Improving Quality of Care during Childbirth: Learnings & Next Steps from the BetterBirth Trial

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1 Improving Quality of Care during Childbirth: Learnings & Next Steps from the BetterBirth Trial 24 April 2018 Katherine Semrau, PhD, MPH Health Systems Global Webinar

Introductions Bejoy Nambiar Chair, Quality in

Semrau Director, BetterBirth Program, Ariadne

2 Introductions Bejoy Nambiar Chair, Quality in Universal Health and Healthcare thematic working group, HSG. Lisa Hirschhorn Co-Chair, Quality in Universal Health and Healthcare thematic working group, HSG. Katherine Semrau Director, BetterBirth Program, Ariadne Labs, & Harvard Medical School

3 Improving Quality of Care during Childbirth: Learnings & Next Steps from the BetterBirth Trial 24 April 2018 Katherine Semrau, PhD, MPH Health Systems Global Webinar

Ariadne Labs: Who We Are Founded in 2012, we are a joint center for

suffering through simple, scalable solutions for better systems of

4 Ariadne Labs: Who We Are Founded in 2012, we are a joint center for health systems innovation at the Brigham and Women s Hospital and Harvard T. H. Chan School of Public Health Our Mission: Saving lives and reducing suffering through simple, scalable solutions for better systems of care at the most critical moments in people s lives everywhere. Our Core Programs BetterBirth Safe Surgery Serious Illness

BetterBirth Program: End preventable suffering and death for women & their newborns Mission: Improve the quality of care, minimize complications and end

5 BetterBirth Program: End preventable suffering and death for women & their newborns Mission: Improve the quality of care, minimize complications and end the preventable deaths of women and newborns in childbirth through effective implementation of evidencebased, scalable solutions at the frontline of care 5

2 million intrapartumrelated stillbirths NMR per 1,000 livebirths 60

6 Maternal & Neonatal Mortality OCCURRING AROUND THE GLOBE EACH YEAR 350, million maternal deaths neonatal deaths 1.2 million intrapartumrelated stillbirths NMR per 1,000 livebirths World Lower Middle Income Country India Uttar Pradesh USA

7 Moments of Greatest Risk MATERNAL & NEONATAL MORTALITY RISK LABOR ONSET ANTENATAL PERIOD ADMISSION TO FACILITY DELIVERY DISCHARGE FROM FACILITY 28 DAYS 42 DAYS TIME 7

8 Biggest Killers Mother Hemorrhage Sepsis Obstructed Labor Eclampsia Baby Asphyxia Prematurity Infection

9 What are the Minimum Required Guidelines? PRENATAL LABOR & DELIVERY POST-PARTUM Early referral for at-risk women Antibiotics for fever, ruptured membranes Magnesium for hypertension, proteinuria Presence of a birth companion Use of handwashing and gloving Informing when to call for help Preparation of oxytocin, clean supplies, bag mask, sterile blade, suction Assistant at the ready Oxytocin within 1 minute of delivery Skin-to-skin care post-partum Newborn antibiotics if high or low temperature Instructions on danger signs for mother and child

10 The WHO Safe Childbirth Checklist 1234 ON ADMISSION ADMISSION

11 WHO Safe Childbirth Checklist: Pause Point 2 11

Safe Childbirth Checklist Collaboration and pilot testing Evaluations for feasibility and acceptability were completed in nine countries The WHO established the Safe Childbirth Checklist

12 Safe Childbirth Checklist Collaboration and pilot testing Evaluations for feasibility and acceptability were completed in nine countries The WHO established the Safe Childbirth Checklist Collaborative to explore factors that influence the use of the Checklist in diverse settings around the world Following a successful pilot study in Karnataka, India, Collaborative members completed a series of implementation studies in Rajasthan, Sri Lanka, and Bangladesh BetterBirth trial in Uttar Pradesh, India was completed in 2017

13 Poll Question Have you heard of and/or used the Safe Childbirth Checklist? Options: (1) Heard of it, but not used it (2) Heard of it and have used it in the past (3) Heard of it and using it currently (4) Never heard of it before now 13

BetterBirth Safe Childbirth Checklist Implementation Included in

to introduce the Checklist and assess facility gaps Coaching

Sustainability Strategy Capacity building of facility and

at district and facility level promotes systemic change Data

14 BetterBirth Safe Childbirth Checklist Implementation Included in Govt. of India Maternal Health Toolkit Launch Motivational event to introduce the Checklist and assess facility gaps Coaching Peer-to-peer model for uptake of essential birth practices Sustainability Strategy Capacity building of facility and district champions to support change beyond program Engage Buy-in at district and facility level promotes systemic change Data feedback for change Feedback from data and observation shared in real time to foster change

15 BetterBirth Theory of Change

The BetterBirth Trial PROJECT GOAL: The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial seeking to establish whether the BetterBirth intervention is effective in reducing

16 The BetterBirth Trial PROJECT GOAL: The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial seeking to establish whether the BetterBirth intervention is effective in reducing deaths and complications in institutional childbirth in resource-limited settings. OUTCOMES OF INTEREST: Adherence to birth practices by birth attendants Early (7-day) maternal morbidity, mortality, & perinatal mortality

