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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.

ABSTRACT: 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).

SUBMITTER: Sherr K

PROVIDER: S-EPMC6487047 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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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.

Sherr Kenneth K Ásbjörnsdóttir Kristjana K Crocker Jonny J Coutinho Joana J de Fatima Cuembelo Maria M Tavede Esperança E Manaca Nélia N Ronen Keshet K Murgorgo Felipe F Barnabas Ruanne R John-Stewart Grace G Holte Sarah S Weiner Bryan J BJ Pfeiffer James J Gimbel Sarah S

Implementation science : IS 20190427 1

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

PMID: 31029171

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Project description:BackgroundThe 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.MethodsWe 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).ResultsWe 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.ConclusionsThe 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 registrationClinicalTrials.gov, NCT03425136 . Registered on 02/06/2018.

Project description:BackgroundTimely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.Methods and findingsIn a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range [IQR] 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk [aRR] 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.ConclusionsIn this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.Trial registrationClinicalTrials.gov Trial Number NCT02350140.

Project description:BackgroundHigh levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care.MethodsWe did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192.FindingsBetween March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99% CI 666·81-1039·11; p<0·0001); 3739 (9·9%) of 37 826 women were screened for proteinuria in the control period, compared with 29 874 (97·1%) of 30 772 in the intervention period (1875·18; 1447·56-2429·11; p<0·0001); and 17 926 (51·4%) of 34 842 received mebendazole in the control period, compared with 24 960 (88·2%) of 28 294 in the intervention period (1·88; 1·70-2·09; p<0·0001). The effect was immediate and sustained over time, with negligible heterogeneity between sites.InterpretationA supply chain strategy that resolves stockouts at point of care can result in a vast improvement in quality during antenatal care visits, when compared with the routine national process for procurement and distribution of supplies.FundingGovernment of Flanders and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Project description:ObjectivesFrontline insights into care delivery correlate with patients' clinical outcomes. These outcomes might be improved through near-real time identification and mitigation of staff concerns. We evaluated the effects of a prospective frontline surveillance system on patient and team outcomes.DesignProspective, stepped wedge, non-randomised, cluster controlled trial; prespecified per protocol analysis for high-fidelity intervention delivery.ParticipantsSeven interdisciplinary medical ward teams from two hospitals in the UK.InterventionProspective clinical team surveillance (PCTS): structured daily interdisciplinary briefings to capture staff concerns, with organisational facilitation and feedback.Main measuresThe primary outcome was excess length of stay (eLOS): an admission more than 24 hours above the local average for comparable patients. Secondary outcomes included safety and teamwork climates, and incident reporting. Mixed-effects models adjusted for time effects, age, comorbidity, palliation status and ward admissions. Safety and teamwork climates were measured with the Safety Attitudes Questionnaire. High-fidelity PCTS delivery comprised high engagement and high briefing frequency.ResultsImplementation fidelity was variable, both in briefing frequency (median 80% working days/month, IQR 65%-90%) and engagement (median 70 issues/ward/month, IQR 34-113). 1714/6518 (26.3%) intervention admissions had eLOS versus 1279/4927 (26.0%) control admissions, an absolute risk increase of 0.3%. PCTS increased eLOS in the adjusted intention-to-treat model (OR 1.32, 95% CI 1.10 to 1.58, p=0.003). Conversely, high-fidelity PCTS reduced eLOS (OR 0.79, 95% CI 0.67 to 0.94, p=0.006). High-fidelity PCTS also increased total, high-yield and non-nurse incident reports (incidence rate ratios 1.28-1.79, all p<0.002). Sustained PCTS significantly improved safety and teamwork climates over time.ConclusionsThis study highlighted the potential benefits and pitfalls of ward-level interdisciplinary interventions. While these interventions can improve care delivery in complex, fluid environments, the manner of their implementation is paramount. Suboptimal implementation may have an unexpectedly negative impact on performance.Trial registration numberISRCTN 34806867 (http://www.isrctn.com/ISRCTN34806867).

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:BackgroundDespite many efforts, long wait times and overcrowding in emergency departments (EDs) have remained a significant health service issue in Canada. For several years, Canada has had one of the longest wait times among the Organisation for Economic Co-operation and Development countries. From a patient's perspective, this challenge has been described as "patients wait in pain or discomfort for hours before being seen at EDs." To overcome the challenge of increased wait times, we developed an innovative ED management platform called SurgeCon that was designed based on continuous quality improvement principles to maintain patient flow and mitigate the impact of patient surge on ED efficiency. The SurgeCon quality improvement intervention includes a protocol-driven software platform, restructures ED organization and workflow, and aims to establish a more patient-centric environment. We piloted SurgeCon at an ED in Carbonear, Newfoundland and Labrador, and found that there was a 32% reduction in ED wait times.ObjectiveThe primary objective of this trial is to determine the effects of SurgeCon on ED performance by assessing its impact on length of stay, the time to a physician's initial assessment, and the number of patients leaving the ED without being seen by a physician. The secondary objectives of this study are to evaluate SurgeCon's effects on patient satisfaction and patient-reported experiences with ED wait times and its ability to create better-value care by reducing the per-patient cost of delivering ED services.MethodsThe implementation of the intervention will be assessed using a comparative effectiveness-implementation hybrid design. This type of hybrid design is known to shorten the amount of time associated with transitioning interventions from being the focus of research to being used for practice and health care services. All EDs with 24/7 on-site physician support (category A hospitals) will be enrolled in a 31-month, pragmatic, stepped wedge cluster randomized trial. All clusters (hospitals) will start with a baseline period of usual care and will be randomized to determine the order and timing of transitioning to intervention care until all hospitals are using the intervention to manage and operationalize their EDs.ResultsData collection for this study is continuing. As of February 2022, a total of 570 randomly selected patients have participated in telephone interviews concerning patient-reported experiences and patient satisfaction with ED wait times. The first of the 4 EDs was randomly selected, and it is currently using SurgeCon's eHealth platform and applying efficiency principles that have been learned through training since September 2021. The second randomly selected site will begin intervention implementation in winter 2022.ConclusionsBy assessing the impact of SurgeCon on ED services, we hope to be able to improve wait times and create better-value ED care in this health care context.Trial registrationClinicalTrials.gov NCT04789902; https://clinicaltrials.gov/ct2/show/NCT04789902.International registered report identifier (irrid)DERR1-10.2196/30454.

Project description:ImportanceInfections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.ObjectiveTo study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.Design, setting, and participantsThis stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.InterventionClean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.Main outcomes and measuresThe primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.ResultsAmong 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P < .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.Conclusions and relevanceIn this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.Trial registrationClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.

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.

Dataset Information

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.

Publications

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.

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