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

ABSTRACT

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.

KEYWORDS:

• Collaborative quality improvement
• perinatal health
• India
• evidence-based practices
• neonatal mortality
• stillbirth
• implementation science

Responsible Editor

Peter Byass, Umeå University, Sweden

Responsible Editor

Peter Byass, Umeå University, Sweden

Acknowledgments

We thank the ACCESS Health International team for their assistance to describe the theory of change. We thank the health providers, mothers and families for their time during the interviews for the baseline survey.

Author contributions

CH, KZ, SS, RS, MT and JS conceptualized the study. The quality improvement intervention was developed by AJ and VP together with other partners of ACCESS. The theory of change was conceptualized jointly by CH, KZ, AS, VP, RS, MT, SS and JS. CH and KZ wrote the first draft of this protocol. All others commented on subsequent drafts. All authors read and approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the authors.

Ethics and consent

Ethical approval is granted from LSHTM (LSHTM Ethics Ref: 10358) and PHFI’s Institutional Ethics Committee (IIPHH/TRCIEC/064/2015). The study complies with the International Ethical Guidelines for Biomedical Research Involving Human Subjects and the principles of the declaration of Helsinki [50]. An information sheet is read out to each participant. Consent is obtained from each participating hospital, health provider and mother. Participants can withdraw at any time. Confidentiality is assured, as per institutional guidelines of both involved institutions.

Paper context

While collaborative quality improvement is globally increasingly employed to improve quality of care and the implementation of essential evidence-based practices, evidence is limited to what extent this approach improves practices and reduces mortality. Our trial aims to add to the limited evidence and also aims to describe the mechanism of change and the context which may or may not support the collaborative quality improvement to impact on the implementation of evidence-based practices.

Supplementary material

Supplemenatal data for this article can be accessed here.

Additional information

Funding

This study is funded by the Children’s Investment Fund Foundation (CIFF, Grant number G-1601-00920). LSHTM acts as a sponsor. The funder had no role in the study design, data collection and management, or the analysis plan.