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.
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
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.
Factorial
Health Navigator Engagement
Other interventionAdding 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.
Team Charter with Performance Monitoring
Other interventionCare 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.
Pre-visit worksheet
Other interventionCare 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.
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.
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.
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.
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.
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.
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.
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.
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Boston Children's Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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