A Nutrition-Focused QIP in Outpatient Clinics

Completed

• Conditions: Malnutrition

• Registration Number: NCT03628196
• Lead Sponsor: Abbott Nutrition

Brief Summary

A nutrition-focused QIP will be implemented with a primary assessment of QIP feasibility, patient health and economic outcomes as well as patient and provider experience data. A 2-phased QIP study group will be prospectively enrolled from outpatient clinics affiliated with the USC health system and compared with historical and concurrent control groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2018-09-26
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• Poor nutritional status
• 2 or more chronic conditions (other than those listed as exclusions)
• Estimated life expectancy of 90 days or greater
• Able to consume foods and beverages orally
• Literate and willing to sign informed consent form

Exclusion Criteria

• Pregnant
• Normal nutritional status
• Unable to consume foods and beverages orally
• Estimated life expectancy of less than 90 days
• Severe dementia or delirium and no dedicated caregiver to assure compliance with QIP study requirements
• Uncontrolled eating disorder, significant neurological or psychiatric disorder (including substance abuse), or other conditions that may interfere with study product consumption or compliance
• Known allergy or intolerance to any ingredient found in ONS products recommended in QIP

Retrospective and Concurrent groups eligibility are reflective of the QIP eligibility criteria however, the timeframe differs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Resource Utilization	Enrollment to 90 days	Number of visits

Secondary Outcome Measures

Name	Time	Method
Nutrition Care Program Health Care Professionals (HCPs) Survey	90 days	11, 5-point Likert scale questions, scaled in the positive direction; 9 program description questions
Change in Medication Usage	Enrollment to 90 days	Obtained from EMR
Quality of Life (QOL) SF-12	Enrollment to 90 days	Patient reported (QOL) questionnaire
Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.	Enrollment to 90 days	QIP patient completed 5-point Likert scale

Trial Locations

Locations (2)

Pasadena - USC Healthcare Center; 🇺🇸 Pasadena, California, United States

Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics; 🇺🇸 Los Angeles, California, United States