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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,200
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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