Clinical trial NCT06753708: Evaluation of the Nutritional Status of Palliative Care Patients
Official title: Evaluation of the Nutritional Status of Patients Hospitalized in the Palliative Care Unit and Receiving Tube Enteral Nutrition Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Palliative Care
Tube Feeding
Keywords: Palliative Care
Malnutrition
Nutritional Status
Tube Feeding
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative Care patients from a State Hospital in Istanbul / Türkiye

Brief summary: This study evaluates the nutritional status of palliative care patients receiving enteral tube feeding. It aims to assess their condition using nutritional screening tools, anthropometric measurements and biochemical data to improve standards of care, patient safety and outcomes. The study will take place at a state hospital palliative care clinic from November 2024 to March 2025, with a possible extension to June 2025.

Participants will be adults aged 18 years and older undergoing enteral tube feeding. Informed consent will be obtained, and data collection will include in-person interviews, patient questionnaires, food consumption records completed by family members, and biochemical data from medical records. Nutritional information will be analyzed using BeBIS software, and SPSS will be used for statistical analysis.

The study aims to create effective nutrition plans, improve clinical protocols, and improve healthcare outcomes. By addressing gaps in the literature, particularly regarding enteral tube feeding in palliative care, this research will benefit patients, families, healthcare providers, and institutions. Anticipated benefits include improved patient care, reduced complications, shorter hospital stays, and cost savings to the healthcare system.

Detailed description: The data obtained from food consumption records will be transferred to the Nutrition Information System (BeBIS) program by the researcher and total energy, macro and micronutrients will be calculated. The data of the individuals participating in the study will be analyzed with SPSS 28.0 (Statistical Package for Social Sciences for Windows) statistical package program.

Institutional, social and economic benefits are also among our goals with this research. The institutional benefits of the research include the evaluation of the nutritional status of patients receiving tube enteral nutrition support, the creation of effective nutrition plans and, when necessary, the provision of improvement recommendations.In addition, by reviewing and updating clinical enteral nutrition protocols, standards of care will be improved and patient safety will increase. This process will encourage more efficient use of resources and increase knowledge and awareness of enteral nutrition among healthcare professionals. It will contribute to the organization's quality improvement efforts, support performance assessments in nutrition and patient care, and improve patient satisfaction and treatment outcomes through effective nutrition support. The societal benefits are to contribute to improving national and international standards for patients receiving tube enteral nutrition support through the development of more effective and targeted nutrition strategies in patient care, efficient use of resources, education on nutrition management for health professionals, families and caregivers, and the development of nutrition management policies based on research findings. The economic benefits of the research will be achieved by improving the nutritional status of patients, reducing complication rates and shortening hospital stays with the effective implementation of tube enteral nutrition management. This will result in a significant reduction in healthcare costs and encourage more efficient use of resources. As a result, reduced material and labor costs will contribute to a more sustainable model of care by reducing the financial burden on the healthcare system.This research aims to evaluate the nutritional status of patients hospitalized in a palliative care ward and receiving tube enteral nutrition support using anthropometric measurements, nutrition screening tools, scales and biochemical findings. Although there are similar studies in the literature, there is no study that specifically examines the status of tube enteral nutrition in palliative care. Existing studies generally focus on enteral nutrition support, deficiencies or malnutrition and quality of life in palliative care. Considering the increase in the elderly population and the number of palliative care hospitalizations, this study aims to make an important contribution to the existing gap in the literature.

