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Prevention of Weight Loss in Long Term Care Veterans

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Intervention Group
Delayed Intervention Group
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Usual Care Control Group

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Long-stay,
  • free of feeding tube,
  • not receiving hospice care,
  • not on a planned weight loss diet,
  • able to speak English

Exclusion Criteria:

  • short stay/rehab only
  • feeding tube
  • hospice
  • planned weight loss diet

Sites / Locations

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Intervention Group

Delayed Intervention Group

Arm Description

Immediate Intervention: Long term care units assigned to the Immediate Intervention group were first to receive the staff training and management intervention to improve nutritional care processes.

Delayed Intervention: Long term care units assigned to the Delayed Intervention group were monitored under usual care conditions to serve as a control for the Immediate Intervention group. Then, these units received the staff training and management intervention at a later date.

Outcomes

Primary Outcome Measures

Quality of Feeding Assistance Care Processes
Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized "feeding assistance care quality indicators" wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal". Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2009
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00841412
Brief Title
Prevention of Weight Loss in Long Term Care Veterans
Official Title
Prevention of Weight Loss in Long-Term Care Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Numerous studies have shown that many LTC residents receive inadequate staff assistance with eating, which places them at risk for under-nutrition, dehydration and weight loss. Moreover, improvements in feeding assistance care have been shown to improve residents' daily food and fluid consumption and weight loss outcomes. Objectives: The purpose of this program evaluation project is to train indigenous LTC staff how to improve nutritional care within the constraints of existing staffing resources. Methods: A multiple baseline design was used to evaluate the effectiveness of the program in one federal and one state VA LTC facility. Research staff collected baseline measures related to nutritional care processes and resident outcomes. All LTC units in each of the two sites were divided into two groups for program implementation. The program was implemented with staff and residents on the units in the immediate intervention group; while, the delayed intervention group remained in usual care and continued to be monitored monthly for all care process and resident outcome measures. Status: This project ended 10/1/13. Five published papers resulted from this study.
Detailed Description
Background: Numerous studies have shown that many long term care (LTC) residents receive inadequate staff assistance with eating, which places them at risk for under-nutrition, dehydration and weight loss. Moreover, improvements in feeding assistance care have been shown to improve residents' daily food and fluid consumption and weight loss outcomes. However, these improvements have only been achieved through the use of research staff as opposed to indigenous LTC staff due to staffing resource limitations that exist in most LTC facilities. The purpose of this program evaluation project is to train indigenous LTC staff how to improve nutritional care within the constraints of existing staffing resources. Objectives: The PI of this proposal has developed standardized assessment, monitoring and staffing needs projection tools that can be used by long-term care (LTC) providers to improve feeding assistance care delivery and unintentional weight loss outcomes. The primary objective of this project is to train indigenous LTC staff how to (1) identify residents in need of feeding assistance, (2) effectively monitor daily care delivery; and, (3) utilize existing, non-nursing staff for some mealtime tasks to improve care. Methods: A multiple baseline design was used to evaluate the effectiveness of the program in one federal and one state VA long-term care (LTC) facility. Research staff collected baseline measures related to organizational characteristics, including staffing, nutritional care processes and resident outcomes including oral food and fluid intake and weight status. All LTC units in each of the two sites were divided into two groups for program implementation purposes (for a total of 4 groups across the 2 sites) based on the proximity of a unit to other units, resident and staff characteristics. The program was implemented with staff and residents on the units in the first site/group; while, the second site/group remained in usual care and continued to be monitored monthly for all care process and resident outcome measures. Research staff trained LTC staff in the implementation of program protocols during a 12-week intervention period. Research staff then monitored LTC staff implementation of the program monthly following intervention to determine the sustainability of the program in the absence of research staff. All staff training and monitoring was repeated for the LTC units in groups three and four. The intent of this program evaluation study was to determine the effectiveness and cost of translating efficacious research protocols into care practice to improve the nutritional status of LTC veterans. Status: This study is officially complete.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Usual Care Control Group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
Immediate Intervention: Long term care units assigned to the Immediate Intervention group were first to receive the staff training and management intervention to improve nutritional care processes.
Arm Title
Delayed Intervention Group
Arm Type
Active Comparator
Arm Description
Delayed Intervention: Long term care units assigned to the Delayed Intervention group were monitored under usual care conditions to serve as a control for the Immediate Intervention group. Then, these units received the staff training and management intervention at a later date.
Intervention Type
Behavioral
Intervention Name(s)
Immediate Intervention Group
Intervention Description
Unit staff received weekly training and feedback for 12-weeks to improve daily nutritional care processes.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Intervention Group
Intervention Description
Research staff monitored this group under usual care conditions, then these units crossed over into intervention.
Primary Outcome Measure Information:
Title
Quality of Feeding Assistance Care Processes
Description
Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized "feeding assistance care quality indicators" wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal". Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures.
Time Frame
3 month intervention and 3 month follow up periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Long-stay, free of feeding tube, not receiving hospice care, not on a planned weight loss diet, able to speak English Exclusion Criteria: short stay/rehab only feeding tube hospice planned weight loss diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra F Simmons, BA MA PhD
Organizational Affiliation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24073169
Citation
Simmons SF, Durkin DW, Shotwell MS, Erwin S, Schnelle JF. A staff training and management intervention in VA long-term care: impact on feeding assistance care quality. Transl Behav Med. 2013 Jun;3(2):189-99. doi: 10.1007/s13142-013-0194-3.
Results Reference
result
PubMed Identifier
25474793
Citation
Simmons SF, Sims N, Durkin DW, Shotwell MS, Erwin S, Schnelle JF. The quality of feeding assistance care practices for long-term care veterans: implications for quality improvement efforts. J Appl Gerontol. 2013 Sep;32(6):669-86. doi: 10.1177/0733464811433487. Epub 2012 Mar 22.
Results Reference
result
PubMed Identifier
24652932
Citation
Durkin DW, Shotwell MS, Simmons SF. The impact of family visitation on feeding assistance quality in nursing homes. J Appl Gerontol. 2014 Aug;33(5):586-602. doi: 10.1177/0733464814522126. Epub 2014 Feb 18.
Results Reference
result
PubMed Identifier
23189996
Citation
Durkin DW, Umayam SP, Sims N, Cleeton P, Simmons SF. Whom do veteran nursing home residents prefer to talk to about satisfaction with care?: implications for nursing staff. J Gerontol Nurs. 2012 Dec;38(12):38-45. doi: 10.3928/00989134-20121109-01.
Results Reference
result
PubMed Identifier
25143465
Citation
Simmons SF, Durkin DW, Rahman AN, Schnelle JF, Beuscher LM. The value of resident choice during daily care: do staff and families differ? J Appl Gerontol. 2014 Sep;33(6):655-71. doi: 10.1177/0733464812454010. Epub 2012 Aug 1.
Results Reference
result

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Prevention of Weight Loss in Long Term Care Veterans

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