Team-based Implementation of Hypertension Management in Childhood Lupus

NCT07792733 | Not Yet Recruiting

• 2 other identifiers: P00054342BPS-2025C1-43826
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to compare the effectiveness of widely used implementation strategies to promote adherence to guideline-concordant evidence-based practices for monitoring and controlling blood pressure in patients with lupus who are in pediatric care. A total of 16 pediatric lupus care teams will be randomly assigned one or more of these implementation strategies. The investigators will determine which strategy is better at ensuring the evidence-based practices reach all patients as intended and concurrently gather additional information about health outcomes as they pertain to children with childhood-onset lupus.

Conditions

Systemic Lupus Erthematosus (SLE)

Keywords

lupus; SLE

Outcome Measures

Primary Outcomes (3)

• Representative Reach of the Implementation Strategies

  The absolute difference in proportion of cSLE patients living in areas with low/very low child opportunity that receive evidence-based intervention components (ABPM and RAS inhibitors) vs. those living in areas with high/very high opportunity. Child opportunity, defined as neighborhood resources and conditions that support healthy childhood development, will be measured by linking FIPS codes to the Child Opportunity Index (COI) version 3.0, a multidimensional area-level composite of 44 indicators in domains of education, physical environment and economic conditions, and categorized according to national rank.

  Evaluated at months 0, 6, 9, and then every 3 months through month 18.

• Fidelity: The extent to which the hypertension evaluation and management interventions are delivered as intended.

  The pre-post intervention change in proportion of cSLE patients that receive core components of the hypertension evaluation and management interventions. 1) Adherence to hypertension evaluation will be measured by change in the % of SLE patients with LN or elevated BP who have an ABPM procedure code within the last year. Elevated BP will be defined according to AAP/AHA guidelines: ≥120/80 if age ≥13 years; ≥90th%ile or 120/80 (whichever is lower) if age \<13 years,17 on 2 or more occasions. 2) Adherence to pharmacologic treatment will be change in % of SLE patients with LN or elevated BP who are prescribed RAS inhibitors.

  Evaluated at months 0, 6, 9, and then every 3 months through month 18.

• Improvement in Blood Pressure Control

  The change in percentage of SLE patients that achieve target clinic BP (\<130/80 if age 13 years or older; lower of \<130/80 or \<90th%ile if age \<13) using the average of the last two clinic SBP or DBP readings on separate days for each patient (oscillometric or auscultory). If ≥1 BP reading is taken on a single day, the daily mean will be used.

  Evaluated at months 0, 6, 9, and then every 3 months through month 18.

Secondary Outcomes (5)

• Fidelity to Dietary Sodium Counseling

  Evaluated at months 0, 18, and 30.

• Maintenance of Intervention Fidelity

  Months 18-42

• Maintenance of Intervention Reach

  Months 18-42

• Maintenance of Blood Pressure Control

  Months 18-42

• 24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis

  Evaluated at months 0, 6, 9, and then every 3 months through month 18.

Study Arms (4)

Health Navigator without a Pre-Visit Worksheet

ACTIVE COMPARATOR

Adding only the health navigator engagement intervention

Other: Health Navigator Engagement

Team Charter with Performance Monitoring without a Pre-Visit Worksheet

ACTIVE COMPARATOR

Adding only the team charter with performance monitoring intervention.

Other: Team Charter with Performance Monitoring

Health Navigator with a Pre-Visit Worksheet

ACTIVE COMPARATOR

Adding both the health navigator engagement and pre-visit worksheet interventions

Other: Health Navigator Engagement; Other: Pre-visit worksheet

Team Charter and Performance Monitoring with a Pre-Visit Worksheet

ACTIVE COMPARATOR

Adding both the team charter and performance monitoring and pre-visit worksheet interventions.

Other: Health Navigator Engagement; Other: Pre-visit worksheet

Interventions

Health Navigator Engagement OTHER

Adding a health navigator to the healthcare team to improve coordination among providers from different specialties and work closely with patients and their families. The health navigator acts as a bridge between families and the care team by helping facilitate care coordination, ensuring patient and family voices are heard, and explaining medical information in clear language. They also assist families with keeping track of medical appointments, connecting to local community resources, and providing extra support throughout the care process.

Health Navigator with a Pre-Visit Worksheet; Health Navigator without a Pre-Visit Worksheet; Team Charter and Performance Monitoring with a Pre-Visit Worksheet

Team Charter with Performance Monitoring OTHER

Care teams will work together to build clear plans that explain everyone's goals, roles, and daily responsibilities. The team will regularly check its performance data to see what is working well and what needs improvement. By making small, step-by-step changes over time, the team can continuously refine its approach until it reaches its goals.

Team Charter with Performance Monitoring without a Pre-Visit Worksheet

Pre-visit worksheet OTHER

Care teams will give patients and families a short worksheet to fill out before their appointment. This form helps them prepare to talk with their doctor about high blood pressure and heart disease risk. It helps patients and caregivers feel ready to ask questions and take an active role in planning their heart health care.

Health Navigator with a Pre-Visit Worksheet; Team Charter and Performance Monitoring with a Pre-Visit Worksheet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ICD-10-CM or SNOMED-CT diagnosis code for SLE
• Completed a pediatric rheumatology outpatient clinical visit at a participating implementation site within 12 months of each data collection timepoint
• Diagnosis of childhood-onset Systemic Lupus Erythematosus (cSLE)
• Must have had a pediatric rheumatology clinical visit at a participating implementation site within 12 months of each data collection timepoint
• Age 12 years or older at enrollment
• Individuals at least 18 years of age
• Parent or guardian of a child with cSLE who is followed by a care team at a participating site
• Individuals at least 18 years of age
• Health care team members within a pediatric subspecialty that manages patients with cSLE at a participating site
• Diagnosis of childhood-onset Systemic Lupus Erythematosus (cSLE)
• Completed a clinical visit in the participating site's outpatient rheumatology clinic within the 12 months prior to enrollment
• Age 12 years or older at enrollment
• Able to provide verbal assent if below age 18 years of age or verbal consent if age 18 years and older. For minors, verbal parental/guardian permission (informed consent) is required.
• Have access to a device with audio or audiovisual conferencing capabilities
• Individuals 18 years old or older at enrollment

You may not qualify if:

• Unable or without cognitive capacity to participate in an interview, as determined by the investigator(s).
• No prospective interview participants will be excluded on the basis of sex, race, ethnicity, or language preference.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08