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

October 5, 2015 updated by: Abbott Nutrition

Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shepherd Hospital
      • Libertyville, Illinois, United States, 60048
        • Advocate Condell Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ONS QIP
Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP.
Other: ONS QIP
Rapid comprehensive ONS, dietary consult, follow up phone calls
ONS Standard Feeding
Two (2) hospitals will use their current "standard" ONS feeding protocol.
Other: ONS Standard Feeding
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-discharge readmissions
Time Frame: November 2014 - April 2015, 30 days post discharge
Non-elective readmission 30 days post discharge.
November 2014 - April 2015, 30 days post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 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.
October 2014 - March 2015, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Collaborators

Advocate Health Care

Investigators

  • Study Director: Jamie Partridge, PhD, MBA, Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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