Evidence Digest

The Latest Evidence on Restraint Use AcrossAges and Clinical Settings

Bernadette Mazurek Melnyk, PhD, RN, CPNP/NPP, FAAN, FNAP

The purpose of Evidence Digest, a recurring column inWorldviews on Evidence-Based Nursing, is to provide

concise summaries of well-designed and clinically im-portant recent studies along with implications for prac-tice, research, administration, and/or health policy. Arti-cles highlighted in this column may include quantitativeand qualitative studies, systematic and integrative reviews,as well as consensus statements by expert panels. Alongwith relevant implications, the level of evidence generatedby the studies or reports highlighted in this column (seeFigure 1) is included at the end of each summary so thatreaders can integrate the strength of evidence into theirhealthcare decisions.

Micek, S.T., Anand, N.J., Laible, B.R., Shannon, W.D.& Killef, M.H. (2005). Delirium as detected by the CAM-ICU predicts restraint use among mechanically ventilatedpatients. Critical Care Medicine, 33(6), 1260–1265.

Purpose. The purposes of this study were to: (1) iden-tify patients with delirium defined by the Confusion As-sessment Method for the Intensive Care Unit (CAM-ICU),and (2) compare clinical interventions that included use ofcontinuous sedation infusions, the number of ventilator-free days, ICU length of stay, hospital mortality, and use ofphysical restraints in mechanically ventilated patients withand without delirium.

Sample. The sample was comprised of 93 mechanicallyventilated patients who were admitted to a 19-bed inten-sive care unit at an academic medical center in the UnitedStates. Study inclusion criteria included being 18 years ofage and older with mechanical ventilation. Exclusion crite-ria included an inability to communicate, severe psychosisor neurological disease, or if the patient or family memberrefused participation in the study.

All patients were enrolled on their first day in the ICU.The median age of the sample was 59, with a range of 46–73 years.

Design. A prospective observational study.Methods/Procedure. Patients admitted to the ICU were

categorized into three groups based on daily assessments

Copyright ©2006 Sigma Theta Tau International1545-102X1/06

using the CAM-ICU: (a) CAM-ICU positive (i.e., with delir-ium), (2) CAM-ICU negative, and (3) comatose. Patients’level of arousal and delirium were assessed daily by the in-vestigators who achieved 100% interrater reliability beforebeginning their observational assessments.

Outcomes. Ventilator-free days during hospitalization,the duration of mechanical ventilation, hospital mortal-ity, length of hospital and ICU stay, the doses of benzodi-azepines and opioids used for ICU sedation, and the use ofphysical restraints were the outcomes assessed.

Findings. Forty-four patients (47%) developed delirium(i.e., had a positive CAM-ICU score) at some point whilereceiving mechanical ventilation and 22 (24%) had normalcognitive behavior throughout the course of ventilation. Asignificantly greater number of patients with delirium as ev-idenced by a positive CAM-ICU score received continuousintravenous sedation with midazolam and fentanyl com-pared to patients without delirium (i.e., CAM-ICU neg-ative). In addition, those patients who had delirium hadstatistically longer durations of mechanical ventilation andprolonged administration of physical restraints. There wereno differences in mortality rate or hospital lengths of staybetween the CAM-ICU positive and CAM-ICU negativepatients.

Commentary with Implications for Clinical Practice andFuture Research. Up to 80% of patients who are mechan-ically ventilated experience delirium during their ICUstays. Despite its high incidence, clinicians often fail torecognize delirium because of the challenges in com-municating with mechanically ventilated patients. Hav-ing a valid and reliable tool to assess delirium, such asthe CAM-ICU, and understanding the factors contribut-ing to this problem are highly important in order to im-plement preventive interventions, which could improvequality of life and cognitive functioning after discharge.

Evidence was gathered in this study to support theuse of the CAM-ICU in identifying delirium in mechan-ically ventilated patients. Therefore, routine use of theCAM-ICU in ICU settings could assist clinicians in therapid identification of patients with this condition so that

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Evidence Digest

• Level I: Evidence from a systematic review or meta-analysis of all relevant randomized controlled trials (RCTs), or evidence-based clinical practice guidelines based on systematic reviews of RCTs

• Level II: Evidence obtained from at least one well-designed RCT

• Level III: Evidence obtained from well-designed controlled trials without randomization

• Level IV: Evidence from well-designed case-control and cohort studies

• Level V: Evidence from systematic reviews of descriptive and qualitativestudies

• Level VI: Evidence from a single descriptive or qualitative study

• Level VII: Evidence from the opinion of authorities and/or reports of expert committees

Modified from Guyatt & Rennie, 2002; Harris et al., 2001

Figure 1. Rating System for the Hierarchy of Evidence (fromMelnyk & Fineout-Overholt, 2005).

early interventions to improve the neurological statusof patients can be implemented. Furthermore, physicalrestraints and continuous sedation should be used veryjudiciously in ICU patients. For those patients in whomrestraints absolutely need to be used for the preventionof physiological complications or self-harm, they shouldbe discontinued as soon as is possible and safe. Since thisresearch used a small convenience sample, which mayhave contributed to the lack of significant findings re-garding the association between delirium and mortalityrates as well as hospital length of stay, there is a need toreplicate this study with a larger sample across multipleICU settings.

Level of Evidence: VI.

Shattell, M, Hogan, B. & Thomas, S. (2005). It’s the peo-ple that make the environment good or bad: The patient’sexperience of the acute care hospital environment. AACNClinical Issues, 16(2), 159–169.

Purpose. The purpose of this study was to describe themedical-surgical patient’s experience of the acute care hos-pital environment.

Sample. A purposeful convenience sample was obtainedthrough an advertisement that was placed in a weekly uni-versity paper calling for individuals to participate in thestudy if they experienced a hospitalization and were will-ing to talk about their experience.

The sample was comprised of 20 individuals who rangedfrom 24 to 90 years in age.

Thirteen of the subjects were white and 7 were African–American; 7 were men and 13 were women.

Design. A phenomenological study.Methods/Procedure. Subjects were asked to describe

their answer to the following question in as much detail aspossible: “What stands out to you when you think about

the acute care hospital environment? Follow-up questions(e.g., Tell me more about the specific experience) wereonly used to clarify descriptions. The interviews were au-dio taped and later transcribed verbatim. Interview lengthranged from 45 to 90 minutes.

Findings. Three prominent themes, which were vali-dated by the subjects, were identified along with the cen-tral finding that survival was the ultimate concern. Thesethemes included: (a) disconnection/connection to nursesand other staff, which affected comfort and their feel-ings of being cared for, (b) fear/less fear, including beingafraid of dying, procedures, and being alone, and (c) con-finement/freedom, specifically commenting on feelings ofpowerlessness and confinement due to physical restraints.Some individuals who described ICU experiences felt lessconfined, which may be related to nursing staff being inclose proximity and feeling more connected.

Commentary with Implications for Clinical Practice andFuture Research. Although this study has some majorlimitations (i.e., no consistency in the length of timesince hospitalization, which might affect cognitive re-call; a very broad age group), findings support prior re-search and validate the importance of certain aspects ofthe hospital environment in enhancing individuals’ abil-ity to cope with the stressful experience.

The central themes of being connected and confinedmay become more of an issue for patients as nursingshortages continue to be problematic in some countriesacross the globe. Findings from this study have severalclinical implications, including the need to: keep pa-tients informed and reassured about their physical andemotional safety, stay connected as often as possible,elicit concerns and fears with key strategies for how tocope with them, and to lessen feelings of confinement.Key elements of care need to focus on the interpersonalaspects of care much more than the physical environ-ment. Future research is needed to develop and test in-terventions targeted to these specific issues.

Level of Evidence: VI.

Dorfman, D.H. & Kastner, B. (2004). The use of re-straint for pediatric psychiatric patients in emergency de-partments. Pediatric Emergency Care, 20(3), 151–156.

Purpose. The purposes of this study were to: (1) identifycurrent practices in restraining and staff education aboutthe use of restraints for children undergoing psychiatricevaluations in an emergency department, and (2) comparerestraint practice and education in facilities with emer-gency medicine residencies (EMRs) and pediatric emer-gency medicine fellowships (PEMFs).

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Evidence Digest

Sample. The sample was comprised of 48 physician di-rectors of EMRs and 33 directors of PEMFs.

Design. A descriptive survey was used.Methods/Procedure. A self-report survey was mailed to

all directors of EMRs and PEMFs that tapped use of re-straints (i.e., restricting a person’s freedom of movement,physical activity, or normal access to his or her bodythrough use of physical or chemical means) in their facili-ties. The survey also included questions about the trainingof staff in these facilities.

Measure. The survey consisted of 23 multiple-choiceand open-ended questions.

Findings. Eighty-four program directors responded tothe survey, including 48 of 118 (41%) EMRs and 33 of50 (66%) of PEMFs. The emergency departments that re-sponded treated a mean of 23,000 pediatric patients andconducted a median of 200 pediatric emergency psychi-atric evaluations every year. Both EMR and PEMF directorsreported infrequent use of restraints for children. Thirty-three of 44 EMRs (75%) and 26 of 31 PEMFs (84%) re-ported that they used physical restraint in 5% or less ofpediatric patients undergoing psychiatric evaluation. Thir-teen of 46 (28%) EMRs and 5 of 33 (15%) PEMFs didnot use chemical restraint for children and teens. Further-more, 23 EMRs (50%) used chemical restraint in 5% orless of patients. All of the PEMF programs reported us-ing chemical restraint in 5% or less of pediatric patients.The majority of emergency departments had formal poli-cies about the use of physical restraints. Substantially fewerprograms that used chemical restraints had formal policiesabout its use. A large percentage of EMRS and PEMFs didnot teach their residents and fellows about restraint, butEMRs programs were more likely than PEMFs to teachtheir fellows about the appropriate use of restraints. Nurs-ing staff received the most frequent training in restraintscompared to other healthcare providers. The decision toplace patients in restraints was most frequently made bythe attending EM and PEM physicians. Nurses and secu-rity staff most often applied physical restraints. The twomedications used most frequently for restraint includedbenzodiazepines (e.g., diazepam) and the butyrophenones(e.g., haloperidol), which were misclassified by many ofthe respondents.

