Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol.

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.Trial registration: ISRCTN67214403.

Scalability of effective adherence interventions for patients using cardiovascular disease medication: A realist synthesis-inspired systematic review.

Upscaling of medication adherence interventions to routine care is still challenging. This realist theory-inspired review aimed to assess which intervention aspects are potentially important for the scalability of effective cardiovascular disease (CVD) medication adherence interventions and how they are reported in effectiveness studies. A total of 4097 articles from four databases were screened of which ultimately 31 studies were included. Relevant information on scalability was extracted using a theoretic framework based on the scalability assessment tool used in the QUALIDEC study for the following domains: (i) innovation, (ii) implementers and patients, (iii) adopting organizations and health system, and (iv) socio-political context. Extracted articles were analysed for themes and chains of inference, which were grouped based on commonality and source of evidence to form new hypotheses. Six different domains relevant for scalability of adherence interventions were identified: (1) Complexity of the intervention; (2) training; (3) customization of the intervention; (4) drivers of the intervention; (5) technical interventions; and (6) stakeholder involvement. These six domains might be useful for the development of more scalable interventions by bridging the gap between research and practice. Data relevant for scalability is not well reported on in effectiveness trials for CVD medication adherence interventions and only limited data on scalability has been published in additional papers. We believe the adoption and reach of effective CVD medication adherence interventions will improve with increased awareness for the necessity of scalability in all phases of intervention development.

Effect of collaborative quality improvement on stillbirths, neonatal mortality and newborn care practices in hospitals of Telangana and Andhra Pradesh, India: evidence from a quasi-experimental mixed-methods study.

BACKGROUND: Improving quality of care is a key priority to reduce neonatal mortality and stillbirths. The Safe Care, Saving Lives programme aimed to improve care in newborn care units and labour wards of 60 public and private hospitals in Telangana and Andhra Pradesh, India, using a collaborative quality improvement approach. Our external evaluation of this programme aimed to evaluate programme effects on implementation of maternal and newborn care practices, and impact on stillbirths, 7- and 28-day neonatal mortality rate in labour wards and neonatal care units. We also aimed to evaluate programme implementation and mechanisms of change. METHODS: We used a quasi-experimental plausibility design with a nested process evaluation. We evaluated effects on stillbirths, mortality and secondary outcomes relating to adherence to 20 evidence-based intrapartum and newborn care practices, comparing survey data from 29 hospitals receiving the intervention to 31 hospitals expected to receive the intervention later, using a difference-in-difference analysis. We analysed programme implementation data and conducted 42 semi-structured interviews in four case studies to describe implementation and address four theory-driven questions to explain the quantitative results. RESULTS: Only 7 of the 29 intervention hospitals were engaged in the intervention for its entire duration. There was no evidence of an effect of the intervention on stillbirths [DiD - 1.3 percentage points, 95% CI - 2.6-0.1], on neonatal mortality at age 7 days [DiD - 1.6, 95% CI - 9-6.2] or 28 days [DiD - 3.0, 95% CI - 12.9-6.9] or on adherence to target evidence-based intrapartum and newborn care practices. The process evaluation identified challenges in engaging leaders; challenges in developing capacity for quality improvement; and challenges in activating mechanisms of change at the unit level, rather than for a few individuals, and in sustaining these through the creation of new social norms. CONCLUSION: Despite careful planning and substantial resources, the intervention was not feasible for implementation on a large scale. Greater focus is required on strategies to engage leadership. Quality improvement may need to be accompanied by clinical training. Further research is also needed on quality improvement using a health systems perspective.

How and under what circumstances do quality improvement collaboratives lead to better outcomes? A systematic review.

BACKGROUND: Quality improvement collaboratives are widely used to improve health care in both high-income and low and middle-income settings. Teams from multiple health facilities share learning on a given topic and apply a structured cycle of change testing. Previous systematic reviews reported positive effects on target outcomes, but the role of context and mechanism of change is underexplored. This realist-inspired systematic review aims to analyse contextual factors influencing intended outcomes and to identify how quality improvement collaboratives may result in improved adherence to evidence-based practices. METHODS: We built an initial conceptual framework to drive our enquiry, focusing on three context domains: health facility setting; project-specific factors; wider organisational and external factors; and two further domains pertaining to mechanisms: intra-organisational and inter-organisational changes. We systematically searched five databases and grey literature for publications relating to quality improvement collaboratives in a healthcare setting and containing data on context or mechanisms. We analysed and reported findings thematically and refined the programme theory. RESULTS: We screened 962 abstracts of which 88 met the inclusion criteria, and we retained 32 for analysis. Adequacy and appropriateness of external support, functionality of quality improvement teams, leadership characteristics and alignment with national systems and priorities may influence outcomes of quality improvement collaboratives, but the strength and quality of the evidence is weak. Participation in quality improvement collaborative activities may improve health professionals' knowledge, problem-solving skills and attitude; teamwork; shared leadership and habits for improvement. Interaction across quality improvement teams may generate normative pressure and opportunities for capacity building and peer recognition. CONCLUSION: Our review offers a novel programme theory to unpack the complexity of quality improvement collaboratives by exploring the relationship between context, mechanisms and outcomes. There remains a need for greater use of behaviour change and organisational psychology theory to improve design, adaptation and evaluation of the collaborative quality improvement approach and to test its effectiveness. Further research is needed to determine whether certain contextual factors related to capacity should be a precondition to the quality improvement collaborative approach and to test the emerging programme theory using rigorous research designs.

Assessing scalability of an intervention: why, how and who?

Public health interventions should be designed with scale in mind, and researchers and implementers must plan for scale-up at an early stage. Yet, there is limited awareness among researchers of the critical value of considering scalability and relatively limited empirical evidence on assessing scalability, despite emerging methodological guidance. We aimed to integrate scalability considerations in the design of a study to evaluate a multi-component intervention to reduce unnecessary caesarean sections in low- and middle-income countries. First, we reviewed and synthesized existing scale up frameworks to identify relevant dimensions and available scalability assessment tools. Based on these, we defined our scalability assessment process and adapted existing tools for our study. Here, we document our experience and the methodological challenges we encountered in integrating a scalability assessment in our study protocol. These include: achieving consensus on the purpose of a scalability assessment; and identifying the optimal timing of such an assessment, moving away from the concept of a one-off assessment at the start of a project. We also encountered tensions between the need to establish the proof of principle, and the need to design an innovation that would be fit-for-scale. Particularly for complex interventions, scaling up may warrant rigorous research to determine an efficient and effective scaling-up strategy. We call for researchers to better incorporate scalability considerations in pragmatic trials through greater integration of impact and process evaluation, more stringent definition and measurement of scale-up objectives and outcome evaluation plans that allow for comparison of effects at different stages of scale-up.

Care practices and neonatal survival in 52 neonatal intensive care units in Telangana and Andhra Pradesh, India: A cross-sectional study.

BACKGROUND: The Indian government supports both public- and private-sector provision of hospital care for neonates: neonatal intensive care is offered in public facilities alongside a rising number of private-for-profit providers. However, there are few published reports about mortality levels and care practices in these facilities. We aimed to assess care practices, causes of admission, and outcomes from neonatal intensive care units (NICUs) in public secondary and private tertiary hospitals and both public and private medical colleges enrolled in a quality improvement collaborative in Telangana and Andhra Pradesh-2 Indian states with a respective population of 35 and 50 million. METHODS AND FINDINGS: We conducted a cross-sectional study between 30 May and 26 August 2016 as part of a baseline evaluation in 52 consenting hospitals (26 public secondary hospitals, 5 public medical colleges, 15 private tertiary hospitals, and 6 private medical colleges) offering neonatal intensive care. We assessed the availability of staff and services, adherence to evidence-based practices at admission, and case fatality after admission to the NICU using a range of tools, including facility assessment, observations of admission, and abstraction of registers and telephone interviews after discharge. Our analysis is adjusted for clustering and weighted for caseload at the hospital level and presents findings stratified by type and ownership of hospitals. In total, the NICUs included just over 3,000 admissions per month. Staffing and infrastructure provision were largely according to government guidelines, except that only a mean of 1 but not the recommended 4 paediatricians were working in public secondary NICUs per 10 beds. On admission, all neonates admitted to private hospitals had auscultation (100%, 19 of 19 observations) but only 42% (95% confidence interval [CI] 25%-62%, p-value for difference is 0.361) in public secondary hospitals. The most common single cause of admission was preterm birth (25%) followed by jaundice (23%). Case-fatality rates at age 28 days after admission to a NICU were 4% (95% CI 2%-8%), 15% (9%-24%), 4% (2%-8%) and 2% (1%-5%) (Chi-squared p = 0.001) in public secondary hospitals, public medical colleges, private tertiary hospitals, and private medical colleges, respectively, according to facility registers. Case fatality according to postdischarge telephone interviews found rates of 12% (95% CI 7%-18%) for public secondary hospitals. Roughly 6% of admitted neonates were referred to another facility. Outcome data were missing for 27% and 8% of admissions to private tertiary hospitals and private medical colleges. Our study faced the limitation of missing data due to incomplete documentation. Further generalizability was limited due to the small sample size among private facilities. CONCLUSIONS: Our findings suggest differences in quality of neonatal intensive care and 28-day survival between the different types of hospitals, although comparison of outcomes is complicated by differences in the case mix and referral practices between hospitals. Uniform reporting of outcomes and risk factors across the private and public sectors is required to assess the benefits for the population of mixed-care provision.

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

BACKGROUND: The collaborative quality improvement approach proposed by the Institute for Healthcare Improvement has the potential to improve coverage of evidence-based maternal and newborn health practices. The Safe Care, Saving Lives initiative supported the implementation of 20 evidence-based maternal and newborn care practices, targeting labour wards and neonatal care units in 85 public and private hospitals in Telangana and Andhra Pradesh, India. OBJECTIVE: We present a protocol for the evaluation of this programme which aims to (a) estimate the effect of the initiative on evidence-based care practices and mortality; (b) evaluate the mechanisms leading to changes in adherence to evidence-based practices, and their relationship with contextual factors; (c) explore the feasibility of scaling-up the approach. METHODS: The mixed-method evaluation is based on a plausibility design nested within a phased implementation. The 29 non-randomly selected hospitals comprising wave II of the programme were compared to the 31 remaining hospitals where the quality improvement approach started later. We assessed mortality and adherence to evidence-based practices at baseline and endline using abstraction of registers, checklists, observations and interviews in intervention and comparison hospitals. We also explored the mechanisms and drivers of change in adherence to evidence-based practices. Qualitative methods investigated the mechanisms of change in purposefully selected case study hospitals. A readiness assessment complemented the analysis of what works and why. We used a difference-in-difference approach to estimate the effects of the intervention on mortality and coverage. Thematic analysis was used for the qualitative data. DISCUSSION: This is the first quality improvement collaborative targeting neonatal health in secondary and tertiary hospitals in a middle-income country linked to a government health insurance scheme. Our process evaluation is theory driven and will refine hypotheses about how this quality improvement approach contributes to institutionalization of evidence-based practices.