Implementation at Scale and Evaluation of KMC
Condition: Newborn Morbidity
Study type: Interventional

Summary: 
      The goal of this quasi-experimental study design is to look at feasibility and document the
      process and challenges of implementing KMC at scale in district Sanghar (Sindh) and Lasbella
      (Balochistan)

      . The main question it aims to answer are:

        -  Does the KMC is feasible to be implemented in rural areas?

        -  What is the process and challenges in implementing KMC in rural areas?

        -  Pregnancy surveillance is going in the secondary level care hospitals and in its
           catchment population. Recruitment of babies is carried who are low birth weight (less
           than 2000grams).

        -  Mothers taught to administer KMC by physician and nursing /LHV staff in the facility
           within first 6 hours after delivery and continue till the mother and baby are discharged
           by trained facility KMC management team.

        -  After training and administration of KMC at facility for 72 hours, the mother and baby
           pair discharged and followed up at home by the team including project-based data
           collector and respective LHWs.

        -  KMC Champions are in development for community mobilization and conducting sessions at
           village level.

        -  We will compare pre and post intervention change in practices at facility level and at
           individual level of household and assess the KMC coverage.
    

Detailed description: 
      KMC Implementation

      Pre KMC-Implementation phase (Community) Birth weight of all newborns in selected facilities
      and home will be captured by trained lady health workers (LHW)/community health workers (CHW)
      with digital scales. LHW/CHW will refer all 2000 g or less newborns to facilities for KMC.
      LHWs will create community awareness and engagement to support and accept referral of
      newborns for KMC through Village Health committee members (VHC) and by approaching existing
      women support groups formed by LHWs during phase 1 of the project.

      KMC Implementing Facilities

      Training of Staff A total of 40 facility-based health care providers and 400 community-based
      workers including LHWs/ LHVs in Sanghar and Lasbela will receive a three-day training session
      on KMC & Essential newborn care followed by a one-day training on DHIS data record keeping.

      KMC Facilities Preparation: Sustainable Provision of KMC and Essential Commodities/supplies
      Spaces already present within the selected facilities will be identified to serve as KMC
      rooms (curtained/ partitioned areas, toilets), so mothers can stay with their babies.
      Facilities will contain essential equipment for maternal and newborn care such as ambu bags,
      weighing scales for newborns, KMC packs, infant heaters, oxygen supply systems and pulse
      oximeters.

      Methodology

      Study Design:

      We have carried out formative research to identify barriers and design a model to deliver KMC
      across the facility-community continuum. A quasi-experimental study design will be adopted.
      District Health Information System (DHIS) data and service data on maternal and newborn
      mortality and morbidity outcomes will be collected from health facilities. A pre and post
      design will be undertaken to look at feasibility and document the process and challenges of
      implementing this at scale.

      Study population The study population are babies of birth weight less than 2000g delivered at
      hospital or in community in the catchment area of 2 district in Sindh and Balochistan.

      Study settings and location:

      This model will be implemented in the facilities and their catchment communities of district
      Sanghar and district Lasbela from July 2021 for 24 months. Four tehsils will be selected from
      each district, health facilities accompanying in these tehsils are already identified along
      with their catchment population to implement community arm of KMC. The facilities that will
      implement KMC include DHQs, THQs and RHCs from public sector and private sector facilities.
      And these facilities have been selected based on the availability of MNCH services and
      logistics. These facilities are level two hospitals (DHQs & THQs) and MNCH centers (RHCs)
      equipped with essential equipment's, supplies, drugs, basic laboratory test, immediate
      referral and human resources. The monthly outpatient turnover of the maternal patients in
      each of these hospitals on average 80 - 120 deliveries for DHQs and THQs takes place each
      month.

      Study Activities

      Base line Survey:

      The UeN midline survey will be used as baseline for this research and end-line surveys will
      be conducted in 2023. The community KMC indicators will be; prevalence of low birth weight
      babies, neonatal mortality, KMC practices, skin-skin contact, breast feeding practices,
      immediate and essential newborn care practices, especial care of low birth weight babies
      provided by families and care seeking behavior for newborns.

      Pregnancy surveillance:

      Pregnancy surveillance will be instituted through LHWs for detection of new pregnancies as a
      continuous monthly activity throughout the study period. Families will be encouraged for
      facility-based delivery and KMC will be administered to all Low-birth-weight babies
      (<2000gms) delivered in the facility. The Pregnancy surveillance data will be validated by
      data collectors during their monthly visit for Birth notification. Identified pregnancies
      will be followed up by data collectors who will monitor sessions on KMC at household level to
      orient pregnant mother and their families on KMC benefits, conducted by respective LHW. This
      will be an antenatal sensitization activity. As soon as a home birth is notified,
      district-based project staff will ensure LHW will visit the household within 72 hours of
      birth. The screening will be carried out and babies with birth weight of 2000 gram or less
      will be referred to KMC facility. After discharge from facility, the LHW will visit the
      household on (days 7, 14, 21, and 28) and district team validate these visits to assess the
      mother and baby and support kangaroo mother care practice.

      Enrollment and KMC administration at Facility:

      Low birth weight babies (<2000gms) delivered in facility will be enrolled at birth if they
      fulfill eligibility criteria and following consent. KMC will be administered to all enrolled
      babies. Mothers will be taught to administer KMC by physician and nursing /LHV staff in the
      facility within first 6 hours after delivery and will continue till the mother and baby are
      discharged by trained facility KMC management team.

      Continuation of KMC administration at Community:

      After training and administration of KMC at facility for 72 hours, the mother and baby pair
      will be discharged and followed up at home by the team including project-based data collector
      and respective LHWs. Team will conduct follow up visits daily for the first week, then weekly
      basis for 6 weeks, then quarterly till 2 years of age to capture process indicators. Data
      collectors will visit all households in the tehsils on the scheduled basis to ensure support
      for providing KMC and reinforcement. For women who deliver low birth weight babies at home,
      window period for enrolment will be 72 hours. KMC will be taught to them at home by LHWs and
      validated by project-based staff. Their responsibility will be to support mothers in
      practicing KMC. Community based Kangaroo Mother Care (cKMC) will be administered by LHWs only
      to enrolled babies discharged from facilities and those born at home belonging to the
      catchment population of already identified KMC facilities.

      Community Mobilization (KMC Champions):

      KMC Champions will be developed for community mobilization and conducting sessions at village
      level. LHW / CHW with the support of village health committee and support groups will also
      conduct one-to-one and group sessions with pregnant women, mothers and mothers-in-law on
      essential newborn care and KMC practices. The sessions will be conducted at regular intervals
      which validated and monitored by project-based district managers. LHW/CHW will also encourage
      recruitment of volunteers to function as KMC champions. The local community members serving
      as KMC champions will also serve as catalyst for mobilization. The mobilization staff will
      also identify and encourage co-champions (a stream of volunteers from the community) who will
      be mentored by KMC champions. This group of local community members will serve to disseminate
      messages on KMC practices and to facilitate its uptake in the community.

      Data Collection A data collection team consisting of 2 members will be instituted for each
      implementing tehsils. Their responsibility will be to collect data on the process indicators
      weekly for the first 6 weeks and then quarterly till 2 years.

      Impact Assessments A midline assessment will be done at all facilities and their catchment
      populations in all tehsils after one year of intervention. This midline assessment will serve
      to provide us with outcomes and evaluation of the intervention. Results of midline will
      identify areas of improvement and re-modeling if needed. A final assessment will be carried
      out after the completion of (Facility KMC plus cKMC) intervention in all tehsils. Through
      this design we will compare pre and post intervention change in practices at facility level
      and at individual level of household. End line assessment will be carried out to estimate
      increase in effective coverage of KMC among newborns having birth weight of 2000grams or
      less.

      Training of Facility and Community Providers This implementation project will be guided by
      the experience of our Dadu-KMC project, and we will adopt the contextual insights and the
      information, education and counselling material used in the project for parents and families
      to create awareness and to explain the benefits of KMC for survival & wellbeing of
      low-birth-weight newborns.

      Facility Based KMC Facility based Kangaroo Mother Care (KMC) will be practiced at health
      facilities, where newborns are delivered or referred. The frontlines workers are health
      professional involved in newborn care will be trained such as physicians, nurses, midwives,
      technicians and obstetricians at facility level. The training will be conducted over 3-4
      days. The content will include the theoretical knowledge as well as teaching the complete set
      of skills. Information, Education and Communication material will be used for implementing
      KMC at the facility. The IEC material will include messages in the pictorial form on KMC
      positioning, nutrition (breast feeding, feeding expressed breast milk or feeding through
      nasogastric tube), criteria for discharge, monitoring and assessment during KMC, recognition
      of danger sings, referral and follow-up. Recording tools will be adapted and developed to
      record the observations when implementing KMC at the facility level. The IEC material is
      comprised of flip charts, wall mounts and a self-explanatory video on steps of KMC, its
      benefits.

      Community Based KMC Community KMC will be practiced at the household levels where newborns
      are cared by mother, father and family members. Health Providers from the community such as
      LHWs will visit households and assess babies according to the scheduled follow-up visits. At
      community level mother, spouse, family members, community leaders, LHVs, LHWs, CHWs, and
      TBAs, which will be trained first for community KMC.

      Experts from AKU will serve as trainers for KMC and essential newborn care. Educational
      material such as information, pictorial booklet, flip charts and video films on KMC in local
      language will be made available for the mothers, families, facility providers, LHWs and study
      staff. These trainings will be conducted at the field site, through KMC videos and flip
      charts. The training routine will consist of 2-day classroom and 2 day real life field
      scenario for facility providers. Similarly, the LHW's of the selected facility catchment area
      will also be trained to pregnancy surveillance, case referral, notification and follow-ups
      and will also be trained to deliver information, education and support for the KMC practices
      at the household level in 2 days training workshop by respective facility providers.
    

Intervention name(s): KMC
Intervention type(s): Behavioral
Intervention description(s): KMC implementation as per protocol
Intervention model: Sequential Assignment
Intervention model description: Quasi experimental study model with pre and post intervention evaluation,
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Low birth weight; Kangaroo Mother Care; Newborn care