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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03628196

Enrollment

1800

Registered

2018-08-14

Start date

2018-09-26

Completion date

2020-03-18

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Medication Usage	Enrollment to 90 days	Obtained from EMR
Quality of Life (QOL) SF-12	Enrollment to 90 days	Patient reported (QOL) questionnaire
Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.	Enrollment to 90 days	QIP patient completed 5-point Likert scale
Nutrition Care Program Health Care Professionals (HCPs) Survey	90 days	11, 5-point Likert scale questions, scaled in the positive direction; 9 program description questions

Countries

United States

Outcome results