Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

NCT04188990 | Completed DMC

• 1 other identifier: PI18/00698
• Study Type: interventional
• Target: 1,051
• Locations: 1 country
• Sites: 2

Brief Summary

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

Pancreatitis, Acute; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases; Pancreatic Cancer; Esophagus Cancer; Gastric Cancer; Colorectal Cancer

Keywords

disease-related malnutrition; effectiveness; cost effectiveness

Outcome Measures

Primary Outcomes (3)

• Mean weight changes

  Mean weight changes from admission to discharge, at hospital at the index admission, and until one year of follow up

  Index hospital admission and 12 months follow up

• Mean length of stay

  Mean length of stay at the index admission

  Index hospital admission

• Mortality rate

  Mortality rate at different points in time

  Index hospital admission to 12 months follow up

Secondary Outcomes (7)

• Number of Participants with complications

  Index hospital admission to 12 months follow up

• Number of Participants with Hospital readmissions

  Index hospital discharge to 12 months follow up

• Other health care resources use

  Index hospital discharge to 12 months follow up

• Number of Participants with Adverse effects of the nutrition program

  Index hospital admission to12 months follow up

• Costs

  Index hospital admission to12 months follow up

Study Arms (3)

Intervention arm

ACTIVE COMPARATOR

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

Dietary Supplement: Nutritional dietary intervention

By demand arm

PLACEBO COMPARATOR

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.

Dietary Supplement: By demand

Usual care arm

PLACEBO COMPARATOR

In the "Usual care arm" usual hospital practice is followed without any explicit nutritional intervention

Dietary Supplement: Usual current care

Interventions

Nutritional dietary intervention DIETARY_SUPPLEMENT

The intervention will be carried out by the Endocrinology and Nutrition Service of hospital 1, where the type of therapeutic action to be developed will be established (Dietary advice, Oral Nutritional Supplementation (SNO), Enteral Feeding or Parenteral Nutrition). The Total Calorie Balance, calories from feeding or with Oral Nutritional Supplementation (ONS), enteral, parenteral, and protein intake will be recorded. The steps to be taken are the following: A.-In patients with preserved oral intake capacity apply the most appropriate dietary measures in each case. B.-If the oral route is contraindicated, it will be assessed if it is possible to use the gastrointestinal tract and enteral nutrition will begin until the patient recovers the oral intake capacity. C.-If the use of the gastrointestinal tract is not indicated, parenteral nutrition will be assessed until digestive function is restored.

Intervention arm

By demand DIETARY_SUPPLEMENT

In the "By demand" arm, it is by clinical judgement of the doctor responsible of each patient that can be demanded a nutritional intervention to the nutrition unit of the center's endocrinology service that will judge the type of intervention. This is their usual care right now

By demand arm

Usual current care DIETARY_SUPPLEMENT

In th "Usual care" arm, there is no explicit nutritional intervention performed at this time for those patients and, therefore, their usual regular nutritional care will be provide

Usual care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (2)

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Spain

Location

Related Publications (9)

• Bally 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 BACKGROUND

• Cederholm 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 BACKGROUND

• Baldwin 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 BACKGROUND

• Parsons 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 BACKGROUND

• Elia 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 BACKGROUND

• 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.

  PMID: 23165541 BACKGROUND

• 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.

  PMID: 23448109 BACKGROUND

• Martin J, Larrea N, Garcia Y, Bolinaga I, Perales A, Sarasqueta C, Quintana JM. One-year post-discharge health-related quality of life in digestive and oncology patients: a three-group comparison by nutritional status and care. Qual Life Res. 2025 Dec 26;35(1):10. doi: 10.1007/s11136-025-04139-y.

  PMID: 41452524 DERIVED

• Garcia Y, Larrea N, Martin J, Bolinaga I, Sarasqueta C, Perales A, Iglesias NC, Yoldi A, Quintana JM; REDISSEC-Malnutrition Research Group. Evaluation of clinical outcomes after an intervention in malnourished hospitalized patients. Clin Nutr. 2025 Nov;54:42-52. doi: 10.1016/j.clnu.2025.04.034. Epub 2025 Sep 18.

  PMID: 41004975 DERIVED

MeSH Terms

Conditions

Pancreatitis; Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Pancreatic Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases

Study Officials

• Natalia Covadonga Iglesias, MD

  Hospital Universitario Basurto

  STUDY CHAIR

• Alfredo Yoldi, MD

  Hospital Donostia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Unit

Model Details: After hospital admission, a nutritional screening in all patients who fulfill the selection criteria of the selected centers will be performed. The first branch 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; a second cohort / branch will include patients in whom the intervention, if given, is performed by demand by the medical staff responsible for each patient. The third branch / cohort where usual hospital practice will be provided without any explicit nutritional intervention, except the screening to be carried out in all branches

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: June 15, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After december 2024
• Access Criteria: By demand and agreement with our institutions

Locations

ES (2)