Clinical trial NCT03073811: Nutritional Perihabilitation in Older Veterans Undergoing Surgery
Official title: Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Nutritional Risk
Abdominal Surgery
Keywords: protein supplementation
older adults
nutrition perihabilitation
perioperative optimization
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
timeFrame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
measure: Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
timeFrame: 30-day post-surgery follow-up (endpoint)
measure: Physical Function
timeFrame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
Secondary outcomes:
measure: Hospital Readmission
timeFrame: endpoint (30 days post-surgery)
measure: Dietary Intake
timeFrame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
measure: Handgrip Strength
timeFrame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
measure: Nutritional Risk Screener-2002
timeFrame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
measure: Patient Generated-Subjective Global Assessment
timeFrame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
measure: Discharge Location
timeFrame: endpoint (30 days post-surgery)
measure: Length of Stay
timeFrame: endpoint (30 days post-surgery)
measure: Emergency Department Readmission
timeFrame: endpoint (30 days post-surgery)
measure: Postoperative Complications
timeFrame: endpoint (30 days post-surgery)
measure: Albumin, g/dL
timeFrame: baseline, day of surgery (midpoint), 30-day post-surgery (endpoint)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kathryn N. Starr, PhD
role: PRINCIPAL_INVESTIGATOR
References: