MalnutritionNCT02262429
Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients
An observational study of Malnutrition, run by Abbott Nutrition at 4 sites in United States.
Trial summary
Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- ONS QIP and ONS Standard Feeding
- Type of treatment
- Pill or oral medicine
- How many people
- 2,386 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Aug 2015
- 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: Newly admitted patients to four hospitals within the Advocate Health Care System that have been identifed to be at risk for malnutrition.
Who may be able to join
- Patient is ≥ 18 years of age.
- Patient is screened for malnutrition with an MST score ≥ 2 (see Appendix C).
- Patient has length of stay of hospital stay > 2 days.
- Patient is able to consume foods and beverages orally.
- Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital stay in connection with the QIP.
Who cannot join
- Patient is pregnant.
- Patient is intubated, receiving tube feeding or parenteral nutrition.
- Patient unable to provide HIPAA authorization and informed consent.
- Patient is discharged to hospice care.
- Patient has a condition that would preclude ingestion / absorption of the oral nutritional supplements, including allergic response to any ONS ingredient.
- Patient has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder.
- Patient has stated an allergy or intolerance to any of the ingredients in the study products.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Advocate Condell Medical Center
Libertyville, Illinois, 60048
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?
Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.
- Conditions
- Malnutrition
- Being tested
- ONS QIP, ONS Standard Feeding
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS QIPOther
Rapid comprehensive ONS, dietary consult, follow up phone calls
ONS Standard FeedingOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| ONS QIP | Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP. Receives: Other: ONS QIP | |
| ONS Standard Feeding | Two (2) hospitals will use their current "standard" ONS feeding protocol. Receives: Other: ONS Standard Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge readmissions
Non-elective readmission 30 days post discharge.
Measured: November 2014 - April 2015, 30 days post discharge
Secondary outcomes (1)
Hospital length of stay
Length of stay in the hospital will be calculated by looking at the admission and discharge dates.
Measured: October 2014 - March 2015, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,386 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
- Jamie Partridge, PhD, MBA, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262429
- Sponsor's protocol ID
- HA13
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sriram K, Sulo S, VanDerBosch G, Kozmic S, Sokolowski M, Summerfelt WT, Partridge J, Hegazi R, Nikolich S. Nutrition-Focused Quality Improvement Program Results in Significant Readmission and Length of Stay Reductions for Malnourished Surgical Patients. JPEN J Parenter Enteral Nutr. 2018 Aug;42(6):1093-1098. doi: 10.1002/jpen.1040. Epub 2018 Feb 2.
PubMed 29392736
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?
- ClinicalTrials.gov ID
- NCT02262429
- Acronym / sponsor ID
- HA13
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2,386 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Oct 2014 (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.
Newly admitted patients will be screened for risk of malnutrition. Patients will receive either the feeding protocol or current oral nutrition supplement (ONS) practice, pending location. Patients will continue the nutrition plan taking the supplement post discharge. Study team will follow-up with telephone calls to help support post-discharge ONS compliance. Quality and service utilization data will be gathered for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS QIP | – | Other: ONS QIPTwo (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP. |
| ONS Standard Feeding | – | Other: ONS Standard FeedingTwo (2) hospitals will use their current "standard" ONS feeding protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly admitted patients to four hospitals within the Advocate Health Care System that have been identifed to be at risk for malnutrition.
Key inclusion criteria (5 listed)
- Patient is ≥ 18 years of age.
- Patient is screened for malnutrition with an MST score ≥ 2 (see Appendix C).
- Patient has length of stay of hospital stay > 2 days.
- Patient is able to consume foods and beverages orally.
- Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital stay in connection with the QIP.
Key exclusion criteria (7 listed)
- Patient is pregnant.
- Patient is intubated, receiving tube feeding or parenteral nutrition.
- Patient unable to provide HIPAA authorization and informed consent.
- Patient is discharged to hospice care.
- Patient has a condition that would preclude ingestion / absorption of the oral nutritional supplements, including allergic response to any ONS ingredient.
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 |
|---|---|---|
| ONS QIPRapid comprehensive ONS, dietary consult, follow up phone calls | Other | ONS QIP |
| ONS Standard FeedingStandard of care | Other | ONS Standard Feeding |
Primary outcome
Post-discharge readmissions
Time frame: November 2014 - April 2015, 30 days post discharge
Non-elective readmission 30 days post discharge.
1 secondary outcome
Hospital length of stay
Time frame: October 2014 - March 2015, up to 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- Derived from this study: PubMed 29392736Sriram K, Sulo S, VanDerBosch G, Kozmic S, Sokolowski M, Summerfelt WT, Partridge J, Hegazi R, Nikolich S. Nutrition-Focused Quality Improvement Program Results in Significant Readmission and Length of Stay Reductions for Malnourished Surgical Patients. JPEN J Parenter Enteral Nutr. 2018 Aug;42(6):1093-1098. doi: 10.1002/jpen.1040. Epub 2018 Feb 2.
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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.
Jamie Partridge, PhD, MBA study director
Abbott Nutrition
4 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 4 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early. Results are not available in the source record.
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?
Post-discharge readmissions (time frame: November 2014 - April 2015, 30 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262429, which also lists 1 linked publication.
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 7 Oct 2015.