HOP-STEP Project -- Healthy Outcomes in Pregnancy with SLE Through Education of Providers (HOP-STEP)
INTERACT is collaborating on the HOP-STEP Project, led by Principal Investigator Megan E. B. Clowse, MD, MPH, from the Division of Rheumatology & Immunology at Duke. The project aims to address the specific needs of women with systemic lupus erythematosus (SLE) regarding pregnancy prevention and planning within the UCMC Rheumatology specialty clinics. The project posits that equipping rheumatology providers with tailored interventions will result in more planned pregnancies and decrease tragic outcomes for both mother and baby. Methods include a participatory design process, a 12-month pragmatic clustered randomized hybrid type 2 trial which is designed to collect and compare effectiveness outcomes (contraception aligned with guidelines; pregnancies conceived when the woman is medically ready) and implementation outcomes (reach, fidelity, and fit).
INTERACT, faculty and staff, are collaborating with the research team to tailor the HOP-STEP intervention to local cultural and clinical requirements. This collaborative effort extends to selecting or adapting measures as needed to capture relevant data regarding the implementation of the intervention. The evaluation of implementation progress is anchored in the rigorous use of the RE-AIM framework, complemented by the FRAME methodology, which allows us to document nuanced changes in implementation strategies. These assessments comprehensively cover critical dimensions such as reach, adoption, effectiveness, and fidelity, thereby facilitating a thorough understanding of the intervention's impact within the clinical context. Publications detailing the project's outcomes are anticipated in 2025.
Principal investigator: Megan E. B. Clowse, MD, MPH, Division of Rheumatology & Immunology
Aims:
- Aim 1: Fit the implementation of the HOP-STEP Intervention to the local UCMC Rheumatology specialty clinic context with key stakeholder input.
- Aim 2: Evaluation of a pilot trial of the HOP-STEP Intervention.
The working hypothesis is that equipping rheumatology providers with this intervention will increase the frequency that women with systemic lupus erythematosus (SLE) receiving effective pregnancy prevention and planning care, which will result in more planned pregnancies and decrease tragic outcomes for both mother and baby.
Methods: Use key stakeholder input to adapt how HOP-STEP is delivered to address barriers to implementation, maximize “fit” and improve HOP-STEP adoption. We will use a participatory, iterative four-phase design process: data gathering, brainstorming, conceptualization, and creation.
- Conduct a pilot of a 12-month pragmatic, clustered randomized hybrid trial at UCMC designed to collect implementation data, plus exploratory effectiveness data, to accelerate future implementation. Rheumatology providers will be stratified and randomized to one of two groups: HOP-STEP implementation providers and Control. Collect patient data of enrolled providers.
- All providers will complete surveys and HOP-STEP providers will also receive intervention training.
- Interview and survey a subset of enrolled providers, associated clinical staff, and patients about experiences related to the HOP-STEP intervention or lack thereof.
- Assess implementation using the RE-AIM framework. Use FRAME to document changes to the implementation including reach, adoption, effectiveness, and implementation.
Outcomes: Reach, effectiveness (for effective contraception, pregnancy timing), adoption, implementation, fidelity, changes to the HOP-STEP implementation, equity analysis
Key Partners: Identify key partners or collaborators integral to the project's success.
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- Patient Collaborator Group (meets quarterly)
- Provider Collaborator Group (meets quarterly)
- Local Design Team (patients, clinic team such as Medical Assistants, OB/GYNs, PCPs, MFMs, rheumatology providers) as needed
- During our study “full team” monthly meetings, we include Collaborators (including from other institutions who have experience with implementation studies and experts in health equity), study staff, statisticians/epidemiologists, qualitative experts, etc.
Publications: Forthcoming when the project is completed.
The National Cancer Institute (NCI) R21-funded two-year study (Jan 2022 – Dec 2024), led by Principal Investigator and Assistant Professor in Population Health Sciences Hannah Lane, PhD, examines the impact of federal child nutrition assistance policies during COVID-19 on access to school meal programs. The study explores system- and setting-level variations in policy implementation and describes the potential for sustaining policy flexibilities beyond the pandemic. Child nutrition programs (CNPs), essential for mitigating child food insecurity and associated cancer risk factors, face challenges in implementation, especially during summer months and in under-resourced districts. However, the COVID-19 crisis prompted the US Department of Agriculture to introduce flexibility, allowing novel implementation strategies like home delivery and waived adoption requirements. Understanding the adoption and implementation of these strategies, particularly across under-resourced districts, is crucial for advocating for equitable policies and tailored implementation support post-crisis.
The study employs a sustainability-focused implementation framework and qualitative secondary analysis, complemented by primary data collection. Leveraging a national research collaborative, the study conducts a secondary analysis of implementation data from six studies during the initial COVID-19 response, coupled with data verification post-response. Guided by the Dynamic Sustainability Framework and CDC’s Policy Analytical Framework, the findings are expected to inform more equitable policies, tailored practice guidance, and a hybrid implementation trial to assess novel CNP strategies' reach, effectiveness, and sustainability.
INTERACT faculty and co-investigators, Leah Zullig, PhD, and Heather King, PhD, are instrumental in guiding the study's implementation science aspects, ensuring methodological rigor and comprehensive analysis.