MalnutritionNCT03628196
A Nutrition-Focused QIP in Outpatient Clinics
An observational study of Malnutrition, run by Abbott Nutrition at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 1,800 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2018to 18 Mar 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in participating outpatient centers of the USC health system.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics
Los Angeles, California, 90033
Pasadena - USC Healthcare Center
Pasadena, California, 91105
About this study
Official title: Assessing the Feasibility and Effectiveness of a Nutrition-Focused Quality Improvement Program (QIP) in Outpatient Clinics Affiliated With an Academic Health System
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.
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Program Basic and Enhanced Phase | Patients that meet the eligibility criteria and participate in the QIP. | |
| Retrospective Group | Patients seen a year prior to the QIP period at the clinic but that did not participate in the QIP. | |
| Concurrent Group | Patients seen during the QIP period at the clinic but that did not participate in the QIP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Resource Utilization
Number of visits
Measured: Enrollment to 90 days
Secondary outcomes (4)
Change in Medication Usage
Obtained from EMR
Measured: Enrollment to 90 days
Quality of Life (QOL) SF-12
Patient reported (QOL) questionnaire
Measured: Enrollment to 90 days
Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.
QIP patient completed 5-point Likert scale
Measured: Enrollment to 90 days
Nutrition Care Program Health Care Professionals (HCPs) Survey
11, 5-point Likert scale questions, scaled in the positive direction; 9 program description questions
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start26 Sep 2018
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
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
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- Suela Sulo, PhD, Msc., Study chair, Abbott NutritionKurt Hong, MD, PhD, FACN, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628196
- Sponsor's protocol ID
- HA35
- Status last verified
- Jul 2020
- First submitted
- 6 Aug 2018
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34009072
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Effectiveness of a Nutrition-Focused Quality Improvement Program (QIP) in Outpatient Clinics Affiliated With an Academic Health System
- ClinicalTrials.gov ID
- NCT03628196
- Acronym / sponsor ID
- HA35
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Program Basic and Enhanced Phase | – | –Patients that meet the eligibility criteria and participate in the QIP. |
| Retrospective Group | – | –Patients seen a year prior to the QIP period at the clinic but that did not participate in the QIP. |
| Concurrent Group | – | –Patients seen during the QIP period at the clinic but that did not participate in the QIP. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in participating outpatient centers of the USC health system.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Resource Utilization
Time frame: Enrollment to 90 days
Number of visits
4 secondary outcomes
Change in Medication Usage
Time frame: Enrollment to 90 days
Quality of Life (QOL) SF-12
Time frame: Enrollment to 90 days
Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.
Time frame: Enrollment to 90 days
Nutrition Care Program Health Care Professionals (HCPs) Survey
Time frame: 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 20 Jul 2020.
- Derived from this study: PubMed 34009072Hong 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.
- 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
Kurt Hong, MD, PhD, FACN principal investigator
University of Southern California
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 5 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 20 Jul 2020. 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?
Health Resource Utilization (time frame: Enrollment to 90 days). 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 NCT03628196, 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 20 Jul 2020.