Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

NCT ID: NCT02567513

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-07-31

Brief Summary

Low oral food and fluid intake and unintentional weight loss are common problems among long-stay nursing home (NH) residents and are associated with adverse, costly clinical outcomes. This study will use a controlled, intervention design to determine the cost-effectiveness of oral liquid nutrition supplements with an alternative nutrition intervention that offers NH residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents across 4 NH sites. Residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation intervention; or (3) choice intervention. The usual care control group will continue to receive standard NH care for supplement or snack delivery. Research staff will provide the same supplements used by the NH (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. Based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). Thus, the labor costs of these interventions will be documented and compared to effectiveness measures. Effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. These outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care control group

Eligible, consented residents continue to receive usual care from nursing home staff and are independently monitored by trained research staff.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Supplement Intervention

Residents are offered a variety of supplement types and flavors consistent with prescribed orders twice per day (morning and afternoon), five days per week, for 24 consecutive weeks by trained research personnel. Research staff also provide the appropriate level and amount of assistance to encourage consumption.

Group Type: EXPERIMENTAL

Supplement Intervention

Intervention Type: BEHAVIORAL

Supplements given twice/day, 5 days/week, for 24 weeks by research staff.

Snack Intervention

Residents are offered a variety of snack options (foods and fluids, including supplement) consistent with prescribed orders twice per day (morning and afternoon), five days per week, for 24 consecutive weeks by trained research personnel. Research staff also provide the appropriate level and amount of assistance to encourage consumption.

Group Type: EXPERIMENTAL

Snack Intervention

Intervention Type: BEHAVIORAL

Snacks given twice/day, 5 days/week for 24 weeks by research staff.

Interventions

Supplement Intervention

Supplements given twice/day, 5 days/week, for 24 weeks by research staff.

Intervention Type: BEHAVIORAL

Snack Intervention

Snacks given twice/day, 5 days/week for 24 weeks by research staff.

Intervention Type: BEHAVIORAL

Other Intervention Names

Experimental Supplement Intervention; Experimental Snack Intervention

Eligibility Criteria

Inclusion Criteria

• Long-stay nursing home residents,
• capable of oral food and fluid intake,
• physician or dietitian order for caloric supplementation.

Exclusion Criteria

• Short-stay nursing home residents (rehabilitation),
• feeding tube,
• hospice care.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Sandra Simmons

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra F Simmons, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Other Identifiers

090948

Identifier Type: -

Identifier Source: org_study_id