CRITICALLY APPRAISED PAPER (CAP) Schweickert, W. D., Pohlman, M. C., Pohlman, A. S., Nigos, C., Pawlik, A. J., Esbrook, C. L., Kress, J.P. (2009). Early physical and occupational therapy in mechanically ventilated, critically ill patients: A randomised controlled trial. Lancet, 373(9678), 1874-1882. http://dx.doi.org/10.1016/s0140-6736(09)60658-9 CLINICAL BOTTOM LINE: Advancements in the medical care of ventilated patients have increased the long-term survival rates of critically ill patients. However, it is well documented that survivors of critical illness experience increased morbidity and decreased quality of life (Engel, Tatebe, Alonzo, Mustille, & Rivera, 2013). Immobility and prolonged sedation have been identified as strong risk factors for these issues (Balas et al., 2014). According to the American Occupational Therapy Association s (AOTA) position paper on scope of practice (2010), occupational therapists are experts at analyzing the performance skills and patterns necessary for people to engage in their everyday activities in the context and environments in which those activities occur (p. S71). Furthermore, occupational therapists: 1) identify factors that limit participation in occupation, 2) generate approaches and strategies to address limitations (i.e., remedial, compensatory, prevention, maintenance), and 3) develop interventions to facilitate safety and participation in occupation (AOTA, 2010). Thus, occupational therapists demonstrate a holistic approach to patient care and have great potential to enhance participation in occupation in patients within the context of a restricted intensive care unit (ICU) environment. Despite the growing body of literature demonstrating the safety and feasibility of early therapy in the ICU, critically ill patients historically have been placed on bed rest under heavy sedation and ventilation. As a result, initiation of therapy services often is delayed. This article provides evidence to support early physical rehabilitation (occupational therapy and physical therapy) as a safe and effective intervention to improve functional outcomes, decrease delirium, and decrease total days on mechanical ventilation when compared to standard care for critically ill patients. This evidence supports the presence and input of occupational therapy services in the ICU, thereby supporting improvement of the delivery of occupational therapy services at an institutional level. RESEARCH OBJECTIVE(S) 1
List study objectives. Assess the effect of combining daily interruption of sedation with occupational and physical therapy on functional and neuropsychiatric outcomes in patients receiving mechanical ventilation in intensive care. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. The authors recruited study participants from two separate medical centers: University of Chicago (Chicago, IL) and University of Iowa Hospitals (Iowa City, IA). The authors received approval from the institutional review boards of both locations. Written informed consent was obtained from the participants or their authorized representatives. Patients in the medical ICU were screened daily according to inclusion and exclusion criteria. The authors screened a total of 1,161 medical ICU patients. 343 patients were excluded because they did not meet eligibility criteria. An additional 714 patients were excluded for the following reasons: 150 due to an inability to obtain consent. 171 had an extubation order at the time of assessment. 122 experienced cardiac arrest as cause for respiratory failure. 126 were irreversible conditions with 6-month mortality estimated at >50%. 103 were rapidly developing neurological or neuromuscular disease. 30 were participating in conflicting studies. 5 had advanced dementia. 1 experienced elevated intracranial pressure. 6 had multiple limb amputations. After exclusion, 104 patients were enrolled and randomized. Inclusion Criteria Adults age 18 years or older who were mechanically ventilated for fewer than 72 hours and expected to continue ventilation for 24 more hours. Additionally, eligible subjects meeting the aforementioned criteria were also required to meet apriori established baseline functional status (Barthel Index score greater than or equal to 70 obtained from a proxy describing patient function 2 weeks prior to admission). Exclusion Criteria Rapidly developing neuromuscular disease, cardiopulmonary arrest, irreversible disorders with 6- month mortality estimated at more than 50%, raised intracranial pressure, absent limbs, and enrollment in another trial were all considered criteria that would exclude one from eligibility within this study. 2
SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 104 patients Intervention = 49 Control = 55 #/ (%) Male N = 52 (50%) Intervention = 20(41%) Control = 32 (58%) #/ (%) Female N = 52(50%) Intervention = 29 (59%) Control = 23 (42%) Ethnicity The authors reported solely on black race Intervention = 30 (61%) Control = 31 (56%) Age (median) Intervention = 57.7 (36.3 69.1) Control = 54.4 (46.5 66.4) Disease/ Disability diagnosis Barthel Index: Median (IQR) Intervention =100 (85 100) Control = 100 (90 100) Body Mass index (kg/m 3) : Median (IQR) Intervention = 27.4 (25.1 32.4) Control = 28.0 (23.5 34.1) APACHE II (Acute Physiology and chronic Health Evaluation II): Median (IQR) Intervention = 20.0 (15.8 24.0) Control = 19.0 (13.3 23.0) Sepsis: percentage Intervention = 42 (86%) Control = 45 (82%) Diabetes: percentage Intervention = 18 (37%) Control =18 (33%) Primary diagnosis on admission to intensive care Acute lung injury Intervention (n = 49) Control (n = 55) 27 (55%) 31 (56%) 3
Primary diagnosis on admission to intensive care Chronic obstructive pulmonary disease exacerbation Acute exacerbation of asthma Intervention (n = 49) Control (n = 4 (8%) 6 (11%) 5 (10%) 4 (7%) Sepsis 7 (14%) 9 (16%) Haemorrhage 1 (2%) 2 (4%) Malignancy 2 (4%) 1 (2%) Other 3 (6%) 2 (4%) IQR=Interquartile range INTERVENTION(S) AND CONTROL GROUPS Group 1 Brief description of the intervention3 Every morning, unresponsive patients underwent passive range of motion exercises for all extremities, 10 repetitions in all cardinal directions. Sedatives were then interrupted (see Sedation below) and therapy was delivered by a physical therapist and occupational therapist (interruption of sedatives and therapy was coordinated daily). Upon increased level of arousal as reflected by patient interaction, sessions of range of motion exercises were initiated at bed level. Pending tolerance of exercises, sessions progressed to bed mobility with transfers to upright sitting. Activity progressed to sitting balance activities, then to participation in ADLs and exercises encouraging functional independence. Sessions progressed to transfer training (sit stands from bed to chair and bed to commode) and finally pregait exercises and ambulation. Progression of activity was dependent on patient tolerance and stability. Therapy was continued until the patient achieved baseline functional status or was discharged. Patient s functional status was assessed every 48 hours. Criteria that prevented initiation or continuation of therapy: Mean arterial pressure (MAP) less than 65 mmhg or more than 110 mmhg or systolic blood pressure more than 200 mmhg 4
Heart rate (HR) less than 40 beats per minute (BPM) or more than 130 BPM Respiratory rate (RR) less than 5 breaths per minute or more than 40 breaths per minute Pulse oximetry (SPO2) less than 88%. Contraindications: Elevated intracranial pressure (ICP) Active gastrointestinal blood loss Active myocardial ischemia Continuing procedures (intermittent hemodialysis) Patient agitation that required increased sedation within past 30 minutes Other considerations: Therapy was discontinued with marked ventilator asynchrony, patient distress, physical combativeness, new arrhythmia, concern for myocardial ischemia, or concern for airway device integrity Sedation: Participants in both groups were managed by goal-directed sedation guided by the Richmond Agitation Sedation Scale (RASS) and underwent daily interruption of sedatives and narcotics. Contraindications to sedation breaks included persisting neuromuscular blockade, sedative infusion for active for active seizures of alcohol withdrawal, evidence myocardial ischemia within past 24 hours, and evidence of increased ICP. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 49 The ICU of both institutions. The authors did not describe environment in detail. Occupational and physical therapists who were blinded to the assignment. To further ensure blinding, the study utilized different therapists to deliver interventions than the therapists providing functional assessments. Daily The participants received therapy until they reached baseline functional status or were discharged. The authors did not include data reflective of number of sessions. 29 patients in this condition achieved an independent functional status (as determined by performance in 6 ADLs and walking independently) discharge. Group 2 5
Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The authors explicitly state the control group received the standard therapy intervention care for ICU patients. They acknowledge that neither institution provided therapy services for patients on the ventilator for less than 2 weeks, nor did they have dedicated therapists to do so. In reviewing the results of the study, it appears that the standard care at these institutions was no therapy during intubation. There is no description of therapy interventions after extubation. However, the authors reported the control group received statistically similar frequency and duration of therapy when compared with intervention group (after extubation). Sedation Participants in both groups were managed by goal-directed sedation guided by the RASS and underwent daily interruption of sedatives and narcotics. Contraindications to sedation breaks included: persisting neuromuscular blockade, sedative infusion for active for active seizures of alcohol withdrawal, evidence myocardial ischemia within past 24 hours, and evidence of increased ICP. 55 The ICU of both institutions. The authors did not describe the environment in detail. NR NR NR Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NR The authors do not explicitly state if contamination was avoided. However, in interpreting the results, it is apparent the control group received no therapy during intubation whereas the intervention group received daily therapy (0 hours per day vs..32 hours per day, respectively). Following extubation, both groups received statistically similar amounts of therapy. The authors report both groups received similar interventions pertaining to sedation breaks, daily spontaneous breathing trials, balanced nutritional intake, and strict glycemic control. Co-intervention: 6
YES NO NR The authors excluded patients enrolled in other trials from the research study. However, the authors do not acknowledge the potential effects of nursing interventions. Timing: YES NR Site: YES NR The authors don t mention timing bias regarding research design, but acknowledge the rates and timing of therapy and nursing behaviors may have been affected by other confounding factors, suggesting the delivery and timing of services may have been affected by the nature of the environment. Use of different therapists to provide intervention: YES NR With the exception of explaining the use of different therapists for interventions and assessments, the authors did not describe whether different therapists carried out treatments between groups or within groups. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Functional Independent Measure Functional status as measured by ability to perform 6 specific ADLs (bathing, dressing, eating, grooming, transferring from bed to chair, and using the toilet) YES NR YES NR Every 48 hours Measure 2: Name/type of measure used: What outcome was measured? Barthel Index Score ADL performance 7
reliable? valid? When is the measure used? Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 4: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? YES NR YES NR Admission and within 24 hours of discharge Medical Research Council (MRC) examination Upper and lower extremity strength testing YES NR YES NR Every 48 hours Hand dynamometry Hand strength YES NR YES NR Every 48 hours and again at discharge The authors identified the Richmond Agitation Sedation Scale (RASS) for arousal and the Coma Assessment Measure (CAM) for delirium and coma as the primary sedation monitoring scales. However, they did not report on the psychometric properties of the tests. Nurses used these scales daily for both conditions. In addition, the authors included APACHE II scores in several tables. The authors did not describe the purpose or process of using the APACHE II. Additionally, psychometric properties were not included on this assessment. Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES NR Serial assessments in which the evaluators were blinded to the treatment status were completed every 48 hours. 8
