The Atlas. Given the sequential nature of the proposed methodology, the design of the clinical audit, rather than being decided at the start, was instead based on the results already obtained in the qualitative stage. This was an observational multicenter study conducted at 17 ICU belonging to 11 secondary- and tertiary-level public university teaching hospitals from February through May The study covered polyvalent ICU, both medical and surgical, and included all patients aged 18 years or over admitted across the study period.
The observation period at each ICU was 96 h, a period subdivided into four monthly intervals of 24 h each to enhance the representativeness of the sample. The research assistant at each ICU recorded the data by direct observation, a review of clinical records CR , and an interview with the health professionals involved in the care of each patient. We recorded different variables pertaining to the general descriptive elements of each ICU; data on institutional PAD-monitoring policies; and elements linked to the quality of PR use.
The set of variables classified in respect of these three criteria can be seen in Table 3. We performed the following: a descriptive analysis of categorical variables using absolute and relative frequencies, and a descriptive analysis of numerical variables using the mean and standard deviation, or the median and 25th P25 and 75th percentiles P75 , according to compliance with the normality assumption.
The relationship between the variables was analyzed using the U Mann—Whitney test for numerical variables and the Chi-squared or Fisher exact test statistic for categorical variables.
Following training of the researchers and a pilot test of the case report form, data were simultaneously collected at all ICUs and analyzed on an aggregate basis, with the participating hospitals, units, patients, and health professionals being anonymized for this purpose.
For integration of the results of the methodologies described above, we opted for a multimethod design of the type, see Figure 5. Methodologies description. Through this process of pooling the results of the DG involving nurses from both types of ICU, and a review of the literature addressing the interpretation of patient behavior and management of agitation, we constructed a theoretical reference framework with respect to PR use in critical patients.
The methodology used, albeit including stages of qualitative and quantitative research, was not conceived as a mixed design, in light of the absence of some of the elements considered crucial for a mixed approach such as dependence on the comprehension of the secondary design components. As explained, rather than adopting a mixed approach, we opted instead for the coexistence of different stages with different designs a multimethod approach , geared to feeding into and enriching the subsequent stages to ultimately obtain a broad, in-depth, holistic, and pragmatic overview of what is regarded as a significantly complex research phenomenon [ 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 ].
As a consequence of this cumulative and progressive integration of the findings of the different study components across the research process, a description of the results displays aspects that are at once explanatory and comparative. In light of the latter, we considered it opportune to merge the Results and Discussion sections by way of providing an internal dialogue between the contributions of the different components of the multimethod study, and a contrast with other external evidence.
In order to contextualize the findings on the decision-making process surrounding PR use as well as the factors that modulate this process, we propose to begin by setting out some of the results of the clinical audit that convey the reality of PR use at the 17 ICUs where the study was undertaken.
With respect to the characteristics of the ICU and in reference to the level of health care complexity, it should be noted that the mean nurse:patient ratio was range Furthermore, it is likewise important to note that only Characterization of intensive care units according to approximation to optimal physical restraint use, prevalence of physical restraints, prevalence of physical restraints in intubated patients, compliance with standard of prevalence of restraints, and nurse:patient ratios.
PR use: optimal physical-restraint use; no. A total of patients were observed, and of these, had some type of PR, amounting to a median prevalence of PR use of the four observation periods of These data are within the range of PR use found in other studies.
Our data indicate a prevalence of Studies undertaken in France, Japan, Jordan, and Canada report prevalence as high as The most frequent adverse effects were edema in the area of application Of the 17 ICUs, five The concept of safety is thus envisaged from two perspectives that lie at opposite ends of a single continuum.
Concept of safety and risk in relation to use of physical restraints. This preventive attitude assumes that all patients admitted to ICU mainly those from whom sedation is being withdrawn in order to advance toward removal of mechanical ventilation are exposed to universal risk situations not considering the particular situation to which the patient is exposed and how they interact with it.
