A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol

Study Overview
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Brief Summary
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This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient.

Detailed Description
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The proposed VIP study will utilize an interventional feasibility design to implement and evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery patients. The VIP study looks to measure patient adherence and acceptability, and practicality of the remote platform in hopes it will illicit change to the current standard of nutrition care being provided to cardiac surgery patients. The current standards of care do not call for dietitian involvement for cardiac surgery patients' pre-surgery and little to no involvement for patients not receiving CABG surgery. This feasibility study looks to address this gap in current patient nutrition care. The study intervention will provide eligible patients (n=20) with access to four 25-30 minute virtual sessions with a registered dietitian during the two-week period prior to surgery. The dietitian will provide the patient with nutrition counseling prior to the patient's elective cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to connect the dietitian virtually with participants during all sessions. The four sessions will follow the same presentation format and will provide all participants with identical nutrition education with curriculum content progressing in each subsequent session. Each session will be comprised of protein education and goal setting, with education content building on previous sessions with a goal of improving patient protein intake perioperatively. Data will be collected on: (1) participant demographics, (2) physical function, (3) nutritional status and (4) nutrition literacy.

Official Title
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A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study

Conditions
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Nutritional Deficiency

Intervention / Treatment
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* Other: Virtual Nutrition Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older undergoing non-emergent/elective cardiac surgery Exclusion Criteria: not able to communicate in English (read or write) in-patients (urgent or emergent care) patients who self report protein supplementation on a regular basis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Study sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely while in the comfort of their own residence or where it is deemed to be comfortable and safe.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual nutritional Intervention<br>This arm will receive the virtual nutritional intervention consisting of 4 - 30 minute sessions to educate cardiac surgery patients before their date of surgery. Each session will provide a different theme such as: 1) nutritional assessment, 2) protein intake education, 3) nutritional adequacy prior to surgery, and 4) protein and nutrition intake post surgery | Other: Virtual Nutrition Education<br>* 4 interventional sessions will be provided using a virtual communication platform and delivered remotely to each participant by a registered dietitian. The virtual counseling sessions will be led by a registered dietitian and delivered to each participant remotely<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Literacy | measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire | Baseline | 
| Nutritional Literacy | measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire | 1 week pre-surgery | 
| Nutritional Literacy | measurement of nutrition related understanding - Modified Social Cognitive Theory questionnaire | I month post Hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Status - MNA | participant nutritional status - Mini nutritional assessment | Baseline | 
| Nutrition Status - MNA | participant nutritional status - Mini nutritional assessment | 1 week pre-surgery | 
| Nutrition Status - MNA | participant nutritional status - Mini nutritional assessment | 1 month post Hospital discharge | 
| Nutrition Status - BMI | participant nutritional status - Body Mass Index (BMI) | Baseline | 
| Nutrition Status - BMI | participant nutritional status - Body Mass Index (BMI) | 1 Week pre-surgery | 
| Nutrition Status - BMI | participant nutritional status - Body Mass Index (BMI) | 1 Month post hospital discharge | 
| Quality of Life - physical function | modified Short Form - 36 questionnaire to measure physical function | Baseline | 
| Quality of Life - physical function | modified Short Form - 36 questionnaire to measure physical function | 1 week pre-surgery | 
| Quality of Life - physical function | modified Short Form - 36 questionnaire to measure physical function | 1 month post hospital discharge | 
| Nutritional behaviour | 3-Day Food Record | Baseline | 
| Nutritional behaviour | 3-Day Food Record | 1 Week pre-surgery | 
| Nutritional behaviour | 3-Day Food Record | 1 month post hospital discharge | 
| Nutrition Status - PA | participant nutritional status - pre-albumin | Baseline | 
| Nutrition Status - PA | participant nutritional status - pre-albumin | 1 week pre-surgery | 
| Nutrition Status - PA | participant nutritional status - pre-albumin | 1 month post hospital discharge |