Clinical trial NCT06121193: Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease
Official title: Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.


Eligibility criteria: Inclusion Criteria:

* Aged 12-17 years at baseline
* at risk for poor CVH (body mass index \>= 85th percentile)
* Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.

Primary outcomes:
measure: Patients' satisfaction of PREVENT tool: survey
timeFrame: 3-months
measure: Provider's satisfaction of PREVENT tool: survey
timeFrame: 3-months
measure: Fidelity of PREVENT tool implementation
timeFrame: 0-3 months
Secondary outcomes:
measure: Change in patient's motivation
timeFrame: At baseline, and 3-months
measure: Change in patient's knowledge of CVH
timeFrame: At baseline, and 3-months
measure: Change in food intake behaviors
timeFrame: At baseline, and 3-months
measure: Change in physical activity behaviors
timeFrame: At baseline, and 3-months
measure: Change in body mass index z-score
timeFrame: At baseline, and 3-months
measure: Change on patient's average systolic and diastolic blood pressure
timeFrame: At baseline, and 3-months
measure: Change in patient's cholesterol
timeFrame: At baseline, and 3-months
measure: Change in patient's blood glucose
timeFrame: At baseline, and 3-months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References: