Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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
Parents
-Semi-structured interviews
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.
干预措施: Wait-List Control (Other)
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.
干预措施: PREVENT Tool (Other)
结局指标
主要结局
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
时间窗: 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 completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Provider's Satisfaction of PREVENT Tool: Survey
时间窗: 3-months
A survey (24-questions) containing validated subscales assessed provider's satisfaction with the PREVENT tool on subscales assessing acceptability, feasibility, and appropriateness of the tool, and satisfaction with specific components of the tool. Items were scored on a 5-point Likert scale with a higher score indicating greater satisfaction. Subscales were summed to generate the average across all questions (range 1-5) and was reported as overall satisfaction.
Fidelity of PREVENT Tool Implementation
时间窗: 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.
Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
时间窗: 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 completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Mean Change in Number of Food Intake Behaviors Met
时间窗: 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. Responses are dichotomized into a binary yes (1)/no (0) score indicating whether or not the patient is meeting the food intake recommendation for each food group. The total number of food intake behaviors are scored on a 5 item scale (range 0-5), maximum improvement in number of behaviors=5. Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups.
次要结局
- Impact of PREVENT Tool on Patient's Fasting Blood Glucose(At baseline and 3-months)
- Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change(At baseline and 3-months)
- Provider's Motivation for Sustained Use of PREVENT Tool(3-months)
- Clinic-level Capacity for Sustainability as Measured by Provider Survey(3-months)
- Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool(3-months)
- Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool(3-months)
- Patient's Perceptions of Usability/Acceptability of PREVENT Tool(3-months)
- Parent's Perceptions of Usability/Acceptability of PREVENT Tool(3-months)
- Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)(At baseline and 3-months)
- Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure(At baseline and 3-months)
- Impact of PREVENT Tool on Patient's Cholesterol(At baseline and 3-months)