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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.

ABSTRACT: 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).

SUBMITTER: Gimbel S

PROVIDER: S-EPMC7059349 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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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.

Gimbel Sarah S Mocumbi Ana Olga AO Ásbjörnsdóttir Kristjana K Coutinho Joana J Andela Leonel L Cebola Bonifacio B Craine Heidi H Crocker Jonny J Hicks Leecreesha L Holte Sarah S Hossieke Rodrigues R Itai Edgar E Levin Carol C Manaca Nelia N Murgorgo Filipe F Nhumba Miguel M Pfeiffer James J Ramiro Isaias I Ronen Keshet K Sotoodehnia Nona N Uetela Onei O Wagner Anjuli A Weiner Bryan J BJ Sherr Kenneth K

Implementation science : IS 20200306 1

<h4>Background</h4>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 engineeri ...[more]

PMID: 32143657

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Project description:Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention's impact on reducing drop-offs along the pMTCT cascade.This study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d'Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The Consolidated Framework for Implementation Research (CFIR) will guide collection and analysis of qualitative data on implementation process.This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade. The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level, and to identify low cost, contextually appropriate pMTCT improvement strategies.ClinicalTrials.gov NCT02023658.

Project description:BackgroundSignificant 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.MethodsUsing 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.DiscussionThis 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 registrationClinicalTrials.gov; NCT05103033 ; 11/2/2021.

Project description:BackgroundThe 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.MethodsThe 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.DiscussionSAIA 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 registrationClinicalTrials.gov NCT03425136 (registered 02/06/2018).

Project description:Our understanding of how chromosomes structurally organize and dynamically interact has been revolutionized through the lens of long-chain polymer physics. Major protein contributors to chromosome structure and dynamics are condensin and cohesin that stochastically generate loops within and between chains, and entrap proximal strands of sister chromatids. In this paper, we explore the ability of transient, protein-mediated, gene-gene crosslinks to induce clusters of genes, thereby dynamic architecture, within the highly repeated ribosomal DNA that comprises the nucleolus of budding yeast. We implement three approaches: live cell microscopy; computational modeling of the full genome during G1 in budding yeast, exploring four decades of timescales for transient crosslinks between 5kbp domains (genes) in the nucleolus on Chromosome XII; and, temporal network models with automated community (cluster) detection algorithms applied to the full range of 4D modeling datasets. The data analysis tools detect and track gene clusters, their size, number, persistence time, and their plasticity (deformation). Of biological significance, our analysis reveals an optimal mean crosslink lifetime that promotes pairwise and cluster gene interactions through "flexible" clustering. In this state, large gene clusters self-assemble yet frequently interact (merge and separate), marked by gene exchanges between clusters, which in turn maximizes global gene interactions in the nucleolus. This regime stands between two limiting cases each with far less global gene interactions: with shorter crosslink lifetimes, "rigid" clustering emerges with clusters that interact infrequently; with longer crosslink lifetimes, there is a dissolution of clusters. These observations are compared with imaging experiments on a normal yeast strain and two condensin-modified mutant cell strains. We apply the same image analysis pipeline to the experimental and simulated datasets, providing support for the modeling predictions.

Project description:Substantial investments are being made to scale-up access to mental healthcare in low- and middle-income countries, but less attention has been paid to quality and performance of nascent public-sector mental healthcare systems. This study tested the initial effectiveness of an implementation strategy to optimize routine outpatient mental healthcare cascade performance in Mozambique [the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH)]. This study employed a pre-post design from September 2018 to August 2019 across four Ministry of Health clinics among 810 patients and 3234 outpatient mental health visits. Effectiveness outcomes evaluated progression through the care cascade, including: (1) initial diagnosis and medication selection; (2) enrolling in follow-up care; (3) returning after initial consultation within 60 days; (4) returning for follow-up visits on time; (5) returning for follow-up visits adherent to medication and (6) achieving function improvement. Clustered generalized linear models evaluated odds of completing cascade steps pre- vs post-intervention. Facilities prioritized improvements focused on the follow-up cascade, with 62.5% (10 of 16) monthly system modifications targeting medication adherence. At baseline, only 4.2% of patient visits achieved function improvement; during the 6 months of SAIA-MH implementation, this improved to 13.1% of patient visits. Multilevel logistic regression found increased odds of returning on time and adherent [aOR = 1.53, 95% CI (1.21, 1.94), P = 0.0004] and returning on time, adherent and with function improvement [aOR = 3.68, 95% CI (2.57, 5.44), P < 0.0001] after SAIA-MH implementation. No significant differences were observed regarding other cascade steps. The SAIA-MH implementation strategy shows promise for rapidly and significantly improving mental healthcare cascade outcomes, including the ultimate goal of patient function improvement. Given poor baseline mental healthcare cascade performance, there is an urgent need for evidence-based implementation strategies to optimize the performance of mental healthcare cascades in low- and middle-income countries.

Dataset Information

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.

Publications

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.

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