MalnutritionNCT03011944
Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients
An observational study of Malnutrition, run by Abbott Nutrition at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Quality Improvement Program
- Type of treatment
- Pill or oral medicine
- How many people
- 1,546 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Malnourished patients receiving care in the targeted branch of the home health division of the health care system.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advocate at Home
Des Plaines, Illinois, 60018
Advocate at Home- South Office
Oak Lawn, Illinois, 60453
About this study
Official title: Assessing the Impact of a Comprehensive Nutrition-Focused Quality Improvement Program (QIP) on Health and Economic Outcomes of Malnourished Adult Patients Across the Continuum of Care
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.
- Conditions
- Malnutrition
- Being tested
- Quality Improvement Program
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement ProgramOther
Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Program | This group will consist of hospitalized and SNF, at-risk/malnourished patients being discharged to home health and outpatients at-risk/malnourished patients enrolled in home health. Receives: Other: Quality Improvement Program | |
| Control | This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmissions or admissions
Measured: Enrollment to Home Health to 90 Days
Secondary outcomes (1)
Healthcare resource utilization and costs
Measured: Enrollment to Home Health to 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Suela Sulo, PhD, MSc, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011944
- Sponsor's protocol ID
- HA25
- Status last verified
- May 2018
- First submitted
- 28 Dec 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Comprehensive Nutrition-Focused Quality Improvement Program (QIP) on Health and Economic Outcomes of Malnourished Adult Patients Across the Continuum of Care
- ClinicalTrials.gov ID
- NCT03011944
- Acronym / sponsor ID
- HA25
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,546 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Program | – | Other: Quality Improvement ProgramThis group will consist of hospitalized and SNF, at-risk/malnourished patients being discharged to home health and outpatients at-risk/malnourished patients enrolled in home health. |
| Control | – | –This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Malnourished patients receiving care in the targeted branch of the home health division of the health care system.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Improvement ProgramNutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care. | Other | Quality Improvement Program |
Primary outcome
Hospital readmissions or admissions
Time frame: Enrollment to Home Health to 90 Days
1 secondary outcome
Healthcare resource utilization and costs
Time frame: Enrollment to Home Health to 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suela Sulo, PhD, MSc study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Abbott Nutrition at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmissions or admissions (time frame: Enrollment to Home Health to 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.