Team-based Implementation of Hypertension Management in Childhood Lupus (ABOUT TIME)

Comparing Implementation Strategies to Advance Cardiovascular Health in Children With Lupus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Lupus Erthematosus (SLE)
• Intervention / Treatment: Other: Health Navigator Engagement; Other: Team Charter with Performance Monitoring; Other: Pre-visit worksheet

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for EHR Data Collection:

• 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

Inclusion Criteria for the Patient Survey Group:

• 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

Inclusion Criteria for the Caregiver Survey Group:

• 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

Inclusion Criteria for the Lupus Care Team Member Survey Group:

• Individuals at least 18 years of age
• Health care team members within a pediatric subspecialty that manages patients with cSLE at a participating site

Inclusion Criteria for the Patient Interview Group:

• 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

Inclusion Criteria for the Caregiver Interview Group:

• Individuals 18 years old or older at enrollment
• Parent or guardian of a child with cSLE who is followed by a care team at a participating pediatric rheumatology site and has completed a clinical visit within the 12 months prior to enrollment
• Able to provide verbal informed consent prior to the interview
• Have access to a device with audio or audiovisual conferencing capabilities

Inclusion Criteria for the Lupus Care Team Member Interview Group:

• Individuals ages 18 years of age or older at enrollment
• Health care team members that are in a pediatric subspecialty clinic that manages patients with cSLE at a participating site
• Able to provide verbal informed consent prior to the interview
• Have access to a device with audio or audiovisual conferencing capabilities

Exclusion Criteria for all Interview Groups:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health Navigator without a Pre-Visit Worksheet; Adding only the health navigator engagement intervention	Other: Health Navigator Engagement; 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.
Active Comparator: Team Charter with Performance Monitoring without a Pre-Visit Worksheet; Adding only the team charter with performance monitoring intervention.	Other: Team Charter with Performance Monitoring; 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.
Active Comparator: Health Navigator with a Pre-Visit Worksheet; Adding both the health navigator engagement and pre-visit worksheet interventions	Other: Health Navigator Engagement; 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.; Other: Pre-visit worksheet; 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.
Active Comparator: Team Charter and Performance Monitoring with a Pre-Visit Worksheet; Adding both the team charter and performance monitoring and pre-visit worksheet interventions.	Other: Health Navigator Engagement; 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.; Other: Pre-visit worksheet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity to Dietary Sodium Counseling	The change in % of sampled patients with elevated blood pressure that report having discussed dietary sodium reduction with their care team.	Evaluated at months 0, 18, and 30.
Maintenance of Intervention Fidelity	The change in adherence to the hypertension evaluation and management intervention at each site between month 18 and month 42. Adherence is defined by the % of SLE patients with lupus nephritis (LN) or elevated blood pressure who have an ABPM procedure code within the last year, and the % of SLE patients with LN or elevated BP who are prescribed RAS inhibitors.	Months 18-42
Maintenance of Intervention Reach	The change in % of SLE patients who receive ambulatory blood pressure monitoring (ABPM) and renin-angiotensin system (RAS) inhibition in low/very low vs. high/very high COI between months 18 and 42.	Months 18-42
Maintenance of Blood Pressure Control	The change in proportion of SLE patients that maintain their target average clinic blood pressure, defined as <130/80 if age 13 years or older; lower of <130/80 or <90th%ile if age <13, between months 18 and 42.	Months 18-42
24-hour Ambulatory Blood Pressure Control among Patients with Lupus Nephritis	Based on their most recent ABPM study, defined as the change in % of patients with a most recent 24-hour mean arterial pressure (MAP) of <125/75 if age 13 years and older or the lower of <125/75 or 90th%ile if age <13 years old.	Evaluated at months 0, 6, 9, and then every 3 months through month 18.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: SLE; lupus
• Other Study ID Numbers: P00054342; BPS-2025C1-43826 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Drug and device information, study documents

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