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Cost-effectiveness Study of the New Nutrition Screening Tool CIPA at Hospital Admission

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CIPA nutritional screening tool
Sponsored by
University Hospital of the Nuestra Señora de Candelaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Malnutrition focused on measuring Nutrition assessment, inpatients, cost-benefit analysis, quality of life, body composition, mass screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Formal consent to participate in the study.
  • Patients admitted to the Internal Medicine or General Surgery wards.

Exclusion Criteria:

  • Patients treated with nutritional support before CIPA screening is performed.
  • Patients transferred from other wards.
  • Patients with an expected length of stay less than 72 hours.
  • CIPA screening unfeasible for any reason.
  • Patients with poor short-term prognosis.
  • Bed destination at hospital admission nonrandomized.
  • Patients participating in other investigation study.
  • Pregnancy

Sites / Locations

  • Hospital Universitario Nuestra Señora de Candelaria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CIPA screening tool

usual hospital clinical care

Arm Description

Patients are evaluated by CIPA nutritional screening tool

Patients are not subject of CIPA screening tool, and continue the usual hospital clinical care

Outcomes

Primary Outcome Measures

Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)

Secondary Outcome Measures

incidence of mortality
Quality of life measured by quality-adjusted life years (QALYs)
mean length of stay (days)
incidence of readmissions

Full Information

First Posted
March 1, 2016
Last Updated
November 11, 2018
Sponsor
University Hospital of the Nuestra Señora de Candelaria
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02721706
Brief Title
Cost-effectiveness Study of the New Nutrition Screening Tool CIPA at Hospital Admission
Official Title
Cost-effectiveness Study of the CIPA Screening Method for Patients With Nutritional Risk at Hospital Admission
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of the Nuestra Señora de Candelaria
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: To evaluate the cost-effectiveness of implementing a malnutrition screening tool "CIPA" at the Hospital Universitario Nuestra Señora de la Candelaria (HUNSC), comparing the impact on health and the healthcare costs of hospitalised patients who are screened for malnutrition and of patients following standard clinical practice. Methodology: The study will consist of a controlled trial on patients admitted to the Internal Medicine and General and Digestive Surgery wards at the HUNSC. In both wards patients will be assigned to a control or to an intervention group. The control group will follow usual hospital clinical care, while the intervention group will be administered the screening tool "CIPA" for early detection of malnutrition cases and they will be treated according to the screening results. The following variables will be evaluated: length of stay in hospital, mortality, readmissions and in-hospital complications. Cost-effectiveness analysis will be undertaken measuring effectiveness by Quality-Adjusted Life Years (QALYs). Cost per patient will be measured by identifying health care resource utilisation, and the cost-effectiveness measure will be the Incremental Cost-Effectiveness Ratio (ICER). Investigators will calculate the incremental cost per QALY gained related to the intervention. This analysis will allow to quantify the costs (incurred and saved) related to the introduction of the malnutrition screening tool CIPA in the hospital context and to measure the health impact of screened patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutrition assessment, inpatients, cost-benefit analysis, quality of life, body composition, mass screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
823 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIPA screening tool
Arm Type
Experimental
Arm Description
Patients are evaluated by CIPA nutritional screening tool
Arm Title
usual hospital clinical care
Arm Type
No Intervention
Arm Description
Patients are not subject of CIPA screening tool, and continue the usual hospital clinical care
Intervention Type
Other
Intervention Name(s)
CIPA nutritional screening tool
Intervention Description
The new nutritional screening tool termed CIPA includes Control of food Intake, Protein, and Anthropometry (CIPA) results positive when at least one of the following parameters is met: control of food intake for 72 h <50%, serum albumin <3 g/dl, body mass index <18.5 kg/m2 or mid-upper arm circumference ≤ 22.5 cm.
Primary Outcome Measure Information:
Title
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
Time Frame
up to 3 months after Hospital discharge time
Secondary Outcome Measure Information:
Title
incidence of mortality
Time Frame
up to 3 months after Hospital discharge time
Title
Quality of life measured by quality-adjusted life years (QALYs)
Time Frame
up to 3 months after Hospital discharge time
Title
mean length of stay (days)
Time Frame
through study completion, an average of 13 days
Title
incidence of readmissions
Time Frame
up to 3 months after hospital discharge time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Formal consent to participate in the study. Patients admitted to the Internal Medicine or General Surgery wards. Exclusion Criteria: Patients treated with nutritional support before CIPA screening is performed. Patients transferred from other wards. Patients with an expected length of stay less than 72 hours. CIPA screening unfeasible for any reason. Patients with poor short-term prognosis. Bed destination at hospital admission nonrandomized. Patients participating in other investigation study. Pregnancy
Facility Information:
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23165541
Citation
Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.
Results Reference
background
PubMed Identifier
24951997
Citation
Suarez Llanos JP, Benitez Brito N, Oliva Garcia JG, Pereyra-Garcia Castro F, Lopez Frias MA, Garcia Hernandez A, Diaz Sirgo B, Llorente Gomez de Segura I. [Introducing a mixed nutritional screening tool (CIPA) in a tertiary hospital]. Nutr Hosp. 2014 May 1;29(5):1149-53. doi: 10.3305/nh.2014.29.5.7299. Spanish.
Results Reference
background
PubMed Identifier
26667749
Citation
Benitez Brito N, Mora Mendoza A, Suarez Llanos JP, Delgado Brito I, Perez Mendez LI, Herrera Rodriguez EM, Oliva Garcia JG, Pereyra-Garcia Castro F. [CONCORDANCE IN THE RESULTS OF CONTROL INTAKE PERFORMANCE OF 72 H BY DIFFERENT HEALTH PROFESSIONALS IN A TERTIARY HOSPITAL]. Nutr Hosp. 2015 Dec 1;32(6):2893-7. doi: 10.3305/nh.2015.32.6.9740. Spanish.
Results Reference
background
PubMed Identifier
23688831
Citation
van Bokhorst-de van der Schueren MA, Guaitoli PR, Jansma EP, de Vet HC. Nutrition screening tools: does one size fit all? A systematic review of screening tools for the hospital setting. Clin Nutr. 2014 Feb;33(1):39-58. doi: 10.1016/j.clnu.2013.04.008. Epub 2013 Apr 19.
Results Reference
background
PubMed Identifier
15681104
Citation
Kruizenga HM, Seidell JC, de Vet HC, Wierdsma NJ, van Bokhorst-de van der Schueren MA. Development and validation of a hospital screening tool for malnutrition: the short nutritional assessment questionnaire (SNAQ). Clin Nutr. 2005 Feb;24(1):75-82. doi: 10.1016/j.clnu.2004.07.015.
Results Reference
background
PubMed Identifier
27494612
Citation
Benitez Brito N, Suarez Llanos JP, Fuentes Ferrer M, Oliva Garcia JG, Delgado Brito I, Pereyra-Garcia Castro F, Caracena Castellanos N, Acevedo Rodriguez CX, Palacio Abizanda E. Relationship between Mid-Upper Arm Circumference and Body Mass Index in Inpatients. PLoS One. 2016 Aug 5;11(8):e0160480. doi: 10.1371/journal.pone.0160480. eCollection 2016.
Results Reference
background
PubMed Identifier
28424063
Citation
Suarez-Llanos JP, Benitez-Brito N, Vallejo-Torres L, Delgado-Brito I, Rosat-Rodrigo A, Hernandez-Carballo C, Ramallo-Farina Y, Pereyra-Garcia-Castro F, Carlos-Romero J, Felipe-Perez N, Garcia-Niebla J, Calderon-Ledezma EM, Gonzalez-Melian TJ, Llorente-Gomez de Segura I, Barrera-Gomez MA. Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol. BMC Health Serv Res. 2017 Apr 20;17(1):292. doi: 10.1186/s12913-017-2218-z.
Results Reference
derived

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Cost-effectiveness Study of the New Nutrition Screening Tool CIPA at Hospital Admission

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