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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Systemic Lupus Erythematosus; Contraception
• Intervention / Treatment: Behavioral: Routine Care; Behavioral: HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine Care Providers; Care Providers in this arm will continue seeing patients as normal in clinic.	Behavioral: Routine Care; Providers will continue to provide reproductive healthcare in their current manner.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraception Documentation	Yes/No: Documentation of contraception use during patient visit; includes if the provider documents that the patient does not use any contraception. This is extracted from the patient's medical record and is part of the HOP-STEP intervention. This will also be analyzed by patient-level characteristics: race, age, teratogen use. Denominator: all eligible patients.	Intervention Period, up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach: Pregnancy intention documentation	Yes/No: Documentation of the patient's pregnancy intention during patient visit. This is extracted from the patient's medical record and is part of the HOP-STEP intervention. This will also be analyzed by patient-level characteristics: race, age, teratogen use. Denominator: all eligible patients.	Intervention Period, up to 12 months
Reach: Contraceptive Counseling	Yes/No: Documentation of any contraceptive counseling during patient visit. Denominator: all eligible patients.	Intervention Period, up to 12 months
Reach: Pregnancy planning	Yes/No: Documentation of any pregnancy planning during patient visit. Denominator: all eligible patients. This is extracted from the patient's medical record. This will also be analyzed by patient-level characteristics: race, age, teratogen use.	Intervention Period, up to 12 months
Effectiveness: ACR-aligned contraception	Yes/No: documentation of use of contraception aligned with ACR RHG a rheumatology clinic visit within 6 months of a visit in the Intervention Period. ACR RHG guidelines recommend: Any woman with SLE: avoid estrogen-containing patch;; Those with prior blood clot, positive antiphospholipid antibodies, or nephrotic syndrome: avoid contraceptives that increase thrombotic risk (pills with estrogen, ring, patch, or depot-medroxyprogesterone);; Those with highly active SLE: avoid contraceptives that contain estrogen (pills with estrogen, ring, patch); and; Those not medically ready for pregnancy: effective or highly effective contraception. Denominator: Eligible patients excluding pregnant women or women who have a documented pregnancy intention AND are medically optimized for pregnancy. This will be coded based on information extracted from the patient's medical record.	Intervention Period, up to 12 months
Effectiveness: Effective and/or highly effective contraception	Yes/No: documentation of use of an effective or highly effective contraception at a Rheumatology clinic visit in the Intervention Period. Effective and highly effective contraception includes hormonal contraception, long-acting reversible contraception, and permanent contraception or the physical inability to get pregnant (menopause, hysterectomy, oophorectomy). Denominator: Eligible patients excluding pregnant women or women who have a documented pregnancy intention AND are medically optimized for pregnancy. This is extracted from the patient's medical record.	Intervention Period, up to 12 months
Effectiveness: Change from no contraception or ineffective contraception to effective and/or highly effective contraception	Yes/No: documentation of use of an effective or highly effective contraception at any Rheumatology clinic visit within 6 months of a visit in the Intervention Period. Denominator: Eligible non-pregnant women who have documentation of either no contraceptive use or low efficacy contraception at a prior rheumatology visit in the Intervention Period. Women without contraception documentation are excluded from this analysis. Effective and highly effective contraception includes hormonal contraception, long-acting reversible contraception, and permanent contraception or the physical inability to get pregnant (menopause, hysterectomy, oophorectomy). Low Efficacy Contraception includes condom, diaphragm, sponge, cervical cap, spermicide, fertility awareness, withdrawal method. This is extracted from the patient's medical record.	Intervention Period, up to 12 months
Effectiveness: Pregnancy when women is medically optimized for pregnancy	Yes/No: conception is aligned with ACR recommendations. Denominator: All pregnancies conceived within 6 months of a rheumatology visit in the Intervention Period. Medically optimized for pregnancy is defined as meeting all 3 criteria: Urine protein:creatinine ratio measured within 3 months before or after conception and with <1g of proteinuria; Not taking any rheumatic teratogens at conception (mycophenolate or mycophenolic acid, methotrexate, leflunamide, cyclophosphamide, thalidomide or lenalidomide); Continued pregnancy-compatible SLE medications after conception (most commonly prednisone, hydroxychloroquine, and/or azathioprine; also tacrolimus, cyclosporin, and/or colchicine) This is extracted from the patient's medical record.	Intervention Period, up to 12 months
Adoption: Providers that ever complete the HOP-STEP intervention	Yes/No: provider that has documentation of completing the whole HOP-STEP intervention with one or more of their patients. Completing the whole HOP-STEP Intervention is defined as documenting all three components of the intervention: current contraception, pregnancy intention, and ACR-aligned contraception and/or pregnancy planning counseling. This is extracted from the provider's patients' medical records and will also be examined by the provider's race, age, gender, and proportion of SLE patients within a provider's practice.	Intervention Period, up to 12 months
Degree of Adoption: Providers' completion of the HOP-STEP intervention	Per provider, the number of eligible patients who received the whole HOP-STEP Intervention at one or more of their visits. Denominator: eligible patients cared for by the provider during the Intervention Period. This is extracted from the provider's patients' medical records and will also be examined by the provider's race, age, gender, and proportion of SLE patients within a provider's practice.	Intervention Period, up to 12 months
Fidelity to the ACR RHG contraception recommendations	Yes/No: contraception recommendations aligned with the ACR RHG. Denominator: eligible patients who received any contraception recommendation. This is extracted from the patient's medical record. This will also be analyzed by patient-level characteristics: race, age, teratogen use.	Intervention Period, up to 12 months
Fidelity to the ACR RHG pregnancy medications recommendations	Yes/No: pregnancy planning recommendations aligned with the ACR RHG. Denominator: eligible patients who received any pregnancy planning. This is extracted from the patient's medical record.	Intervention Period, up to 12 months
FRAME system to document local changes to the Implementation	1.) when and how a change is made, 2.) whether the change was planned or not, 3.) who determined that the change could be made, 4.) what the change was, 5.) where within the delivery the change was made, 6.) the type of content- or context-level change, 7.) the degree that the change is consistent with intervention fidelity, and 8.) the reasons for the change, including intended impact on equity of reach, adoption, effectiveness, and/or maintenance of the HOP-STEP intervention.	Intervention Period, up to 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Chicago; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Megan E Clowse, MD, Duke University

Publications and helpful links

Helpful Links

• HOP-STEP website

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Contraception; SLE; Family Planning
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Investigative Techniques; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Methods; Pregnancy
• Other Study ID Numbers: Pro00112931; 1R01AR082673 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No