A Nutrition-Focused QIP in Outpatient Clinics

NCT03628196 | Completed

• 1 other identifier: HA35
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Health Resource Utilization

  Number of visits

  Enrollment to 90 days

Secondary Outcomes (4)

• Change in Medication Usage

  Enrollment to 90 days

• Quality of Life (QOL) SF-12

  Enrollment to 90 days

• Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.

  Enrollment to 90 days

• Nutrition Care Program Health Care Professionals (HCPs) Survey

  90 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Poor nutritional status
• Estimated life expectancy of 90 days or greater
• Able to consume foods and beverages orally
• Literate and willing to sign informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead
• University of Southern California: collaborator

Study Sites (2)

Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics

Los Angeles, California, 90033, United States

Location

Pasadena - USC Healthcare Center

Pasadena, California, 91105, United States

Location

Related Publications (1)

• 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.

  PMID: 34009072 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Suela Sulo, PhD, Msc.

  Abbott Nutrition

  STUDY CHAIR

• Kurt Hong, MD, PhD, FACN

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 14, 2018
• Study Start: September 26, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (2)