This risk of experiencing accidents such as self-extubations is attributed to patient behavior such as psychomotor agitation, without taking into account the causes or the magnitude of the consequences of the risk or of the preventive interventions restraint themselves.
In relation with health professional-oriented safety, there is a culture focused on defensive intervention aimed at minimizing any possible incidents that might be attributed to the health professional. Similarly, there is a lack of communication within the team, and an absence of individualized assessment or consensus-based protocols. This would be in line with some of the results of the clinical audit, which bear out the fact that the PR-application profile fundamentally corresponds to patients with AAs General characteristics of patients WITH physical restraints observed in the clinical audit stage.
Abbreviations: PR: physical restraint; no. The goal here is PR use in the smallest number of cases, and always with an awareness justified intervention, taking into account the possible complications arising from their use.
What do we do? Do we restrain everyone before waking them up? Furthermore, the concept of safety and professional risk is approached from a different perspective.
Hence, at an ICU with OU, both physicians and PCNA see the risk of undesirable events as something intrinsic to professional practice, even though resources and advances in knowledge mean that these are less frequent and that safety in the workplace is far greater.
Thus, they do not perceive PR use as a means to prevent incidents that might reveal or highlight personal error in professional praxis: what they see instead is that the real solution to the occurrence of undesirable events is a feeling of group responsibility.
Think about it]. The use of bold is to highlight the results in which statistically significant differences were found. In relation with the above, there is an evident need for a cultural change, a conclusion and at the same time, a demand, that other authors have also contemplated [ 2 , 8 , 38 , 94 , 95 , 96 ].
In this regard, the principal reason cited by health professionals to justify PR use i. The qualitative findings yielded by examining the experience of ICU nurses showed that in units with FU of PR, the presence of artificial airways or the initiation of the process of weaning patients off mechanical ventilation is used to justify the practice as a way of preventing self-removal of life-sustaining devices, without there being any assessment of the need for their use.
Accordingly, PR use could not be attributed to a decision-making process for the management of restraints: a clinical judgment of this nature would not appear to exist. This would be in line with the results of the clinical audit, which concluded that in While this reality might differ in an ICU with an OU of PR, where the health professionals acknowledge that such a decision-making process does indeed exist, they nonetheless experience difficulties when it comes to consciously putting it into words.
On what do you base yourselves in order to take the decision? I continue to keep an eye on him. As can be seen in Figure 8 , in both subtypes of ICU, the indication for the use of restraints is the prevention of the self-removal of life-sustaining devices, however, there are differences in the way in which nurses interpret patient behavior. In contrast to this, an ICU with OU of PR adopts a wait-and-see attitude, with the decision to apply or not to apply restraints being taken in accordance with the assessment of each patient.
At an ICU with FU of PR, however, there is acknowledgment of the under-use of such tools and mismanagement of some causes of agitation such as pain see Figure 9. With respect to the above, the clinical audit found that, when it came to the monitoring of pain, Whereas We analyzed the relationship between compliance with the standard and variables of PAD monitoring as well as the use of protocols and training of health professionals Table 9.
With regard to the association with the monitoring of delirium, no conclusions can be drawn, given the negligible number of ICUs that monitored delirium appropriately. In our results, the most frequent indications for use were agitation, attempted removal of AAs and other devices, which might be related with pain or delirium [ 2 , 29 , 97 , 98 ]. As with other authors, our data indicate that monitoring of pain in noncommunicative patients and delirium are the least reliable elements in the interpretation of patient behavior [ 21 , 94 , 99 , ].
Even so, the association found between appropriate monitoring of pain in noncommunicative patients and low prevalence of PR use is noteworthy, a situation that could be accounted for by better interpretation of patient behavior: a better understanding of pain behaviors in noncommunicative patients facial muscle tension, frequent movements, increased muscle tone, lack of adaptation to mechanical ventilation, etc.
This same result would have been expected in the case of the monitoring of delirium, but the low prevalence of appropriate delirium monitoring in the sample meant that this could not be analyzed. This idea seems to be reinforced by the results such as those published by Pun, Hsieh or Gu, who argued that appropriate detection of both pain in communicative and noncommunicative patients alike and delirium would reduce the profiles of agitation and need of PR [ 91 , 97 , ].
According to studies conducted in settings other than critical patients [ 3 , 16 , 17 , 37 , 39 , 43 , 48 , 50 , ], health professionals cite the influence of individual, group, and organizational factors. The nurse […] your patient has become accidentally extubated All of these are matters that could favor the use of restraints.
In connection with the organizational factors, though health professionals of both subtypes of units acknowledged the influence of the nurse:patient ratio, it was noteworthy that the ratios were similar in the two subtypes of ICU i. Hence, although this factor is considered relevant by nursing professionals, it may possibly not be quite so decisive in clinical practice [ 26 , 39 , 45 ].
This hypothesis was explored using the results of the clinical audit by analyzing the possible relationship between optimal PR use, as shown by percentage compliance with the criteria considered, and institutional strategies use of protocols or educational interventions , prevalence of PR, and nurse:patient ratios Table 9. No statistical relationship was found with the existence of a protocol, specific training, or ratios.
Along these lines, the literature indicates that there are a number of authors who initially singled out the ratio as a variable associated with increased application of PR.
However, other studies have shown wide differences in the use of restraints in countries with the same ratios as the United Kingdom or northern European countries, which not only have an average nurse:patient ratio of , but which also include figures such as respiratory therapists in their staff rota [ 27 , ].
Even so, we agree with Luk et al. With regard to the profile of ICU staff, aside from nurse:patient ratios, a number of authors have highlighted the importance of ICU skill and training levels when it comes to decision-making about PR use [ 5 , , ]. Similarly, feelings of helplessness might justify the use of restraints as a nursing response in the face of the many problems that lie outside their professional scope [ 48 , , ].
Inappropriate management, the elements cited as modulators of PR use, and the simultaneous demand for safety, may place health professionals in a predicament that they seek to resolve by using restraints. This approach is based on the following four premises: patient- and family-centered care; well-being-comfort and self-determination as outcome criteria; clinical judgment and planning of consensus-based interdisciplinary health care interventions; and the provision of adequate human and material resources Table From this standpoint, achievement of a subjective feeling of well-being and comfort is seen as a priority.
Some key elements to facilitate such well-being are linked to the presence of a figure that would serve as a reference and effective support.
What we ourselves do in the case of some patients is to increase visits for family relatives. Furthermore, correct analgosedation is essential to place patients in the best condition to maintain their self-control and consciously participate in their recovery process.
Providing the patient and family with information about clinical status and training in care are indispensable for making decisions and participating in caregiving, thereby achieving a feeling of control and self-esteem. None of this is possible, however, without a consensus-based interdisciplinary approach based on in-depth knowledge of the patient and joint decision-making.
A routine multicomponent assessment that envisaged PAD monitoring, the risk factors for its implementation, and the pertinence of the continuity of invasive devices, would be crucial in such a decision-making process. In such a context, interpersonal communication oral and written-recorded is fundamental, as is formal regulation of the prescription of PR, which, being ambiguous, generates invisibility and a dilution of responsibilities.
With respect to human and material resources, different factors were identified that would foster the promotion of restraint-free ICUs Table Examples of these are: an adequate nurse:patient ratio that would allow for nursing proximity and bedside presence; pharmacological resources for elective analgosedation; and team training in aspects of assessment and psycho-socio-emotional interventions.
There are many variables. Returning to the basic premises, by virtue of which patient safety would be construed as a collective responsibility, and decisions the issuing of clinical opinions and treatment planning would be based on consensus reached by health care teams, these give rise to the need to think about the prescription of PR use.
