Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial

It is now well documented that critically ill patients in intensive care units (ICUs) are exposed to stressful conditions and experience discomforts from multiple sources [1‐7]. These forms of discomforts, also called stressors, may be differentiated into the following three categories: environmental discomforts (noise, excessive light); discomforts related to the specific organization of ICU care (frequent monitoring, short timeslots for visitors, unavoidable isolation); and discomforts related to the health state of the patient and the care provided (pain, mechanical ventilation or noninvasive ventilation, gastric tube, intravenous access, urinary probe, pleural drain). Some authors have distinguished the discomforts into two other categories: physical (pain, sleep deprivation, thirst, hunger, feeling of cold, feeling of heat) and psychological (communication restriction, lack of autonomy, isolation, anxiety, no respect for intimacy) [3]. These may have significant short-term and long-term consequences for the patients, such as agitation and/or confusion during the ICU stay, which is also called ICU delirium [8‐11], or various degrees of anxiety and/or depression [12] or posttraumatic stress disorder after the ICU stay [13‐15] that may affect their quality of life [16]. Indirect consequences could also be related to the general representation of the ICU as interpreted by the patients themselves or by their relatives, and patients may develop a fear of the ICU [17, 18]. This could lead to late admissions to the ICU and worsened organ functions, which may impact patient outcomes.

Quantification of discomforts is commonly performed using standardized methods as well as objective or subjective measures. Quantification of noise [19] or lighting [20] and quantification of physiologic parameters [21] were used as stressor indicators, but they did not entirely explore patient discomfort, especially the self-perceived discomfort. Patient-reported outcomes are now considered a better picture of patient feelings and perceptions compared to objective indicators [2, 4, 6, 7] that have led to the development of several ICU-related perceived discomfort tools [3, 4]. Recently, a well-validated questionnaire of self-perceived patient discomforts related to an ICU stay, the IPREA, has been proposed. The IPREA is differentiated from other tools by a validation process based on international guidelines and is performed using a large sample (n = 868) of unselected critically ill patients hospitalized in different types of ICUs (medical, surgical, and mixed medical–surgical) in different institutions (university and non-university hospitals) and a large range (n = 16) of discomforts. Moreover, the IPREA allows the possibility of obtaining a synthetic overall discomfort score [22].

Different actions have previously demonstrated effectiveness in correcting and reducing specific discomforts. The optimization of alarm management and monitoring, the control of the sound level during verbal transmissions between the teams, and the implementation of music sessions, cycling light, and unrestrictive visiting policies have been shown to be efficacious in experimental and/or controlled studies [23‐27]. These actions generally focus on one single discomfort, but they have not addressed a more global approach.

An alternative intervention can be proposed. The "assessment-feedback" approach, which combines systematic assessment with feedback to the healthcare teams, previously demonstrated its effectiveness by sensitizing the healthcare team. For example, patient satisfaction assessment combined with feedback has emerged as an important source of information for screening specific problems and developing effective plans of action for quality improvement in healthcare organizations [28]. Also, assessment of patients’ quality of life with systematic feedback to clinicians has been shown to improve patient–physician communication and patient satisfaction in oncology and psychiatry [29‐32]. In the specific context of the ICU, we can hypothesize that systematic assessment/feedback of discomforts may also highlight specific discomforts, may have implications for managing care, including considerations of ethical issues, and may assist the healthcare teams in choosing the most appropriate interventions. The identification of specific discomforts may allow for implementing minimal interventions expediently or developing more complex actions. To date, no randomized controlled study has assessed the impact of an "assessment" of discomforts and "feedback" to ICU healthcare teams.

These observations prompted us to establish a multicenter, cluster-randomized, controlled study with the objective of assessing the effectiveness of a multicomponent program of discomfort reduction in critically ill adult patients. This program combines three main components: assessment and identification of discomforts; feedback to the healthcare workers; and implementation of corrective actions. We hypothesized that this program may have a positive effect on the discomfort level self-reported by critically ill patients.

To our knowledge, this is the first study assessing the effectiveness of a program of discomfort reduction for ICU patients using a randomized controlled design, which is the most appropriate design to demonstrate the efficacy of a new experimental intervention in accordance with the levels of evidence classification of the Evidence-Based Medicine Working Group (Evidence-Based Medicine Working Group 1992; produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, and Martin Dawes since November 1998; updated by Jeremy Howick in March 2009).

