Study design and setting
This is a quasi-experimental observational study implemented in the state of Rajasthan in India from March 2013 to April 2014.
This study compared health providers’ use of the SCC and adherence with SCC items in 8 intervention and 8 comparison facilities at the baseline (March- April 2013) and end line (March- April 2014). Intervention and comparison facilities included two district hospitals and six Community Health Centres (CHC)/Sub-District Hospitals (SDH) in each arm, from the intervention and comparison districts matched by average annual delivery load. These facilities were selected randomly from the overall available sample of 13 District Hospitals and 187 CHC/ SDHs.
Intervention
The Government of Rajasthan implemented the SCC program at Community Health Centers (CHC), Sub-district Hospitals and District Hospitals of selected districts with technical support from Jhpiego. Technical assistance of Jhpiego was aimed at pilot testing of SCC, modification in SCC to adapt to the local context, orientation of providers, facility readiness assessments, and conducting post-training follow-up and support visits at pre-defined frequency.
Several modifications to the SCC were informed by an initial pilot test of the SCC and input of a Technical Advisory Group (TAG). Modifications included introduction of a designated space to record maternal and newborn vital signs (e.g., mother’s temperature and blood pressure, newborn’s weight). The modified SCC included 31 critical practices and retained the original four pause points distributed across two pages. For this checklist there were four pause points: at admission, just prior to or during pushing, immediately after delivery and prior to discharge. But of this 31 practices only 28 were observed during this study and mentioned in the results.
Prior to the implementation program staff assessed availability of essential drugs, supplies and functionality of equipment required to implement SCC practices in both intervention and comparison facilities. Essential commodities and equipment identified as missing during assessments were provided by the program for both intervention and comparison facilities. Availability of supplies was monitored periodically in both intervention and comparison facilities.
The SCC program included two main components-a 1.5 day orientation of facility-based health workers on using the SCC as a part of their care delivery and post-training on-site support in using the SCC.
After the training, the health workers in intervention facilities attached the SCC to the existing case-sheets of the individual patient. It is important to note that at the time of intervention, templates of case-sheets were already in use at both intervention and comparison facilities. For implementation purposes, the SCC was externally attached to the existing case-sheets in intervention facilities. Case-sheets in comparison facilities remained un-changed.
After the initial training, Jhpiego staff made site visits to the intervention sites on a set frequency. to assess the progress of SCC use in the facility and to address barriers to its smooth implementation of the checklist. The first on-site visit was made to a facility where orientation of all health workers has been completed within 15 days of the completion of orientation. Fortnightly visits continued up to 2 months. After 2 months, the frequency of visits was reduced to once a month for next 6 months. After 6 months, the facilities were visited at least once every quarter for the remaining duration of the study. Visits typically included the following activities: observation of SCC use by on-duty health workers and onsite support in effectively using it, facilitation of the availability of the SCC at the sites, and any administrative barriers to the health workers in using the SCC. Apart from this, Jhpiego staff also facilitated all-staff meetings in the intervention facilities at least once every quarter as a part of the onsite visits where all relevant health workers from the facilities came together and discussed their experiences with SCC use; challenges faced, and suggested remedies to these challenges.
An important characteristic of the SCC program was that implementation approach was developed in close collaboration with the Ministry of Health and was firmly grounded in the existing public health system. For example, resources of the public health system were used to support most implementation activities such as provider orientations. Existing Skilled birth attendants (SBA) trainers in the public health system were used to orient the providers on the SCC, at training sites which were mostly public sector district hospitals of the state. As far as possible, the system’s resources were leveraged to ensure availability of essential supplies in intervention and comparison facilities.
Sample size
The sample size calculation was based on the conservative assumption that the essential practices would be done in 50 % of deliveries, and having 80 % power to detect a 20 % increase in practice coverage. Alpha was set at 0.0017 using Bonferroni’s correction considering 28 comparisons. The design effect-adjusted group sample size in comparison and intervention arm was found to be 20 observations per group considering 0.01 intra-class correlation coefficient. This resulted in 960 observations overall in each comparison and intervention arm, total sample size was 240 per pause point per arm. Some clients were observed in more than one pause point.
Sampling method
Every woman delivering in a facility during observation period who was not in active labour and was an appropriate state of mind to consent were approached and those who consented were included in the study until the required number of observations were achieved for a pause point in a facility.
Data collection tools
The number of providers available and the delivery load initial infrastructure, supplies and training status of staff available were collected during baseline using a rapid facility assessment tool. A Periodic assessment tool which had information about the facility type, average delivery load, staff available and supplies was also used every quarter to assess the resource availability and practices. Training data was available from training data formats which updated data as trainings happened. The details of supplies came from the monthly reports of facilities which reported on availability of number of supplies.
Observers used pre-designed structured observation format to collect data on different pause points, which was supplemented by a self-contained step by step procedure guide (Algorithm). This Algorithm clearly defined the practice to be performed by a provider was performed or not. For example for Appropriate hand hygiene is considered to be performed only if Provider had access to running water, soap, gloves and performed six steps of hand washing before each internal examination and wore gloves.
Procedures
Each facility was approached for permission to observe the deliveries. Observers were typically a Graduate Nursing (BSc) school student/intern who had basic knowledge of maternal and childbirth-related practices. Observers were oriented for one day on the checklist and how to use a standardized algorithm to classify practices as being performed, not being performed or not applicable. Supervised observations in the labor room (at least once for each of observers) and 2 days mock sessions were also part of the training. The observers worked in round-the-clock shifts of 8 h each till the time the required sample size was achieved for one facility. Observations were made in the facilities only after at least 6 months were completed after the initial introduction.
The unit of observation was a pause point rather than a delivery. One delivery (if followed from the period of admission to discharge) made for four independent pause point observations. 240 observations were made for each pause point. Each data collector continuously observed care for a pregnant woman at all the pause points applicable to his/her shift at the facilities. These observations lasted for the whole duration for which the provider completed activities relevant to that pause point. Apart from observing practices, the data collectors also observed the SCC use for that pause point. In addition, they made periodic observations and record checks to confirm where activities such as use of partograph were completed. At each pause point, they observed relevant practices where they were performed (admission room, labor room, and post-partum ward). For efficiency of operations, they prioritized observing different pause points on all available cases during one shift rather than following one case from point of admission to discharge.
Providers were recruited in their free time in a private space. Observers explained the study purpose and process to the providers that they would be observed for their practices at four different pause points and obtained informed oral consent at the beginning of the baseline and endline data collection.
Informed oral consent of mothers was taken at the admission for observing her at various points of her child birth using a local vernacular consent form. If the observer was a male, presence of a female attendant was ensured during observation. Mothers who did not consent, were in severe pain, or were in a state in which they were unable to consent were not included for observation.
Each practice was observed at every pause point and was categorised based on the algorithm as practiced, not practiced and or not applicable. Data quality was assured by using standardised formats and algorithms, standardised training, periodic review and mentoring of observers and data quality checks in data entry. The completed observation forms were entered in CS-Pro and the data was cleaned for inconsistencies using data validation and internal consistency.
Data analysis
Data was analysed using MS excel 2010, Stata version 13.0 and SPSS version 22.0. Frequencies and categorical analysis was done for the cleaned data. Proportions were calculated for all categorical variables. Chi-square test was performed for statistical significance of proportions. A composite index was developed for availability of supplies and equipment based on the availability of such supplies during the time of the study. which was used for the regression analysis. Multiple Linear Regression analysis was done to find the difference in difference (DID) in average number of practices performed during intrapartum and postpartum care in intervention and comparison facilities between baseline and endline. The model estimate was created with robust standard error and considering the clustering at client level and the facility level and adjusting for health worker type and availability of supplies and drugs. Difference in difference of means was determined by an interaction term in the regression model between intervention/comparison and baseline/endline (time) variables. A difference in difference logistic regression analysis was performed for individual practices and DID estimator-which was the interaction term in the model-was calculated for each of the practices. This DID estimator was adjusted for clustering by health worker, and a composite index for supplies, health worker categories.
P value less than 0.0017 was considered statistically significant considering Bonferroni’s correction.
Ethical considerations
This observational study was reviewed and approved by Government of Rajasthan and the institutional review board (IRB) of Johns Hopkins Bloomberg School of Public health, Baltimore, USA (IRB 0004816). Verbal Consent of providers and mothers was obtained for participation in this study as per the protocol approved by IRB. Written consent was not obtained as we did not want to record any identifiable information of the client or the provider. Consent was obtained by allowing the study participant to read the consent form in local vernacular language or loudly read the consent forms to the study participant and the person who administers the consent signed it and left a copy of the consent with the study participant.