Prevention of Weight Loss in Long Term Care Veterans

• ClinicalTrials.gov Identifier: NCT00841412
• Recruitment Status: Completed
• First Posted: February 11, 2009
• Results First Posted: November 10, 2014
• Last Update Posted: April 27, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease	Intervention/treatment	Phase
Malnutrition	Behavioral: Immediate Intervention Group; Behavioral: Delayed Intervention Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevention of Weight Loss in Long-Term Care Veterans
• Study Start Date: February 2009
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Immediate Intervention Group; 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.	Behavioral: Immediate Intervention Group; Unit staff received weekly training and feedback for 12-weeks to improve daily nutritional care processes.
Active Comparator: Delayed Intervention Group; 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.	Behavioral: Delayed Intervention Group; Research staff monitored this group under usual care conditions, then these units crossed over into intervention.

Outcome Measures

Primary Outcome Measures :

1. Quality of Feeding Assistance Care Processes [ Time Frame: 3 month intervention and 3 month follow up periods ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Tennessee

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Sandra F Simmons, BA MA PhD; Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

More Information

Publications of Results:

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.

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.

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.

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: 10.3928/00989134-20121112-99.

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.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00841412
• Other Study ID Numbers: IIR 07-250
• First Posted: February 11, 2009
• Results First Posted: November 10, 2014
• Last Update Posted: April 27, 2015
• Last Verified: October 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Usual Care Control Group

Additional relevant MeSH terms:

Malnutrition; Weight Loss; Body Weight Changes; Body Weight; Nutrition Disorders