Clinical trial NCT05818254: The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Contraception
Keywords: Family Planning
SLE
Contraception
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: University of Chicago
First posted: 2023-04-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Contraception Documentation
timeFrame: Intervention Period, up to 12 months
Secondary outcomes:
measure: Reach: Pregnancy intention documentation
timeFrame: Intervention Period, up to 12 months
measure: Reach: Contraceptive Counseling
timeFrame: Intervention Period, up to 12 months
measure: Reach: Pregnancy planning
timeFrame: Intervention Period, up to 12 months
measure: Effectiveness: ACR-aligned contraception
timeFrame: Intervention Period, up to 12 months
measure: Effectiveness: Effective and/or highly effective contraception
timeFrame: Intervention Period, up to 12 months
measure: Effectiveness: Change from no contraception or ineffective contraception to effective and/or highly effective contraception
timeFrame: Intervention Period, up to 12 months
measure: Effectiveness: Pregnancy when women is medically optimized for pregnancy
timeFrame: Intervention Period, up to 12 months
measure: Adoption: Providers that ever complete the HOP-STEP intervention
timeFrame: Intervention Period, up to 12 months
measure: Degree of Adoption: Providers' completion of the HOP-STEP intervention
timeFrame: Intervention Period, up to 12 months
measure: Fidelity to the ACR RHG contraception recommendations
timeFrame: Intervention Period, up to 12 months
measure: Fidelity to the ACR RHG pregnancy medications recommendations
timeFrame: Intervention Period, up to 12 months
measure: FRAME system to document local changes to the Implementation
timeFrame: Intervention Period, up to 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: Duke University
name: Megan E Clowse, MD
role: PRINCIPAL_INVESTIGATOR
References: