Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients

May 24, 2018 updated by: Abbott Nutrition

Assessing the Impact of a Comprehensive Nutrition-Focused Quality Improvement Program (QIP) on Health and Economic Outcomes of Malnourished Adult Patients Across the Continuum of Care

A nutrition-focused QIP will be implemented as standard of care at select branches of the home health division of the health care system. The QIP will be comprised of three groups of patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being discharged to home health. Groups will be followed for 90 days post enrollment. The QIP groups will be compared to historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1546

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
      • Des Plaines, Illinois, United States, 60018
        • Advocate at Home
      • Oak Lawn, Illinois, United States, 60453
        • Advocate at Home- South Office

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Malnourished patients receiving care in the targeted branch of the home health division of the health care system.

Description

Inclusion Criteria:

  • Admitted to home health from within the healthcare system's hospitals, skilled nursing facility (SNF) or outpatient clinics
  • Patient is screened positive for malnutrition during hospital stay and/or by home health nutrition screening tool upon enrollment into home health
  • Patient is able to consume foods and beverages orally and the physician has not indicated otherwise

Exclusion Criteria:

  • Enrollment to home health from a hospital, SNF or outpatient clinic not affiliated with the healthcare system
  • Patient is pregnant
  • Patient is intubated, receiving tube feeding or parenteral nutrition
  • Patient has severe dementia or delirium
  • History of significant psychiatric disorder
  • Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures as per the admitting clinicians
  • Subject has stated an allergy or intolerance to any of the ONS ingredients
  • Patients receiving hospice care

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Quality Improvement Program
This group will consist of hospitalized and SNF, at-risk/malnourished patients being discharged to home health and outpatients at-risk/malnourished patients enrolled in home health.
Other: Quality Improvement Program
Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.
Control
This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital readmissions or admissions
Time Frame: Enrollment to Home Health to 90 Days
Enrollment to Home Health to 90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Healthcare resource utilization and costs
Time Frame: Enrollment to Home Health to 90 Days
Enrollment to Home Health to 90 Days

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 Chair: Suela Sulo, PhD, MSc, Abbott Nutrition

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

December 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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