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

Malnutrition Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011944
• Other study ID #: HA25
• Status: Completed
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1546
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Quality Improvement Program
Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.

Locations

Country	Name	City	State
United States	Advocate at Home	Des Plaines	Illinois
United States	Advocate at Home- South Office	Oak Lawn	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Nutrition	Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmissions or admissions		Enrollment to Home Health to 90 Days
Secondary	Healthcare resource utilization and costs		Enrollment to Home Health to 90 Days