Community-Based Behaviour Change Management on Neonatal Mortality

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Articles Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: a cluster-randomised controlled trial Vishwajeet Kumar, Saroj Mohanty, Aarti Kumar, Rajendra P Misra, Mathuram Santosham, Shally Awasthi, Abdullah H Baqui, Pramod Singh, Vivek Singh, Ramesh C Ahuja, Jai Vir Singh, Gyanendra Kumar Malik, Saifuddin Ahmed, Robert E Black, Mahendra Bhandari, Gary L Darmstadt, for the Saksham Study Group Summary Background In rural India, most birt
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  Articles www.thelancet.com   Vol 372 September 27, 2008 1151 Effect of community-based behaviour changemanagement on neonatal mortality in Shivgarh,Uttar Pradesh, India: a cluster-randomised controlled trial Vishwajeet Kumar, Saroj Mohanty, Aarti Kumar, Rajendra P Misra, Mathuram Santosham, Shally Awasthi, Abdullah H Baqui, Pramod Singh,Vivek Singh, Ramesh C Ahuja, Jai Vir Singh, Gyanendra Kumar Malik, Saifuddin Ahmed, Robert E Black, Mahendra Bhandari, Gary L Darmstadt,for the Saksham Study Group Summary Background In rural India, most births take place in the home, where high-risk care practices are common. Wedeveloped an intervention of behaviour change management, with a focus on prevention of hypothermia, aimed atmodifying practices and reducing neonatal mortality. Methods  We did a cluster-randomised controlled effi cacy trial in Shivgarh, a rural area in Uttar Pradesh. 39 villageadministrative units (population 104 123) were allocated to one of three groups: a control group, which received theusual services of governmental and non-governmental organisations in the area; an intervention group, whichreceived a preventive package of interventions for essential newborn care (birth preparedness, clean delivery and cordcare, thermal care [including skin-to-skin care], breastfeeding promotion, and danger sign recognition); or another intervention group, which received the package of essential newborn care plus use of a liquid crystal hypothermiaindicator (ThermoSpot). In the intervention clusters, community health workers delivered the packages via collectivemeetings and two antenatal and two postnatal household visitations. Outcome measures included changes innewborn-care practices and neonatal mortality rate compared with the control group. Analysis was by intention totreat. This study is registered as International Standard Randomised Control Trial, number NCT00198653. Findings   Improvements in birth preparedness, hygienic delivery, thermal care (including skin-to-skin care), umbilicalcord care, skin care, and breastfeeding were seen in intervention arms. There was little change in care-seeking.Compared with controls, neonatal mortality rate was reduced by 54% in the essential newborn-care intervention (rateratio 0·46 [95% CI 0·35–0·60], p<0·0001) and by 52% in the essential newborn care plus ThermoSpot arm (0·48[95% CI 0·35–0·66], p<0·0001). Interpretation   A socioculturally contextualised, community-based intervention, targeted at high-risk newborn-carepractices, can lead to substantial behavioural modification and reduction in neonatal mortality. This approach can beapplied to behaviour change along the continuum of care, harmonise vertical interventions, and build communitycapacity for sustained development. Funding USAID and Save the Children-US through a grant from the Bill & Melinda Gates Foundation. Introduction Most neonatal deaths occur at home in low resourcesettings against a backdrop of poverty, unskilled homedeliveries, suboptimum care-seeking, and weak healthsystems. 1–3 Emerging evidence suggests that a substantialreduction in neonatal mortality can be achieved withsimple, low-cost interventions within family andcommunity settings. 1–11  In a study in Maharashtra, India, Bang andcolleagues 2,6 reported a 62–70% reduction in theneonatal mortality rate, and attributed 93% of thereduction to active management of sick newborn babiesand 7% to primary prevention. Baqui and colleagues 4   reported that an adaptation of this approach inBangladesh in an effectiveness trial had half the effect(34% reduction) on neonatal mortality. Manandhar andco-workers 3 tested a different approach in Nepal with acommunity-based participatory action-cycle with noprespecified intervention package, in which women’sgroups identified priorities and implemented localsolutions, and reported improvements in care practices,care-seeking, and a 30% reduction in neonatal mortalityrate.Most neonatal deaths in high-mortality regions areattributable to preventable and behaviourally modifiablecauses. 1–11 However, the extent to which a preventivepackage of evidence-based interventions at thecommunity level could reduce neonatal mortality isunknown. Estimates based on modelling of limitedempirical data suggest that 18–32% of neonatal mortalitycould be averted through high (90%) coverage of simple,affordable, methods for preventive family andcommunity newborn care. 1  Identification of an effective approach to preventivecare that builds on existing capacities and acceleratesprogramme effectiveness is important. The limited Lancet 2008; 372: 1151–62 See Comment page 1124 International Center forAdvancing Neonatal Health(ICANH), Department of International Health,Bloomberg School of PublicHealth, Johns HopkinsUniversity, Baltimore, MD, USA  (V Kumar MPH,Prof M Santosham MD,A H Baqui DrPH, S Ahmed PhD,Prof R E Black MD,G L Darmstadt MD) ; ClinicalEpidemiology Unit (V Kumar,S Mohanty MPhil, A Kumar MS,Prof R C Ahuja MD, R P Misra MA,P Singh MSW, V Singh MSW,Prof S Awasthi MD,Prof J V Singh MD,Prof G K Malik MD) ,   Departmentof Pediatrics (Prof G K Malik MD,Prof S Awasthi MD) , andDepartment of Social andPreventive Medicine  (Prof JV Singh MD) , CSM MedicalUniversity, Lucknow, India; andVattikuti Urology Institute,Henry Ford Health System,Detroit MI, USA  (Prof M Bhandari MD)Correspondence to:Gary L Darmstadt, IntegratedHealth Solutions Development,Global Health Program,Bill & Melinda Gates Foundation,PO Box 23350, Seattle,WA 98102, USA gdarmsta@jhsph.edu  Articles 1152 www.thelancet.com   Vol 372 September 27, 2008 success of large-scale studies of behaviour changeinterventions has been attributed to poor considerationof the social context that shapes behaviours whiletreating individual health behaviours as stand-aloneentities. 12–18  We postulated that an intervention based on asocioculturally contextualised approach of behaviourchange management systematically applied to modi-fiable, high-risk newborn-care practices, with anemphasis on hypothermia, within a community with ahigh neonatal mortality rate could lead to improvedcare practices and reduced mortality. Methods Study area and population The state of Uttar Pradesh, India, accounts for a quarterof India’s neonatal deaths and for 8% of thoseworldwide, and shares similar sociocultural, demo-graphic, and health system characteristics with otherhigh-mortality Indian states and south Asiancountries. 3–5,19–21 The study was done in Shivgarh, a ruralblock in Uttar Pradesh, with a population of 104 123divided into 39 village administrative units. Socio-economic indicators are among the lowest in the state.The formal health-care system in Shivgarh consists of a community health centre and two primary healthcentres operated by trained physicians and paramedicalstaff supported by 18 auxiliary nurse midwives, who areoutreach workers catering to a population of 6000–7000each, and trained to deliver babies, and providevaccinations and antenatal check-ups. Care-seekingfrom them, however, is low. 22   Study design This study was designed as a three-arm cluster-randomised controlled trial. A control group receivedthe usual services of governmental and non-governmentalorganisations in the area. One intervention groupreceived a package of preventive essential newborn care,including skin-to-skin care between the infant and afamily member, promoted through behaviour changemanagement, layered on existing services available tothe control group. The other intervention group receivedessential newborn care plus the use of a liquid crystalsticker that indicates hypothermia by changing colour   (ThermoSpot, Camborne Consultants, Dorset, UK).The cluster unit, called a  gram sabha , is the basicgeopolitical and administrative unit for village-levelhealth planning and implementation; use of smallerunits would have posed a higher risk of contaminationof intervention activites in control clusters. Onecommunity-based worker catered to one cluster unit.Stratified cluster randomisation was done at JohnsHopkins University using Stata 7.0 (StataCorp, CollegeStation, TX, USA) to allocate the 39 cluster unitsrandomly to the three study groups, yieldingthree allocation sequences of 13 clusters each. Baselinecovariates used for stratification were standard of livingindex, an indicator associated with mortality, and reli-gion, which was assumed to be associated withdifferences in care practices. 23  The study had two distinct and administrativelyindependent components: the intervention (devel-opment phase and implementation phase), andevaluation. Because of the visible nature of the inter-vention, allocation was not masked; however, boundariesto limit communication between the two teams wereclosely monitored.The study was registered at clinicaltrials.gov,number NCT00198653. The Committee on HumanResearch at the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA, and theEthical Review Committee at King George MedicalUniversity, Lucknow, India, approved the study protocol.A data safety and monitoring board consisting of American and Indian investigators monitored thestudy. Intervention Design of the community-based intervention forbehaviour change management took place from May–September, 2003, and required strategic inputs on:high-risk behaviours for neonatal mortality; individualswith key roles in the practice and continuation of thesebehaviours; and potential barriers, opportunities, andfactors affecting behaviour change. Participatory socialmapping of all villages in the study area provided anintroduction to the community, initiated the process of collaborative engagement, served to identify communityresources for newborn health, and facilitated theplanning of home visitations and group interventions.Qualitative research activities provided the evidencebase for investigators and community members to co-develop the intervention strategy, which underwentfurther refinement based on findings of trials of improved practices.Domiciliary care practices were mapped against theexisting evidence base of risk factors for neonatal mortalityand morbidity. Practices that were assessed to bepotentially