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OpenTrials
Completed

NCT Number: NCT03628196

A Nutrition-Focused QIP in Outpatient Clinics

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keck Medical Center of USC, Internal Medicine and Family Medicine Clinics, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

QIP Group

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Health Resource Utilization

    Time frame: Enrollment to 90 days

    Number of visits

Secondary outcomes

  1. Change in Medication Usage

    Time frame: Enrollment to 90 days

    Obtained from EMR

  2. Quality of Life (QOL) SF-12

    Time frame: Enrollment to 90 days

    Patient reported (QOL) questionnaire

  3. Satisfaction with Nutritional Care including screening, education and oral nutrition supplementation recommendations and follow up.

    Time frame: Enrollment to 90 days

    QIP patient completed 5-point Likert scale

  4. Nutrition Care Program Health Care Professionals (HCPs) Survey

    Time frame: 90 days

    11, 5-point Likert scale questions, scaled in the positive direction; 9 program description questions

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Collaborators

  • University of Southern California

Registry information

Official study title

Assessing the Feasibility and Effectiveness of a Nutrition-Focused Quality Improvement Program (QIP) in Outpatient Clinics Affiliated With an Academic Health System

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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