A Nutrition-Focused QIP in Outpatient Clinics

NCT ID: NCT03628196

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-26

Study Completion Date

2020-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quality Improvement Program Basic and Enhanced Phase

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

No interventions assigned to this group

Retrospective Group

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

No interventions assigned to this group

Concurrent Group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern California

OTHER

Sponsor Role collaborator

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suela Sulo, PhD, Msc.

Role: STUDY_CHAIR

Abbott Nutrition

Kurt Hong, MD, PhD, FACN

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Los Angeles, California, United States

Site Status

Pasadena - USC Healthcare Center

Pasadena, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34009072 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HA35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Trial of Menu Labeling
NCT01948752 COMPLETED NA
Eat Well for Life: A Weight Loss Maintenance Study
NCT01849627 ACTIVE_NOT_RECRUITING NA