NCT02262429

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

10 months

First QC Date

October 8, 2014

Last Update Submit

October 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-discharge readmissions

    Non-elective readmission 30 days post discharge.

    November 2014 - April 2015, 30 days post discharge

Secondary Outcomes (1)

  • Hospital length of stay

    October 2014 - March 2015, up to 6 months

Study Arms (2)

ONS QIP

Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP.

Other: ONS QIP

ONS Standard Feeding

Two (2) hospitals will use their current "standard" ONS feeding protocol.

Other: ONS Standard Feeding

Interventions

ONS QIPOTHER

Rapid comprehensive ONS, dietary consult, follow up phone calls

ONS QIP

Standard of care

ONS Standard Feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

Location

Advocate Condell Medical Center

Libertyville, Illinois, 60048, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jamie Partridge, PhD, MBA

    Abbott Nutrition

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations