Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,051
- 试验地点
- 3
- 主要终点
- Mean weight changes
研究概览
简要总结
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) .
详细描述
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 4. - 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) 5. - 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients consecutively admitted to each center in their Digestive, Oncology or Surgery Services and that meet the inclusion criteria and none of the
排除标准
- •. 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
结局指标
主要结局
Mean weight changes
时间窗: Index hospital admission and 12 months follow up
Mean weight changes from admission to discharge, at hospital at the index admission, and until one year of follow up
Mean length of stay
时间窗: Index hospital admission
Mean length of stay at the index admission
Mortality rate
时间窗: Index hospital admission to 12 months follow up
Mortality rate at different points in time
次要结局
- Other health care resources use(Index hospital discharge to 12 months follow up)
- 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)
- Costs(Index hospital admission to12 months follow up)
- Number of Participants with Adverse effects of the nutrition program(Index hospital admission to12 months follow up)
- Health-related quality of life (HRQoL) changes(Index hospital admission to 12 months follow up)
- Patient's functional status(Index hospital admission to 12 months follow up)
研究者
JOSE M QUINTANA-LOPEZ, MD PhD
Head of Research Unit
Hospital Galdakao-Usansolo