Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
研究概览
简要总结
The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control.
In this pilot trial, the intervention group (N=10 primary care providers [PCPs], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes
- •Have a scheduled medical appointment with a study enrolled PCP within the study enrollment period
- •Fluent in either English or Spanish
- •Access to a computer, tablet, or smartphone and reliable internet
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •HIPAA authorization for Health Information Exchange
排除标准
- •Currently pregnant
- •Diagnosed with an eating disorder
研究组 & 干预措施
Nutri
PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients
干预措施: Collaborative Diet Goal Setting Clinical Decision Support (Behavioral)
Control
Usual care
结局指标
主要结局
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention
时间窗: 1-day post medical encounter
Patient self-report of a diet goal set during medical appointment, coded y/n
Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index)
时间窗: Patient pre-assessment and 7-day post medical encounter
Change in diet quality measured via the Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, higher score means better outcome.
Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior)
时间窗: 1-day post medical encounter
Patient self-report of self-efficacy (ie, confidence) in changing their diet after appointment, 7-point Likert scale, a higher score means a better outcome
次要结局
- Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention(1 day post-medical encounter)
- Completion of patient ASA24 survey(patient pre-assessment & 7 days post-appointment)
- Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index)(Patient pre-assessment and 7 days post-medical encounter)
- Nutri (Intervention) Usability(PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment)
- Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire(1 day post-medical encounter)
- Number and timeline of PCPs and patients recruited into the study(through study completion, expected to be at 8 weeks after enrollment)
- Number and timeline of PCPs and patients who drop out of the study(through study completion,expected to be at 8 weeks after enrollment)
研究者
Marissa Burgermaster
Assistant Professor
University of Texas at Austin