Nutritional Perihabilitation in Older Veterans Undergoing Surgery

Study Overview
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Brief Summary
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This research study will be conducted in two parts. The first part will consist of selecting appropriate screening and assessment tools for Veterans undergoing elective surgery and identifying the number of Veterans who are malnourished and at risk of malnutrition. The second portion of the study will be to determine if a protein-enhanced diet before and after surgery will improve function and postoperative outcomes and compare the results to an education control group.

Detailed Description
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In year 1 of the two-part research study, an observational, prospective study of 75 Veterans preparing for elective surgery will be conducted. The purpose of this study will be to select appropriate nutrition screening and assessment tools and to employ them to characterize malnutrition prevalence and severity and establish cut-off values associated with malnutrition in this population. In years 2-5 of the research two-part research study, a pilot randomized controlled trial will be conducted. The purpose of this study will be evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced intervention compared to an educational control. Veterans who are malnourished or at risk of being malnourished will be randomly assigned on a 1:1 ratio to either an education (nutritional counseling) control or high-protein perihabilitation arm. Participants in the high-protein perihabilitation arm will be provided with 30 grams of high quality protein supplements three times per day. The study will take place two weeks prior to an elective abdominal or GI surgery and will continue 4 weeks post surgery.

Official Title
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Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

Conditions
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Malnutrition, Nutritional Risk, Abdominal Surgery

Intervention / Treatment
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* Dietary Supplement: Protein enhanced nutrition intervention
* Other: Education Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective abdominal surgery upper GI colorectal hepatobiliary pancreatic intra-abdominal Abdominal aortic aneurysm Referred to the VA Perioperative Optimization of Senior Health Clinic Able to record dietary intake or has a proxy who can record dietary intake Exclusion Criteria: Cognitive impairment Unwillingness to be randomized to either intervention arm, submit to study testing, or continuously participate in the intervention for six weeks Living in skilled nursing facility No access to telephone

Ages Eligible for Study
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Minimum Age: 60 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PeriHab<br>Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. | Dietary Supplement: Protein enhanced nutrition intervention<br>* Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.<br>* Other names: Perihabilitation;|
| Active Comparator: PoshControl<br>Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. | Other: Education Control<br>* provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.<br>* Other names: PoshControl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function | Short physical performance battery | Baseline, day of surgery, 30-days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital readmission | determine from medical records | endpoint (30 days post-surgery) | 
| Change in Physical activity | 3-axis accelerometer will be used to measure activity counts, step counts, and physical activity intensity. | Baseline and endpoint (30-days post-surgery) | 
| Change in Dietary Intake | Three day food records will be collected. | baseline, 3 days before surgery, and 30-days post-surgery | 
| serum albumin | serum | baseline, day of surgery, and 30-days post-surgery | 
| Change in Handgrip strength | Hand dynamometer will be used to determine grip strength. Maximum grip strength will be determined by conducting two trials on the dominant hand, with 30 second rest between trials. | baseline, day of surgery, 30-days post-surgery | 
| Change in Nutritional Risk Screener-2002 | Validated Nutritoinal Risk Screener-2002 Questionnaire to determine nutritional risk | baseline, day of surgery, and 30-days post-surgery | 
| Change in Patient Generated-Subjective Global Assessment | Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status | Baseline, day of surgery, and 30-days post-surgery | 
| Change in ICD-10 Malnutrition Code | Nutrition focused physical assessment will be conducted to determine the standard diagnostic classification of malnutrition | baseline, day of surgery, and endpoint | 
| discharge location | determine from medical records | endpoint (30 days post-surgery) | 
| length of stay | determine from medical records | endpoint (30 days post-surgery) | 
| length of skilled care if needed | determine from medical records | endpoint (30 days post-surgery) | 
| emergency department readmission | determine from medical records | endpoint (30 days post-surgery) | 
| postoperative complications | determine from medical records | endpoint (30 days post-surgery) | 
| high sensitivity C-reactive protein | serum | baseline, day of surgery, and 30-days post-surgery | 
| tumor necrosis factor-alpha | serum | baseline, day of surgery, and 30-days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans