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

Duke University

Status: Active, not recruiting

Conditions: Contraception; Systemic Lupus Erythematosus

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05818254

Pro00112931

1R01AR082673 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Routine Care Providers

Experimental group

Description:

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

Treatment:

Behavioral: Routine Care

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

Experimental group

Description:

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

Treatment:

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