Clinical trial NCT05569317: Patient-related Effects of Primary Nursing
Official title: Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: delirium
intensive care units
primary nursing
professional practice
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2022-10-06
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: duration of delirium
timeFrame: 3 times per day over one year.
Secondary outcomes:
measure: incidence of delirium
timeFrame: 3 times per day over one year.
measure: pain (incidence and strength of pain)
timeFrame: 3 times per day over one year.
measure: incidence and risk of decubitus
timeFrame: Once per day over one year.
measure: anxiety
timeFrame: 3 times per day over one year.
measure: need of care (Barthel-Index)
timeFrame: Once per week over one year.
measure: satisfaction of the relatives
timeFrame: Once during ICU-care over one year.
measure: effects of PP on nurses (only intervention group)
timeFrame: Once during the study in one year.
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North Rhine-Westphalia (HDZ NRW), University clinic of the Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Heart and Diabetes Center North-Rhine Westfalia
name: Lars Krüger, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.