"We should be resourcing their liberation:" a qualitative formative study to guide introduction of a systems engineering intervention at a King County, WA juvenile detention center clinic.

BACKGROUND: There are ongoing efforts to eliminate juvenile detention in King County, WA. An essential element of this work is effectively addressing the health needs of youth who are currently detained to improve their wellbeing and reduce further contact with the criminal legal system. This formative study sought to inform adaptation and piloting of an evidence-based systems engineering strategy - the Systems Analysis and Improvement Approach (SAIA) - in a King County juvenile detention center clinic to improve quality and continuity of healthcare services. Our aims were to describe the priority health needs of young people who are involved in Washington's criminal legal system and the current system of healthcare for young people who are detained. METHODS: We conducted nine individual interviews with providers serving youth. We also obtained de-identified quantitative summary reports of quality improvement discussions held between clinic staff and 13 young people who were detained at the time of data collection. Interview transcripts were analyzed using deductive and inductive coding and quantitative data were used to triangulate emergent themes. RESULTS: Providers identified three priority healthcare cascades for detention-based health services-mental health, substance use, and primary healthcare-and reported that care for these concerns is often introduced for the first time in detention. Interviewees classified incarceration itself as a health hazard, highlighting the paradox of resourcing healthcare quality improvement interventions in an inherently harmful setting. Fractured communication and collaboration across detention- and community-based entities drives systems-level inefficiencies, obstructs access to health and social services for marginalized youth, and fragments the continuum of care for young people establishing care plans while detained in King County. 31% of youth self-reported receiving episodic healthcare prior to detention, 15% reported never having medical care prior to entering detention, and 46% had concerns about finding healthcare services upon release to the community. CONCLUSIONS: Systems engineering interventions such as the SAIA may be appropriate and feasible approaches to build systems thinking across and between services, remedy systemic challenges, and ensure necessary information sharing for care continuity. However, more information is needed directly from youth to draw conclusions about effective pathways for healthcare quality improvement.

The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya.

BACKGROUND: Although HIV testing in family planning (FP) clinics is a promising approach for engaging women in HIV treatment and prevention services, HIV testing rates are low in FP clinics in Kenya. In 2018, a cluster randomized trial was implemented in Mombasa, Kenya applying the Systems Analysis and Improvement Approach (SAIA) to integrate HIV testing into FP services (1K24HD088229-01). We estimated the incremental costs and explored cost drivers of the FP HIV SAIA implementation in Mombasa, Kenya. METHODS: We conducted a costing evaluation from the payer perspective for the FP HIV SAIA randomized control trial. We identified relevant activities for the intervention including start-up, training, research and FP HIV SAIA. We estimated activity time burden using a time-and motion study. We derived unit costs through staff interviews and programmatic budgets. We present cost estimates for two different scenarios: as-implemented including research and projected costs for a Ministry of Health-supported intervention. All costs are reported in 2018 USD. RESULTS: For an annual program output of 36,086 HIV tests administered to new FP clients, we estimated the total annual program cost to be $91,994 with an average cost per new FP client served of $2.55. Personnel and HIV rapid testing kits comprised 55% and 21% of programmatic costs, respectively. Assuming no changes to program outputs and with efficiency gains under the MOH scenario, the estimated cost per new FP client served decreased to $1.30 with a programmatic cost reduction of 49%. CONCLUSION: FP HIV SAIA is a low-cost and flexible implementation strategy for facilitating integrated delivery of HIV testing alongside FP services. Although cost implications of the FP HIV SAIA intervention must continue to be evaluated over time, these findings provide context-specific cost data useful for budget planning and decision-making regarding intervention delivery and expansion. TRIAL REGISTRATION: The trial was registered on December 15, 2016, with clinicaltrials.gov (NCT02994355).

Scaling-up and scaling-out the Systems Analysis and Improvement Approach to optimize the hypertension diagnosis and care cascade for HIV infected individuals (SCALE SAIA-HTN): a stepped-wedge cluster randomized trial.

BACKGROUND: Undiagnosed and untreated hypertension is a main driver of cardiovascular disease and disproportionately affects persons living with HIV (PLHIV) in low- and middle-income countries. Across sub-Saharan Africa, guideline application to screen and manage hypertension among PLHIV is inconsistent due to poor service readiness, low health worker motivation, and limited integration of hypertension screening and management within HIV care services. In Mozambique, where the adult HIV prevalence is over 13%, an estimated 39% of adults have hypertension. As the only scaled chronic care service in the county, the HIV treatment platform presents an opportunity to standardize and scale hypertension care services. Low-cost, multi-component systems-level strategies such as the Systems Analysis and Improvement Approach (SAIA) have been found effective at integrating hypertension and HIV services to improve the effectiveness of hypertension care delivery for PLHIV, reduce drop-offs in care, and improve service quality. To build off lessons learned from a recently completed cluster randomized trial (SAIA-HTN) and establish a robust evidence base on the effectiveness of SAIA at scale, we evaluated a scaled-delivery model of SAIA (SCALE SAIA-HTN) using existing district health management structures to facilitate SAIA across six districts of Maputo Province, Mozambique. METHODS: This study employs a stepped-wedge design with randomization at the district level. The SAIA strategy will be "scaled up" with delivery by district health supervisors (rather than research staff) and will be "scaled out" via expansion to Southern Mozambique, to 18 facilities across six districts in Maputo Province. SCALE SAIA-HTN will be introduced over three, 9-month waves of intensive intervention, where technical support will be provided to facilities and district managers by study team members from the Mozambican National Institute of Health. Our evaluation of SCALE SAIA-HTN will be guided by the RE-AIM framework and will seek to estimate the budget impact from the payer's perspective. DISCUSSION: SAIA packages user-friendly systems engineering tools to support decision-making by frontline health workers and to identify low-cost, contextually relevant improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial will determine an effective strategy for national scale-up and inform program planning. TRIAL REGISTRATION: ClinicalTrials.gov NCT05002322 (registered 02/15/2023).

