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Prevention of Weight Loss in Long Term Care Veterans

Prevention of Weight Loss in Long-Term Care Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00841412
Enrollment
222
Registered
2009-02-11
Start date
2009-02-28
Completion date
2013-09-30
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Usual Care Control Group

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.

Interventions

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

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

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Feeding Assistance Care Processes3 month intervention and 3 month follow up periodsResearch 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Overall (Both Groups Combined)
Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
200
Total200

Baseline characteristics

CharacteristicOverall (Both Groups Combined)
Age, Continuous76.00 years
STANDARD_DEVIATION 11.97
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
29 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
171 Participants
Region of Enrollment
United States
200 participants
Sex: Female, Male
Female
23 Participants
Sex: Female, Male
Male
177 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 200
serious
Total, serious adverse events
0 / 200

Outcome results

Primary

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.

Time frame: 3 month intervention and 3 month follow up periods

Population: Each participants was observed during six scheduled meals per person per study phase. A total of 130 participants completed all study phases and had complete data for analyses.

ArmMeasureGroupValue (NUMBER)
Overall (Both Groups Combined)Quality of Feeding Assistance Care ProcessesPercent of Meals with Accurate Chart Documentation66.7 percentage of meal observations
Overall (Both Groups Combined)Quality of Feeding Assistance Care ProcessesPercent of Meals with Social Interaction47.2 percentage of meal observations
Overall (Both Groups Combined)Quality of Feeding Assistance Care ProcessesPercent of Meals with Assistance61.4 percentage of meal observations
p-value: <0.0595% CI: [0.59, 0.96]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026