Clinical trial NCT03628196: A Nutrition-Focused QIP in Outpatient Clinics
Official title: Assessing the Feasibility and Effectiveness of a Nutrition-Focused Quality Improvement Program (QIP) in Outpatient Clinics Affiliated With an Academic Health System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2018-08-14
Enrollment: 1800
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in participating outpatient centers of the USC health system.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Health Resource Utilization
timeFrame: Enrollment to 90 days
Secondary outcomes:
measure: Change in Medication Usage
timeFrame: Enrollment to 90 days
measure: Quality of Life (QOL) SF-12
timeFrame: Enrollment to 90 days
measure: Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.
timeFrame: Enrollment to 90 days
measure: Nutrition Care Program Health Care Professionals (HCPs) Survey
timeFrame: 90 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics
state: California
city: Pasadena
country: United States
facility: Pasadena - USC Healthcare Center
state: California
Study officials:
affiliation: Abbott Nutrition
name: Suela Sulo, PhD, Msc.
role: STUDY_CHAIR
affiliation: University of Southern California
name: Kurt Hong, MD, PhD, FACN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.