Furthermore, nurses are regarded by physicians and PCNA as the figure that centralizes information and serves as the manager of patient needs by coordinating therapeutic interventions.
Furthermore, the nurse is acknowledged as being the professional carrying front-line responsibility for ensuring patient safety with this being construed as a basic need or functional pattern. In this respect, their judgment, far from being questioned, is trusted and relied upon.
The findings revealed opposing points of view, with feelings of empowerment on the one hand and vulnerability on the other. They refer to the fact that their use must be agreed upon and never imposed by physicians, alluding to the fact that this sometimes entails a moral dilemma for them i. This proposal can be seen in Figure 12 , which shows the distribution and overlapping of tasks and responsibilities in the inter-disciplinary approach to a common goal.
Proposed physical restraints prescribing and interprofessional roles. Well, I feel it ought to be a joint or delegated prescription. They should be the ones participating in this prescription, just as they participate in many other aspects of care.
As has already been noted, on discussing the process of taking judicious and consensus-based decisions, anxiety, agitation, and rest-sleep feature prominently as fundamental pillars of pain assessment. Integrated multidimensional information leads to planning of health care interventions at a pharmacological and non-pharmacological level, which in turn implies impeccable coordination among the various professional figures.
Having come thus far, it is necessary to introduce another actor with a say in matters and operational capacity, namely, the family, which may exert a major influence. Hence, such a transformational participation would reach a maximum and translate as a true dialogue between clinicians and family as the result of a continuous interaction, which would guide decision-making, and ultimately lead to the design and implementation of pluralist decision-making models [ ].
In addition, the role of mid- and high-level managers should also be kept in mind. With regard to the latter, health care professionals highlight the passivity of managers with respect to PR use [ 5 ]. These results seem to be in line with the lack of involvement of managers nurses as well as physicians and PCNA detected in the discourse.
Institutional positioning and involvement could be crucial in achieving changes in clinical practice, with the introduction of policies and strategic lines that would generate a culture of restraint-free care and provide the structural resources material and human and necessary knowledge to implement it [ 40 ]. This multimethod project was conducted throughout from a pragmatic and translational stance, and has sought to provide a broad overview of a complex reality.
Indeed, acquiring in-depth knowledge of the reality surrounding PR and the factors associated with their use, opens up the possibility of reflexive management of restraints, which would in turn translate as a real reduction in clinical practice. In this respect, one of the undeniable strengths of the study is the use of multimethod strategies to minimize the specific limitations of each of the methodologies used.
Even so, there are some limitations in each of the stages that warrant consideration. In both stages of the qualitative interpretative phenomenological component, a comparative analysis was made of the discourse of health professionals drawn from ICU with OU or FU of PR.
Hence, in light of the absence, both in the literature and at the ICU involved, of reliable data on the real prevalence of PR use and the modulating factors of such use, the ICU were stratified on the basis of a purpose-designed questionnaire, which though unvalidated, was nonetheless agreed upon by the whole research team. Given the nature of the audit of the proposed clinical practice, a high number of cases were observed. Due, however, to the characteristics of this data-collection no collection of individual data from each patient, thus conceivably including all the patients admitted, and omitting the need to sign the IC form , this inevitably gave rise to other related limitations such as the fact that the data were collected on an aggregate basis.
The fact that only ICUs that voluntarily wished to do so participated in the study may influence the findings and exhibit an excessively benevolent image of PR use in this country. The study included health professionals from a single region in Spain, and as a result, the conclusions must be contextualized and can only be extrapolated to cultural contexts with similar ethical conceptualizations such as other regions of this country or countries in the Mediterranean Basin.
The chronological order of the study and the time elapsed between the different stages may have amounted to a limitation in light of the changing nature of reality. Although the difference between theoretical advances and the translation of results to clinical practice is undeniable, with this being a long, and costly process, it is nonetheless likely that, across the years covered by this study, small changes may have occurred in the ICUs involved, with the result that, as of the date of writing, the reality recorded during the initial years may have undergone certain modifications.
The multimethod strategy has shown itself to be of great utility. Initially, the qualitative approach made it possible to gain greater insights into a complex and multifactorial phenomenon to then be able to validate some of the emerging hypotheses via the quantitative approach.
This study revealed a reality of use that might be similar to that of other countries with frequent use of restraints. Different profiles of PR use among the units studied were identified.
Interventions such as interdisciplinary rounds, in which the nurse would act as the central reference figure, or the establishment of a model with quality standards for the application of restraints, may prove useful. Conceptualization, M. All authors have read and agreed to the published version of the manuscript.
The study was conducted according to the guidelines of the Declaration of Helsinki. The approval report was obtained from the Ethics Committees of each of the centers involved in the study, acting Puerta de Hierro Majadahonda University Hospital-Ethics Committee as a reference center Certificate no.
Informed consent was obtained from all professionals involved in the study. Patient consent was waived due to the audit nature of the study so individual consent was not necessary. Anonymous or aggregated data were provided from the CCU. National Center for Biotechnology Information , U. Published online Nov Author information Article notes Copyright and License information Disclaimer.
Received Sep 30; Accepted Nov 8. Associated Data Data Availability Statement Data are stored under the custody of the main researcher. Abstract Aim: The general aim of this study was to explore the decision-making process followed by Intensive Care Unit ICU health professionals with respect to physical restraint PR administration and management, along with the factors that influence it.
Decision-Making about and Explanatory Models of PR Use What appears to be evident at the present time is that systematic PR use is becoming increasingly difficult to justify. Open in a separate window. Figure 1. Hypothesis and Objectives The general aim of this study was to explore the decision-making process surrounding PR use and the factors that influence it among the various professionals comprising the ICU health care team nurses, physicians, and PCNA.
Table 1 Specific research goals. Methods The methodology adopted responds to the need to examine a little explored phenomenon that is also rather complex.
Figure 2. Ethical Considerations All the health professionals participated in the study voluntarily and were asked to sign the informed consent IC form. Qualitative Interpretative Phenomenological Component 3. Stage I—Registered Nurses Study Design We conducted a qualitative interpretative phenomenological study [ 4 ] as proposed by Heidegger [ 63 , 64 ].
Study Scope Data were collected from December through January , and generally included health professionals drawn from eight public hospitals and 14 of the ICUs included in the study.
Participants and Sampling We carried out intentional purposive sampling [ 62 , 65 ]. In your unit, is there some type of patient to whom PRs are systematically applied? How would you rate PR use in your unit, occasional or frequent?
Figure 3. Data Collection A total of five DGs were held [ 67 ]. The DGs were tape-recorded and transcribed for subsequent analysis. Rigor Criteria Epistemological adequacy, adjusted to the subject of study, was monitored in terms of relevance, validity, and reflexivity [ 75 , 76 ]. Study Scope Data were collected from December through March and included health professionals PCNA and physicians from 14 ICUs belonging to 10 secondary- and tertiary-level public hospitals in the Madrid region.
Figure 4. Data Analysis We performed a thematic analysis of the free-discourse content on theoretical reference frameworks [ 81 , 82 ]. Quantitative Component—Clinical Audit Given the sequential nature of the proposed methodology, the design of the clinical audit, rather than being decided at the start, was instead based on the results already obtained in the qualitative stage.
Study Design and Scope This was an observational multicenter study conducted at 17 ICU belonging to 11 secondary- and tertiary-level public university teaching hospitals from February through May Participants and Sampling The study covered polyvalent ICU, both medical and surgical, and included all patients aged 18 years or over admitted across the study period.
Data Collection The observation period at each ICU was 96 h, a period subdivided into four monthly intervals of 24 h each to enhance the representativeness of the sample. Variables Recorded We recorded different variables pertaining to the general descriptive elements of each ICU; data on institutional PAD-monitoring policies; and elements linked to the quality of PR use. Table 3 Variables recorded in the clinical audit stage.
