The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .

ePOCT+ and the medAL-suite: Development of an electronic clinical decision support algorithm and digital platform for pediatric outpatients in low- and middle-income countries.

Electronic clinical decision support algorithms (CDSAs) have been developed to address high childhood mortality and inappropriate antibiotic prescription by helping clinicians adhere to guidelines. Previously identified challenges of CDSAs include their limited scope, usability, and outdated clinical content. To address these challenges we developed ePOCT+, a CDSA for the care of pediatric outpatients in low- and middle-income settings, and the medical algorithm suite (medAL-suite), a software for the creation and execution of CDSAs. Following the principles of digital development, we aim to describe the process and lessons learnt from the development of ePOCT+ and the medAL-suite. In particular, this work outlines the systematic integrative development process in the design and implementation of these tools required to meet the needs of clinicians to improve uptake and quality of care. We considered the feasibility, acceptability and reliability of clinical signs and symptoms, as well as the diagnostic and prognostic performance of predictors. To assure clinical validity, and appropriateness for the country of implementation the algorithm underwent numerous reviews by clinical experts and health authorities from the implementing countries. The digitalization process involved the creation of medAL-creator, a digital platform which allows clinicians without IT programming skills to easily create the algorithms, and medAL-reader the mobile health (mHealth) application used by clinicians during the consultation. Extensive feasibility tests were done with feedback from end-users of multiple countries to improve the clinical algorithm and medAL-reader software. We hope that the development framework used for developing ePOCT+ will help support the development of other CDSAs, and that the open-source medAL-suite will enable others to easily and independently implement them. Further clinical validation studies are underway in Tanzania, Rwanda, Kenya, Senegal, and India.

Can changes to improve person-centred maternity care be spread across public health facilities in Uttar Pradesh, India?

Poor quality person-centred maternity care (PCMC) leads to delays in care and adverse maternal and newborn outcomes. This study describes the impact of spreading a Change Package, or interventions that other health facilities had previously piloted and identified as successful, to improve PCMC in public health facilities in Uttar Pradesh, India. A quasi-experimental design was used including matched control-intervention facilities and pre-post data collection. This study took place in Uttar Pradesh, India in 2018-2019. Six large public health facilities participated in the evaluation of the spread study, including three intervention and three control facilities. Intervention facilities were introduced to a quality improvement (QI) Change Package to improve PCMC. In total, 1200 women participated in the study, including 600 women at baseline and 600 women at endline. Difference-in-difference estimators are used to examine the impact of spreading a QI Change Package across spread sites vs. control sites and at baseline and endline using a validated PCMC scale. Out of a 100-point scale, a 24.93 point improvement was observed in overall PCMC scores among spread facilities compared to control facilities from baseline to endline (95% CI: 22.29, 27.56). For the eight PCMC indicators that the Change Package targeted, spread facilities increased 33.86 points (95% CI: 30.91, 36.81) relative to control facilities across survey rounds. Findings suggest that spread of a PCMC Change Package results in improved experiences of care for women as well as secondary outcomes, including clinical quality, nurse and doctor visits, and decreases in delivery problems.Trial registration: ClinicalTrials.gov identifier: NCT04208841..

Results of a person-centered maternal health quality improvement intervention in Uttar Pradesh, India.

BACKGROUND: Poor patient experiences during delivery in Uttar Pradesh, India is a common problem. It delays presentation at facilities after the onset of labor and contributes to poor maternal health outcomes. Patient-centered maternity care (PCMC) is recognized by the World Health Organization as critical to overall quality. Changing PCMC requires changing the process of care, and is therefore especially challenging. METHODS: We used a matched case-control design to evaluate a quality improvement process directed at PCMC and based on widely established team-based methods used in many OECD countries. The intervention was introduced into three government facilities and teams supported to brainstorm and test improvements over 12 months. Progress was measured through pre-post interviews with new mothers, scored using a validated PCMC scale. Analysis included chi-squared and difference-in-difference tests. FINDINGS: On a scale to 100, the PCMC score of the intervention group increased 22.9 points compared to controls. Deliveries attended by midwives, dais, ASHAs or non-skilled providers resulted in significantly higher PCMC scores than those attended to by nurses or doctors. The intervention was associated with one additional visit from a doctor and over two additional visits from nurses per day, compared to the control group. INTERPRETATION: This study has demonstrated the effectiveness of a team-based quality improvement intervention to ameliorate women's childbirth experiences. These improvements were locally designed and led, and offer a model for potential replication.

A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India.

BACKGROUND: Poor patient experiences during delivery leads to delayed presentation at facilities and contributes to poor maternal health outcomes. Person-centered maternity care (PCMC) is a key component of quality. Improving PCMC requires changing the process of care which can be complex and necessitate significant external input, making replication and scale difficult. This study compares the effectiveness two Quality Improvement (QI) intervention phases, one Intensive, one Light-Touch. METHODS: We use a matched case-control design to compare two phases of a QI Intervention targeting PCMC, with three facilities in each. The Intensive phase was introduced into three government facilities where teams were supported to identify, design, and test potential improvements over 12 months. The Light-Touch phase was subsequently introduced in three other government facilities and changes were tracked over six months. We compared the two groups using multivariate linear regression and difference-in-difference models to assess changes in PCMC outcome RESULTS: Both Intensive and Light-Touch arms demonstrated large improvements in PCMC. On a scale from 0 to 100, Intensive facilities increased in PCMC scores from 85.02 to 97.13, while Light-Touch facilities increased from 63.42 to 87.47. For both there was a 'halo' effect, with a similar improvement recorded for the specific improvement activities focused on, as w ell as aspects of PCMC not directly addressed. CONCLUSIONS: This study demonstrates that a short, inexpensive, light-touch and directive intervention can change staff practices and significantly improve the experiences of women during childbirth. It also shows that improvements in a few areas of provider-patient interaction have a 'halo' effect, changing many other aspects of patient-provider interaction at the same time. TRIAL REGISTRATION: QI Phase 1 - NCT04208867 . Retrospectively registered. December 19th, 2019. QI Phase 2 - NCT04208841 . Retrospectively registered. December 23, 2019.