- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188990
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
Study Overview
Status
Conditions
Detailed Description
Objectives
- -After a nutritional screening of all patients, evaluate the effectiveness of an intervention in patients admitted to a hospital in relationship to disease-related malnutrition (DRM) by comparing 3 cohorts: cohort-1: organized intervention to patients with DRM or at risk; group 2: intervention on demand by health personnel; Group 3: usual care without any explicit intervention. Effectiveness will be evaluated in relation to multiple outcomes such as: length of hospital stay of the index admission; and the following parameters during admission and until one year after admission, mortality, occurrence of complications (mainly infectious, or surgical in surgical patients), readmissions, use of health resources after discharge (primary care consultations, hospital and emergency consultations), changes in weight during admission and up to one year, changes in their health related quality of life (SF-36 and/or EQ-5d) and fragility (Barthel I.) from admission to one year after admission.
- -Evaluate the cost and cost-effectiveness of those strategies.
- Evaluate in the three groups the evolution of patients in relation to the previous parameters of results according to their classification after screening at the time of admission to DRM, risk of DRM or no problem of DRM detected.
Secondary Objectives
- - Evaluate the three groups of patients classified according to their level of DRM according to their level of fragility and in relation to their evolution during admission and up to one year (based on all the outcome parameters indicated above)
- - Identify risk factors of worse evolution during hospital admission and up to one year of follow up based on the previously described outcome parameters and study the role that the DRM level plays as predictor of evolution.
DESIGN: Prospective cohorts with three branches. SCOPE: Three public hospitals. The first center, where the study intervention will be carried out (branch 1), is the Galdakao - Usánsolo University Hospital that serves a population of about 300,000 urban inhabitants and semi-urban The second center, the University Hospital of Basurto (HUB), where the intervention will be carried out by demand (branch 2), serves the population of Bilbao, some 350,000 urban inhabitants. The third center, Donostia University Hospital (HUD) where there will be no specific organized intervention (branch 3), attends the population of San Sebastián-Donostia and surrounding areas covering a population of about 400,000 inhabitants of urban and semi-urban characteristics. All of them have similar human and technological resources being the population that attend similar on sociodemographic and clinical characteristics.
SUBJECTS OF THE STUDY. See detailed information in other sections. SAMPLE SIZE. It is estimated at least 10-15% of DRM and up to 30-35% of patients at risk of DRM (with a global of almost 40-50%) in the selected pathologies of patients.
Sample size calculation. We have made the estimates for an alpha error of 0.05 and a power of 80%. We have chosen the following outcome parameter in which we expect relevant differences between branches: we estimate that the average length of stay will decrease from an average of 12 days (DS: 5) in the DRM group or at risk without any explicit intervention (HUD) to an average of 10 days (DS: 5) in the DRM group or at risk where the intervention will be performed (HGU) for which we will need 100 patients by each comparisons group but we will try to recruit at least 100 patients from the previous three nutritional groups per center. We estimate a percentage of losses in the follow-up of 10-15% so, overall, 350 patients per center will be sufficient to meet the objectives and respond to the hypotheses of the study. Data from 2017 for each hospital and established patients selection criteria indicate that we should have more than those patients admitted by hospital in 12 months.
DESCRIPTION OF THE SCREENING: all admitted patients of the three centers that meet the selection criteria will be evaluated in the first 72 hours after admission and again upon discharge (if a patient remained admitted more than one week, this assessment will be repeated weekly). The nutritional risk assessment will be done by applying the Malnutrition Universal Screening Tool (MUST) and the Global Leadership Initiative on Malnutrition (GLIM) questionnaires.
VARIABLES TO COLLECT: in summary, A.-From the clinical history: Sociodemographic data will be collected (age, gender, educational level ..) and clinical data such as: comorbidities, based on the Charlson Comorbidity Index , weight, height, health habits, usual treatments (dose, number of drugs), diagnosis of admission (Major Diagnostic Categories ICD-10), severity of pathology (TNM if pathology tumor), source of admission (emergency vs scheduled), admission service. During admission: complications, treatments, procedures and referral to special units (ICU,...). Analytical data available (biochemistry and blood cells count, including urea, creatinine, glucose, electrolytes, albumin, pre-albumin, lymphocytes, total cholesterol, triglycerides, transferrin, and liver function tests). This analytics will be obtained in the first 48 hours of admission and in surgical patients before the intervention if scheduled. They will be repeated at discharge and weekly in prolonged income.
Main results of interest: see separate section. B.-Health-related quality of life questionnaires: 1.- The patient's functional will be calculated using the Barthel index. 2. - General health and utilities: they will be measured by the EuroQol-5d questionnaire, which will mainly be used for economic analysis. 3.-SF-36.
STATISTIC ANALYSIS. A descriptive analysis of the entire sample and univariate analysis to determine potential variables related to the outcomes of interest will be performed. In the multivariable analysis, different models will be used according to the dependent/outcome variable of interest. In the case of dichotomous dependent variables (mortality, complications, readmissions ...) logistic regression models will be used. For continuous dependent variables (changes in HRQoL) generalized linear models will be used; and for dependent variables that have other distributions, such as length of stay, Poisson regression models will be used. The main comparison will be between the intervention groups (HGU) versus intervention by demand (HUB) versus control group (HUD). In all multivariables analyzes, the use of a Propensity Score (PS) as an adjustment system for the differences between the characteristics of the patients of the three centers will be considered.
Economic analysis: A cost-effectiveness analysis of the intervention corresponding to the first branch will be carried out with respect to the second and third branches. Only medical costs associated with medical assistance will be included. The measure for the cost-effectiveness analysis will be the incremental cost for each year of life adjusted by Quality Adjusted Life Year (QALY) earned. The QALY will be calculated from the EuroQol-5d-5l questionnaire scores, in the baseline moment and one year after admission, and the mortality variable up to the year.
PROBLEMS AND LIMITATIONS OF THE STUDY. 1.-As in any study prospective study, main problem is the losses in the follow up. To reduce them, patients will be fully informed and a close contact will be established during follow-up to all patients. 2.-This project is proposed as an intervention study adapted to the current circumstances of the usual clinical care practice, which should guarantee a greater feasibility of a subsequent implementation of this patient care strategy if our results show its benefits. 3.- The comparability between the different cohorts will be guaranteed in the statistical analysis by the adjustment by the propensity scores. 4.-The strategy of the study poses an ethical problem since after screening in all the centers some of the patients will be identified as with DRM or at risk and therefore this will be communicated to the physicians in charge of each patient so that they proceed in the way they create timely by writing down their attitude therapy. We will collect information about any additional nutritional strategy given to any patient.
ETHICAL AND CONFIDENTIALITY ASPECTS. The project has been evaluated and approved by the research commissions of all the participant centers and approved by the accredited Clinical Research Ethics Committee (CEIC) of the Basque Country. EU and Spanish laws on personal data protection will be followed, ensuring that patient information data obtained cannot be associated with identifiable persons. Study data base will be encrypted and protected to assure confidentiality. Only research personal will have access to it with specific passwords.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Donostia / San Sebastián, Spain
- Hospital Universitario Donostia
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Galdakao, Spain
- Hospital Galdakao-Usansolo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention arm
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
|
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.
|
Placebo Comparator: By demand arm
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.
|
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
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Placebo Comparator: Usual care arm
In the "Usual care arm" usual hospital practice is followed without any explicit nutritional intervention
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean weight changes
Time Frame: Index hospital admission and 12 months follow up
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Mean weight changes from admission to discharge, at hospital at the index admission, and until one year of follow up
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Index hospital admission and 12 months follow up
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Mean length of stay
Time Frame: Index hospital admission
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Mean length of stay at the index admission
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Index hospital admission
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Mortality rate
Time Frame: Index hospital admission to 12 months follow up
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Mortality rate at different points in time
|
Index hospital admission to 12 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with complications
Time Frame: Index hospital admission to 12 months follow up
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Clinical complications, especially infectious complications during admission (CHADx classification) or events during admission, surgical complications (Clavien- Dindo classification ), surgical procedures performed
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Index hospital admission to 12 months follow up
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Number of Participants with Hospital readmissions
Time Frame: Index hospital discharge to 12 months follow up
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Hospital readmissions
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Index hospital discharge to 12 months follow up
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Other health care resources use
Time Frame: Index hospital discharge to 12 months follow up
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Number of Participants with primary care consultations, hospital consultations, emergency consultations, separately.
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Index hospital discharge to 12 months follow up
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Number of Participants with Adverse effects of the nutrition program
Time Frame: Index hospital admission to12 months follow up
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Infections, Hyperglycemia, Digestive intolerance, Bronchoaspiration, Refeeding syndrome.
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Index hospital admission to12 months follow up
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Costs
Time Frame: Index hospital admission to12 months follow up
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Monetary costs
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Index hospital admission to12 months follow up
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Health-related quality of life (HRQoL) changes
Time Frame: Index hospital admission to 12 months follow up
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General HRQoL: It will be measured through the EuroQol-5d questionnaire.
Scores from 0 to 100.
Higher values indicate best health status
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Index hospital admission to 12 months follow up
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Patient's functional status
Time Frame: Index hospital admission to 12 months follow up
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The patient's functional will be calculated using the Barthel index.
Scores 0 to 100.
Higher values indicate best functional status
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Index hospital admission to 12 months follow up
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Natalia Covadonga Iglesias, MD, Hospital Universitario Basurto
- Study Chair: Alfredo Yoldi, MD, Hospital Universitario Donostia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Nutrition Disorders
- Gastroenteritis
- Head and Neck Neoplasms
- Intestinal Diseases
- Esophageal Diseases
- Pancreatic Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Malnutrition
- Pancreatitis
- Esophageal Neoplasms
Other Study ID Numbers
- PI18/00698
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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