Prevention of Weight Loss in Long Term Care Veterans
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- Quality of Feeding Assistance Care Processes [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
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIR 07-250
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Immediate Intervention Group/Units | Delayed Intervention Group/Units |
|---|---|---|
| Arm/Group Description | Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes. | Delayed Intervention units (control group) was monitored by research staff under usual care conditions. |
| Period Title: Overall Study | ||
| STARTED | 120 | 80 |
| COMPLETED | 80 | 50 |
| NOT COMPLETED | 40 | 30 |
Baseline Characteristics
| Arm/Group Title | Overall (Both Groups Combined) |
|---|---|
| Arm/Group Description | Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined. |
| Overall Participants | 200 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
76.00
(11.97)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
23
11.5%
|
| Male |
177
88.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
29
14.5%
|
| White |
171
85.5%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
200
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Overall (Both Groups Combined) |
|---|---|
| Arm/Group Description | Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined. |
| Measure Participants | 130 |
| Measure Meal Observations | 1560 |
| Percent of Meals with Accurate Chart Documentation |
66.7
|
| Percent of Meals with Social Interaction |
47.2
|
| Percent of Meals with Assistance |
61.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Overall (Both Groups Combined) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.76 | |
| Confidence Interval |
(2-Sided) 95% 0.59 to 0.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention. | |
Adverse Events
| Time Frame | Three months of Intervention | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Overall (Both Groups Combined) | |
| Arm/Group Description | Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined. | |
All Cause Mortality |
||
| Overall (Both Groups Combined) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Overall (Both Groups Combined) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/200 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Overall (Both Groups Combined) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/200 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/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 |
| Phone | 615-343-6729 |
| Sandra.Simmons@Vanderbilt.edu |
- IIR 07-250