Patient-related Effects of Primary Nursing

Nurse's Role Clinical Trial

— ENGAGE  

Official title:

Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569317
• Other study ID #: HeartDiabetesCNRW
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW. PP plan, coordinate and evaluate the nursing carried out. In the further course, an examination between the project ICU and another ICU without PP with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out. The primary goal of this pilot study is to test the feasibility of a large-scale RCT with patient-related outcomes.

Description:

After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW. Previously, the system of room care (standard care) was carried out. PP plan, coordinate and evaluate the nursing carried out. In addition, they take on the care responsibility for a maximum of two patients and also carry out the care at the same time. In the further course, an examination between the project ICU and another ICU with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out. The primary goal of this pilot study is to test the feasibility of a large-scale RCT. For this purpose, the duration of delirium after the introduction of a PP on the project ICU should be compared with the previous care organization as standard care in a surgical ICU. Secondary goals e.g. include: the incidence of delirium, anxiety, as well as the satisfaction of the relatives and the effects of PP on nurses are shown.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• All patients are included who are at least 65 years old,
• understand German language,
• whose health insurance company has concluded a quality contract with the Heart and Diabetes Center NRW (HDZ NRW),
• Elective thoracic and cardiovascular surgery,
• Intensive care for at least three days on ICU.

Relatives:

• at least 18 years old,
• patients have to receive PP.

Focus group interview with nurses of the intervention-ICU:

• Nurses have to be at least 18 years old,
• Nurses belong the the intervention-ICU. Exclusion Criteria: Patients who
• are < 65 years old,
• whose health insurance company has not concluded a quality contract with the HDZ NRW,
• cannot be admitted due to allocation by randomization and a lack of free bed on the destination ICU,
• have not given their informed consent,
• cannot participate in the CAM-ICU screening due to neurological diseases,
• in whom the screening using CAM-ICU could not be carried out over the entire intensive care stay and/or
• belong to the target group but stay less than three days after their elective operation in the ICU.

Relatives:

• not at least 18 years old and/or
• the patients do not receive PP.

Focus group interview with nurses of the intervention-ICU:

• Nurses who are not at least 18 years old and
• Nurses do not belong to the intervention-ICU.

Related Conditions & MeSH terms

• Nurse's Role

Intervention

Other:
• primary nursing
The primary responsibility of one nurse for the planning, evaluation, and care of a patient throughout the course of illness, convalescence, and recovery.

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center North Rhine-Westphalia (HDZ NRW), University clinic of the Ruhr-University Bochum	Bad Oeynhausen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia	Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of delirium	As a syndrome, delirium represents a serious brain-organic emergency situation with dangerous consequences. The incidence of delirium in cardiac surgery ranges from <10% to >25%. Data collection: Confusion Assessment Method for Intensive Care Unit (CAM-ICU).	3 times per day over one year.
Secondary	incidence of delirium	As a syndrome, delirium represents a serious brain-organic emergency situation with dangerous consequences. The incidence of delirium in cardiac surgery ranges from <10% to >25%. Data collection: Confusion Assessment Method for Intensive Care Unit (CAM-ICU).	3 times per day over one year.
Secondary	pain (incidence and strength of pain)	An unpleasant sensation induced by noxious stimuli which are detected by nerve endings. Data collection: Numeric Rating Scale (NRS) or Critical Care Pain Observation Tool (CPOT).	3 times per day over one year.
Secondary	incidence and risk of decubitus	An ulceration caused by prolonged pressure on the skin and tissues when one stays in one position for a long period of time, such as lying in bed. Data collection: Braden-Scale and documentation.	Once per day over one year.
Secondary	anxiety	Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with anxiety disorders. Data collection: Numeric Rating Scale (NRS).	3 times per day over one year.
Secondary	need of care (Barthel-Index)	Need of care describes, how much time and extend of care a patient needs. Data-Collection: Barthel-Index.	Once per week over one year.
Secondary	satisfaction of the relatives	Satisfaction of relatives means the satisfaction with care of the relatives' patients trough nurses. Data collection: Data collection: standardized questionaire.	Once during ICU-care over one year.
Secondary	effects of PP on nurses (only intervention group)	Effects of PP on nurses means the effects of the new organizational system of nursing care on nurses. Data collection: focus group interview with nurses.	Once during the study in one year.