Commentary with Implications for Clinical Practice, Ad-ministration and Future Research. A limitation of thisstudy was the fact that the response rate was some-what low for the EMRs (i.e., 48/118 or 41%) versus66% (33/50) for the PEMFs, therefore, the data ob-tained may not be fully reflective of the practices forthe great majority of the EMRs. Despite this limitation,

this is the first published study that has addressed the useof restraints for children and teens in emergency depart-ments. Findings from this survey indicate that many at-tending physicians, residents, and fellows do not receivetraining on the use of restraints in children and policiesneed to be created regarding restraints in pediatric andadolescent patients. In addition, the misclassification ofmedications by the respondents indicates the need forintensive education. Nurses can assume a vital role indeveloping policies and also in the training of fellows inthe proper use of restraints if they must be used with pa-tients who are high risk of self-injury in the emergencysetting. Administrators must assure that these policiesare developed. Further research is needed to determinethe efficacy and safety of these procedures and whetherthe use of restraints in the emergency department pre-dicts in-patient hospital admissions.

Level of Evidence: VI.

Hamers, J.P.H., Gulpers, M.J.M. & Strik, W. (2004). Useof physical restraints with cognitively impaired nursinghome residents. Journal of Advanced Nursing, 45(3), 246–251.

Purpose. The purpose of this study was to evaluate theprevalence of physical restraint use in cognitively impairednursing home residents, the manner in which restraintsare used and the rationale for their use, as well as the re-lationships among residents’ characteristics and the use ofphysical restraints.

Sample. The sample consisted of 260 cognitively im-paired residents housed in two nursing homes and onenursing home unit in the Netherlands. The mean age ofthe residents was 81 years and consisted of 26% men and74% women.

Design. Descriptive survey.Methods/Procedure. Seventy-five nurses who cared for

the residents were asked to complete a questionnaire aboutrestraint use.

Measures. Assessment tools included a questionnairethat contained questions about the demographic charac-teristics of the resident, mobility, psychoactive drug use,fall risk, and use of physical restraints. Activities of dailyliving and psychosocial performance were measured us-ing a Dutch care inventory that assesses the care needs ofresidents. Care dependency was measured using a 23-itemDutch assessment scale.

Findings. Physical restraints were used with 128 (49%)of the residents. In 67 (26%) of these cases, physical re-straints were used both in the bed and chair whereas for60 (23%) of the residents, restraints were only used in bed.The most frequently used restraints in bed were bed rails

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Evidence Digest

(i.e., 98% of restrained residents) and belts (27%). Ninetypercent of the residents had restraints used for at least3 months. In 91% of the restrained residents, restraintswere used as a routine measure. The most common reasoncited for using restraints was to prevent falls, followed byrestlessness and to allow the safe use of medical devices. Re-strained residents were older than unrestrained residents.There was a trend for restraints to be used more often inwomen than men. Furthermore, the activities in daily liv-ing functions of restrained residents were more severelyimpaired and their psychosocial performance was poorerthan nonrestrained residents. In addition, restrained resi-dents were more dependent on care and had higher risk forfalls than nonrestrained residents.

Three major factors were found to determine use of re-straints: (a) mobility, (b) care dependency, and (c) risk forfalling. Noteworthy is the fact that the chance of using re-straints was 11 times as high in those residents with poormobility as in those residents who are mobile.

Commentary with Implications for Clinical Practice andFuture Research. Findings from this study indicate thatrestraints are commonly used with nursing home res-idents who are cognitively impaired in the Nether-lands. Furthermore, restraints were typically used formore than 3 months, which raises a level of con-cern that they were being used routinely. It is notknown whether reevaluation of restraint use was being

conducted, which is important in the ongoing care ofcognitively impaired older adults. It is clear that the ma-jor reason in using restraints by this sample was to pre-vent falls; however, evidence in the literature indicatesthat reducing the use of physical restraints does not nec-essarily lead to an increased number of falls and maybe related to reduced injuries (Neufeld et al. 1999). In-tervention studies are urgently needed to develop andtest alternative strategies to the use of restraints for thepurpose of preventing adverse outcomes in cognitivelyimpaired nursing home residents.

Level of Evidence: VI.

ReferencesGuyatt G. & Rennie D. (2002). Users’ guides to the medical

literature, Washington, DC: American Medical Associa-tion Press.

Harris R.P., Hefland M., Woolf S.H. et al (2001). Currentmethods of the U.S. Preventive Services Task Force: Areview of the process. American Journal of PreventiveMedicine, 20(3 Suppl), 21–35.

Melnyk B.M. & Fineout-Overholt E. (2005). Evidence-based practice in nursing & healthcare. A guide to bestpractice. Philadelphia: Lippincott, Williams & Wilkins.

Neufeld R.R., Libow L.S., Foley W.J., Dunbar J.M., CohenC. & Breuer B. (1999). Restraint reduction reduces se-rious injuries among nursing home residents. Journal ofthe American Geriatric Society, 47, 1202–1207.

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