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MalnutritionNCT02721706

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

A study testing CIPA nutritional screening tool in people with Malnutrition, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malnutrition
What is being tested?
CIPA nutritional screening tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
823 participants
Where
1 siteSpain
Study dates
Jan 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

Other trials in Spain

About this study

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

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.

Conditions
Malnutrition
Being tested
CIPA nutritional screening tool
Keywords
Nutrition assessment, inpatients, cost-benefit analysis, quality of life, body composition, mass screening
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIPA nutritional screening toolOther

    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.

Study groups in NCT02721706
Study groupRoleWhat they receive
CIPA screening toolExperimentalPatients are evaluated by CIPA nutritional screening tool
Receives: Other: CIPA nutritional screening tool
usual hospital clinical careNo interventionPatients are not subject of CIPA screening tool, and continue the usual hospital clinical care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 3 months after Hospital discharge time

Secondary outcomes (4)

  1. incidence of mortality

    Measured: up to 3 months after Hospital discharge time

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

    Measured: up to 3 months after Hospital discharge time

  3. mean length of stay (days)

    Measured: through study completion, an average of 13 days

  4. incidence of readmissions

    Measured: up to 3 months after hospital discharge time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2017
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721706
Sponsor's protocol ID
PI14/01226
Status last verified
Nov 2018
First submitted
1 Mar 2016
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing CIPA nutritional screening tool in people with Malnutrition, run by University Hospital of the Nuestra Señora de Candelaria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER) (time frame: up to 3 months after Hospital discharge time). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02721706, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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