CTRI Number	CTRI/2018/04/013014 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On:	23/03/2018
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Preventive Behavioral
Study Design	Non-randomized, Active Controlled Trial
Public Title of Study Modification(s)	Evaluation of Safe Care Saving Lives project
Scientific Title of Study Modification(s)	Evaluation of the Safe Care, Saving Lives (SCSL) quality improvement collaborative in Telangana and Andhra Pradesh
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Samiksha Singh  Address  Indian Institute of Public Health-Hyderabad, Public Health Foundation of India Plot no 1 Anv Arcade Amar Co-op Society Kavuri Hills, Madhapur Hyderabad ANDHRA PRADESH 500081 India  Phone  91-40-49006000   Fax  91-40-49006060   Email  samiksha.singh@iiphh.org
Details Contact Person Scientific Query Modification(s)	Name  Samiksha Singh  Address  Indian Institute of Public Health-Hyderabad, Public Health Foundation of India Plot no 1 Anv Arcade Amar Co-op Society Kavuri Hills, Madhapur Hyderabad ANDHRA PRADESH 500081 India  Phone  91-40-49006000   Fax  91-40-49006060   Email  samiksha.singh@iiphh.org
Details Contact Person Public Query Modification(s)	Name  Samiksha Singh  Address  Indian Institute of Public Health-Hyderabad, Public Health Foundation of IndiaPlot no 1 Anv Arcade Amar Co-op Society Kavuri Hills, Madhapur Hyderabad ANDHRA PRADESH 500081 India  Phone  91-40-49006000   Fax  91-40-49006060   Email  samiksha.singh@iiphh.org
Source of Monetary or Material Support	Childrens Investement Fund Foundation (CIFF), 7 Clifford Street, London, W1S 2FT, UK
Primary Sponsor	Name  London School of Hygiene and Tropical Medicime  Address  Keppel Street, London WC1E 7HT, United Kingdom  Type of Sponsor  Other [Educational Institute]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Samiksha Singh  60 hospitals from Telangna and Andhra Pradesh  These are public and private hospitals which has SNCUs/NICUs and are empanaled under Aaragyosree Hyderabad   8886111290 8886111290 samiksha.singh@iiphh.org
Details of Ethics Committee	No of Ethics Committees= 2   Name of Committee  Approval Status  Institutional Ethics Committee, PHFI, Hyderabad  Approved  London School of Hygiene and Tropical Medicine, Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  pregnant women, newborns, newborns admitted to SNCU or NICU
Intervention / Comparator Agent	Type  Name  Details  Intervention  Collaborative Quality Improvment in labour ward and SNCU/NICU in hospitals enrolled in the state health insurance platforms  The intervention is composed of mentoring, collaborative learning session supported by leadership development and policy exchange with state representative to support the adherence to 20 potentially better practices  Comparator Agent  Labour ward and SNCU/NICU in hospitals enrolled in the state health insurance platforms  These hospitals are similar in characteristics to intervention hospitals and will receive intervention in next phase after endline
Inclusion Criteria Modification(s)	Age From  1.00 Day(s) Age To  45.00 Day(s) Gender  Both  Details  1.Pregnant women giving birth and newborn babies aged 0-27 days born or admitted in the study hospitals. 2.Health workers in study hospitals 3.Study hospitals with a SNCU/NICU which are included into the state insurance schemes (CEO Aarogyasri Health Care Trust in Telengana State; and the Dr. NTR Vaidya Seva Scheme )
ExclusionCriteria	Details  1.Hospitals that are not included into the state insurance schemes (Aarogyasri Health Care Trust in Telengana State; and the Dr. NTR Vaidya Seva Scheme) 2.pregnant Women, and health workers who do not consent to be observed
Method of Generating Random Sequence	Other
Method of Concealment	Other
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Stillbirth rate, 7-day and 28-day case-fatality per 100 SNCU/NICU admissions; Morbidity in SNCU/NICU admissions at hospital/cluster level   3 months before intervention (June-August 2016) and 18 months after intervention start (June - August 2018)
Secondary Outcome Modification(s)	Outcome  TimePoints  Adherence to potentially better practices of: Risk screening at labour ward admission Partograph use Hygiene during birth Management of high risk delivery/asphyxia in labour ward Hand washing Hygiene in cannulation Kangaroo mother care in premature birth Exclusive breastfeeding of babies admitted to SNCU   Before intervention and 18 months after intervention start
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	Phase 1
Date of First Enrollment (India) Modification(s)	30/05/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="3" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details Modification(s)	None yet
Brief Summary	Indian Institute of Public Health-Hyderabad is collaborator with London School of Hygiene and Tropical Medicine to evaluate a quality improvement collaborative approach in 60 hospitals with SNCU/NICUs enrolled into the state ensurance schemes. The implementer of this intervention is ACCESS Health International. The study is conceptualised as a prgagmatic trial where impact and process indicators reflecting practices and mortality in 29 intervention hospitals and compared to 31 comparison hopsitals where the same intervention will be implemented with 18 months delay (stepped wedge design). Each of the included hospital represents one cluster and the intervention target improvements in processes in hospitals rather than individual clients . Therefore our study will compare changes in outcomes in intervention and comparison hospitals between the baseline and end-line assessments. The allocation of facilities in intervention and comparison group was done in August 2016 with a view to balance groups in relation to facilities’ case-fatality category in SNCU/NICU, their location, and their caseload, but then adjusted to allow implementation through a hub and spoke model. Therefore, the study is  a non-randomized trial.  We did data collection for baseline from May-August 2016. The implementation has started in February 2017, we plan to conduct mid-line process evaluation in October 2017 and endline July / August 2018.