We hypothesize that routine assessment of patient discomforts will be useful for further investigation and implementation of targeted preventive/curative actions. A previous study using the IPREA questionnaire for patient discomforts assessment has shown that most of the identified discomforts may be relatively easily relieved by interventions conducted by the ICU team. This program is in accord with the message of the 2009 French consensus conference centered on “a better life in ICU,” which lists recommendations to reduce stressors and discomforts. This program is based on the "plan-do-check-act" (PDCA), which is a management method for the control and continuous improvement of widespread processes and products in business and contributes to quality management and continuous quality improvement in healthcare [39]. The PDCA involves the planning and selection of interventions intended to improve the selected process, implementation of the selected intervention, assessment of its effectiveness, and embedding of changes into the existing quality improvement structure. If this program is effective, then it may provide a significant improvement in the negative experiences reported by ICU patients, such as stressors and discomforts.

However, some issues related to this specific protocol study should be developed. First, the choice of a cluster design should be discussed. Because the experimental program is applied to the whole ICU and affects all the individuals within the ICU, the individual randomization will not be appropriate [40]. To fit the intervention application and to avoid contamination within the unit, cluster randomization is advocated [41, 42]. However, one bias should also be taken into account: because of the consecutive inclusion of patients, there is a greater chance of fluctuations, potentially causing selection bias, which needs to be assessed and adjusted for if present. The cluster approach has previously addressed pertinent issues of ethics. The decision regarding whether a particular cluster will participate in the trial is made by one single person (also called a guardian in a previous debate article) who decides to participate on the behalf of the cluster [41]. In this work, the authors noted that guardians, like physicians in conventional trials, might have potential conflicts of interest and/or scientific interests in the results. In our specific case, the guardian is generally the head of the ICU and is in a position to volunteer. The coordinating investigator contacted each of them, and we can assume that any policy-maker or chief executive of the hospital participated in making the decision. In the same way, the consent of the patient to participate or not is not really applicable. If a patient declines participation, then we can only ensure that the discomforts assessment will not be performed. However, the multicomponent program will be implemented throughout the whole ICU.

Second, the option of parallel design may be discussed. Although the large differences in patient populations between ICUs should lead us to prefer a crossover design (between-group and within-group comparisons will also be permitted [43]) over a parallel design, crossover trials imply having no carryover effect. The carryover effect corresponds to an effect that "carries over" from one experimental condition to another [44] that could potentially distort the results obtained during the second period (the experimental condition from the first time period may impact the effectiveness of the experimental condition during the second time period). In our specific case, it was not possible to hypothesize that the implementation of the multicomponent program during the first time period (6 months) would not have an effect on the second time period. The implementation of targeted interventions in the ICU will probably lead to changes in the behavior of healthcare professionals. Therefore, the observed effects will depend on the order in which the interventions will be applied [45]. We have decided that any washout period will be sufficient to prevent this carryover effect [46, 47]. Moreover, this design allows us to assess the potential sustainability of the effect of program implementation. Assessment of sustainability is an important goal of evidence-based medicine and evidence-based practice to ensure that research findings are translated into clinical practice [48]. Effectiveness (and implementation) studies must particularly examine the local circumstances in which the programs would be applied and necessarily adapted. There are no data regarding seasonality, but the case mix of diseases may be different from a period of one year to another. Therefore, it could be hypothesized that perceived discomforts might vary according to the main diagnosis leading to admission to the ICU.

Third, the fact that the healthcare team will not be blinded should be considered in the interpretation of the final results. The implementation of a program of discomfort reduction associated with systematic assessment of patient discomforts may have a direct influence on healthcare behaviors. The caregivers could make more of an effort than usual, leading to better attention to the patient’s discomfort and the potential sources of discomfort. This phenomenon is well described and is known as the Hawthorne effect, and it may involve underestimation of the intervention effect [49, 50]. This potential Hawthorne effect was actually desired during the implementation of the program and must be considered as the first stage of the multicomponent program, but this effect also applies during the baseline assessment period. Therefore, the Hawthorne effect, if present, could induce an artificial reduction in the overall discomfort score due to the implementation of the program. Suppressing this potential bias would have required administration of IPREA by actors not in the ICU and without knowledge by the ICU team, which is impracticable.

Despite the acknowledged need to consider discomfort issues, self-reported assessment remains underutilized in clinical practice. Environmental barriers have been described to explain why self-reported measures have not been routinely implemented in clinical practice [51, 52]. Time and resources are both constraints on clinicians, whose main role is to provide patient care. The ergonomics of the questionnaire, such as shorter length, an electronic format, or computer-adaptive testing, may improve the acceptability [53, 54]. Although the psychometric properties and acceptability of the IPREA questionnaire are satisfactory, the development and validation of shorter or web versions should be considered to improve its implementation and use in routine clinical practice.

In conclusion, the results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy for the care of critically ill patients.