Nurse's RoleENGAGENCT05569317
Patient-related Effects of Primary Nursing
A study testing primary nursing in people with Nurse's Role, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- primary nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Center North Rhine-Westphalia (HDZ NRW), University clinic of the Ruhr-University Bochum
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
Official title: Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege
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.
Read the 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.
- Conditions
- Nurse's Role
- Being tested
- primary nursing
- Keywords
- delirium, intensive care units, primary nursing, professional practice
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary nursingOther
Also called process-responsible nursing (PP)
The primary responsibility of one nurse for the planning, evaluation, and care of a patient throughout the course of illness, convalescence, and recovery.
| Study group | Role | What they receive |
|---|---|---|
| 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
* the responsibility of the nursing process
* the daily care according to the individual patient case
* direct communication with all professional groups involved in care
* responsibility for the quality of care of the assigned patients over a fixed period of at least 14 and a maximum of 50 days - after that the primary nurse will change.
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 Receives: Other: primary nursing |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 times per day over one year.
Secondary outcomes (7)
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).
Measured: 3 times per day over one year.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once during the study in one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Sponsor
- Investigators
- Lars Krüger, M.Sc., Principal investigator, Heart and Diabetes Center North-Rhine Westfalia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569317
- Sponsor's protocol ID
- HeartDiabetesCNRW
- Acronym
- ENGAGE
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Possible on request.
Publications
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.
PubMed 38875775Kruger 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.
PubMed 36971803
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege
- ClinicalTrials.gov ID
- NCT05569317
- Acronym / sponsor ID
- ENGAGE / HeartDiabetesCNRW
- Conditions
- Nurse's Role
- Keywords
- delirium, intensive care units, primary nursing, professional practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| primary nursing | Experimental | Other: primary nursingThe 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 * the responsibility of the nursing process * the daily care according to the individual patient case * direct communication with all professional groups involved in care * responsibility for the quality of care of the assigned patients over a fixed period of at least 14 and a maximum of 50 days - after that the primary nurse will change. 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| primary nursingAlso: process-responsible nursing (PP)The primary responsibility of one nurse for the planning, evaluation, and care of a patient throughout the course of illness, convalescence, and recovery. | Other | primary nursing |
Primary outcome
duration of delirium
Time frame: 3 times per day over one year.
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).
7 secondary outcomes
incidence of delirium
Time frame: 3 times per day over one year.
pain (incidence and strength of pain)
Time frame: 3 times per day over one year.
incidence and risk of decubitus
Time frame: Once per day over one year.
anxiety
Time frame: 3 times per day over one year.
need of care (Barthel-Index)
Time frame: Once per week over one year.
satisfaction of the relatives
Time frame: Once during ICU-care over one year.
effects of PP on nurses (only intervention group)
Time frame: Once during the study in one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 38875775Kruger 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.
- Background: PubMed 36971803Kruger 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.
- Individual participant dataSharing planned: No. Possible on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Krüger, M.Sc. principal investigator
Heart and Diabetes Center North-Rhine Westfalia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary nursing in people with Nurse's Role, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of delirium (time frame: 3 times per day over one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.