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

NCT ID: NCT03011944

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Quality Improvement Program

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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Quality Improvement Program

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suela Sulo, PhD, MSc

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Advocate at Home

Des Plaines, Illinois, United States

Site Status

Advocate at Home- South Office

Oak Lawn, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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HA25

Identifier Type: -

Identifier Source: org_study_id

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