Recall or memory bias. Check yes, no, or NR, and if yes, explain. YES NR Others (list and explain): RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported The median duration of occupational and physical therapy during mechanical ventilation was statistically different between groups. Intervention =.32 hours per day; Control = 0 hours per day; p < 0.0001. The intervention group received more therapy during mechanical ventilation. The median time to first intervention was statistically different between groups. Intervention = 1.5 days after intubation, controls = 7.4 days after intubation; p < 0.0001. The intervention group received their consult significantly sooner or earlier than the intervention. Return to functional independence by discharge from the hospital occurred in more patients in the intervention group (n = 29 [59%]) compared to the control group (19 [35%]); p = 0.02, odds ratio = 2.7. The intervention group had higher median Barthel Index scores at time of discharge. Intervention = 75, control = 55; p =.05. ICU days of delirium and total hospital days of delirium were significantly fewer in the intervention group when compared with the control group (2.0 vs 4.0, p =.03; 2.0 vs 4.0, p =.02, respectively). The intervention group had more ventilator-free days (23.5 days, 7.4 25.6 vs 21.1 days, 0.0 23.8; p=0.05). Although not statistically significant, the intervention group had a higher number of independent ADLs at discharge from the hospital compared with the control group (6 vs 4, p =.06). At time of discharge, the intervention group was walking greater distances than the control group. Median scores of 33.4 meters (0 91.4) vs. 0 meters (0 30.4), p =.004. The intervention group achieved motor milestones sooner than the control group. Time from intubation to motor milestone 9
Motor milestone Intervention Control P value median (IQR) Median (IQR) Out of bed 1.7 days (1.1 3.0) 6.6 days (4.2 8.3) <.0001 Standing 3.2 days (1.5 5.6) 6.0 days (4.5 8.9) <.0001 Marching in place 3.3 days (1.6 5.8) 6.2 days (4.6 9.6) <.0001 Transferring to 3.1 days (1.8 4.5) 6.2 days (4.5 8.4) <.0001 chair Walking 3.8 days (1.9 5.8) 7.3 days (4.9 9.6) <.0001 Note. IQR= Interquartile range Although not significant (p =.06), there is a trend to better discharge rates to home (intervention 43% vs. control 24%). There was no significant difference between groups when comparing length of stay in hospital and in the ICU. o Length of stay ICU: Intervention 5.9 days (4.5 13.2); control 7.9 (6.1 12.9), p =.08 Length of stay hospital: Intervention 13.5 (8.0 23.1); control 12.9 (8.9 19.8), p =.93 Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES NR Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES NR Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES Was the percent/number of subjects/participants who dropped out of the study reported? YES Other than the deaths the authors reported, there was no attrition. 10
Limitations: What are the overall study limitations? The nature of the interventions prevented blinding from patient and health care providers. knowledge of group allocation and interventions risk bias of results. Potential for learning effect. However, by viewing the changes in function and finding no statistical differences in MRC scores, the authors speculate there may have been a learning effect due to serial assessments. Decisions regarding initiation or reinitiation of sedation as well as intubation and extubation were not guided by protocol and could have been influenced by knowledge of the study. There is a possibility the sites are not a true representation of ICU culture in respect to occupational therapy and physical therapy delivery of services. No defined dose of therapy (there was mention of duration of intervention but not intensity). CONCLUSIONS State the authors conclusions related to the research objectives. Early whole-body rehabilitation for critically ill patients consisting of interruptions in sedation combined with occupational and physical therapy is safe and leads to improved functional outcomes at hospital discharge, shorter duration of delirium, and more ventilator-free days when compared with standard care. References American Occupational Therapy Association. (2010). Scope of practice. American Journal of Occupational Therapy, 64(Suppl.) S70 S77. http://dx.doi.org/10.5014/ajot.2010.64s70-64s77 Balas, M. C., Vasilevskis, E. E., Olsen, K. M., Schmid, K. K., Shostrom, V., Cohen, M. Z.,... Burke, W. J. (2014). Effectiveness and safety of the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle. Critical Care Medicine, 42(5), 1024 1036. Engel, H. J., Tatebe, S., Alonzo, P. B., Mustille, R. L., & Rivera, M. J. (2013). Physical therapistestablished intensive care unit early mobilization program: Quality improvement project for critical care at the University of California San Francisco Medical Center. Physical Therapy, 93(7), 975 985. This work is based on the evidence-based literature review completed by B. Mason Haymes, MS, OTR/L, and Stacey Reynolds, PhD, Faculty Advisor, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, VA. CAP Worksheet adapted from Critical Review Form--Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 11