The why, what and how of preconception care: an exploratory descriptive qualitative study in Karnataka, India.

BACKGROUND: Women's health and nutrition are key to their reproductive health and are important for optimising pregnancy outcomes. Formation of most foetal organs starts soon after conception and much before the woman has her first antenatal visit. The provision of biomedical, behavioural and social interventions to couples to address health, nutrition, behaviour issues and individual environmental risk factors that could contribute to improved maternal and child health outcomes before conception is crucial. Most rural women in India, do not seek pregnancy care before the second trimester because of socio-cultural factors. Therefore, intervening in the preconception period is important. The objective of the study was to explore the challenges and opportunities of implementing preconception care interventions. METHODS: Individual, in-depth, semi-structured interviews (n = 25) were conducted with primary stakeholders (newly married women, newly married men, and family members) in Shorapur taluk of Yadgir district and Devadurga taluk of Raichur district. Thirty-one interviews were conducted with taluk, district, state officials and academicians. This descriptive qualitative study conducted four focus group discussions with front-line health workers. The in-depth interviews (IDIs) and Focus-group discussions (FGDs) used separate pre-tested semi-structured interview/discussion guides. Data analysis was carried out using NVivo software using a phenomenological approach with both inductive and deductive analysis. RESULTS: A strong influence of social and cultural norms shapes healthcare-seeking behaviour at the community level. Poor dietary diversity, lack of awareness, poor literacy levels, work pressure for women, lack of decision-making power and empowerment among women, pressure to conceive early, and gender norms are the roadblocks to successful preconception care programs in the rural Karnataka setting. The stakeholders expressed the need for interventions during the preconception period. The government functionaries recommended several interventions which could be potentially integrated into the existing Reproductive Maternal, Neonatal, Child and Adolescent Health (RMNCH + A) strategy to improve the health and nutrition of women before they conceive. CONCLUSION: The study highlights the need for structured interventions during the preconception period to improve maternal health and pregnancy outcomes. The recommendations provided by government functionaries are indicative of the feasibility of integrating interventions in the RMNCH + A strategy.

Accelerated scale-up of Kangaroo Mother Care: Evidence and experience from an implementation-research initiative in south India.

AIM: Though Kangaroo Mother Care (KMC) has demonstrated benefits for low birth weight newborns, coverage continues to be low in India. As part of a World Health Organization (WHO) multi-country study, we explored intervention models to accelerate KMC coverage in a high priority district of Karnataka, India. METHODS: We used implementation-research methods, formative assessments and quality improvement approaches to design and scale-up interventions. Evaluation was done using prospective cohort study design; data were collected from facility records, and client interviews during KMC initiation, at discharge and at home after discharge. RESULTS: KMC was initiated at health facilities for 87.6% of LBW babies under 2000 g. At discharge, 85.0% received KMC; 67.9% continued to receive KMC at home on the 7th day post-discharge. The interventions included training, mentoring and constant advocacy at many levels: public health facilities, private sector and the community. Innovations like a KMC case sheet, counselling, peer support group triggered KMC in the facilities; a KMC-link card, a microplanning and communication tool for CHWs helped to sustain practice at homes. CONCLUSION: The study provides a novel approach to designing and scaling up interventions and suggests lessons that are applicable to KMC as well as to broader reproductive, maternal, neonatal and child health programmes.

Socio-demographic, behavioural and clinical factors influencing control of diabetes and hypertension in urban Mysore, South India: a mixed-method study conducted in 2018.

BACKGROUND: Inadequate control of diabetes and hypertension is a major concern in India because of rising mortality and morbidity. Few studies in India have explored factors that influence control of diabetes and hypertension. The current study aimed to improve the understanding of multifactorial influence on the control of diabetes and hypertension among patients in Primary Health Care Settings(PHC) of urban Karnataka. METHODS: We used a mixed-method study design, within a project aiming to improve non-communicable disease (NCD) continuum of care across PHC in Mysore city, India, conducted in 2018. The quantitative study was conducted among 399 patients with diabetes and/or hypertension and a logistic regression model was used to assess the factors responsible for biological control levels of diabetes and hypertension measured through Glycated Haemoglobin(HbA1c) and blood pressure. Further, in-depth interviews(IDI) were conducted among these patients and the counsellors at PHCs to understand the barriers and enablers for better control. RESULT: The quantitative assessment found odds of poor control amongst diabetics' increased with older age, longer duration of disease, additional chronic conditions, and tobacco consumption. For hypertensives, odds of poor control increased with higher body mass index(BMI), alcohol consumption, and belongingness to lower social groups. These findings were elaborated through qualitative assessment which found that the control status was affected by stress as a result of family or financial worries. Stress, poor lifestyle, and poor health-seeking behaviour interplay with other factors like diet and exercise leading to poor control of diabetes and hypertension. CONCLUSION: A better understanding of determinants associated with disease control can assist in designing focused patient outreach plans, customized communication strategies, need-based care delivery plans, and specific competency-based capacity-building models for health care workers. Patient-centric care focusing on biological, social and behavioural determinants is pivotal for appropriate management of NCDs at community level in low-middle income countries.

Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study.

OBJECTIVES: Kangaroo Mother Care (KMC), prolonged skin-to-skin care of the low birth weight baby with the mother plus exclusive breastfeeding reduces neonatal mortality. Global KMC coverage is low. This study was conducted to develop and evaluate context-adapted implementation models to achieve improved coverage. DESIGN: This study used mixed-methods applying implementation science to develop an adaptable strategy to improve implementation. Formative research informed the initial model which was refined in three iterative cycles. The models included three components: (1) maximising access to KMC-implementing facilities, (2) ensuring KMC initiation and maintenance in facilities and (3) supporting continuation at home postdischarge. PARTICIPANTS: 3804 infants of birth weight under 2000 g who survived the first 3 days, were available in the study area and whose mother resided in the study area. MAIN OUTCOME MEASURES: The primary outcomes were coverage of KMC during the 24 hours prior to discharge and at 7 days postdischarge. RESULTS: Key barriers and solutions were identified for scaling up KMC. The resulting implementation model achieved high population-based coverage. KMC initiation reached 68%-86% of infants in Ethiopian sites and 87% in Indian sites. At discharge, KMC was provided to 68% of infants in Ethiopia and 55% in India. At 7 days postdischarge, KMC was provided to 53%-65% of infants in all sites, except Oromia (38%) and Karnataka (36%). CONCLUSIONS: This study shows how high coverage of KMC can be achieved using context-adapted models based on implementation science. They were supported by government leadership, health workers' conviction that KMC is the standard of care, women's and families' acceptance of KMC, and changes in infrastructure, policy, skills and practice. TRIAL REGISTRATION NUMBERS: ISRCTN12286667; CTRI/2017/07/008988; NCT03098069; NCT03419416; NCT03506698.

Is a differentiated care model needed for patients with TB? A cohort analysis of risk factors contributing to unfavourable outcomes among TB patients in two states in South India.

BACKGROUND: TB is a preventable and treatable disease. Yet, successful treatment outcomes at desired levels are elusive in many national TB programs, including India. We aim to identify risk factors for unfavourable outcomes to TB treatment, in order to subsequently design a care model that would improve treatment outcomes among these at-risk patients. METHODS: We conducted a cohort analysis among TB patients who had been recently initiated on treatment. The study was part of the internal program evaluation of a USAID-THALI project, implemented in select towns/cities of Karnataka and Telangana, south India. Community Health Workers (CHWs) under the project, used a pre-designed tool to assess TB patients for potential risks of an unfavourable outcome. CHWs followed up this cohort of patients until treatment outcomes were declared. We extracted treatment outcomes from patient's follow-up data and from the Nikshay portal. The specific cohort of patients included in our study were those whose risk was assessed during July and September, 2018, subsequent to conceptualisation, tool finalisation and CHW training. We used bivariate and multivariate logistic regression to assess each of the individual and combined risks against unfavourable outcomes; death alone, or death, lost to follow up and treatment failure, combined as 'unfavourable outcome'. RESULTS: A significantly higher likelihood of death and experiencing unfavourable outcome was observed for individuals having more than one risk (AOR: 4.19; 95% CI: 2.47-7.11 for death; AOR 2.21; 95% CI: 1.56-3.12 for unfavourable outcome) or only one risk (AOR: 3.28; 95% CI: 2.11-5.10 for death; AOR 1.71; 95% CI: 1.29-2.26 for unfavourable outcome) as compared to TB patients with no identified risk. Male, a lower education status, an initial weight below the national median weight, co-existing HIV, previous history of treatment, drug-resistant TB, and regular alcohol use had significantly higher odds of death and unfavourable outcome, while age > 60 was only associated with higher odds of death. CONCLUSION: A rapid risk assessment at treatment initiation can identify factors that are associated with unfavourable outcomes. TB programs could intensify care and support to these patients, in order to optimise treatment outcomes among TB patients.

A narrative review of gaps in the provision of integrated care for noncommunicable diseases in India.

