Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients

Terminated

• Conditions: Malnutrition
• Interventions: Other: ONS QIP; Other: ONS Standard Feeding

• Registration Number: NCT02262429
• Lead Sponsor: Abbott Nutrition

Brief Summary

Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2386

Inclusion Criteria

• Patient is ≥ 18 years of age.
• Patient is screened for malnutrition with an MST score ≥ 2 (see Appendix C).
• Patient has length of stay of hospital stay > 2 days.
• Patient is able to consume foods and beverages orally.
• Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital stay in connection with the QIP.

Exclusion Criteria

• Patient is pregnant.
• Patient is intubated, receiving tube feeding or parenteral nutrition.
• Patient unable to provide HIPAA authorization and informed consent.
• Patient is discharged to hospice care.
• Patient has a condition that would preclude ingestion / absorption of the oral nutritional supplements, including allergic response to any ONS ingredient.
• Patient has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder.
• Patient has stated an allergy or intolerance to any of the ingredients in the study products.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ONS QIP	ONS QIP	Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP.
ONS Standard Feeding	ONS Standard Feeding	Two (2) hospitals will use their current "standard" ONS feeding protocol.

Primary Outcome Measures

Name	Time	Method
Post-discharge readmissions	November 2014 - April 2015, 30 days post discharge	Non-elective readmission 30 days post discharge.

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	October 2014 - March 2015, up to 6 months	Length of stay in the hospital will be calculated by looking at the admission and discharge dates.

Trial Locations

Locations (4)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

Advocate Condell Medical Center; 🇺🇸 Libertyville, Illinois, United States

Advocate Good Shepherd Hospital; 🇺🇸 Barrington, Illinois, United States