A Nutrition-Focused QIP in Outpatient Clinics

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics
    • Pasadena, California, United States, 91105
      • Pasadena - USC Healthcare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in participating outpatient centers of the USC health system.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Quality Improvement Program Basic and Enhanced Phase; Patients that meet the eligibility criteria and participate in the QIP.
Retrospective Group; Patients seen a year prior to the QIP period at the clinic but that did not participate in the QIP.
Concurrent Group; Patients seen during the QIP period at the clinic but that did not participate in the QIP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Resource Utilization	Number of visits	Enrollment to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medication Usage	Obtained from EMR	Enrollment to 90 days
Quality of Life (QOL) SF-12	Patient reported (QOL) questionnaire	Enrollment to 90 days
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
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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Collaborators: University of Southern California
• Investigators: Study Chair: Suela Sulo, PhD, Msc., Abbott Nutrition; Principal Investigator: Kurt Hong, MD, PhD, FACN, University of Southern California

Publications and helpful links

General Publications

• Hong K, Sulo S, Wang W, Kim S, Huettner L, Taroyan R, Kerr KW, Kaloostian C. Nutrition Care for Poorly Nourished Outpatients Reduces Resource Use and Lowers Costs. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211017014. doi: 10.1177/21501327211017014.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: HA35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No