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

Malnutrition Clinical Trial

Official title:

Cost-effectiveness Study of the CIPA Screening Method for Patients With Nutritional Risk at Hospital Admission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721706
• Other study ID #: PI14/01226
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: November 2018
• Source: University Hospital of the Nuestra Señora de Candelaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• CIPA 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of the Nuestra Señora de Candelaria	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Álvarez-Hernández J, Planas Vila M, León-Sanz M, García de Lorenzo A, Celaya-Pérez S, García-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. — View Citation

Benítez Brito N, Mora Mendoza A, Suárez Llanos JP, Delgado Brito I, Pérez Méndez LI, Herrera Rodríguez EM, Oliva García JG, Pereyra-García 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. — View Citation

Benítez Brito N, Suárez Llanos JP, Fuentes Ferrer M, Oliva García JG, Delgado Brito I, Pereyra-García Castro F, Caracena Castellanos N, Acevedo Rodríguez 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. — View 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. — View Citation

Suárez Llanos JP, Benitez Brito N, Oliva García JG, Pereyra-García Castro F, López Frías MA, García Hernández A, Díaz Sirgo B, Llorente Gómez 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)		up to 3 months after Hospital discharge time
Secondary	incidence of mortality		up to 3 months after Hospital discharge time
Secondary	Quality of life measured by quality-adjusted life years (QALYs)		up to 3 months after Hospital discharge time
Secondary	mean length of stay (days)		through study completion, an average of 13 days
Secondary	incidence of readmissions		up to 3 months after hospital discharge time