Patient-related Effects of Primary Nursing

NCT05569317 | Completed

• 1 other identifier: HeartDiabetesCNRW
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role

Keywords

delirium; intensive care units; primary nursing; professional practice

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• incidence of delirium

  3 times per day over one year.

• pain (incidence and strength of pain)

  3 times per day over one year.

• incidence and risk of decubitus

  Once per day over one year.

• anxiety

  3 times per day over one year.

• need of care (Barthel-Index)

  Once per week over one year.

Study Arms (2)

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

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.

Interventions

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.

Also known as: process-responsible nursing (PP)

primary nursing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead
• Martin-Luther-Universität Halle-Wittenberg: collaborator

Study Sites (1)

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

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (2)

• 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.

  PMID: 38875775 BACKGROUND

• 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.

  PMID: 36971803 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Primary Nursing

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nursing Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lars Krüger, M.Sc.

  Heart and Diabetes Center North-Rhine Westfalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 6, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)