17 BetterBirth Trial in Uttar Pradesh, India Nov Jan ,145 births (mother-baby pairs) 149 maternal deaths MMR 7-day : 94 per 100, Facilities (60 control) 7,445 perinatal deaths PMR: 47 per 1,000 livebirths 24 Districts

19 Who is the BetterBirth Mother? On average: Age: 25 Number of children: 2 Time between admission and delivery: 202 minutes Caste: largely OBC and scheduled caste Delivery time evenly spread throughout 24 hours Delivery type: 97% normal 1.7 % c-section Referred out 6%

20 Who is the BetterBirth Baby? 49% male, 46% female, 5% unknown 98% singletons 28% low birth weight 21% pre-term 1.5% referred out

21 Who is the BetterBirth Birth Attendant? On average: Age: 37 Experience: 9 years Time since last training: 4 years Delivery attendance: 81% Staff nurse 18% Auxiliary nurse midwife 14% Doctor 6% Other Facility staffing: 78% Staff nurse 16% Auxiliary nurse midwife 7% Lady Medical Officer Caste: Largely OBC and general caste

22 Trial size, fidelity & data quality assurance protocol Monitoring & Evaluation Team Data Quality Assurance: Audits Feedback Supervision Training Standard Operating Procedures Electronic Data Collection & Reporting Data Quality Assurance Protocol achieved 98.3% accuracy across all research data-collection activities in the trial

23 Average number of essential birth practices performed was significantly higher in intervention sites at 2 and 12 months Mean number of 18 essential birth practices performed at 15 facility pairs Control Intervention 2 months months months 12 months Completed Not Completed Completed Not Completed At 2 months: 2,563 deliveries observed across arms At 12 months: 2,325 deliveries observed across arms Intervention vs. Control: p<0.0001

24 Intervention sites had a significantly higher adherence rate to practices after 2 months of coaching SMALLEST GREATEST 100% Percent of deliveries where practice performed 80% 60% 40% 20% 19% 30% 20% 79% 70% 11% 79% 15% 84% 0% 0% 1% 0% 1% At admission: Partograph started Within 1 hour: Skin to skin at 1 hour* Just before pushing: Proper hand hygiene* Within 1 minute: Oxytocin administered* 4% Within 1 hour: Breastfeeding initiated* Within 1 hour: Skin to skin initiated* Just before pushing: Clean towel available* * p< Control Intervention

25 Poll Question In your experience, which essential birth practice has been most difficult to change? Options: (1) Handwashing/proper hand hygiene (2) Vital sign assessment (temperature, blood pressure, weight) (3) Initiating and maintaining skin-to-skin (4) Appropriate medication use (uterotonic/oxytocin, antibiotics, etc.) (5) Other, please specify Placeholder for instructions on how to use poll?

26 At scale, 7-day health outcomes were not different across arms 120 Perinatal Mortality rate per 1,000 births 500 Maternal Mortality 7-day ratio per 100,000 births 35 Maternal Morbidity % Control Intervention 0 0

27 Why these results?

28 Why was there no mortality impact? Practice improvements were incomplete: Preventive measures may not have risen enough Hand hygiene, oxytocin, skin to skin warming, etc. Complication management may not have been strong enough Coaching & checklist alone were insufficient to overcome additional barriers: Supply availability Required skill levels Empowerment for decision making Accountability and incentives

29 Framework: Context Matters Provider Skills Motivation Community/ Patient Factors Processes Leadership and Culture Communication Supplies Surveillance Facility Infrastructure

30 Poll Question In your experience, what has been the most significant barrier to effecting change in facilitybased childbirth? Options: (1) Leadership (2) Birth attendant skills/competencies (3) Supplies/equipment availability (4) Community relationships (5) Other, please specify Placeholder for instructions on how to use poll?

Themes for Further Exploration: Impact and Data Richness high Timely Referral and Safe

Antenatal and Postnatal Care Provider Skill Level Accountability, Motivation and

Respectful Care Supply Availability and Use Inter- and Intra-Facility Communication

31 Themes for Further Exploration: Impact and Data Richness high Timely Referral and Safe Transportation of Patients Readiness for Change (Leadership, Provider Empowerment) Antenatal and Postnatal Care Provider Skill Level Accountability, Motivation and Misaligned Incentives Potential for Outcomes Impact Provider-Patient Communication and Respectful Care Supply Availability and Use Inter- and Intra-Facility Communication Facility Infrastructure and Staffing Community Perceptions Around Childbirth low BetterBirth Data Richness high

33 Acknowledgements Thank you to all study participants, birth attendants, women, and their newborns. Partners: Government of India (GoI) Government of Uttar Pradesh (GoUP) World Health Organization (WHO) Population Services International (PSI) Community Empowerment Lab, Lucknow Jawaharlal Nehru Medical College, Belgaum The Bill and Melinda Gates Foundation The John D. and Catherine T. MacArthur Foundation Ariadne Labs at Brigham & Women's Hospital and Harvard T.H. Chan School of Public Health BetterBirth Scientific Advisory Board Members

34 Thank you and Questions! Contact information: Katherine Semrau Director, BetterBirth Program

Capsular Training on Skilled Birth Attendance: Lessons from an Operations Research Study in Bahraich District, Uttar Pradesh

Capsular Training on Skilled Birth Attendance: Lessons from an Operations Research Study in Bahraich District, Uttar Pradesh Background Objectives Capsular Training Approach End of project brief Access