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

NCT03011944 | Completed

• 1 other identifier: HA25
• Study Type: observational
• Target: 1,546
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Hospital readmissions or admissions

  Enrollment to Home Health to 90 Days

Secondary Outcomes (1)

• Healthcare resource utilization and costs

  Enrollment to Home Health to 90 Days

Study Arms (2)

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

Control

This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.

Interventions

Quality Improvement Program OTHER

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

Quality Improvement Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

Advocate at Home

Des Plaines, Illinois, 60018, United States

Location

Advocate at Home- South Office

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Suela Sulo, PhD, MSc

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

US (2)