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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121193
• Other study ID #: 202004230
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' satisfaction of PREVENT tool: survey	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.	3-months
Primary	Provider's satisfaction of PREVENT tool: survey	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-months
Primary	Fidelity of PREVENT tool implementation	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.	0-3 months
Secondary	Change in patient's motivation	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.	At baseline, and 3-months
Secondary	Change in patient's knowledge of CVH	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.	At baseline, and 3-months
Secondary	Change in food intake behaviors	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.	At baseline, and 3-months
Secondary	Change in physical activity behaviors	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.	At baseline, and 3-months
Secondary	Change in body mass index z-score	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.	At baseline, and 3-months
Secondary	Change on patient's average systolic and diastolic blood pressure	Collected from patient's medical record	At baseline, and 3-months
Secondary	Change in patient's cholesterol	Collected from patient's medical record	At baseline, and 3-months
Secondary	Change in patient's blood glucose	Collected from patient's medical record	At baseline, and 3-months