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Clinical Trials/NCT06121193
NCT06121193CompletedNot Applicable

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

Washington University School of Medicine2 sites in 1 country36 target enrollmentStarted: June 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Patients' satisfaction of PREVENT tool: survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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

  • Change in patient's motivation(At baseline, and 3-months)
  • Change in patient's knowledge of CVH(At baseline, and 3-months)
  • Change in food intake behaviors(At baseline, and 3-months)
  • Change in physical activity behaviors(At baseline, and 3-months)
  • Change on patient's average systolic and diastolic blood pressure(At baseline, and 3-months)
  • Change in patient's blood glucose(At baseline, and 3-months)
  • Change in body mass index z-score(At baseline, and 3-months)
  • Change in patient's cholesterol(At baseline, and 3-months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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