harmful, preventable, within communitycontrol, and amenable to change were selected forbehavioural modification (webtable 1). The correspondingset of ideal practices formed the intervention package of essential newborn care, broadly categorised into birthpreparedness, hygienic delivery, and immediate newborncare including clean umbilical cord and skin care, thermalcare including skin-to-skin care, breastfeeding, andcare-seeking from trained providers (webtable 1).We focused on hypothermia during the initialformative research phase, and findings led the team toexpand to a broader package of essential newborn care.Moreover, when we learned during the formative phaseof the success of the Makwanpur study, Nepal, onneonatal mortality reduction through a community See Online for webtable 1  Articles www.thelancet.com   Vol 372 September 27, 2008 1153 action cycle approach, we added mortality reduction asan outcome in addition to care practices. 3 Almost alltargeted, high-risk practices were associated withdisruption in the warm chain (a cycle of procedurestaken at birth to prevent heat loss) and susceptibility toinfection such as sepsis (webtable 1). Prevention,recognition, and management of hypothermia wereperceived by the community to be within behaviouralcontrol, by contrast with other risks that were commonlyattributed to supernatural factors, such as “evil spirits”.Thus, we used attention to hypothermia to facilitate theuptake of the broader essential newborn-care packageby the community.Individual behaviours were influenced by collectivebehaviours and social norms, and sustained by a complex,multilevel network of relationships within the community.We therefore developed a multilevel strategy targeting:community stakeholders, newborn stakeholders, andhouseholds with immediate support groups (webpanel).At each level, the target group consisted of individualswho were identified to have key roles as influencers,decision makers, supporters, and practitioners of newborncare and normative behaviour within the community. Thesupport of community stakeholders such as village heads,community leaders, respected members, priests, andteachers was crucial in building trust with the communityand ensuring acceptance of the programme. The newbornstakeholder target group included traditional newborn-care providers and birth attendants, unqualified medicalpractitioners, and, to a lesser extent, health systemworkers, some of whom had strategic access to thenewborn and mother during post-partum confinement,were perceived by the community as domain experts, andplayed an active part in sustaining targeted practices.Health system workers such as auxillary nurse midwiveswere engaged only at the community level as part of newborn stakeholder group meetings in order to keepcontamination of the intervention into control clusters toa minimum. The household target group included thepregnant woman or mother, who was the primary careprovider, but usually not empowered to make decisions;the mother-in-law, who was usually the key decision makeron newborn-care practices; other female members whoplayed supportive roles; and male members, includingthe father-in-law and husband, who controlled access tothe household, made financial and logistical arrangements,and influenced care-seeking decisions. The family’simmediate support group included neighbours andrelatives who influenced family behaviours and helpedwith deliveries.Formative research revealed that the high-risk practiceswere perceived by the community to be favourable fornewborn health, and that multiple barriers to behaviourchange existed in the form of knowledge, skills, andsociocultural, economic, and spiritual factors. Thebehaviour change management approach was based ontrust, and developed as a participatory process of respectful engagement with the community to leadindividuals and families from current towards improvedbehaviours through a path of least social, cultural,economic, and spiritual resistance to change. We soughtto understand existing practices, design relevantbehaviour change messages, create a shift in reasoningin favour of improved practices, negotiate barriers tochange by optimising available resources and providingviable alternatives, equip households with necessaryskills, build self-confidence, and create a supportiveenvironment.To minimise resistance to change, messages weredesigned to promote improved newborn-care practicesto align with existing cultural values and traditions, sothat they were not perceived as externally imposed     T   y   p   e   o    f   a   c    t    i   v    i    t   y    I   n    d    i   r   e   c    t    P   r   o   g   r   a   m   m   a    t    i   c InterventionactivityHousehold visitation(by appointment)Community meetingsFolk song meetings(by invitation)Traditional newborncare during post-partumconfinementCommunity volunteerdriven initiativesType of ExposurePersonalisedGroupPersonalisedPersonalisedgroupOpportunitiesPrimaryinterventionproviders SakshamSahayak SakshamSahayak  NewbornstakeholdersCommunityvolunteersSupportiveroles/co-ownershipFirst trimesterConceptionDeliveryAntenatalvisit 1Antenatalvisit 2Pregnancy tracking,consentCommunity volunteers,role modelsCommunity volunteers,role models, newbornstakeholdersCommunity volunteers,role modelsRole models, newbornstakeholders, key/influential peopleSecond trimesterThird trimesterNeonatalperiod Post-partumconfinement Postnatalvisit 1 & 2Regular care through daily visitationsMonthly meetingsOccasional interactions Figure 1: Exposure of pregnant women, households, and the Shivgarh community to the intervention package Saksham Sahayak  =community health worker. See Online for webpanel  Articles 1154 www.thelancet.com   Vol 372 September 27, 2008 interventions. Behaviour change messages drewanalogies between the improved newborn-care practicesand other commonly observed and favourably perceivedbehaviours and practices, while exposing inconsistenciesbetween the corresponding high-risk practices andhealthful practices in other domains (webtable 1). Thisapproach created a condition of cognitive dissonance,and thus motivation for change in behaviour, therebyreducing the challenge of behaviour change to one of behavioural alignment with already existing beliefs andpractices in other areas of daily life. 24   The primary enablers of behaviour change were paid(US$35–40 per month) community-based health workers,the Saksham Sahayak (n=26) , who were recruited from thelocal community based on 12 years or more of education,proficient communication and reasoning skills,commitment towards community work, and references of community stakeholders. 25 They received a combinationof classroom-based and apprenticeship-based fieldtraining over 7 days on knowledge, attitudes, and practicesrelated to essential newborn care within the community,behaviour change management, and trust-building. Aftertraining, suitable candidates were closely mentored andsupervised by a regional programme supervisor (n=4)responsible for 6–7 Saksham Sahayaks , for an additionalweek before final selection was made.Newborn-care stakeholders within the community,considered specialists and domain experts, had strategicaccess to newborn babies during the confinementperiod for the first 4–9 days after delivery, and weresimultaneously targets of the intervention as well asnatural partners of the Saksham Sahayak for workingwith families to ensure adherence with the intervention(figure 1, webpanel). Volunteers from within thecommunity, called Saksham Karta , played a key part inprogramme advocacy, trust-building, and sociallegitimisation of changes in behaviour. Theirparticipation, therefore, was aimed to promote thecontinuation of behaviour change beyond the studyperiod, and they were able to support families withknowledge, skills, and resources. Additionally, motherswho were beneficiaries of the intervention and displayedexemplary practices were promoted as role models toinspire other pregnant women in their community.The intervention was delivered from January, 2004, toMay, 2005. Saksham Sahayaks first engaged withcommunity stakeholders in community meetings toseek their approval, sensitise them towards theimportance of their role in newborn survival, encourageshared learning, and create a supportive environment(figure 1, webtable 2). Folk song group meetings, wheremessages to promote behaviour change were in-corporated into folk songs, were held by Saksham Sahayaks on a monthly basis with participants fromdiverse target groups. They also held separate monthlymeetings with newborn-care stakeholders and withcommunity volunteers to discuss experiences, chal-lenges, and strategies.Early identification of pregnant women by Saksham Sahayaks was a prerequisite for seeking consent, 39 clusters randomly allocated13 clusters allocated intervention IIMedian households 376 (range 218–868)1149 participants (pregnant women)13 clusters received intervention13 clusters allocated to control armMedian households 367 (range 265–757)1141 participants (pregnant women)13 clusters received intervention13 clusters allocated intervention IMedian households 620 (range 283–1121)1600 participants (pregnant women)13 clusters received intervention1575 had one pregnancy13 clusters received intervention1625 pregnancies1123 had one pregnancy26 clusters received intervention1175 pregnancies1111 had one pregnancy31 clusters received intervention1173 pregnanciesLoss to follow-up0 clusters64 pregnancies miscarried before 7 month2 participants gave wronginformation on pregnancy13 clusters analysedParticipants analysed: 1559 deliveries 1581 outcomes (1537 singletons and 22 pairsof twins)59 stillbirths (55 singletons) 1522 livebirths (1482 singletons)64 neonatal deaths (51 singletons) 1458 infants alive at 28 days13 clusters analysedParticipants analysed:1122 deliveries 1135 outcomes (1110 singletons, 11 pairsof twins and 1 triplet)48 stillbirths (45 singletons) 1087 livebirths (1065 singletons)48 neonatal deaths (44 singletons) 1039 infants alive at 28 days13 clusters analysedParticipants analysed: 1129 deliveries 1143 outcomes (1115 singletons and 14pairs of twins)64 stillbirths (61 singletons) 1079 livebirths (1054 singletons)91 neonatal deaths (83 singletons)988 infants alive at 28 daysLoss to follow-up0 clusters52 pregnancies miscarried before 7 month1 participants gave wronginformation on pregnancyLoss to follow-up0 clusters44 pregnancies miscarried before 7 month0 participants gave wronginformation on pregnancy     E   n   r   o    l   m   e   n    t    A    l    l   o   c   a    t    i   o   n    F   o    l    l   o   w  -   u   p    A   n   a    l   y   s    i   s Figure 2: Trial profile See Online for webtable 2
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