HOP-STEP Program for Lupus

(HOP-STEPsIRB Trial)

Overseen By Dana Burshell, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Rheumatology fellows, non-consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve pregnancy planning and prevention care for women with lupus at a high-minority, high-poverty academic center. The main goal is to determine if the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program can be successfully adapted and implemented at the University of Chicago Medical Center. The trial includes two groups: one where care providers use the HOP-STEP program to guide family planning, and another where providers continue with routine care. Providers who may be a good fit have seen at least six women aged 18-44 in the past year at the rheumatology clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative care improvements for women with lupus.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the HOP-STEP program is safe for implementation?

Research has shown that the HOP-STEP program helps women with lupus by improving pregnancy planning and care. The program educates healthcare providers to better document and guide family planning for these patients, aiming to enhance how clinics manage reproductive health for women with lupus.

The HOP-STEP program does not involve new medications or invasive procedures, focusing instead on education and improving clinic processes. Consequently, there are no reported physical risks or side effects directly related to the program. Its goal is to improve the support and information available to patients.

No safety concerns or negative effects have been linked to this program, as it changes how healthcare providers deliver care rather than introducing new medical treatments. This makes it a safe option for improving pregnancy outcomes in women with lupus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOP-STEP Program for lupus because it focuses on improving pregnancy outcomes through education and personalized care, which is not a standard approach. Unlike typical treatments for lupus that primarily manage symptoms with medications like corticosteroids or immunosuppressants, the HOP-STEP intervention aims to empower healthcare providers with tools to address family planning and pregnancy management. By integrating education and personalized guidance on contraceptive use and pregnancy plans, this program hopes to enhance maternal and fetal health outcomes for women with lupus.

What evidence suggests that the HOP-STEP intervention could be effective for improving pregnancy planning care in lupus patients?

Research has shown that the HOP-STEP program, a treatment arm in this trial, can enhance care for women with lupus who wish to become pregnant. The program boosts doctors' confidence and ensures improved record-keeping of birth control use. It also promotes equitable pregnancy planning, particularly in clinics serving diverse populations. By restructuring clinic operations, HOP-STEP offers women with lupus improved opportunities to manage their reproductive health, potentially leading to healthier pregnancies and better outcomes for both mothers and babies. Meanwhile, the other arm of this trial involves Routine Care, where providers continue seeing patients as usual in the clinic. ^{2 3 4 6 7}

Who Is on the Research Team?

Megan E Clowse, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for clinical rheumatology providers at the University of Chicago Medical Center. It aims to improve maternal health in women with lupus by educating providers on pregnancy planning and contraception.

Inclusion Criteria

Adult and/or pediatric clinical rheumatology providers within UCMC clinics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Period

Implementation and evaluation of the HOP-STEP intervention in a high-minority, high-poverty academic rheumatology center

12 months

Regular clinic visits for intervention activities

Follow-up

Participants are monitored for the effectiveness and adoption of the HOP-STEP intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention
• Routine Care

Trial Overview The HOP-STEP program, designed to boost provider confidence and ensure equitable care in pregnancy planning for lupus patients, is being tested against routine care practices to measure its effectiveness.

How Is the Trial Designed?

Group I: Routine Care Providers Experimental Treatment 1 Intervention

Care Providers in this arm will continue seeing patients as normal in clinic.

Group II: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Providers Experimental Treatment 1 Intervention

HOP-STEP providers will inquire and document their patients about contraceptive usage and pregnancy interest, then provide personalized guidance on family planning.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 172 pregnancies among women with systemic lupus erythematosus (SLE), it was found that Black women experienced higher rates of adverse pregnancy outcomes compared to White women, particularly in electronic medical record (EMR)-derived data.

However, the confirmed SLE cohort showed that all women with SLE, regardless of race, are at a high risk for adverse pregnancy outcomes, highlighting the importance of accurate diagnosis and monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the accuracy of diagnostic algorithms for systemic lupus on our understanding of racial disparities in pregnancy outcomes. Clowse, MEB., Oates, J., Barnado, A., et al.[2023]

Obstetric providers believe that patient navigation programs could significantly enhance postpartum care for low-income patients, emphasizing the need for navigators to have strong interpersonal skills and advocacy qualities.

Recommendations for implementing these programs include comprehensive training for navigators on the healthcare system and effective health education, as well as identifying valuable services they can provide to improve care continuity and coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. Ruderman, RS., Dahl, EC., Williams, BR., et al.[2023]

Implementing a multidisciplinary clinical pathway with prepregnancy counselling for women with systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS) significantly reduced the risk of disease flares and thromboembolic events during pregnancy, with an adjusted odds ratio of 0.20.

The study included 78 patients with 112 pregnancies, and while the clinical pathway reduced the risk of SLE flares by fivefold, it did not show a significant difference in maternal and fetal complications compared to those not in the pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary clinical pathway for women with systemic lupus erythematosus and/or antiphospholipid syndrome. Wind, M., Hendriks, M., van Brussel, BTJ., et al.[2021]

A systematic review of 13 studies, including 5 randomized controlled trials (RCTs), found that various interventions like education, financial incentives, and text messaging can improve medication adherence in pregnant women with chronic diseases, potentially leading to better clinical and perinatal outcomes.

