Trial Outcomes & Findings for Prevention of Weight Loss in Long Term Care Veterans (NCT NCT00841412)

NCT ID: NCT00841412

Last Updated: 2015-04-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 222 participants
• Primary outcome timeframe: 3 month intervention and 3 month follow up periods
• Results posted on: 2015-04-27

Participant Flow

Participant milestones

Measure	Immediate Intervention Group/Units Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.	Delayed Intervention Group/Units Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
Overall Study STARTED	120	80
Overall Study COMPLETED	80	50
Overall Study NOT COMPLETED	40	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Weight Loss in Long Term Care Veterans

Baseline characteristics by cohort

Measure	Overall (Both Groups Combined) n=200 Participants Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
Age, Continuous	76.00 years STANDARD_DEVIATION 11.97 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants
Race (NIH/OMB) White	171 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Overall (Both Groups Combined) n=1560 Meal Observations Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
Quality of Feeding Assistance Care Processes Percent of Meals with Accurate Chart Documentation	66.7 percentage of meal observations
Quality of Feeding Assistance Care Processes Percent of Meals with Social Interaction	47.2 percentage of meal observations
Quality of Feeding Assistance Care Processes Percent of Meals with Assistance	61.4 percentage of meal observations

Adverse Events

Overall (Both Groups Combined)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandra F. Simmons, PhD, Associate Professor of Medicine

Tennessee Valley Healthcare System, GRECC and Vanderbilt University, School of Medicine, Division of Geriatrics, Center for Quality Aging

Phone: 615-343-6729

Email: Sandra.Simmons@Vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place