Cost Effectiveness of Nutrition Intervention in Long Term Care
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Between-Meal Intervention Group
Sponsored by

About this trial
This is an interventional health services research trial for Weight Loss focused on measuring food and fluid intake, nursing home residents, staffing
Eligibility Criteria
Inclusion Criteria:
- Long-stay nursing home residents
- Capable of oral food and fluid intake
- Physician or dietitian order for caloric supplementation
Exclusion Criteria:
- Short-stay (rehabilitation only)
- Feeding tube
- Hospice care
- History of Aspiration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care Control Group
Between-meal Intervention Group
Arm Description
Eligible, consented residents continued to receive usual care from nursing home staff and were monitored by trained research staff.
Non-nursing staff trained as Feeding Assistants were utilized to deliver supplements and snacks twice per day, between meals for 24 study weeks.
Outcomes
Primary Outcome Measures
total caloric intake during and between meals
Weighed intake methods were used to determine total caloric intake during and between meals before and after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT02567526
First Posted
October 1, 2015
Last Updated
October 31, 2016
Sponsor
Vanderbilt University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02567526
Brief Title
Cost Effectiveness of Nutrition Intervention in Long Term Care
Official Title
Cost Effectiveness of Nutrition Intervention in Long Term Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inadequate food and fluid intake is a common problem among nursing home (NH) residents and one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even death. The most common nutrition intervention for at-risk NH residents is oral liquid nutrition supplementation, although, there is limited controlled evidence of the efficacy of supplements in promoting weight gain in NH residents. Moreover, studies show that supplements are not provided consistent with orders and residents receive little to no staff assistance to promote consumption in daily NH care practice. The result is that nutritionally at-risk NH residents with supplement orders receive few additional daily calories from supplements. Recent evidence strongly suggests that offering residents a choice among a variety of foods and fluids multiple times per day between meals coupled with assistance is effective in increasing daily caloric intake and promoting weight gain. However, the provision of the between-meal choice intervention requires significantly more staff time relative to the amount of time NH staff currently spend on between-meal nutritional care provision.
A new federal regulation allows NHs to train non-nursing staff to provide feeding assistance care. Preliminary research has demonstrated that non-nursing staff trained as "feeding assistants" provide mealtime feeding assistance care that is comparable to or better than their indigenous nurse aide counterparts. Moreover, a recent demonstration project showed that these staff can be used to effectively augment nurse aide staff for mealtime feeding assistance care provision in daily care practice. The proposed translational study will utilize the federal regulation to train non-nursing staff for between-meal nutritional care delivery. Specifically, the proposed study will use a controlled, intervention design to determine the cost-effectiveness of the between-meal choice intervention relative to a usual care control group in a group of 200 residents across 4 NH sites. Residents with an order for caloric supplementation will be included in this study and randomized into either a usual care control group or a choice intervention group (100 residents per group). The usual care control group will continue to receive standard NH care for supplement or snack delivery between meals, as provided by indigenous nurse aide staff. Non-nursing staff trained as "feeding assistants" will offer residents in the intervention group a choice between supplements and other snack foods and fluids twice daily, five days per week, for 24 weeks while also providing a standardized prompting protocol to enhance intake and independence in eating. Research staff will independently document the costs of intervention implementation and compare these costs to effectiveness measures which include improvements in caloric intake, weight and quality of life. These outcomes will be independently monitored for both groups across 24 study weeks by trained research staff using standardized, validated protocols. This translational research effort will provide critical information to improve care practices in nursing homes for nutritionally at risk residents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
food and fluid intake, nursing home residents, staffing
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Control Group
Arm Type
No Intervention
Arm Description
Eligible, consented residents continued to receive usual care from nursing home staff and were monitored by trained research staff.
Arm Title
Between-meal Intervention Group
Arm Type
Experimental
Arm Description
Non-nursing staff trained as Feeding Assistants were utilized to deliver supplements and snacks twice per day, between meals for 24 study weeks.
Intervention Type
Behavioral
Intervention Name(s)
Between-Meal Intervention Group
Intervention Description
Non-nursing staff trained as Feeding Assistants were responsible for supplement and snack delivery in the mornings and afternoons between meals supervised by research staff
Primary Outcome Measure Information:
Title
total caloric intake during and between meals
Description
Weighed intake methods were used to determine total caloric intake during and between meals before and after intervention
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Long-stay nursing home residents
Capable of oral food and fluid intake
Physician or dietitian order for caloric supplementation
Exclusion Criteria:
Short-stay (rehabilitation only)
Feeding tube
Hospice care
History of Aspiration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra F Simmons, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27664171
Citation
Hollingsworth EK, Long EA, Simmons SF. Comparison Between Quality of Care Provided by Trained Feeding Assistants and Certified Nursing Assistants During Between-Meal Supplementation in Long-Term Care Settings. J Appl Gerontol. 2018 Nov;37(11):1391-1410. doi: 10.1177/0733464816669806. Epub 2016 Sep 22.
Results Reference
derived
Learn more about this trial
Cost Effectiveness of Nutrition Intervention in Long Term Care
We'll reach out to this number within 24 hrs