Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130488
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2022-11-28
Brief Title:
Implementation at Scale and Evaluation of KMC
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Implementation at Scale and Evaluation of KMC Kangaroo Mother Care
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KMC
Brief 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
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 LHWcommunity health workers CHW with digital scales LHWCHW 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 Commoditiessupplies 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 equipments 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 LHWCHW 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 LHWs 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
Pre KMC-Implementation phase Community Birth weight of all newborns in selected facilities and home will be captured by trained lady health workers LHWcommunity health workers CHW with digital scales LHWCHW 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 Commoditiessupplies 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 equipments 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 LHWCHW 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 LHWs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None