Assessing drivers of implementing "Scaling-up the Systems Analysis and Improvement Approach" for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves.

BACKGROUND: The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA's effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases. METHODS: We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi). RESULTS: We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA's compatibility with organizational structures, processes, and priorities of Mozambique's health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds. CONCLUSIONS: The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

The Systems Analysis and Improvement Approach: specifying core components of an implementation strategy to optimize care cascades in public health.

BACKGROUND: Healthcare systems in low-resource settings need simple, low-cost interventions to improve services and address gaps in care. Though routine data provide opportunities to guide these efforts, frontline providers are rarely engaged in analyzing them for facility-level decision making. The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multi-component implementation strategy that engages providers in use of facility-level data to promote systems-level thinking and quality improvement (QI) efforts within multi-step care cascades. SAIA was originally developed to address HIV care in resource-limited settings but has since been adapted to a variety of clinical care systems including cervical cancer screening, mental health treatment, and hypertension management, among others; and across a variety of settings in sub-Saharan Africa and the USA. We aimed to extend the growing body of SAIA research by defining the core elements of SAIA using established specification approaches and thus improve reproducibility, guide future adaptations, and lay the groundwork to define its mechanisms of action. METHODS: Specification of the SAIA strategy was undertaken over 12 months by an expert panel of SAIA-researchers, implementing agents and stakeholders using a three-round, modified nominal group technique approach to match core SAIA components to the Expert Recommendations for Implementing Change (ERIC) list of distinct implementation strategies. Core implementation strategies were then specified according to Proctor's recommendations for specifying and reporting, followed by synthesis of data on related implementation outcomes linked to the SAIA strategy across projects. RESULTS: Based on this review and clarification of the operational definitions of the components of the SAIA, the four components of SAIA were mapped to 13 ERIC strategies. SAIA strategy meetings encompassed external facilitation, organization of provider implementation meetings, and provision of ongoing consultation. Cascade analysis mapped to three ERIC strategies: facilitating relay of clinical data to providers, use of audit and feedback of routine data with healthcare teams, and modeling and simulation of change. Process mapping matched to local needs assessment, local consensus discussions and assessment of readiness and identification of barriers and facilitators. Finally, continuous quality improvement encompassed tailoring strategies, developing a formal implementation blueprint, cyclical tests of change, and purposefully re-examining the implementation process. CONCLUSIONS: Specifying the components of SAIA provides improved conceptual clarity to enhance reproducibility for other researchers and practitioners interested in applying the SAIA across novel settings.

Systems analysis and improvement approach to optimize outpatient mental health treatment cascades in Mozambique (SAIA-MH): study protocol for a cluster randomized trial.

BACKGROUND: Significant investments are being made to close the mental health (MH) treatment gap, which often exceeds 90% in many low- and middle-income countries (LMICs). However, limited attention has been paid to patient quality of care in nascent and evolving LMIC MH systems. In system assessments across sub-Saharan Africa, MH loss-to-follow-up often exceeds 50% and sub-optimal medication adherence often exceeds 60%. This study aims to fill a gap of evidence-based implementation strategies targeting the optimization of MH treatment cascades in LMICs by testing a low-cost multicomponent implementation strategy integrated into routine government MH care in Mozambique. METHODS: Using a cluster-randomized trial design, 16 clinics (8 intervention and 8 control) providing primary MH care will be randomized to the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) or an attentional placebo control. SAIA-MH is a multicomponent implementation strategy blending external facilitation, clinical consultation, and provider team meetings with system-engineering tools in an overall continuous quality improvement framework. Following a 6-month baseline period, intervention facilities will implement the SAIA-MH strategy for a 2-year intensive implementation period, followed by a 1-year sustainment phase. Primary outcomes will be the proportion of all patients diagnosed with a MH condition and receiving pharmaceutical-based treatment who achieve functional improvement, adherence to medication, and retention in MH care. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success. Specific Aim 1b will include the evaluation of mechanisms of the SAIA-MH strategy using longitudinal structural equation modeling as well as specific aim 2 estimating cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique to provincial and national levels. DISCUSSION: This study is innovative in being the first, to our knowledge, to test a multicomponent implementation strategy for MH care cascade optimization in LMICs. By design, SAIA-MH is a low-cost strategy to generate contextually relevant solutions to barriers to effective primary MH care, and thus focuses on system improvements that can be sustained over the long term. Since SAIA-MH is integrated into routine government MH service delivery, this pragmatic trial has the potential to inform potential SAIA-MH scale-up in Mozambique and other similar LMICs. TRIAL REGISTRATION: ClinicalTrials.gov; NCT05103033 ; 11/2/2021.

Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial.

BACKGROUND: Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation. METHODS: We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN. DISCUSSION: SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT04088656 (registered 09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656).

Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial.

BACKGROUND: The introduction of option B+-rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women-can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up. METHODS: The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE's evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up. DISCUSSION: SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03425136 (registered 02/06/2018).