BACKGROUND: Low- and middle-income countries (LMICs) account for a higher burden of noncommunicable diseases (NCD) and home to a higher number of premature deaths (before age 70) from NCDs. NCDs have become an integral part of the global development agenda; hence, the scope of action on NCDs extends beyond just the health-related sustainable development goal (SDG 3). However, the organization and integration of NCD-related health services have faced several gaps in the LMIC regions such as India. Although the national NCD programme of India has been in operation for a decade, challenges remain in the integration of NCD services at primary care. In this paper, we have analysed existing gaps in the organization and integration of NCD services at primary care and suggested plausible solutions that exist. METHOD: The identification of gaps is based out of a review of peer-reviewed articles, reports on national and global guidelines/protocols. The gaps are organized and narrated at four levels such as community, facility, health system, health policy and research, as per the WHO Innovative Care for Chronic Conditions framework (WHO ICCC). RESULT: The review found that challenges in the identification of eligible beneficiaries, shortage and poor capacity of frontline health workers, poor functioning of community groups and poor community knowledge on NCD risk factors were key gaps at the community level. Challenges at facility level such as poor facility infrastructure, lack of provider knowledge on standards of NCD care and below par quality of care led to poor management of NCDs. At the health system level, we found, organization of care, programme management and monitoring systems were not geared up to address NCDs. Multi-sectoral collaboration and coordination were proposed at the policy level to tackle NCDs; however, gaps remained in implementation of such policies. Limited research on the effect of health promotion, prevention and, in particular, non-medical interventions on NCDs was found as a key gap at the research level. CONCLUSION: This paper reinforces the need for an integrated comprehensive model of NCD care especially at primary health care level to address the growing burden of these diseases. This overarching review is quite relevant and useful in organizing NCD care in Indian and similar LMIC settings.

Potential contributions of an on-site nurse mentoring program on neonatal mortality reductions in rural Karnataka state, South India: evidence from repeat community cross-sectional surveys.

BACKGROUND: We assessed the effects of a nurse mentoring program on neonatal mortality in eight districts in India. METHODS: From 2012 to 2015, nurse mentors supported improvements in critical MNCH-related practices among health providers at primary health centres (PHCs) in northern Karnataka, South India. Baseline (n = 5240) and endline (n = 5154) surveys of randomly selected ever-married women were conducted. Neonatal mortality rates (NMR) among the last live-born children in the three years prior to each survey delivered in NM and non-NM-supported facilities were calculated and compared using survival analysis and cumulative hazard function. Mortality rates on days 1, 2-7 and 8-28 post-partum were compared. Cox survival regression analysis measured the adjusted effect on neonatal mortality of delivering in a nurse mentor supported facility. RESULTS: Overall, neonatal mortality rate in the three years preceding the baseline and endline surveys was 30.5 (95% CI 24.3-38.4) and 21.6 (95% CI 16.3-28.7) respectively. There was a substantial decline in neonatal mortality between the survey rounds among children delivered in PHCs supported by NM: 29.4 (95% CI 18.1-47.5) vs. 9.3 (95% CI 3.9-22.3) (p = 0.09). No significant declines in neonatal mortality rate were observed among children delivered in other facilities or at home. In regression analysis, among children born in nurse mentor supported facilities, the estimated hazard ratio at endline was significantly lower compared with baseline (HR: 0.23, 95% CI: 0.06-0.82, p = 0.02). CONCLUSION: The nurse mentoring program was associated with a substantial reduction in neonatal mortality. Further research is warranted to delineate whether this may be an effective strategy for reducing NMR in resource-poor settings.

Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation.

INTRODUCTION: Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. Consequently, only a small fraction of newborns that could benefit from KMC receive it. METHODS AND ANALYSIS: This implementation research project aims to develop and evaluate district-level models for scaling up KMC in India and Ethiopia that can achieve high population coverage. The project includes formative research to identify barriers and contextual factors that affect implementation and utilisation of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. Implementation actions would happen at three levels: 'pre-KMC facility'-to maximise the number of newborns getting to a facility that provides KMC; 'KMC facility'-for initiation and maintenance of KMC; and 'post-KMC facility'-for continuation of KMC at home. Stable infants with birth weight<2000 g and born in the catchment population of the study KMC facilities would form the eligible population. The primary outcome will be coverage of KMC in the preceding 24 hours and will be measured at discharge from the KMC facility and 7 days after hospital discharge. ETHICS AND DISSEMINATION: Ethics approval was obtained in all the project sites, and centrally by the Research Ethics Review Committee at the WHO. Results of the project will be submitted to a peer-reviewed journal for publication, in addition to national and global level dissemination. STUDY STATUS: WHO approved protocol: V.4-12 May 2016-Protocol ID: ERC 2716. Study implementation beginning: April 2017. Study end: expected March 2019. TRIAL REGISTRATION NUMBER: Community Empowerment Laboratory, Uttar Pradesh, India (ISRCTN12286667); St John's National Academy of Health Sciences, Bangalore, India and Karnataka Health Promotion Trust, Bangalore, India (CTRI/2017/07/008988); Society for Applied Studies, Delhi (NCT03098069); Oromia, Ethiopia (NCT03419416); Amhara, SNNPR and Tigray, Ethiopia (NCT03506698).

