Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission (Nutriker)

Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.

This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

Study Overview

• Status: Unknown
• Conditions: Malnutrition
• Intervention / Treatment: Other: Malnourished patients

Detailed Description

All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.

Data concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.

A qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: DRI Direction de la recherhce clinique; Phone Number: 0299282555; Email: dri@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Rennes University Hospital
    • Contact: Lilian Alix; Email: lilian.alix@chu-rennes.fr
    • Principal Investigator: Lilian Alix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Malnourished patients diagnosed during their hospitalization in the post-emergency unit of Rennes Universisty Hospital

Description

Inclusion Criteria:

• Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :
• age ≥ 70 years old: weight loss ≥ 5% within 1 month or ≥ 10% within 6 months and/or BMI <21 and or serum albumin level < 35 g/l
• age < 70 years old : weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to the usual weight before the onset of the disease; or BMI <18.5 kg / m2

Non-inclusion criteria :

• refusing to participate in the study
• age < 18 years old
• patients under tutorship or guardianship
• patients living in retirement home
• Patients without a fixed address

Exclusion criteria :

-patients transferred in another unit

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Malnourished patients	Other: Malnourished patients; Data of included patients will be recorded during hospitalization using medical charts. Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evolution of malnutrition after hospital discharge	Malnutrition diagnostic criteria defined by the French Health Authority : If age ≥ 70 years old : weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 21 kg/m² and/or serum albumin level < 35 g/l; If age < 70 years old: weight loss ≥ 5% within 1 month and/or ≥ 10% within 6 months and/or BMI < 18,5 kg/m² level	3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital	Number of hospital readmissions; Number of family physician consultations	3 months after discharge
Evaluate appropriation of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Evaluate the perception of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Evaluate expectations of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Evaluate the needs of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Evaluate the expectations of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Evaluate knowledge of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2020
• Primary Completion (ANTICIPATED): October 4, 2020
• Study Completion (ANTICIPATED): October 4, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: qualitative study; Malnutrition,
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 35RC19_30034_NUTRIKer; 2019-A01809-48 (OTHER: ansm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No