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✪ Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD)

Authors:

Sarah Gimbel, Anirban Basu, Emily Callen, Abraham D. Flaxman, Omeid Heidari, Julia E. Hood, Anna Kellogg, Eli Kern, Judith I. Tsui, Ericka Turley, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

Between 2012–2022 opioid-related overdose deaths in the United States, including Washington State, have risen dramatically. Opioid use disorder (OUD) is a complex, chronic, and criminalized illness with biological, environmental, and social causes. One-fifth of people with OUD have recent criminal-legal system involvement; > 50% pass through WA jails annually.

Medications for Opioid Use Disorder (MOUD) can effectively treat OUD. WA has prioritized improving access to MOUD, including for those in jails. As patients in jail settings are systematically marginalized due to incarceration, it is critical to foster connections to MOUD services upon release, an acknowledged period of high overdose risk. Currently, there is insufficient focus on developing strategies to foster linkages between jail-based MOUD and referral services.

The Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation strategy, may optimize complex care cascades like MOUD provision and improve linkages between jail- and community-based providers. SAIA bundles systems engineering tools into an iterative process to guide care teams to visualize cascade drop-offs and prioritize steps for improvement; identify modifiable organization-level bottlenecks; and propose, implement, and evaluate modifications to overall cascade performance. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care across jail and referral clinics in King County, WA, and ultimately reduce recidivism and mortality.

Methods

We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics; examine determinants of SAIA-MOUD adoption, implementation, and sustainment; and determine SAIA-MOUD’s cost and cost-effectiveness. Clinic teams with study team support will deliver the SAIA-MOUD intervention at the jail-based MOUD program and three referral clinics over a two-year intensive phase, followed by a one-year sustainment phase where SAIA implementation will be led by King County Jail MOUD staff without study support to enable pragmatic evaluation of sustained implementation.

Discussion

SAIA packages user-friendly systems engineering tools to guide decision-making by front-line care providers to identify low-cost, contextually appropriate health care improvement strategies. By integrating SAIA into MOUD care provision in jail and linked services, this pragmatic trial is designed to test a model for national scale-up.

Trial registration

ClinicalTrials.gov NCT06593353 (registered 09/06/2024).

Contributions to the literature
  • Our study examines whether the introduction of an evidence-based, user-friendly, low-cost package of systems engineering tools can optimize investments in providing medications for opioid use disorder for individuals during the high-risk period immediately after exiting jail.
  • This is the first application of the Systems Analysis and Improvement Approach (SAIA) across health system levels to optimize both care delivery and continuity of care.
  • Our study is designed to provide decision-makers with evidence they need to decide whether to invest in systems engineering approaches during the expansion of MOUD in jail settings, including information on acceptability, feasibility, effectiveness and cost.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Peer Review reports

✪ Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial

Authors:

Brittney J. van de Water, Meredith B. Brooks, Refiloe Matji, Betty Ncanywa, Freck Dikgale, Nadia N. Abuelezam, Bulelwa Mzileni, Miyakazi Nokwe, Singilizwe Moko, Lindiwe Mvusi, Marian Loveday, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Implementation Science Communication

Abstract:

Background

The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set “90–90-90” targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities.

Methods

This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics.

Discussion

This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements.

Trial registration

Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Strengthening integrated depression services within routine primary health care using the RE-AIM framework in South Africa

Authors:

Inge Petersen, Christopher G. Kemp, Deepa Rao, Bradley H. Wagenaar, Max Bachmann, Kenneth Sherr, Tasneem Kathree, Zamasomi Luvuno, André Van Rensburg, Sithabisile Gugulethu Gigaba, Londiwe Mthethwa, Merridy Grant, One Selohilwe, Nikiwe Hongo, Gillian Faris, Christy-Joy Ras, Lara Fairall, Sanah Bucibo, & Arvin Bhana

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2023

Read the full text in the open access journal PLOS Global Public Health

Abstract:

Integration of mental health into routine primary health care (PHC) services in low-and middle-income countries is globally accepted to improve health outcomes of other conditions and narrow the mental health treatment gap. Yet implementation remains a challenge. The aim of this study was to identify implementation strategies that improve implementation outcomes of an evidence-based depression care collaborative implementation model integrated with routine PHC clinic services in South Africa. An iterative, quasi-experimental, observational implementation research design, incorporating the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, was applied to evaluate implementation outcomes of a strengthened package of implementation strategies (stage two) compared with an initial evaluation of the model (stage one). The first stage package was implemented and evaluated in 10 PHC clinics and the second stage strengthened package in 19 PHC clinics (inclusive of the initial 10 clinics) in one resource-scarce district in the province of KwaZulu-Natal, South Africa. Diagnosed service users were more likely to be referred for counselling treatment in the second stage compared with stage one (OR 23.15, SE = 18.03, z = 4.04, 95%CI [5.03–106.49], p < .001). Training in and use of a validated, mandated mental health screening tool, including on-site educational outreach and technical support visits, was an important promoter of nurse-level diagnosis rates (OR 3.75, 95% CI [1.19, 11.80], p = 0.02). Nurses who perceived the integrated care model as acceptable were also more likely to successfully diagnose patients (OR 2.57, 95% CI [1.03–6.40], p = 0.043). Consistent availability of a clinic counsellor was associated with a greater probability of referral (OR 5.9, 95%CI [1.29–27.75], p = 0.022). Treatment uptake among referred service users remained a concern across both stages, with inconsistent co-located counselling services associated with poor uptake. The importance of implementation research for strengthening implementation strategies along the cascade of care for integrating depression care within routine PHC services is highlighted.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial

Authors:

Jessica E. Long, McKenna C. Eastment, George Wanje, Barbra A. Richardson, Emily Mwaringa, Mwanakarama Athman Mohamed, Kenneth Sherr, Ruanne V. Barnabas, Kishorchandra Mandaliya, Walter Jaoko, and R. Scott McClelland

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2022

Read the full text in the open access journal Implementation Science

Abstract:

Background

In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed.

Methods

Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery.

Results

Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68–4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29–4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight.

Conclusions

Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities.

Trial registration

ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms

Anjuli D. Wagner, Sarah Gimbel, Kristjana H. Ásbjörnsdóttir, Peter Cherutich, Joana Coutinho, Jonny Crocker, Emiliae Cruz, Fatima Cuembelo, Vasco Cumbe, McKenna Eastment, Jennifer Einberg, Florencia Floriano, Douglas Gaitho, Brandon L. Guthrie, Grace John-Stewart, Alex H. Kral, Barrot H. Lambdin, Shan Liu, Martin Bcom Maina, Nelia Manaca, Mika Matsuzaki, Loris Mattox, Nancy Mburu, R. Scott McClelland, Mark A. Micek, Ana Olga Mocumbi, Albertoe Muanido, Ruth Nduati, Irene N. Njuguna, Geoffrey Oluoch, Laura B. Oyiengo, Keshet Ronen, Caroline Soi, Bradley H. Wagenaar, George Wanje, Lynn D. Wenger, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

Published: December 2019

Read the full text in the subscription access JAIDS: Journal of Acquired Immune Deficiency Syndromes

✪ Development and Implementation of a Mobile Phone–Based Prevention of Mother-To-Child Transmission of HIV Cascade Analysis Tool: Usability and Feasibility Testing in Kenya and Mozambique

Authors:

Nami Kawakyu, Ruth Nduati, Khátia Munguambe, Joana Coutinho, Nancy Mburu, Georgina DeCastro, Celso Inguane, Andrew Zunt, Neil Abburi, Kenneth Sherr, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

Published: March 2019

Read the full text in the open access journal JMIR mHealth and uHealth

Abstract:

Background

Prevention of mother-to-child HIV transmission (PMTCT) care cascade failures drive pediatric HIV infections in sub-Saharan Africa. As nurses’ clinical and management role in PMTCT expand, decision-support tools for nurses are needed to facilitate identification of cascade inefficiencies and solutions. The mobile phone–based PMTCT cascade analysis tool (mPCAT) provides health facility staff a quick summary of the number of patients and percentage drop-off at each step of the PMCTC care cascade, as well as how many women-infant pairs would be retained if a step was optimized.

Objective

The objective of this study was to understand and improve the mPCAT’s core usability factors and assess the health workers’ experience with using the mPCAT.

Methods

Overall, 2 rounds of usability testing were conducted with health workers from 4 clinics and leading experts in maternal and child health in Kenya and Mozambique using videotaped think aloud assessment techniques. Semistructured group interviews gauged the understanding of mPCAT’s core usability factors, based on the Nielsen Usability Framework, followed by development of cognitive demand tables describing the needed mPCAT updates. Post adaptation, feasibility was assessed in 3 high volume clinics over 12 weeks. Participants completed a 5-point Likert questionnaire designed to measure ease of use, convenience of integration into work, and future intention to use the mPCAT. Focus group discussions with nurse participants at each facility and in-depth interviews with nurse managers were also conducted to assess the acceptability, use, and recommendations for adaptations of the mPCAT.

Results

Usability testing with software engineers enabled real-time feedback to build a tool following empathic design principles. The revised mPCAT had improved navigation and simplified data entry interface, with only 1 data entry field per page. Improvements to the results page included a data visualization feature and the ability to share results through WhatsApp. Coding was simplified to enable future revisions by nontechnical staff—critical for context-specific adaptations for scale-up. Health care workers and facility managers found the tool easy to use (mean=4.3), used the tool very often (mean=4.1), and definitely intended to continue to use the tool (mean=4.8). Ease of use was the most common theme identified, with emphasis on how the tool readily informed system improvement decision making.

Conclusions

The mPCAT was well accepted by frontline health workers and facility managers. The collaborative process between software developer and user led to the development of a more user-friendly, context-specific tool that could be easily integrated into routine clinical practice and workflow. The mPCAT gave frontline health workers and facility managers an immediate, direct, and tangible way to use their clinical documentation and routinely reported data for decision making for their own clinical practice and facility-level improvements.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ 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

Authors:

Kenneth Sherr, Kristjana Ásbjörnsdóttir, Jonny Crocker, Joana Coutinho, Maria de Fatima Cuembelo, Esperança Tavede, Nélia Manaca, Keshet Ronen, Felipe Murgorgo, Ruanne Barnabas, Grace John-Stewart, Sarah Holte, Bryan J. Weiner, James Pfeiffer & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2019

Read the full text in the open access journal Implementation Science

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).

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**