Comparing Implementation Strategies to Advance Cardiovascular Health in Children With Lupus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 主要终点
- Representative Reach of the Implementation Strategies
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Health Navigator without a Pre-Visit Worksheet
Adding only the health navigator engagement intervention
干预措施: Health Navigator Engagement (Other)
Team Charter with Performance Monitoring without a Pre-Visit Worksheet
Adding only the team charter with performance monitoring intervention.
干预措施: Team Charter with Performance Monitoring (Other)
Health Navigator with a Pre-Visit Worksheet
Adding both the health navigator engagement and pre-visit worksheet interventions
干预措施: Health Navigator Engagement (Other)
Health Navigator with a Pre-Visit Worksheet
Adding both the health navigator engagement and pre-visit worksheet interventions
干预措施: Pre-visit worksheet (Other)
Team Charter and Performance Monitoring with a Pre-Visit Worksheet
Adding both the team charter and performance monitoring and pre-visit worksheet interventions.
干预措施: Health Navigator Engagement (Other)
Team Charter and Performance Monitoring with a Pre-Visit Worksheet
Adding both the team charter and performance monitoring and pre-visit worksheet interventions.
干预措施: Pre-visit worksheet (Other)
结局指标
主要结局
Representative Reach of the Implementation Strategies
时间窗: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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.
时间窗: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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
时间窗: Evaluated at months 0, 6, 9, and then every 3 months through month 18.
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.
次要结局
- Maintenance of Intervention Reach(Months 18-42)
- Fidelity to Dietary Sodium Counseling(Evaluated at months 0, 18, and 30.)
- Maintenance of Intervention Fidelity(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.)
研究者
Joyce Chang
Assistant Professor of Pediatrics
Boston Children's Hospital