A Nutrition-Focused QIP in Outpatient Clinics

Malnutrition Clinical Trial

Official title:

Assessing the Feasibility and Effectiveness of a Nutrition-Focused Quality Improvement Program (QIP) in Outpatient Clinics Affiliated With an Academic Health System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628196
• Other study ID #: HA35
• Status: Completed
• Start date: September 26, 2018
• Est. completion date: March 18, 2020

Study information

• Verified date: July 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

QIP Group

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.

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
United States	Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics	Los Angeles	California
United States	Pasadena - USC Healthcare Center	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Nutrition	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

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