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NCT Number: NCT02721706

Cost-effectiveness Study of the New Nutrition Screening Tool CIPA 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIPA nutritional screening tool

Other

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 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

Sponsors and collaborators

Lead sponsor

University Hospital of the Nuestra Señora de Candelaria

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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