Nutritional Perihabilitation in Older Veterans Undergoing Surgery

Not Applicable

Completed

Interventions: Dietary Supplement: Protein enhanced nutrition intervention
Other: Education Control

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
PeriHab	Protein enhanced nutrition intervention	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.
PoshControl	Education Control	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.

Primary Outcome Measures

Name	Time	Method
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control	30-day post-surgery follow-up (endpoint)	Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree
Physical Function	Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery	Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)
Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.	day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)	Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.

Secondary Outcome Measures

Name	Time	Method
Dietary Intake	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)	Three day food records will be collected.
Handgrip Strength	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)	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.
Length of Stay	endpoint (30 days post-surgery)	determine from medical records
Emergency Department Readmission	endpoint (30 days post-surgery)	Prevalence of emergency department admissions following surgery.
Albumin, g/dL	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)	A measure of protein in the blood. Lower level may indicate infection or inflammation.
Hospital Readmission	endpoint (30 days post-surgery)	determine from medical records
Nutritional Risk Screener-2002	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)	Validated Nutritional Risk Screener-2002 Questionnaire to determine nutritional risk
Discharge Location	endpoint (30 days post-surgery)	determine from medical records
Postoperative Complications	endpoint (30 days post-surgery)	determine from medical records
Patient Generated-Subjective Global Assessment	baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)	Validated Patient Generate Subjective Global Assessment Questionnaire to determine malnutrition status

Locations (1): Durham VA Medical Center, Durham, NC
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Durham, North Carolina, United States