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CompletedNCT02721706Updated Nov 14, 2018

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

An interventional study of CIPA nutritional screening tool in Malnutrition, sponsored by University Hospital of the Nuestra Señora de Candelaria. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by University Hospital of the Nuestra Señora de Candelaria · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
823
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Malnutrition

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Keywords

  • Nutrition assessment
  • inpatients
  • cost-benefit analysis
  • quality of life
  • body composition
  • mass screening
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 823 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University Hospital of the Nuestra Señora de Candelaria is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
823 participants (actual)

Study arms

  • Experimental
    CIPA screening tool

    Patients are evaluated by CIPA nutritional screening tool

    Other: CIPA nutritional screening tool

  • No intervention
    usual hospital clinical care

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

Interventions

  • OtherCIPA nutritional screening tool

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: up to 3 months after Hospital discharge time

Secondary outcomes

  1. incidence of mortality

    Time frame: up to 3 months after Hospital discharge time

  2. Quality of life measured by quality-adjusted life years (QALYs)

    Time frame: up to 3 months after Hospital discharge time

  3. mean length of stay (days)

    Time frame: through study completion, an average of 13 days

  4. incidence of readmissions

    Time frame: up to 3 months after hospital discharge time

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Study locations

1 site
  • Hospital Universitario Nuestra Señora de Candelaria
    Santa Cruz de Tenerife, 38010, Spain
08

References and documents

Publications

  • 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. PubMed 23165541 ↗
  • 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. PubMed 24951997 ↗
  • 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. PubMed 26667749 ↗
  • 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. PubMed 23688831 ↗
  • 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. PubMed 15681104 ↗
  • 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. PubMed 27494612 ↗
  • 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. PubMed 28424063 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02721706
Lead sponsor
University Hospital of the Nuestra Señora de Candelaria
Collaborators
Instituto de Salud Carlos III
Responsible party
José Pablo Suárez Llanos (Ph.D, M.D., University Hospital of the Nuestra Señora de Candelaria) — Principal investigator
First posted
Mar 29, 2016
Start date
Jan 2015
Primary completion
Oct 2017
Completion
Feb 2018
Last update
Nov 14, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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