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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
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 1, 2015
    Last Updated
    October 31, 2016
    Sponsor
    Vanderbilt University
    Collaborators
    National Institute on Aging (NIA)
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    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

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