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

October 1, 2020 updated by: Abbott Nutrition

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Historical Control Group
Retrospective chart review
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Malnutrition
Time Frame: Change from Baseline to Week 10 post-QIP enrollment
Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition
Change from Baseline to Week 10 post-QIP enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare Resource Utilization
Time Frame: 10-weeks follow-up period post enrollment from ambulatory care facility
Chart Review
10-weeks follow-up period post enrollment from ambulatory care facility

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: Baseline and Week 10 post-QIP enrollment
BMI calculated Weight (kg)/Height (m)2
Baseline and Week 10 post-QIP enrollment
Calf Circumference (CC)
Time Frame: Baseline and Week 10 post-QIP enrollment
Measurement at largest circumference of calf
Baseline and Week 10 post-QIP enrollment
Short Physical Performance Battery (SPPB)
Time Frame: Baseline and Week 10 post-QIP enrollment
Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction
Baseline and Week 10 post-QIP enrollment
Hand Grip
Time Frame: Baseline and Week 10 post-QIP enrollment
Participant assessed with hand dynamometers
Baseline and Week 10 post-QIP enrollment
Quality of Life EuroQOL EQ-5D
Time Frame: Baseline and Week 10 post-QIP
Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction
Baseline and Week 10 post-QIP
Nutritional Supplement Consumption
Time Frame: Baseline and Week 10 post-QIP
Participant reported
Baseline and Week 10 post-QIP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Collaborators

Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Investigators

  • Study Chair: Suela Sulo, PhD, MSc, Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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