Clinical trial · Interventional
Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition
Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: To evaluate the effectiveness, and cost-effectiveness, of three hospitalized patient care strategies in relation to disease-related malnutrition (DRM) hospital admissions based on results such as length of stay of the index admission, and from admission until one year after admission, mortality rate, appearance of complications, changes in weight and nutritional state, changes in their health related quality of life and functional status, readmissions, use of health services resources (primary care, hospital and emergency consultations) and costs. Methodology: Intervention study involving three hospitals with three branches in which, after nutritional screening in all centers, the first branch / hospital includes a intervention strategy for nutritional improvement in patients who after screening are identified as having DRE or at risk of DRE, and follow-up of other patients; a second cohort / hospital will include similar patients in which if there is any nutritional intervention it will be carried out by demand of the medical staff in charge of the patient; and a third branch /hospital in which the usual practice of the center will be followed without any explicit intervention. Subjects of the study: At least 300 patients in each center admitted to the digestive services, due to digestive pathologies, and surgery services due to tumor and digestive system pathologies. In all patients, sociodemographic and clinical data will be collected and of the outcomes described above during admission and until the year of follow-up. Statistical analysis: through appropriate multiple regression models for each outcome variable and with adjustments through propensity scores to compare the three centers based on each outcome parameter. A cost-effectiveness analysis will be carried out through of the incremental cost for each year of quality-adjusted life (QALY) .
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Crohn Disease | — | UNRESOLVED | — |
| Esophagus Cancer | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatitis, Acute | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| By demand | Dietary Supplement | — | UNRESOLVED |
| Nutritional dietary intervention | Dietary Supplement | — | UNRESOLVED |
| Usual current care | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Intervention arm
- description
- The "Intervention arm" includes an intervention in the groups of patients who, after screening, are identified as having disease-related malnutrition (DRM) or at risk of DRM, and a follow-up of the rest of the patients
- interventionNames
- Dietary Supplement: Nutritional dietary intervention
- type
- PLACEBO_COMPARATOR
- label
- By demand arm
- description
- The "By demand arm" will include patients in whom the nutritional intervention, if given, is performed by demand by the medical staff responsible for each patient.
- interventionNames
- Dietary Supplement: By demand
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients consecutively admitted to each center in their Digestive, Oncology or Surgery Services and that meet the inclusion criteria and none of the exclusion criteria * . Pathologies to be included according to ICD 10 criteria : A-Digestive pathologies: acute pancreatitis, ulcerative colitis, Crohn's disease, Inflammatory bowel disease. * Pathologies to be included according to ICD 10 criteria : .-Oncological pathologies (surgery or admissions at follow up for oncologic patients): esophageal, gastric, colon and rectum cancers , pancreatic cancer, and ulcerative colitis and Crohn's disease admitted with surgical indication. -. Patients older than 18 years and who are recruited in the first 48 hours after admission * . Patients who sign the informed consent. Exclusion Criteria: * Patients with serious organic or psychopathological problems or in a terminal situation; * Patients with neurosensory problems, * Patients that do not understand the Spanish or Basque language, * Patients that prevent them from giving their consent * Patients unable to complete the questionnaires used in the study. * Patients who are to have surgery by colon or rectum cancers detected by screening (not applicable if they are later admitted by complications of their oncological disease) * Age under 18, * Pregnancy, * Admission to critical units, * Admission to a short stay unit (\<72 hours) * Admission to a psychiatry, * Admission to study by weightloss. * Or those who do not wish to participate or who do not sign the informed consent
References
Publications (9)
- BACKGROUNDBally MR, Blaser Yildirim PZ, Bounoure L, Gloy VL, Mueller B, Briel M, Schuetz P. Nutritional Support and Outcomes in Malnourished Medical Inpatients: A Systematic Review and Meta-analysis. JAMA Intern Med. 2016 Jan;176(1):43-53. doi: 10.1001/jamainternmed.2015.6587. PMID 26720894
- BACKGROUNDCederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9. PMID 25799486
- BACKGROUNDBaldwin C, Kimber KL, Gibbs M, Weekes CE. Supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD009840. doi: 10.1002/14651858.CD009840.pub2. PMID 27996085
- BACKGROUNDParsons EL, Stratton RJ, Cawood AL, Smith TR, Elia M. Oral nutritional supplements in a randomised trial are more effective than dietary advice at improving quality of life in malnourished care home residents. Clin Nutr. 2017 Feb;36(1):134-142. doi: 10.1016/j.clnu.2016.01.002. Epub 2016 Jan 11. PMID 26847947
- BACKGROUNDElia M, Normand C, Norman K, Laviano A. A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in the hospital setting. Clin Nutr. 2016 Apr;35(2):370-380. doi: 10.1016/j.clnu.2015.05.010. Epub 2015 May 29. PMID 26123475
- BACKGROUNDAlvarez-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. PMID 23165541
- Philipson TJ, Snider JT, Lakdawalla DN, Stryckman B, Goldman DP. Impact of oral nutritional supplementation on hospital outcomes. Am J Manag Care. 2013 Feb;19(2):121-8.