NCT00841412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 10, 2014

Completed
Last Updated

April 27, 2015

Status Verified

October 1, 2014

Enrollment Period

2.7 years

First QC Date

February 9, 2009

Results QC Date

October 28, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Usual Care Control Group

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 month intervention and 3 month follow up periods

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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

Delayed Intervention Group

ACTIVE COMPARATOR

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

Interventions

Unit staff received weekly training and feedback for 12-weeks to improve daily nutritional care processes.

Immediate Intervention Group

Research staff monitored this group under usual care conditions, then these units crossed over into intervention.

Delayed Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Related Publications (5)

  • 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: 10.3928/00989134-20121109-01.

  • 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.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Limitations and Caveats

This study was conducted in only two VA facilities in one geographic region with predominately White, male residents. All study results have been published in a series of papers.

Results Point of Contact

Title
Sandra F. Simmons, PhD, Associate Professor of Medicine
Organization
Tennessee Valley Healthcare System, GRECC and Vanderbilt University, School of Medicine, Division of Geriatrics, Center for Quality Aging

Study Officials

  • Sandra F Simmons, BA MA PhD

    Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2011

Study Completion

September 1, 2013

Last Updated

April 27, 2015

Results First Posted

November 10, 2014

Record last verified: 2014-10

Locations