Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients

NCT ID: NCT04042987

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-06-12

Brief Summary

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This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Historical Control Group

Retrospective chart review

No interventions assigned to this group

Prospective QIP Group

Participants that meet eligibility criteria will be prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient is screened as being malnourished or at risk for malnutrition
* Patient can consumer beverages and food orally
* Patients have a life expectancy of equal or greater than 90 days
* Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained

Exclusion Criteria

* Patient is pregnant
* Patient is intubated, receiving tube feeding or parenteral nutrition
* Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials
* Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures
* Patient has an allergy or intolerance to any of the ONS ingredients
* Patients does not want to participate or sign ICF
* Patient is bedridden or confined in a wheelchair
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

UNKNOWN

Sponsor Role collaborator

Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suela Sulo, PhD, MSc

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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Gomez G, Botero-Rodriguez F, Misas JD, Garcia-Cifuentes E, Sulo S, Brunton C, Venegas-Sanabria LC, Gracia DA, Cano Gutierrez CA. A nutritionally focused program for community-living older adults resulted in improved health and well-being. Clin Nutr. 2022 Jul;41(7):1549-1556. doi: 10.1016/j.clnu.2022.05.003. Epub 2022 May 13.

Reference Type DERIVED
PMID: 35667271 (View on PubMed)

Chavarro-Carvajal DA, Ayala AM, Venegas-Sanabria LC, Gomez G, Sulo S, Misas JD, Cano-Gutierrez C. Use of a nutrition-focused quality improvement program for community-living older adults at malnutrition risk is associated with better nutritional outcomes. Clin Nutr ESPEN. 2022 Apr;48:291-297. doi: 10.1016/j.clnesp.2022.01.032. Epub 2022 Feb 2.

Reference Type DERIVED
PMID: 35331504 (View on PubMed)

Other Identifiers

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HA38

Identifier Type: -

Identifier Source: org_study_id

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