A Nutrition-Focused QIP in Outpatient Clinics

Abbott

Status: Completed

Conditions: Malnutrition

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03628196

HA35

Details and patient eligibility

About

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.

Enrollment: 1,800 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,800 participants in 3 patient groups

Quality Improvement Program Basic and Enhanced Phase

Description:

Patients that meet the eligibility criteria and participate in the QIP.

Retrospective Group

Description:

Patients seen a year prior to the QIP period at the clinic but that did not participate in the QIP.

Concurrent Group

Description:

Patients seen during the QIP period at the clinic but that did not participate in the QIP.