Dataset Information

Effects of the World Health Organization Safe Childbirth Checklist on Quality of Care and Birth Outcomes in Aceh, Indonesia: A Cluster-Randomized Clinical Trial.

ABSTRACT:

Importance

To address major causes of perinatal and maternal mortality, the World Health Organization developed the Safe Childbirth Checklist (SCC), which to our knowledge has been rigorously evaluated only in combination with high-intensity coaching.

Objective

To evaluate the effect of the SCC with medium-intensity coaching on health care workers' performance of essential birth practices.

Design, setting, and participants

This cluster randomized clinical trial without blinding included 32 hospitals and community health centers in the province of Aceh, Indonesia (a medium-resource setting) that met the criterion of providing at least basic emergency obstetric and newborn care. Baseline data were collected from August to October 2016, and outcomes were measured from March to April 2017. Data were analyzed from January 2020 to October 2021.

Interventions

After applying an optimization method, facilities were randomly assigned to the treatment or control group (16 facilities each). The SCC with 11 coaching visits was implemented during a 6-month period.

Main outcomes and measures

For the primary outcome, clinical observers documented whether 36 essential birth practices were applied at treatment and control facilities at 1 or more of 4 pause points during the birthing process (admission to the hospital, just before pushing or cesarean delivery, soon after birth, and before hospital discharge). Probability models for binary outcome measures were estimated using ordinary least-squares regressions, complemented by Firth logit and complier average causal effect estimations.

Results

Among the 32 facilities that participated in the trial, a significant increase of up to 41 percentage points was observed in the application of 5 of 36 essential birth practices in the 16 treatment facilities compared with the 16 control facilities, including communication of danger signs at admission (treatment: 136 of 155 births [88%]; control: 79 of 107 births [74%]), measurement of neonatal temperature (treatment: 9 of 31 births [29%]; control: 1 of 20 births [5%]), newborn feeding checks (treatment: 22 of 34 births [65%]; control: 5 of 21 births [24%]), and the rate of communication of danger signs to mothers and birth companions verbally (treatment: 30 of 36 births [83%]; control: 14 of 22 births [64%]) and in a written format (treatment: 3 of 24 births [13%]; control: 0 of 16 births [0%]).

Conclusions and relevance

In this cluster randomized clinical trial, health facilities that implemented the SCC with medium-intensity coaching had an increased rate of application for 5 of 36 essential birth practices compared with the control facilities. Medium-intensity coaching may not be sufficient to increase uptake of the SCC to a satisfying extent, but it may be worthwhile to assess a redesigned coaching approach prompting long-term behavioral change and, therefore, effectiveness.

Trial registration

isrctn.org Identifier: ISRCTN11041580.

SUBMITTER: Kaplan LC

PROVIDER: S-EPMC8642783 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe World Health Organization (WHO) published the WHO Safe Childbirth Checklist in 2015, which included the key evidence-based practices to prevent the major causes of maternal and neonatal morbidity and mortality during childbirth. We assessed the current use of the WHO Safe Childbirth Checklist (SCC) and adaptations regarding the SCC tool and implementation strategies in different contexts from Africa, Southeast Asia, Europe, and North America.MethodsThis explanatory, sequential mixed methods study-including surveys followed by interviews-of global SCC implementers focused on adaptation and implementation strategies, data collection, and desired improvements to support ongoing SCC use. We analyzed the survey results using descriptive statistics. In a subset of respondents, follow-up virtual semi-structured interviews explored how they adapted, implemented, and evaluated the SCC in their context. We used rapid inductive and deductive thematic analysis for the interviews.ResultsOf the 483 total potential participants, 65 (13.5%) responded to the survey; 55 completed the survey (11.4%). We analyzed completed responses from those who identified as having SCC implementation experience (n = 29, 52.7%). Twelve interviews were conducted and analyzed. Ninety percent of respondents indicated that they adapted the SCC tool, including adding clinical and operational items. Adaptations to structure included translation into local language, incorporation into a mobile app, and integration into medical records. Respondents reported variation in implementation strategies and data collection. The most common implementation strategies were meeting with stakeholders to secure buy-in, incorporating technical training, and providing supportive supervision or coaching around SCC use. Desired improvements included clarifying the purpose of the SCC, adding guidance on relevant clinical topics, refining items addressing behaviors with low adherence, and integrating contextual factors into decision-making. To improve implementation, participants desired political support to embed SCC into existing policies and ongoing clinical training and coaching.ConclusionAdditional adaptation and implementation guidance for the SCC would be helpful for stakeholders to sustain effective implementation.

