A Nutrition-Focused QIP in Outpatient Clinics

Study Overview
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Brief Summary
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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.

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

Conditions
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Malnutrition

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality Improvement Program Basic and Enhanced Phase<br>Patients that meet the eligibility criteria and participate in the QIP. | |
| Retrospective Group<br>Patients seen a year prior to the QIP period at the clinic but that did not participate in the QIP. | |
| Concurrent Group<br>Patients seen during the QIP period at the clinic but that did not participate in the QIP. | |

What is the study measuring?
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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 |