learning, e-learning has advantages as it can reach a large number of learners in a shorter time, there are opportunities of repeated synchronous (web-meetings and chat session) and asynchronous (discussion boards and group emails) interactions and standardization of learning material. We believe that in a vast country like India with tens of thousands of healthcare providers involved in neonatal care, it is important to use e-learning platforms. We have previously demonstrated the effectiveness of the e-learning approach in improving knowledge and skills of healthcare providers.\[[@ref12]\]

Conclusion {#sec1-5}
==========

Due to weak and fragmented health systems, even skilled and knowledgeable healthcare providers may face challenges in using evidence-based practices. Some of the health system-related challenges are due to poor infrastructure (e.g., lack of an adequate number of pulse oximeters) but many are related to lack of point-of-care policies or standard operating procedures (e.g., identifying neonates needing oxygen therapy). A QI approach managed by local teams of doctors and nurses can overcome these contextual issues. The success of such an approach in improving clinical practices has been demonstrated in both resource-rich and resource-limited settings.\[[@ref6][@ref13]\] Therefore, we planned to integrate the QI approach with knowledge and skill-building.

Financial support and sponsorship {#sec2-1}
---------------------------------

The Queen Elizabeth Diamond Jubilee Trust, London, UK and National Health Misson, Madhya Pradesh, India.

Conflicts of interest {#sec2-2}
---------------------

There are no conflicts of interest.
