CompletedNot Applicable

A Nutrition-Focused QIP in Outpatient Clinics

United States1,800 participantsStarted 2018-09-26

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Health Resource Utilization

Timeframe: Enrollment to 90 days

Trial details

NCT IDNCT03628196

SponsorAbbott Nutrition

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-03-18

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