This trial is active, not recruiting.

Condition malnutrition
Treatment cipa nutritional screening tool
Sponsor University Hospital of the Nuestra Señora de Candelaria
Collaborator Instituto de Salud Carlos III
Start date January 2015
End date September 2016
Trial size 824 participants
Trial identifier NCT02721706, PI14/01226


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 randomised 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose screening
Patients are evaluated by CIPA nutritional screening tool
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)
Patients are not subject of CIPA screening tool, and continue the usual hospital clinical care

Primary Outcomes

Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
time frame: up to 3 months after Hospital discharge time

Secondary Outcomes

incidence of mortality
time frame: 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
mean length of stay (days)
time frame: through study completion, an average of 13 days
incidence of readmissions
time frame: up to 3 months after hospital discharge time

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cost-effectiveness Study of the CIPA Screening Method for Patients With Nutritional Risk at Hospital Admission
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital of the Nuestra Señora de Candelaria.