HOP-STEP Program for Lupus

(HOP-STEPsIRB Trial)

Overseen by Megan E Clowse, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Rheumatology fellows, non-consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to adapt and test the HOP-STEP program at a new location to help women with lupus plan their pregnancies and use contraception more effectively. The program educates healthcare providers and restructures clinics to offer better support, especially in high-minority, high-poverty areas.

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 data supports the effectiveness of the HOP-STEP treatment for lupus?

Research shows that educating healthcare providers and using tools like weight gain charts can improve communication and patient outcomes during pregnancy. This suggests that the HOP-STEP program, which focuses on educating providers, may help improve pregnancy outcomes for women with lupus. ^{1 2 3 4 5}

How is the HOP-STEP treatment for lupus different from other treatments?

The HOP-STEP treatment is unique because it focuses on educating healthcare providers to improve pregnancy outcomes for women with lupus, rather than directly treating the disease itself. This approach emphasizes pre-pregnancy counseling and a multidisciplinary care pathway to manage the complex risks associated with lupus during pregnancy. ^{6 7 8 9 10}

Research Team

Megan E Clowse, MD

Principal Investigator

Duke University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

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

Collaborator

Trials

508

Recruited

1,090,000+

Dr. Lindsey A. Criswell

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

Director since 2021

MD, MPH, DSc

Dr. Robert Colbert

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

Clinical Director since 2014

MD

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Examination of Routine Use of Prenatal Weight Gain Charts as a Communication Tool for Providers. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Interventions to enhance medication adherence in pregnancy- a systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Diet and pregnancy: health-care providers and patient behaviors. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary clinical pathway for women with systemic lupus erythematosus and/or antiphospholipid syndrome. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Pregnancy Outcomes in Chinese Patients with Systemic Lupus Erythematosus (SLE): A Retrospective Study of 109 Pregnancies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Racial Differences in Contraception Encounters and Dispensing Among Female Medicaid Beneficiaries With Systemic Lupus Erythematosus. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Implications of the accuracy of diagnostic algorithms for systemic lupus on our understanding of racial disparities in pregnancy outcomes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Systemic Lupus Erythematosus: Diagnosis and Treatment. [2023]