Despite some positive associations between interventions and adherence or clinical outcomes, most studies had high or unclear risk of bias, highlighting the need for more rigorous RCTs to confirm these findings and evaluate both adherence and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to enhance medication adherence in pregnancy- a systematic review. Davies, A., Mullin, S., Chapman, S., et al.[2023]

In a study of 109 pregnancies involving 83 women with systemic lupus erythematosus (SLE), the live birth rate was 61.5%, indicating that while pregnancy is possible, there are significant risks involved.

Women with new-onset lupus during pregnancy experienced worse outcomes for both mothers and babies compared to those with a history of SLE, particularly those with lupus nephritis, who faced even greater maternal risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy Outcomes in Chinese Patients with Systemic Lupus Erythematosus (SLE): A Retrospective Study of 109 Pregnancies. Ku, M., Guo, S., Shang, W., et al.[2022]

Provider education and the use of prenatal weight gain charts significantly improved communication about weight gain between patients and providers, with 92.3% of patients in intervention clinics receiving advice compared to only 66.4% in control clinics.

Patients in intervention clinics also reported higher satisfaction with discussions about weight gain (83.1% vs. 64.3%) and better knowledge of target weight gain goals (72.3% vs. 50.4%), indicating that these strategies effectively enhanced understanding and adherence to the IOM guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of Routine Use of Prenatal Weight Gain Charts as a Communication Tool for Providers. Aguilera, M., Sidebottom, AC., McCool, BR.[2021]

Pregnant women who received dietary counseling from their healthcare providers (HCPs) were more than twice as likely to adopt healthy dietary practices compared to those who did not receive such counseling, highlighting the importance of HCP involvement in dietary discussions.

HCPs who addressed multiple health behaviors were nearly four times more likely to discuss diet with their pregnant patients, suggesting that comprehensive health education for HCPs can enhance patient dietary behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and pregnancy: health-care providers and patient behaviors. May, L., Suminski, R., Berry, A., et al.[2021]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

In a study of 24,693 reproductive-age women with systemic lupus erythematosus (SLE), African American and Asian women were found to have lower odds of receiving contraception compared to White women, highlighting significant racial disparities in family planning.

Despite these disparities, women with SLE were more likely to use highly effective contraception (HEC) compared to the general population and women with diabetes, indicating that SLE may influence contraceptive choices positively in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial Differences in Contraception Encounters and Dispensing Among Female Medicaid Beneficiaries With Systemic Lupus Erythematosus. Williams, JN., Xu, C., Costenbader, KH., et al.[2023]

Hydroxychloroquine is essential for all patients with systemic lupus erythematosus (SLE) as it helps prevent flare-ups, organ damage, and improves long-term survival, highlighting its efficacy in managing this chronic autoimmune disease.

Pregnant patients with SLE face higher risks of complications such as spontaneous abortions and preeclampsia, making preconception counseling and a multidisciplinary management approach crucial for their health and the health of their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Lupus Erythematosus: Diagnosis and Treatment. Lam, NV., Brown, JA., Sharma, R.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05818254

The HOP-STEP Intervention: Improving Maternal Health in ... The study creates opportunities for SLE (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment.

2. reporter.nih.gov reporter.nih.gov/search/UBfDFdUYhEyBnvOCeM2eEA/project-details/10658976

Project Details - NIH RePORTER The long-term goal is to enable all women with SLE to maintain a healthy pregnancy while enjoying a high level of mental and physical health as they build the ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT05818254

The HOP-STEP Intervention: Improving Maternal Health in Women ... The study creates opportunities for SLE (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment.

4. physicians.dukehealth.org physicians.dukehealth.org/articles/new-tools-promote-pregnancy-plans-patients-lupus

New Tools Promote Pregnancy Plans for Patients with Lupus Known as Healthy Outcomes in Pregnancy with SLE Through Education of Providers (HOP-STEP, the materials offer step-by-step symptom ...

5. lupuspregnancy.org lupuspregnancy.org/

Lupus and Pregnancy HOP-STEP - Duke University of Medicine Almost all women with lupus can have a successful pregnancy, but some pregnancies will be more challenging than others.

6. reporter.nih.gov reporter.nih.gov/search/xRpg907A_E6siZccOeYOJA/project-details/10658976

RePORT RePORTER - National Institutes of Health (NIH) | To fill the existing gap in provider knowledge, skills, and practice, we created the simple in-clinic Healthy Outcomes in Pregnancy with SLE Through Education ...

7. researchgate.net researchgate.net/figure/Healthy-Outcomes-in-Pregnancy-With-Systemic-Lupus-Erythematosus-Through-Education-of_fig1_341836858

Healthy Outcomes in Pregnancy With Systemic Lupus ... Results Data from 478 women (52% African American, 25% Caucasian) with SLE were included. Rheumatology was the subspecialty to document contraception ...