Project description:Although strong evidence exists about the effectiveness of basic childbirth services in reducing maternal and newborn mortality, these services are not provided in every childbirth, even those at health facilities. The WHO Safe Childbirth Checklist (SCC) was developed as a job aide to remind health workers of evidenced-based practices to be provided at specific points in the childbirth process. The Zambian government requested context-specific evidence on the feasibility and outcomes associated with introducing the checklist and related mentorship. A study was conducted on use of the SCC in four facilities in Nchelenge District of Zambia. Observations of childbirth services were conducted just before and six months after the introduction of the intervention. Observers used a structured tool to record adherence to essential services indicated on the checklist. The primary outcome of interest was the change in the average proportion of essential childbirth practices completed. Feedback questionnaires were administered to health workers before and six months after the intervention. At baseline and endline, 108 and 148 pause points were observed, respectively. There was an increase from 57% to 76% of tasks performed (p = 0.04). Considering only these cases where necessary supplies were available, health workers completed 60% of associated tasks at baseline compared to 84% at endline (p<0.01). Some tasks, such as taking an infant's temperature and hand washing, were never or rarely performed at baseline. Feedback from the health workers indicated that nearly all health workers agreed or strongly agreed with positive statements about the intervention. The performance of health workers in Zambia in completing essential practices in childbirth was low at baseline but improvements were observed with the introduction of the SCC and mentorship. Our results suggest that such interventions could improve quality of care for facility-based childbirth. However, national-level commitment to ensuring availability of trained staff and supplies is essential for success. Trial registration Clinical Trials.gov (NCT03263182) Registered August 28, 2017 This study adheres to CONSORT guidelines.

Project description:BackgroundThe WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned.MethodsThe East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis.ResultsA total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues.ConclusionThis study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.

Project description:BackgroundThe prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes.MethodsWe conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention.ResultsOf 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes.ConclusionsBirth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).

Project description:BackgroundMost maternal deaths, intrapartum-related stillbirths, and newborn deaths in low income countries are preventable but simple, effective methods for improving safety in institutional births have not been devised. Checklist-based interventions aid management of complex or neglected tasks and have been shown to reduce harm in healthcare. We hypothesized that implementation of the WHO Safe Childbirth Checklist program, a novel childbirth safety program for institutional births incorporating a 29-item checklist, would increase delivery of essential childbirth practices linked with improved maternal and perinatal health outcomes.Methods and findingsA pilot, pre-post-intervention study was conducted in a sub-district level birth center in Karnataka, India between July and December 2010. We prospectively observed health workers that attended to women and newborns during 499 consecutively enrolled birth events and compared these with observed practices during 795 consecutively enrolled birth events after the introduction of the WHO Safe Childbirth Checklist program. Twenty-nine essential practices that target the major causes of childbirth-related mortality, such as hand hygiene and uterotonic administration, were evaluated. The primary end point was the average rate of successful delivery of essential childbirth practices by health workers. Delivery of essential childbirth-related care practices at each birth event increased from an average of 10 of 29 practices at baseline (95%CI 9.4, 10.1) to an average of 25 of 29 practices afterwards (95%CI 24.6, 25.3; p<0.001). There was significant improvement in the delivery of 28 out of 29 individual practices. No adverse outcomes relating to the intervention occurred. Study limitations are the pre-post design, potential Hawthorne effect, and focus on processes of care versus health outcomes.ConclusionsIntroduction of the WHO Safe Childbirth Checklist program markedly improved delivery of essential safety practices by health workers. Future study will determine if this program can be implemented at scale and improve health outcomes.

Project description:ObjectiveEvaluate the impact of a World Health Organization Safe Childbirth Checklist coaching-based intervention (BetterBirth Program) on availability and procurement of essential childbirth-related supplies.DesignMatched pair, cluster-randomized controlled trial.SettingUttar Pradesh, India.Participants120 government-sector health facilities (60 interventions, 60 controls). Supply-availability surveys were conducted quarterly in all sites. Coaches collected supply procurement sources from intervention sites.InterventionsCoaching targeting implementation of Checklist with data feedback and action planning.Main outcome measuresMean supply availability by study arm; change in procurement sources for intervention sites.ResultsAt baseline, 6 and 12 months, the intervention sites had a mean of 20.9 (95% confidence interval (CI): 20.2-21.5); 22.4 (95% CI: 21.8-22.9) and 22.1 (95% CI:21.4-22.8) items, respectively. Control sites had 20.8 (95% CI: 20.3-21.3); 20.9 (95% CI: 20.3-21.5) and 21.7 (95% CI: 20.8-22.6) items at the same time-points. There was a small but statistically significant higher availability in intervention sites at 6 months (difference-in-difference (DID) = 1.43, P < 0.001), which was not seen by 12 months (DID = 0.37, P = 0.53). Greater difference between intervention and control sites starting in the bottom quartile of supply availability was seen at 6 months (DID = 4.0, P = 0.0002), with no significant difference by 12 months (DID = 1.5, P = 0.154). No change was seen in procurement sources with ~5% procured by patients with some rates as high as 29% (oxytocin).ConclusionsImplementation of the BetterBirth Program, incorporating supply availability, resulted in modest improvements with catch-up by control facilities by 12 months. Supply-chain coaching may be most beneficial in sites starting with lower supply availability. Efforts are needed to reduce reliance on patient-funding for some critical medications.Trial registrationClinicalTrials.gov #NCT02148952; Universal Trial Number: U1111-1131-5647.