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OpenTrials
Completed

NCT Number: NCT03011944

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate at Home, Des Plaines, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality improvement program

Other

Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.

Primary outcomes

  1. Hospital readmissions or admissions

    Time frame: Enrollment to Home Health to 90 Days

Secondary outcomes

  1. Healthcare resource utilization and costs

    Time frame: Enrollment to Home Health to 90 Days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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