- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00841412
Prevention of Weight Loss in Long Term Care Veterans
Prevention of Weight Loss in Long-Term Care Veterans
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Tennessee
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Nashville, Tennessee, Forente stater, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
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Unit staff received weekly training and feedback for 12-weeks to improve daily nutritional care processes.
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Aktiv komparator: 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.
|
Research staff monitored this group under usual care conditions, then these units crossed over into intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Quality of Feeding Assistance Care Processes
Tidsramme: 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.
|
3 month intervention and 3 month follow up periods
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Sandra F Simmons, BA MA PhD, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIR 07-250
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