Clinical trial NCT03425435: Quality of Care of Oncological Patients With HPN
Official title: Quality of Care of Oncological Patients With Home Parenteral Nutrition
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tumors and Home Parenteral Nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solid tumors with indication for home parenteral nutrition.

Brief summary: Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other aspects, the transition from the inpatient to the outpatient setting (discharge management), the organization of HPN at home or in a care facility (care management), the expertise required to care for patients with HPN and consistent compliance with standards are key to the quality of care for patients requiring HPN.

Hospital patients on parenteral nutrition (PN) to be continued at home are often discharged at very short notice. A good interlocking of all players is required to collect and distribute the relevant information, to secure proper training for those involved and to have all utilities and equipment at hand when the patient arrives.

This study collects nutritional and clinical parameters (including patient-reported parameters) along the continuum of care of HPN patients to evaluate the impact of the quality of care of HPN patients on their quality of life.

Detailed description: The HPN management will be evaluated by using a self-developed patient and a standardized quality of life questionnaire.

Patients will be recruited at the participating hospital by their treating physician before discharge and will continue their study participation after discharge.

The documentation period for the individual patients will be 3 months.

The questions of the patient´s questionnaire cover areas of interest like: satisfaction with discharge management, nutrition, satisfaction with HPN.

Eligibility criteria: Inclusion Criteria:

* Men and women with an initial prescription for HPN during the current hospital stay
* Planned PN must at least contain the macronutrients glucose and amino acids.
* Solid, malignant tumor
* Anticipated duration of the HPN is at least 28 days
* Age ≥18 years
* Full legal capacity or legal guardian available
* Fluent in German language
* Able to read and write in German language
* Signed patient informed consent form
* Indication for PN

Exclusion Criteria:

* Contraindication for PN
* ECOG performance status \>3
* Pregnant and breast-feeding women
* Concurrent participation in another clinical study that requires deviations from the hospital's routine PN, nutrition and/or nursing procedures

Primary outcomes:
measure: Patient´s questionnaire
timeFrame: Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Hannover Medical School, Germany
name: Andrea Schneider, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: