Nutri Diet Goal Setting Software Pilot Trial

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pilot Trial of Nutri, a Clinical Decision Support Software to Improve Diet Goal-Setting in Primary Care

Conditions
-----------------
Type 2 Diabetes, Pre-diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Collaborative Diet Goal Setting Clinical Decision Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Currently pregnant Diagnosed with an eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutri<br>PCPs will receive an alert to use Nutri personalized diet goal setting software with enrolled patients | Behavioral: Collaborative Diet Goal Setting Clinical Decision Support<br>* Receives Nutri<br>* Other names: Nutri;|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavioral Intention | Patient self-report of a diet goal set during medical appointment, coded y/n | 1-day post medical encounter | 
| Variance and Within-Provider Covariance of Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior) | 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 | 1-day post medical encounter | 
| Variance and Within-Provider Covariance of Patient Change in Diet Quality (measured via Healthy Eating Index) | 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. | Patient pre-assessment and 7-day post medical encounter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutri (Intervention) Usability | System Usability Scale, 0-100 score range, higher score means better outcome | PCP post-assessment (after 4 medical encounters), expected to be at 8 weeks after enrollment | 
| Number and timeline of PCPs and patients recruited into the study | Recruitment of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility. | through study completion, expected to be at 8 weeks after enrollment | 
| Number and timeline of PCPs and patients who drop out of the study | Loss to follow up of patients and providers into the study, including timeline and total number. The outcome will be used to inform pragmatic trial feasibility. | through study completion,expected to be at 8 weeks after enrollment | 
| Completion of patient ASA24 survey | Patient completion of the ASA24 survey pre and post-test. The outcome will be used to inform pragmatic trial feasibility. | patient pre-assessment & 7 days post-appointment | 
| Impact of Nutri on Patient Self-Reported Dietary Behavioral Intention | Difference between intervention and control in the frequency of patient self-reported diet goal. | 1 day post-medical encounter | 
| Impact of Nutri on Patient Self-Reported Dietary Behavior Change Self-Efficacy (Confidence in ability to change dietary behavior), measured via questionnaire | The difference between intervention and control in the amount of patient self-reported self-efficacy (confidence) in changing their diet after the appointment, 7-point Likert scale, a higher score means a better outcome. | 1 day post-medical encounter | 
| Impact of Nutri on Patient Diet Quality (measured via Healthy Eating Index) | Difference between intervention and control in change in Healthy Eating Index (HEI) score calculated from 24-hour recall, 0-100 score range, a higher score means a better outcome. | Patient pre-assessment and 7 days post-medical encounter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Decision Support, Dietary Management