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

November 11, 2018 updated by: José Pablo Suárez Llanos, University Hospital of the Nuestra Señora de Candelaria

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
823

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CIPA screening tool
Patients are evaluated by CIPA nutritional screening tool
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.
No Intervention: usual hospital clinical care
Patients are not subject of CIPA screening tool, and continue the usual hospital clinical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
Time Frame: up to 3 months after Hospital discharge time
up to 3 months after Hospital discharge time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
incidence of mortality
Time Frame: up to 3 months after Hospital discharge time
up to 3 months after Hospital discharge time
Quality of life measured by quality-adjusted life years (QALYs)
Time Frame: up to 3 months after Hospital discharge time
up to 3 months after Hospital discharge time
mean length of stay (days)
Time Frame: through study completion, an average of 13 days
through study completion, an average of 13 days
incidence of readmissions
Time Frame: up to 3 months after hospital discharge time
up to 3 months after hospital discharge time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital of the Nuestra Señora de Candelaria

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI14/01226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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