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| Name | Class |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary nursing | Experimental | The intervention group with patients who are cared with primary nursing (process-responsible nursing; PP) after elective thoracic and/or cardiovascular surgery are on the intervention ICU. Patients are assigned to the intervention group if they stay for at least 3 days on the ICU. PP take on
In this way, PP also take on the nursing anamnesis as well as the planning, implementation and evaluation of the nursing care. The nursing care ratio is at least 1:2 |
|
| standard care | No Intervention | The control group with patients who are cared for according to the principle of standard care (area care or room care) is located on another ICU. There is no PP responsible for the target group and the allocation of nursing staff to patients is redefined at the start of each shift. The nursing care ratio is at least 1:2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| primary nursing | Other | The primary responsibility of one nurse for the planning, evaluation, and care of a patient throughout the course of illness, convalescence, and recovery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Relatives:
Focus group interview with nurses of the intervention-ICU:
Exclusion Criteria:
Patients who
Relatives:
Focus group interview with nurses of the intervention-ICU:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Krüger, M.Sc. | Heart and Diabetes Center North-Rhine Westfalia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Diabetes Center North Rhine-Westphalia (HDZ NRW), University clinic of the Ruhr-University Bochum | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38875775 | Background | Kruger L, Zittermann A, Mannebach T, Wefer F, Becker T, Lohmeier S, Luttermann A, von Dossow V, Rojas SV, Gummert J, Langer G. Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay. Intensive Crit Care Nurs. 2024 Oct;84:103748. doi: 10.1016/j.iccn.2024.103748. Epub 2024 Jun 14. | |
| 36971803 |
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Possible on request.
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011321 | Primary Nursing |
| ID | Term |
|---|---|
| D009732 | Nursing Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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RCT
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|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Kruger L, Mannebach T, Zittermann A, Wefer F, von Dossow V, Rojas Hernandez S, Gummert J, Langer G. Patient-related effects of primary nursing : Protocol of a pilot randomized controlled trial. Med Klin Intensivmed Notfmed. 2023 May;118(4):257-262. doi: 10.1007/s00063-023-00998-w. Epub 2023 Mar 27. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |