PREVENT Tool Study: Late Effects Clinic

The Washington University

Status: Completed

Conditions: Childhood Obesity; Cardiovascular Disease

Treatments: Other: Wait-List Control; Other: PREVENT Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04530825

K12HL137942 (U.S. NIH Grant/Contract)

202007026

Details and patient eligibility

About

The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.

Enrollment: 65 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patient Eligibility Criteria:

• Adolescents 12 to 19 years
• Prior diagnosis of pediatric cancer (diagnosed <21 years of age)
• Not receiving active therapy for their cancer
• Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital or the St. Louis Children's Specialty Care Center (CSCC)
• At risk for poor cardiovascular health (CVH) (BMI greater than or equal to 85th percentile)

Provider Eligibility Criteria -All providers and staff (physicians, nurses, clinic staff, clinical research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC

Parent Eligibility Criteria

-A parent or legal guardian of a study participant. The parent or legal guardian must have been present at the clinic visit in which the PREVENT tool was administered to the study participant.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 4 patient groups

Providers

No Intervention group

Description:

* All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline * A subset of 5-10 providers will be recruited via email, at the baseline training,or by using snowball-sampling approach within the clinic to participate in qualitative in-depth interviews

Parents

No Intervention group

Description:

-Semi-structured interviews

Patients - Wait-List Control

Active Comparator group

Description:

* Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients will also take part in semi-structured interviews * A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.

Treatment:

Other: Wait-List Control

Patients - PREVENT tool

Experimental group

Description:

* Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients will also take part in semi-structured interviews * At the clinic visit, the provider will use PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT will calculate patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations.

Treatment:

Other: PREVENT Tool