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

Primary Purpose

Pancreatitis, Acute, Crohn Disease, Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nutritional dietary intervention
By demand
Usual current care
Sponsored by
Hospital Galdakao-Usansolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Acute focused on measuring disease-related malnutrition, effectiveness, cost effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Donostia
  • Hospital Galdakao-Usansolo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Intervention arm

By demand arm

Usual care arm

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

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

Outcomes

Primary Outcome Measures

Mean weight changes
Mean weight changes from admission to discharge, at hospital at the index admission, and until one year of follow up
Mean length of stay
Mean length of stay at the index admission
Mortality rate
Mortality rate at different points in time

Secondary Outcome Measures

Number of Participants with complications
Clinical complications, especially infectious complications during admission (CHADx classification) or events during admission, surgical complications (Clavien- Dindo classification ), surgical procedures performed
Number of Participants with Hospital readmissions
Hospital readmissions
Other health care resources use
Number of Participants with primary care consultations, hospital consultations, emergency consultations, separately.
Number of Participants with Adverse effects of the nutrition program
Infections, Hyperglycemia, Digestive intolerance, Bronchoaspiration, Refeeding syndrome.
Costs
Monetary costs
Health-related quality of life (HRQoL) changes
General HRQoL: It will be measured through the EuroQol-5d questionnaire. Scores from 0 to 100. Higher values indicate best health status
Patient's functional status
The patient's functional will be calculated using the Barthel index. Scores 0 to 100. Higher values indicate best functional status

Full Information

First Posted
December 2, 2019
Last Updated
September 19, 2023
Sponsor
Hospital Galdakao-Usansolo
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1. Study Identification

Unique Protocol Identification Number
NCT04188990
Brief Title
Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition
Official Title
Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Galdakao-Usansolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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) .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Pancreatic Cancer, Esophagus Cancer, Gastric Cancer, Colorectal Cancer
Keywords
disease-related malnutrition, effectiveness, cost effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1051 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Active Comparator
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
Arm Title
By demand arm
Arm Type
Placebo Comparator
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.
Arm Title
Usual care arm
Arm Type
Placebo Comparator
Arm Description
In the "Usual care arm" usual hospital practice is followed without any explicit nutritional intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional dietary intervention
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
By demand
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Usual current care
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean weight changes
Description
Mean weight changes from admission to discharge, at hospital at the index admission, and until one year of follow up
Time Frame
Index hospital admission and 12 months follow up
Title
Mean length of stay
Description
Mean length of stay at the index admission
Time Frame
Index hospital admission
Title
Mortality rate
Description
Mortality rate at different points in time
Time Frame
Index hospital admission to 12 months follow up
Secondary Outcome Measure Information:
Title
Number of Participants with complications
Description
Clinical complications, especially infectious complications during admission (CHADx classification) or events during admission, surgical complications (Clavien- Dindo classification ), surgical procedures performed
Time Frame
Index hospital admission to 12 months follow up
Title
Number of Participants with Hospital readmissions
Description
Hospital readmissions
Time Frame
Index hospital discharge to 12 months follow up
Title
Other health care resources use
Description
Number of Participants with primary care consultations, hospital consultations, emergency consultations, separately.
Time Frame
Index hospital discharge to 12 months follow up
Title
Number of Participants with Adverse effects of the nutrition program
Description
Infections, Hyperglycemia, Digestive intolerance, Bronchoaspiration, Refeeding syndrome.
Time Frame
Index hospital admission to12 months follow up
Title
Costs
Description
Monetary costs
Time Frame
Index hospital admission to12 months follow up
Title
Health-related quality of life (HRQoL) changes
Description
General HRQoL: It will be measured through the EuroQol-5d questionnaire. Scores from 0 to 100. Higher values indicate best health status
Time Frame
Index hospital admission to 12 months follow up
Title
Patient's functional status
Description
The patient's functional will be calculated using the Barthel index. Scores 0 to 100. Higher values indicate best functional status
Time Frame
Index hospital admission to 12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Covadonga Iglesias, MD
Organizational Affiliation
Hospital Universitario Basurto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alfredo Yoldi, MD
Organizational Affiliation
Hospital Universitario Donostia
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Donostia
City
Donostia / San Sebastián
Country
Spain
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from the study will be available after main publications
IPD Sharing Time Frame
After december 2024
IPD Sharing Access Criteria
By demand and agreement with our institutions
Citations:
PubMed Identifier
26720894
Citation
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.
Results Reference
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PubMed Identifier
25799486
Citation
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.
Results Reference
background
PubMed Identifier
27996085
Citation
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.
Results Reference
background
PubMed Identifier
26847947
Citation
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.
Results Reference
background
PubMed Identifier
26123475
Citation
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.
Results Reference
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PubMed Identifier
23165541
Citation
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.
Results Reference
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PubMed Identifier
23448109
Citation
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.
Results Reference
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Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

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