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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-07-14

Brief Summary

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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.

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Detailed Description

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The study creates opportunities for SLE (systemic lupus erythematosus) patients seeking reproductive care by restructuring the rheumatology clinic environment. Specifically through:

Aim 1: Fit the implementation of the HOP-STEP Intervention to the local Rheumatology specialty clinic context with key stakeholder input.

Aim 2: Evaluation of a pilot trial of the HOP-STEP Intervention. At the completion of this study, the investigators will know how to equitably implement and study the HOP-STEP Intervention within an academic rheumatology setting that cares for a high-minority, high-poverty population of women with SLE.

Conditions

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Systemic Lupus Erythematosus Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Routine Care Providers

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

Group Type EXPERIMENTAL

Routine Care

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Routine Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Provider Inclusion Criteria: Rheumatology providers who have seen at least 6 females 18-44 years old within the last year (at least 3 if provider has been at UCMC clinics for less than a year).

Exclusion Criteria: Rheumatology Fellows\*. Does not consent to join the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes