CompletedNot Applicable

Patient-related Effects of Primary Nursing

Germany94 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

duration of delirium

Timeframe: 3 times per day over one year.

Trial details

NCT IDNCT05569317

SponsorHeart and Diabetes Center North-Rhine Westfalia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

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