Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol

Abstract

Introduction: Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients' individual freedom. Moreover, the incidence of invasive therapeutic devices' self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers' decision is safe and efficient.

Methods and analysis: ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents' rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Ethics and dissemination: Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

Trial registration number: (ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.

Keywords: Adult intensive & critical care; Clinical Trial; Nurses; Randomized Controlled Trial; Safety.

Figure 1. Consolidated Standards of Reporting Trials flow diagram of the ARBORea trial. Flow chart (N=) will be filled during or at the end of the trial. * Because, in some cases, patients’ condition interferes with effective communication, the study protocol provides for a waiver of informed consent from the patient. The consent from the patient’s next of kin will therefore be sought actively. In case the patient’s next of kin cannot be reached in a timely manner, the investigator will decide to include the patient in the study using an emergent consent procedure. Deferred informed consent will be obtained from participants for potential continuation of the research.

Figure 2. Example of decision-making algorithm to guide physical restraint use in ICU patients. Each item entered in the electronic web-based case report form to be used in the algorithm is depicted in grey rectangles (with identification in the top part of the rectangle). Each possible option for individual items is presented within grey rectangles. Example of algorithm, results concerning physical restraint use and item reassessment are presented and must be constructed from left to right side. CAM-ICU: confusion assessment method for the intensive care unit; RASS: Richmond Agitation Sedation Scale. Levels of conditioning: C1 (Class 1): peripheral venous catheter, nasogastric tube, Foley and subcutaneous drains; C2 (Class 2): central venous access, Swan-Ganz catheter, continuous renal replacement therapy catheter, peripherally inserted central catheter (peripherally inserted central catheter and midline), arterial line, intracranial pressure sensor, endotracheal tube, chest tube and surgically inserted drains; C3 (Class 3): veno-venous and veno-arterial extracorporeal membrane oxygenation, intra-aortic counterpulsion balloon and external pacemaker probe.