Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective abdominal surgery
- •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
排除标准
- •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
结局指标
主要结局
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
- Dietary Intake(baseline, day of surgery (midpoint), 30-day post-surgery (endpoint))
- Handgrip Strength(baseline, day of surgery (midpoint), 30-day post-surgery (endpoint))
- Length of Stay(endpoint (30 days post-surgery))
- Emergency Department Readmission(endpoint (30 days post-surgery))
- Albumin, g/dL(baseline, day of surgery (midpoint), 30-day post-surgery (endpoint))
- Hospital Readmission(endpoint (30 days post-surgery))
- Nutritional Risk Screener-2002(baseline, day of surgery (midpoint), 30-day post-surgery (endpoint))
- Discharge Location(endpoint (30 days post-surgery))
- Postoperative Complications(endpoint (30 days post-surgery))
- Patient Generated-Subjective Global Assessment(baseline, day of surgery (midpoint), 30-day post-surgery (endpoint))