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.

Determinants of Kangaroo Mother Care Uptake for Small Babies Along the Health Facility to Community Continuum in Karnataka, India.

INTRODUCTION: Kangaroo mother care (KMC) scale-up is a proposed strategy to accelerate reduction in neonatal mortality rates. We aimed to identify determinants of KMC uptake for small babies (less than 2,000 g birth weight) along the health facility to community continuum in Karnataka, India. METHODS: From June 2017 to March 2020, data on characteristics of health facilities and health care workers (HCWs) from 8 purposively selected health facilities were assessed. Knowledge, attitude, and support the mothers received for KMC uptake were assessed once between 4 weeks and 8 weeks unadjusted age of the cohort of babies. Secondary data on KMC were obtained from the district-wide implementation research project database. Bivariate analysis was used to assess the association of characteristics of health facilities, HCWs, mothers, and small babies with the day of KMC initiation and its duration. Log-binomial regression analysis was then computed to identify determinants of KMC. RESULTS: We recruited 227 (91.5%) of 248 babies eligible to participate with a mean unadjusted age of 35.6 days (±7.5) and 1,693.9 g (±263.1 g) birth weight. KMC was initiated for 95.2% of 227 babies at the health facility; initiated at 3 days or earlier of life for 59.6% of 226 babies; and babies continued to receive KMC for more than 4 weeks (30.2 days [±8.4]) at home. Determinants of KMC initiation were HCWs' attitudes, initiation support at the health facility, and place of hospitalization. Determinants of KMC maintenance at the health facility were HCWs' skills and support the mother received at the facility after initiating KMC. Place of hospitalization and HCWs' knowledge determined KMC duration at home 1 week after discharge. CONCLUSION: These findings emphasize the importance of competent HCWs and support for mothers at the health facility for initiation and maintenance of KMC within the health facility and 1 week after discharge.

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.

Continuous, real-time monitoring of neonatal position and temperature during Kangaroo Mother Care using a wearable sensor: a techno-feasibility pilot study.

BACKGROUND: Remote biomonitoring of vital parameters in hospitals and homes has the potential to improve coverage and quality of maternal and neonatal health. Wearable sensors coupled with modern information and communication technology now offer an opportunity to monitor temperatures and kangaroo mother care (KMC) adherence in a continuous and real-time manner remotely for several days' duration in hospital and home settings. Using an innovative remote biomonitoring device to measure both temperature and baby position, we undertook a techno-feasibility study in preparation for a clinical trial. METHODS: We designed and developed a wearable sensor for tracking KMC adherence and neonatal temperature, using social innovation design principles. After screening mother-infant dyads using clinical and logistic eligibility criteria, we piloted this wearable sensor along with a gateway device and the commercial cellular network. The dyads were recruited during hospitalization and followed up in the hospital and home phases for several days. Simple descriptive statistical analysis was undertaken. RESULTS: Recruitment rate was 50% (6/12), and consenting rate was 83% (5/6) during a 2-month period. These five neonates contributed a total of 39 study days (15 hospital days and 24 home days). Their mean [± standard deviation (S.D.)] birth weight was 1490 (± 244) g.The mean (± S.D.) of the vital signs for the five babies was temperature [36.5 °C (± 0.3)], heart rate [146.5/min (± 14)], and oxygen saturation [94% (± 4)]. No severe or moderate side-effects were noted; one baby developed mild dermatitis under the device that was transient and self-limiting, yielding an incidence proportion of 20% and incidence rate of 2.6/100 person-days.None of the mothers reported any discomfort with the use of the device. Temperatures detected from 81 paired readings revealed that those from the wearable sensor were 0.2 °C lower than those detected by clinical thermometers [36.4 (± 0.7) vs 36.6 (± 0.3); < 0.001].There was also iterative feedback that was useful for hardware and software design specifications of the wearable sensor, the gateway device, and the analytics platform. Lastly, lessons were learnt with regard to the logistics of research team interactions with healthcare professionals and study participants during the hospitalization and post-discharge home phases of the study. CONCLUSIONS: The pilot study has shown that it is feasible and acceptable to track KMC adherence as well as maternal and newborn temperatures in a potentially safe manner on a real-time mode for several days' duration during hospitalization and home phases. The pilot has also helped inform modifications in clinical monitoring, technological modifications, and logistics planning in preparation for the definitive clinical trial. TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2017/09/009789.

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.

Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India.

OBJECTIVE: Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. METHODS: Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice. RESULTS: Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of -0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates. CONCLUSIONS: This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health.

Adoption and Completeness of Documentation Using a Structured Delivery Record in Secondary Care, Subdistrict Government Hospitals of Karnataka State, India.

OBJECTIVE: Poor medical record documentation remains a pervasive problem in hospital delivery rooms, hampering efforts aimed at improving the quality of maternal and neonatal care in resource-limited settings. We evaluated the feasibility and completeness of labor room documentation within a quasi-experimental study aimed at improving emergency preparedness for obstetric and neonatal emergencies in 8 nonteaching, subdistrict, secondary care hospitals of Karnataka state, India. METHODS: We redesigned the existing open-ended case sheet into a structured, delivery record cum job aide adhering to principles of local clinical relevance, parsimony, and computerizability. Skills and emergency drills training along with supportive supervision were introduced in 4 "intervention arm" hospitals while the new delivery records were used in eight intervention and control hospitals. RESULTS: Introduction of the new delivery record was feasible over a "run-in" period of 4 months. About 92% (6103 of 6634) of women in intervention facilities and 80% (6205 of 7756) in control facilities had their delivery records filled in during the 1-year study period. Completeness of delivery record documentation fell into one of two subsets with one set of parameters being documented with minimal inputs (in both intervention and control sites) and another set of parameters requiring more intensive training efforts (and seen more in intervention than in control sites; P < .05). CONCLUSION: Under the stewardship of the local government, it was possible to institute a robust, reliable, and valid medical record documentation system as part of efforts to improve intrapartum and postpartum maternal and newborn care in hospitals.

Limited Effectiveness of a Skills and Drills Intervention to Improve Emergency Obstetric and Newborn Care in Karnataka, India: A Proof-of-Concept Study.

OBJECTIVE: The majority of the maternal and perinatal deaths are preventable through improved emergency obstetric and newborn care at facilities. However, the quality of such care in India has significant gaps in terms of provider skills and in their preparedness to handle emergencies. We tested the feasibility, acceptability, and effectiveness of a "skills and drills" intervention, implemented between July 2013 and September 2014, to improve emergency obstetric and newborn care in the state of Karnataka, India. METHODS: Emergency drills through role play, conducted every 2 months, combined with supportive supervision and a 2-day skills refresher session were delivered across 4 sub-district, secondary-level government facilities by an external team of obstetric and pediatric specialists and nurses. We evaluated the intervention through a quasi-experimental design with 4 intervention and 4 comparison facilities, using delivery case sheet reviews, pre- and post-knowledge tests among providers, objective structured clinical examinations (OSCEs), and qualitative in-depth interviews. Primary outcomes consisted of improved diagnosis and management of selected maternal and newborn complications (postpartum hemorrhage, pregnancy-induced hypertension, and birth asphyxia). Secondary outcomes included knowledge and skill levels of providers and acceptability and feasibility of the intervention. RESULTS: Knowledge scores among providers improved significantly in the intervention facilities; in obstetrics, average scores between the pre- and post-test increased from 49% to 57% (P=.006) and in newborn care, scores increased from 48% to 56% (P=.03). Knowledge scores in the comparison facilities were similar but did not improve significantly over time. Skill levels were significantly higher among providers in intervention facilities than comparison facilities (mean objective structured clinical examination scores for obstetric skills: 55% vs. 46%, respectively; for newborn skills: 58% vs. 48%, respectively; P<.001 for both obstetric and newborn), along with their confidence in managing complications. However, this did not result in significant differences in correct diagnosis and management of complications between intervention and comparison facilities. Shortage of trained nurses and doctors along with unavailability of a consistent supply chain was cited by most providers as major health systems barriers affecting provision of care. CONCLUSIONS: Improvements in knowledge, skills, and confidence levels of providers as a result of the skills and drills intervention was not sufficient to translate into improved diagnosis and management of maternal and newborn complications. System-level changes including adequate in-service training may also be necessary to improve maternal and newborn outcomes.

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.

Nurse Mentors to Advance Quality Improvement in Primary Health Centers: Lessons From a Pilot Program in Northern Karnataka, India.

High-quality care during labor, delivery, and the postpartum period is critically important since maternal and child morbidity and mortality are linked to complications that arise during these stages. A nurse mentoring program was implemented in northern Karnataka, India, to improve quality of services at primary health centers (PHCs), the lowest level in the public health system that offers basic obstetric care. The intervention, conducted between August 2012 and July 2014, employed 53 full-time nurse mentors and was scaled-up in 385 PHCs in 8 poor rural districts. Each mentor was responsible for 6 to 8 PHCs and conducted roughly 6 mentoring visits per PHC in the first year. This paper reports the results of a qualitative inquiry, conducted between September 2012 and April 2014, assessing the program's successes and challenges from the perspective of mentors and PHC teams. Data were gathered through 13 observations, 9 focus group discussions with mentors, and 25 individual and group interviews with PHC nurses, medical officers, and district health officers. Mentors and PHC staff and leaders reported a number of successes, including development of rapport and trust between mentors and PHC staff, introduction of team-based quality improvement processes, correct and consistent use of a new case sheet to ensure adherence to clinical guidelines, and increases in staff nurses' knowledge and skills. Overall, nurses in many PHCs reported an increased ability to provide care according to guidelines and to handle maternal and newborn complications, along with improvements in equipment and supplies and referral management. Challenges included high service delivery volumes and/or understaffing at some PHCs, unsupportive or absent PHC leadership, and cultural practices that impacted quality. Comprehensive mentoring can build competence and improve performance by combining on-the-job clinical and technical support, applying quality improvement principles, and promoting team-based problem solving.