Clinical trial NCT02262429: Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients
Official title: Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2014-10-13
Enrollment: 2386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly admitted patients to four hospitals within the Advocate Health Care System that have been identifed to be at risk for malnutrition.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-discharge readmissions
timeFrame: November 2014 - April 2015, 30 days post discharge
Secondary outcomes:
measure: Hospital length of stay
timeFrame: October 2014 - March 2015, up to 6 months
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Advocate Good Shepherd Hospital
state: Illinois
city: Libertyville
country: United States
facility: Advocate Condell Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Abbott Nutrition
name: Jamie Partridge, PhD, MBA
role: STUDY_DIRECTOR
References:
citation: Sriram K, Sulo S, VanDerBosch G, Kozmic S, Sokolowski M, Summerfelt WT, Partridge J, Hegazi R, Nikolich S. Nutrition-Focused Quality Improvement Program Results in Significant Readmission and Length of Stay Reductions for Malnourished Surgical Patients. JPEN J Parenter Enteral Nutr. 2018 Aug;42(6):1093-1098. doi: 10.1002/jpen.1040. Epub 2018 Feb 2.