Designing a comprehensive Non-Communicable Diseases (NCD) programme for hypertension and diabetes at primary health care level: evidence and experience from urban Karnataka, South India.

BACKGROUND: India accounts for more than two-third of mortality due to non-communicable diseases (NCDs) in south-east Asia. The burden is high in Karnataka, one of the largest states in southern India. There is a need for integration of disease prevention, health promotion, treatment and care within the national program at primary level. A public-private partnership initiative explored evidence gaps to inform a health system based, integrated NCD programme across care continuum with a focus on hypertension and diabetes. METHODS: The study was conducted during 2017-18 in urban parts of Mysore city, covering a population of 58,000. Mixed methods were used in the study; a population-based screening to estimate denominators for those with disease and at risk; cross-sectional surveys to understand distribution of risk factors, treatment adherence and out of pocket expenses; facility audits to assess readiness of public and private facilities; in-depth interviews and focus group discussions to understand practices, myths and perceptions in the community. Chi-square tests were used to test differences between the groups. Framework analysis approach was used for qualitative analysis. RESULTS: Twelve and 19% of the adult population had raised blood sugar and blood pressure, respectively, which increased with age, to 32 and 44% for over 50 years. 11% reported tobacco consumption; 5.5%, high alcohol consumption; 40%, inadequate physical activity and 81%, inappropriate diet consumption. These correlated strongly with elderly age and poor education. The public facilities lacked diagnostics and specialist services; care in the private sector was expensive. Qualitative data revealed fears and cultural myths that affected treatment adherence. The results informed intervention design across the NCD care continuum. CONCLUSIONS: The study provides tools and methodology to gather evidence in designing comprehensive NCD programmes in low and middle income settings. The study also provides important insights into public-private partnership driving effective NCD care at primary care level.

Design and Implementation of a Structured Programme for Validation of Birth Weights in a District of Southern India: A Case Study.

In India, though the prevalence of low birth weight (LBW) is estimated to be nearly 30%, routine reporting by the government consistently under-reports it as 12%, with resulting mismatched rectification efforts. We designed a programme comprising weight measurement standardization training, a pilot study-based sample size calculation, re-training and certification of personnel and finally a validation exercise. Paired birth weight readings of 404 newborns by a staff nurse and a research nurse were compared. LBW (<2,500 g) prevalence was 18% and 36% according to staff nurse and research nurse, respectively. Thus, it is feasible to set up simple validation exercises.

Influence of integrated community- and facility-based interventions on select maternal and neonatal outcomes in Northern Karnataka, India: Lessons for implementation and measurement.

BACKGROUND: Sukshema project provided technical assistance to National Health Mission of government of Karnataka to improve maternal, newborn and child health (MNCH) outcomes in eight districts of Karnataka between 2009 and 2015. The project designed tools, processes and provided mentoring to frontline workers, community structures, and facilities to improve demand generation and quality of MNCH services. OBJECTIVES: To assess over time changes in selected MNCH care indicators among women who had delivered in the past 2 months in Bagalkot and Koppal districts. METHODS: An innovative strategy was designed to collect routine monitoring data, namely community behavior tracking survey using mobile technology. The catchment area of an Accredited Social Health Activist (ASHA) was the primary sampling unit, and in each district 200, ASHA areas were selected. Women from these selected ASHA areas were interviewed and information collected on various MNCH care outcomes. Multivariate logistic regression was used to assess changes in selected MNCH care indicators. RESULTS: Gradual increase was noticed in institutional delivery, hospital stay for 48 or more hours, initiation of breastfeeding within 1 hour and continuum of MNCH care. Forty-eight hours stay and initiation of breastfeeding improved marginally possibly due to health systems and cultural norms. CONCLUSIONS: Results indicated that the interventions were successful in changing the critical MNCH care indicators and hence have potential for replication in similar high priority district settings.

Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial.

BACKGROUND: In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. METHODS: All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. RESULTS: Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional $5.60 overall per delivery. CONCLUSIONS: The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02004912.