Variables Recorded General descriptive elements of each ICU Number of patients admitted; number of patients with PR; number of patients fitted with artificial airways AAs endotracheal tube ETT , tracheostomy cannula , number of patients with non-invasive mechanical ventilation NIMV , number of self-removed devices; and type of device.
Data relating to institutional PAD monitoring policies. Table 4 shows the definitions for each of these variables. Table 4 Glossary of variables recorded in the clinical audit stage. Glossary of Variables [ 8 , 14 , 84 , 85 ] Specific PR protocol in writing Existence of a written protocol governing patient management with PR or subsidiary restrictive measures.
The protocol must be ICU-specific general hospital protocol not deemed valid unless it makes specific considerations for ICU. Optimal PR use Based on the bibliographic review, a set of 15 criteria was defined that would reflect optimal PR use. Table 5 Optimal use of physical restraints—Criteria. Non-pharmacological management 5 PR use after verbal or psychological approach ruled out Patients with PR, after attempt to control symptoms with verbal patient-management skills and invitation to dialogue, while ensuring a calm and soothing atmosphere, and providing information about their process and maintenance of spatio-temporal orientation.
Ethical and legal aspects 8 PR with certified material Patients with PR applied with certified material, authorized by the institution for this purpose. Follow-up 14 Re-assessment of need for PR use during every nursing shift Patients with routine shift-based assessment by a professional ICU staff member of the need to continue using PR.
Data Analysis We performed the following: a descriptive analysis of categorical variables using absolute and relative frequencies, and a descriptive analysis of numerical variables using the mean and standard deviation, or the median and 25th P25 and 75th percentiles P75 , according to compliance with the normality assumption. Rigor Criteria Following training of the researchers and a pilot test of the case report form, data were simultaneously collected at all ICUs and analyzed on an aggregate basis, with the participating hospitals, units, patients, and health professionals being anonymized for this purpose.
Integration of Results For integration of the results of the methodologies described above, we opted for a multimethod design of the type, see Figure 5. Figure 5. Figure 6. Findings and Discussion As a consequence of this cumulative and progressive integration of the findings of the different study components across the research process, a description of the results displays aspects that are at once explanatory and comparative. Characteristics of the Clinical Context In order to contextualize the findings on the decision-making process surrounding PR use as well as the factors that modulate this process, we propose to begin by setting out some of the results of the clinical audit that convey the reality of PR use at the 17 ICUs where the study was undertaken.
Background: Physical restraint has been widely used among intensive care unit patients in many countries. Despite the benefits it offers in protecting patients from disrupting their medical treatment, it has been reported that restraint has many physical and psychological adverse effects.
Method: A cross-sectional and observational study was conducted during a period of 3 months April-June A sample of intensive care unit patients was selected from five governmental and one university-affiliated hospital in the north and middle of Jordan.
The Restraint Prevalence Tool was used to collect data from the patients. Address for correspondence: Prof. E-mail: moc. This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4. Abstract Restraint and seclusion are measures to restrict the movement of a person.
Here are some suggestions for alternatives practices that can be used in different settings: In elderly caring nursing homes, the restraint alternative guide issued by Ohio's quality improvement organization, the guidelines are predominantly around individualizing the care — it advocates regularization of activities, minimizing the changes in daily schedule, feeding regularly, easing the activities of daily living, and reducing pain as alternatives that can lead to reduced use of restraint in those with cognitive decline.
Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest. Fisher WA. Restraint and seclusion: A review of the literature. Am J Psychiatry. Retsas AP. Survey findings describing the use of physical restraints in nursing homes in victoria, Australia. Int J Nurs Stud. Restraint prevalence and perceived coercion among psychiatric inpatients from South India: A prospective study. Asian J Psychiatr. Raveesh BN, Lepping P. Mysore declaration on coercion in psychiatry.
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