Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients

Malnutrition Clinical Trial

Official title:

Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02262429
• Other study ID #: HA13
• Status: Terminated
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 5, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2386
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 18 years of age.

• Patient is screened for malnutrition with an MST score = 2 (see Appendix C).

• Patient has length of stay of hospital stay > 2 days.

• Patient is able to consume foods and beverages orally.

• Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital stay in connection with the QIP.

Exclusion Criteria:

• Patient is pregnant.

• Patient is intubated, receiving tube feeding or parenteral nutrition.

• Patient unable to provide HIPAA authorization and informed consent.

• Patient is discharged to hospice care.

• Patient has a condition that would preclude ingestion / absorption of the oral nutritional supplements, including allergic response to any ONS ingredient.

• Patient has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder.

• Patient has stated an allergy or intolerance to any of the ingredients in the study products.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• ONS QIP
Rapid comprehensive ONS, dietary consult, follow up phone calls
• ONS Standard Feeding
Standard of care

Locations

Country	Name	City	State
United States	Advocate Good Shepherd Hospital	Barrington	Illinois
United States	Advocate Condell Medical Center	Libertyville	Illinois
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Advocate Lutheran General Hospital	Park Ridge	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	Post-discharge readmissions	Non-elective readmission 30 days post discharge.	November 2014 - April 2015, 30 days post discharge	No
Secondary	Hospital length of stay	Length of stay in the hospital will be calculated by looking at the admission and discharge dates.	October 2014 - March 2015, up to 6 months	No