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OpenTrials
Completed

NCT Number: NCT06121193

Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREVENT tool

Behavioral

PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.

Wait-list control

Behavioral

Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

Primary outcomes

  1. Patients' satisfaction of PREVENT tool: survey

    Time frame: 3-months

    A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.

  2. Provider's satisfaction of PREVENT tool: survey

    Time frame: 3-months

    A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.

  3. Fidelity of PREVENT tool implementation

    Time frame: 0-3 months

    Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

Secondary outcomes

  1. Change in patient's motivation

    Time frame: At baseline, and 3-months

    A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 4-point Likert scale (range: 15-60) with a higher score indicating greater motivation.

  2. Change in patient's knowledge of CVH

    Time frame: At baseline, and 3-months

    A survey (3-question) administered to patients to assess their knowledge of CVH risk (perceived value/importance of healthy behaviors) and awareness of resources. Questions are asked using a 4-point Likert scale (range: 3-12) with a higher score indicating greater knowledge.

  3. Change in food intake behaviors

    Time frame: At baseline, and 3-months

    Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey.

  4. Change in physical activity behaviors

    Time frame: At baseline, and 3-months

    Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week.

  5. Change in body mass index z-score

    Time frame: At baseline, and 3-months

    Collected from patient's medical record. BMI z-score was calculated using the Centers for Disease Control and Prevention Growth Charts. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.

  6. Change on patient's average systolic and diastolic blood pressure

    Time frame: At baseline, and 3-months

    Collected from patient's medical record

  7. Change in patient's cholesterol

    Time frame: At baseline, and 3-months

    Collected from patient's medical record

  8. Change in patient's blood glucose

    Time frame: At baseline, and 3-months

    Collected from patient's medical record

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2023
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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