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Completed

NCT Number: NCT05569317

Patient-related Effects of Primary Nursing

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.

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Key information

Conditions

Nurse's Role Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and Diabetes Center North Rhine-Westphalia (HDZ NRW), University clinic of the Ruhr-University Bochum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: process-responsible nursing (PP)

Primary outcomes

  1. 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).

Secondary outcomes

  1. incidence 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).

  2. pain (incidence and strength of pain)

    Time frame: 3 times per day over one year.

    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. incidence and risk of decubitus

    Time frame: Once per day over one year.

    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.

  4. anxiety

    Time frame: 3 times per day over one year.

    Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with anxiety disorders. Data collection: Numeric Rating Scale (NRS).

  5. need of care (Barthel-Index)

    Time frame: Once per week over one year.

    Need of care describes, how much time and extend of care a patient needs. Data-Collection: Barthel-Index.

  6. satisfaction of the relatives

    Time frame: Once during ICU-care over one year.

    Satisfaction of relatives means the satisfaction with care of the relatives' patients trough nurses. Data collection: Data collection: standardized questionaire.

  7. effects of PP on nurses (only intervention group)

    Time frame: Once during the study in one year.

    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.

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

Registry information

Official study title

Patient*Innenbezogene Auswirkungen Prozessverantwortlicher Pflege

Acronym: ENGAGE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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