Evaluation of the Safe Care, Saving Lives (SCSL) quality improvement collaborative for neonatal health in Telangana and Andhra Pradesh, India: a study protocol

Figures & data

Table 1. Timeline.

Safe Care, Saving Lives Programme timeline
	Year
					2017				2018
Phase	2013	2014	2015	2016	Jan–Mar	Apr–Jun	Jul–Aug	Sep–Dec	Jan–Mar	Apr–Jun	Jul–Aug	Sep–Dec
Programme design phase
Design of Quality Improvement toolkit
Wave 1 (25 hospitals)
Programme review and adaptation of design
Wave 2 (29 hospitals)
Wave 3 (31 hospitals)*
Baseline data collection				X
Endline data collection											X

*wave 3 is currently on hold.

Figure 1. The study area.

Table 2. General information on hospitals included.

	Explanation of those missing	Telangana N = 25	Andhra Pradesh N = 35	Public N = 34	Private N = 26
Refused participation in baseline assessment		4 private	3 public & 1 private college	3 public facilities	5 private
Have a neonatal care unit		21	31	31	21
Facility assessment done in neonatal care unit	3 missing ~	21*	28	30	19
Mean/median (IQR) no. of admission per month		127/106 (47–152)	90/58 (31–121)	130/106 (67–170)	67/41 (22–53)
Have a breastfeeding room	1 missing	15 (71%)	26 (93%)	25 (83%)	16 (84%)
Have a Kangaroo Mother Care (KMC) room	5 missing	13 (62%)	13 (46%)	17 (57%)	9 (47%)
Mean/median		1.9/1	2.3/1	1.4/1	3.3/2
(IQR) no. of paediatricians working during the day-shift		(1−2)	(1–3)	(1–1)	(1–4)
Have a labour room	12 hospitals without labour ward, one refused data collection	15	24	30	9
Facility assessment done in labour room		15	24	30	9
Mean/median	3 missing information on mean no. of deliveries	348/267	229/197	328/315	99/39
(IQR) of no. of deliveries per month		(99–382)	(81–338)	(166–400)	(29–177)
Working 24 × 7 operation theatre for Caesarean section		13 (87%)	21 (88%)	25 (83%)	9 (100%)
Mean (IQR) no. of obstetricians working during the day-shift		.9/2	3.0/2	2.8/2	3.3/2
		(1–5)	(1–3.5)	(1−4)	(2–5)

Source: Facility checklists ~ 1 SNCU/NICU register were not available due to reconstruction of the SNCU/NICU; and two SNCU/NICU data could not be retrieved as the data base was not maintained. *Three of the 21 neonatal care units were Newborn Stabilization Units (NBSU) in process of upgrading at the time of assessment.

Table 3. Evidence-based practices included in the Safe Care, Saving Lives initiative.

	Sepsis bundle	Prematurity bundle	Asphyxia bundle
Practices promoted in labour rooms	Antibiotics to women at risk of sepsis Hand hygiene & gloves during per-vaginal examination WHO 6 cleans	Ante-natal steroids Early breastfeeding	High risk categorization of woman in labour Trained personnel for high risk delivery Compliance with partogram Pre-delivery checklist Compliance with oxytocin infusion protocol Resuscitation with bag and mask
Practices promoted in neonatal care units	Hand hygiene Protocol for central vascular catheter Aseptic Peripheral IV line insertion Antibiotics to neonates born to mother with risk factors for sepsis Prevent ventilator associated Pneumonia	First temperature in 15 minutes from admission Exclusive breastfeeding Kangaroo Mother Care	CPAP in preterm neonates with respiratory distress
Total no. of practices	8	5	7

Table 4. Sample size calculation for the impact and output indicators.

Indicator	Power to detect expected change	Baseline estimates	k-factor	Cluster size	Expected change (%)
7-day mortality (register and phone interviews)	50%	9.0%	0.0001	95	20%
	80%			190
28-day mortality (register and phone interviews)	52%	9.5%	0.0001	95	20%
Stillbirths (registers)	70%	2.1%	0.01	420	25%
	80%			260	35%
High risk admission (case sheets)	80%	61%	0.01	20	16%
Partograph use (case sheets)	80%	10%	0.01	20	70%
Pre-delivery checklist (case sheets)	80%	30%	0.01	20	32%
Exclusive breastfeeding (phone interview)	80%	93%	0.01	95	3%
Temperature measurement (observations)	80%	52%	0.24	12	35%
Hygienic vaginal examination (observation)	80%	25%	0.24	12	57%
Six cleans in labour ward (observations)	80%	6%	0.24	8	170%
Hygienic cannulations/iv line insertion (observations)	80%	5%	0.24	8	195%
Handwashing	80%	22%	0.24	19	50%
Kangaroo Mother Care	80%	5%	0.24	7	210%

*a priori estimate as Kangaroo Mother Care was not introduced at baseline

Figure 2. Trial flowchart.