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ACTIVE NOT RECRUITING
NCT05818254
NA

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

While the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

Official title: The HOP-STEP (Healthy Outcomes in Pregnancy With SLE Through Education of Providers) Intervention: Improving Maternal Health in Women With Lupus Through Improved Pregnancy Prevention and Planning sIRB

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2024-10-07

Completion Date

2026-08-01

Last Updated

2026-02-27

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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

The HOP-STEP Intervention is simple with 3-steps: (1) ascertain and document current pregnancy intention and contraceptive use, (2) patient and provider collaboratively arrive at her optimal contraceptive and/or pregnancy plan using a Decision Guide directed conversation, and (3) create a warm handoff with a patient-specific SLE risk assessment and guideline-aligned recommendations.

BEHAVIORAL

Routine Care

Providers will continue to provide reproductive healthcare in their current manner.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States