Patient-related effects of primary nursing: Protocol of a pilot randomized controlled trial

Abstract

Background: Since January 2022, a primary nursing system called process-responsible nursing (PP) has substituted the standard room care system in an intensive care unit (ICU) at our institution. The process of the development and implementation of PP is already being evaluated in a separate study as an actual analysis prior to implementation, as well as after 6 and 12 months. Aim: This pilot randomized controlled trial (RCT) aims to test the feasibility of an RCT. For this purpose, the duration of delirium, among other things, will be compared in the project ICU with the results of standard care in another ICU at the university hospital. As secondary aims, the incidence of delirium, anxiety, the satisfaction of relatives, and the effects of PP on nurses will be assessed. Methods: It is planned to recruit about 400–500 patients over a period of one year. They will be allocated to PP or standard care. Delirium will be assessed using the Confusion Assessment Method for Intensive Care Units by specifically trained nurses three times a day. Anxiety in patients, the satisfaction of relatives, and the effects of PP on nurses will be evaluated using the numeric rating scale, a standardized questionnaire, and a focus group interview, respectively. Expected results: The primary hypothesis is that compared to usual care PP reduces the duration of delirium by at least 8 h. Additional hypotheses are that PP reduces anxiety in patients and increases the satisfaction of relatives.