Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients (NCT03011944) | Clinical Trial Compass
CompletedNot Applicable
Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients
United States1,546 participantsStarted 2016-12
Plain-language summary
A nutrition-focused QIP will be implemented as standard of care at select branches of the home health division of the health care system. The QIP will be comprised of three groups of patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being discharged to home health. Groups will be followed for 90 days post enrollment. The QIP groups will be compared to historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Admitted to home health from within the healthcare system's hospitals, skilled nursing facility (SNF) or outpatient clinics
* Patient is screened positive for malnutrition during hospital stay and/or by home health nutrition screening tool upon enrollment into home health
* Patient is able to consume foods and beverages orally and the physician has not indicated otherwise
Exclusion Criteria:
* Enrollment to home health from a hospital, SNF or outpatient clinic not affiliated with the healthcare system
* Patient is pregnant
* Patient is intubated, receiving tube feeding or parenteral nutrition
* Patient has severe dementia or delirium
* History of significant psychiatric disorder
* Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures as per the admitting clinicians
* Subject has stated an allergy or intolerance to any of the ONS ingredients
* Patients receiving hospice care
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.