The study is planned to include patients over 18 years of age who received inpatient treatment in the Palliative Care Clinic of a Hospital between November 2024 and March 2025 and who received tube enteral nutrition. Approval was obtained from Marmara University Institute of Health Sciences Non-Interventional Clinical Research Ethics Committee for the conduct of this study. A power analysis was performed with the Epi-Info program and the sample size was determined as 132 participants. Considering the losses, 145 patients will be included in the study. If the targeted sample size is not reached, the data collection process is planned to be extended until June 2025. Verbal and written informed consent will be obtained from the patients before data collection. All patients who agree to participate in the study will be interviewed face-to-face and the questionnaire form will be filled out by the researcher. The questionnaire form will include sections on general information about the patient, medical nutrition therapy, anthropometric measurements and biochemical parameters. In addition, each patient's relatives will be asked to fill in the food consumption record form. The nutrition screening tools NRS-2002 and GLIM Criteria will be applied to each patient by the investigator. Filling out the enteral nutrition record form and taking anthropometric measurements will be done by the investigator. Biochemical findings required for the study will be obtained from patient files.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Being treated in the Palliative Care Clinic
* Being fed with one of the tube enteral nutrition methods (only enteral/enteral + oral/enteral)

Exclusion Criteria:

* Having any limb amputation
* Being hospitalized in the Palliative Care Clinic for less than 3 days
* Receiving parenteral nutrition support

Primary outcomes:
measure: Malnutrition Status - NRS-2002 Score
timeFrame: 7 days after admission to the palliative care unit
measure: Body Mass Index (BMI)
timeFrame: 7 days after admission to the palliative care unit
measure: Upper Mid-Arm Circumference
timeFrame: 7 days after admission to the palliative care unit
measure: Skinfold Thickness
timeFrame: 7 days after admission to the palliative care unit
measure: Enteral Nutrition Record
timeFrame: 7 days after admission to the palliative care unit
measure: Food Consumption Record
timeFrame: 7 days after admission to the palliative care unit
measure: Nutritional Biomarker Index
timeFrame: 7 days after admission to the palliative care unit
Secondary outcomes:
measure: Phenotypic Criteria - Weight Loss
timeFrame: 7 days after admission to the palliative care unit
measure: Phenotypic Criteria - Body Mass Index (BMI)
timeFrame: 7 days after admission to the palliative care unit
measure: Phenotypic Criteria - Muscle Mass
timeFrame: 7 days after admission to the palliative care unit
measure: Etiologic Criteria - Food Intake
timeFrame: 7 days after admission to the palliative care unit
measure: Etiologic Criteria - Inflammatory Status
timeFrame: 7 days after admission to the palliative care unit
measure: Knee Length
timeFrame: 7 days after admission to the palliative care unit
measure: Calf Circumference
timeFrame: 7 days after admission to the palliative care unit
measure: Height
timeFrame: 7 days after admission to the palliative care unit
measure: Body Weight
timeFrame: 7 days after admission to the palliative care unit
measure: Hemoglobin
timeFrame: 7 days after admission to the palliative care unit
measure: Hematocrit
timeFrame: 7 days after admission to the palliative care unit
measure: Platelet Count
timeFrame: 7 days after admission to the palliative care unit
measure: Leukocyte Count
timeFrame: 7 days after admission to the palliative care unit
measure: Neutrophil Count
timeFrame: 7 days after admission to the palliative care unit
measure: Lymphocyte Count
timeFrame: 7 days after admission to the palliative care unit
measure: Blood Urea Nitrogen (BUN)
timeFrame: 7 days after admission to the palliative care unit
measure: Creatinine
timeFrame: 7 days after admission to the palliative care unit
measure: Magnesium
timeFrame: 7 days after admission to the palliative care unit
measure: Sodium
timeFrame: 7 days after admission to the palliative care unit
measure: Potassium
timeFrame: 7 days after admission to the palliative care unit
measure: Chlorine
timeFrame: 7 days after admission to the palliative care unit
measure: Calcium
timeFrame: 7 days after admission to the palliative care unit
measure: CRP
timeFrame: 7 days after admission to the palliative care unit
measure: Albumin
timeFrame: 7 days after admission to the palliative care unit
measure: Prealbumin
timeFrame: 7 days after admission to the palliative care unit
measure: Glomerular Filtration Rate (GFR)
timeFrame: 7 days after admission to the palliative care unit
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Health Sciences
state: Maltepe
city: Istanbul
country: Turkey
facility: Marmara University
state: Maltepe
Study officials:
affiliation: Marmara University
name: Zehra M Celik
role: STUDY_DIRECTOR
References: