Quality of Care of Oncological Patients With HPN

Tumors and Home Parenteral Nutrition Clinical Trial

— VHPE-S  

Official title:

Quality of Care of Oncological Patients With Home Parenteral Nutrition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03425435
• Other study ID #: HPNM-001-CNI
• Status: Terminated
• Start date: October 15, 2018
• Est. completion date: January 14, 2022

Study information

• Verified date: January 2022
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tumors and Home Parenteral Nutrition

Intervention

Other:
• QoL and developed questionnaires for healthcare research
Questionnaires

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient´s questionnaire	Mean changes in total scores of QoL-questionnaire from baseline.	Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital