Clinical trial NCT04042987: Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients
Official title: Assessing Malnutrition Prevalence and Impact of a Nutrition-Focused Quality Improvement Program (QIP) Among Community-Dwelling Malnourished Colombian Patients Receiving Care in an Ambulatory Health Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
First posted: 2019-08-02
Enrollment: 1325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sites will recruit patients for QIP group at discharge from hospital (after 3 months) or in ambulatory care facility.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Malnutrition
timeFrame: Change from Baseline to Week 10 post-QIP enrollment
Secondary outcomes:
measure: Healthcare Resource Utilization
timeFrame: 10-weeks follow-up period post enrollment from ambulatory care facility
Other outcomes:
measure: Body mass index (BMI)
timeFrame: Baseline and Week 10 post-QIP enrollment
measure: Calf Circumference (CC)
timeFrame: Baseline and Week 10 post-QIP enrollment
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and Week 10 post-QIP enrollment
measure: Hand Grip
timeFrame: Baseline and Week 10 post-QIP enrollment
measure: Quality of Life EuroQOL EQ-5D
timeFrame: Baseline and Week 10 post-QIP
measure: Nutritional Supplement Consumption
timeFrame: Baseline and Week 10 post-QIP
Locations:
city: Bogota,
country: Colombia
facility: Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana
Study officials:
affiliation: Abbott Nutrition
name: Suela Sulo, PhD, MSc
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.