PREVENT Tool Study: Late Effects Clinic
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Providers 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 |
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| No Intervention: Parents -Semi-structured interviews |
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| Active Comparator: Patients - Wait-List Control 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. |
Other: 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
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| Experimental: Patients - PREVENT tool 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. |
Other: PREVENT Tool
-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese adolescent 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.
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Outcome Measures
Primary Outcome Measures
- Change in minutes of physical activity [At baseline and 3-months]
Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants will also complete a brief Health Behavior & Attitudes Survey.
- Change in food intake behaviors [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.
- Provider's satisfaction of PREVENT tool: survey [3-months]
A survey (15-questions) will assess provider's 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: 15-75) with a higher score indicating greater satisfaction
- Fidelity of PREVENT tool implementation [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 Outcome Measures
- Provider's motivation for sustained use of PREVENT tool [3-months]
A survey (12 questions) will assess provider's intent to change their behavior and continue using PREVENT were adapted from Legare's CPD Reaction Questionnaire. . Questions are asked using a 7-point Likert scale (range: 12-84) with a higher score indicating greater motivation for sustained use.
- Maintenance of PREVENT tool as measured by provider perceptions [3-months]
Qualitative in-depth interview with providers who used the PREVENT tool.
- Patient's perceptions of usability/acceptability of PREVENT tool [3-months]
Semi-structured interviews with adolescent study participants (n=10).
- Parent's perceptions of usability/acceptability of PREVENT tool [3-months]
Semi-structured interviews with parents/guardians (n=10) of study participants.
- Impact of PREVENT tool on patient's body mass index (BMI) [At baseline and 3-months]
Collected from patient's medical record.
- Impact of PREVENT tool on patient's systolic and diastolic blood pressure [At baseline and 3-months]
Collected from patient's medical record.
- Impact of PREVENT tool on patient's cholesterol [At baseline and 3-months]
Collected from patient's medical record
- Impact of PREVENT tool on patient's fasting blood glucose [At baseline and 3-months]
Collected from patient's medical record
- Impact of PREVENT tool on patient's attitudes toward behavior change [At baseline and 3-months]
A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change. Questions are asked using a 5-point Likert scale (range: 0-30) with a higher score indicating more positive attitudes.
- Clinic-level capacity for sustainability as measured by provider survey [3-months]
The Clinical Sustainability Assessment Tool (CSAT) will assess clinic-level readiness and capacity for sustainability of the PREVENT tool. The CSAT tool will examine organization, financial, regulatory and political factors that may influence sustainability.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patient Eligibility Criteria:
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Adolescents 15 to 19 years
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Prior diagnosis of pediatric cancer (diagnosed <21 years of age)
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Not receiving active therapy for their cancer
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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)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Maura Kepper, Ph.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202007026
- K12HL137942