Analyze the Design and Methodology in Two Quantitative Studies Recall the two quantitative studies you read for this lesson from the eReserves; use these to answer the following questions: Identify the variables for each of the quantitative studies. Describe the measurement of variables for each study. Compare techniques used in each study to ensure validity and reliability of measures. Identify the extraneous variables considered in each study. Describe the sampling methods used in each study. Describe the data analysis of each study. Describe the conclusions of each study. In your opinion, which of the two studies was the strongest in design? Give at least three reasons for this conclusion. Critical Illness Special Series Move to Improve: The Feasibility of Using an Early Mobility Protocol to Increase Ambulation in the Intensive and Intermediate Care Settings Anne Drolet, Patti DeJuilio, Sherri Harkless, Sherry Henricks, Elizabeth Kamin, Elizabeth A. Leddy, Joanna M. Lloyd, Carissa Waters, Sarah Williams Background. Prolonged bed rest in hospitalized patients leads to deconditioning, impaired mobility, and the potential for longer hospital stays. Objective. The purpose of this study was to determine the effectiveness of a nurse-driven mobility protocol to increase the percentage of patients ambulating during the rst 72 hours of their hospital stay. Design. A quasi-experimental design was used before and after intervention in a 16-bed adult medical/surgical intensive care unit (ICU) and a 26-bed adult intermediate care unit (IMCU) at a large community hospital. Method. A multidisciplinary team developed and implemented a mobility order set with an embedded algorithm to guide nursing assessment of mobility potential. Based on the assessments, the protocol empowers the nurse to consult physical therapists or occupational therapists when appropriate. Daily ambulation status reports were reviewed each morning to determine each patient's activity level. Retrospective and prospective chart reviews were performed to evaluate the effectiveness of the protocol for patients 18 years of age and older who were hospitalized 72 hours or longer. Results. In the 3 months prior to implementation of the Move to Improve project, 6.2% (12 of 193) of the ICU patients and 15.5% (54 of 349) of the IMCU patients ambulated during the rst 72 hours of their hospitalization. During the 6 months following implementation, those rates rose to 20.2% (86 of 426) and 71.8% (257 of 358), respectively. Limitations. The study was carried out at only one center. Conclusion. The initial experience with a nurse-driven mobility protocol suggests that the rate of patient ambulation in an adult ICU and IMCU during the rst 72 hours of a hospital stay can be increased. A. Drolet, MS, ANP-BC, CCRN, Central DuPage Physician Group, 25 N Wineld Rd, Wineld, IL 60190 (USA). Address all correspondence to Ms Drolet at: anne.drolet@cadencehealth.org. P. DeJuilio, MS, RRT-NPS, Respiratory Therapy, Central DuPage Hospital, Wineld, Illinois. S. Harkless, MSN, APRN/CNS, CCNS, CCRN, Central DuPage Hospital. S. Henricks, MSN, ACNP-BC, CCRN, Central DuPage Physician Group. E. Kamin, RN, BSN, MSCRN, Central DuPage Hospital. E.A. Leddy, PharmD, DuPage Hospital. Central J.M. Lloyd, MS, Central DuPage Hospital. C. Waters, RN, BSN, CCRN, 2ICU- Intensive Care Unit, Central DuPage Hospital. S. Williams, PT, MPT, Central DuPage Hospital. [Drolet A, DeJuilio P, Harkless S, et al. Move to Improve: the feasibility of using an early mobility protocol to increase ambulation in the intensive and intermediate care settings. Phys Ther. 2013;93:197-207.] 2013 American Physical Therapy Association Published Ahead of Print: September 13, 2012 Accepted: September 4, 2012 Submitted: November 14, 2011 Post a Rapid Response to this article at: ptjournal.apta.org February 2013 Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 197 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings P hysical inactivity associated with hospital care for a range of medical conditions can have many unfavorable consequences. They include neuromuscular dysfunction, metabolic disturbances, and other organ system abnormalities that add to the disease burden.1 Prolonged bed rest is associated with extended hospital stays and persistent physical and neuropsychiatric disabilities in intensive care unit (ICU) settings.1 A meta-analysis of 39 randomized controlled trials revealed bed rest was not benecial and may be harmful.2 Studies also have demonstrated that reducing the use of sedation and introducing physical activity as soon as clinically feasible can decrease the frequency and severity of these complications.3,4 Although these problems have been carefully studied in ICU settings, few studies are available about the complications of inactivity outside the ICU. Studies of the consequences of prolonged bed rest have been conducted in volunteers without illness.5 Skeletal muscle changes can be documented within 72 hours of physical inactivity.6 In addition, physiologic dysfunction has been found across a range of organ systems and metabolic processes. When non-ICU patients are subjected to bed rest, it is reasonable to assume Available With This Article at ptjournal.apta.org Listen to a special Craikcast on the Special Series on Rehabilitation in Critical Care with editors Patricia Ohtake, Dale Strasser, and Dale Needham. Audio Podcast: \"Rehabilitation of Patients With Critical Illness\" symposium recorded at CSM 2013, San Diego, California. 198 f Physical Therapy they will experience similar degrees of dysfunction.7 The application of bed rest in hospital-based medical care is widespread and enduring. There exists a time-honored impression that bed rest is therapeutic and physical activity harmful in the presence of illness. There are practical barriers to mobilizing some patients due to monitoring or life support equipment, frailty, and weakness. In such circumstances, considerable resources may be needed for safe mobilization.8 At our 313-bed acute care community hospital, we were concerned about the adverse effects of inactivity in both our adult ICU and intermediate care populations. Increasing patient activity through mobilization is associated with improved respiratory function, reducing adverse effects of immobility, increased levels of consciousness, increased functional independence, improved cardiovascular tness, and psychological well-being.9 Prior to the early mobility protocol initiative, common practice was a slower approach to mobilizing patients who are critically ill. Often the physical therapist was the rst member of the health care team to begin mobilizing the patient. The physical therapist is only with the patient for approximately 30 minutes per day in our setting. As the nurses are the primary caregivers for 8 to 12 hours at a time, we hypothesized that a nurse-driven mobility protocol could provide important benets. Little is known about how nurses make decisions about whether to ambulate, how they ambulate, and when they ambulate older patients. In a recent qualitative study, factors that seemed to have a greater impact on nurses' decisions regarding patient ambulation were the risk/opportunity assessment, preventing complications, and the presence of unit expectation to ambulate patients.10 Furthermore, Kalisch11 found that ambulation was regularly missed in the provision of nursing care. Reasons given by nurses were related to time required to carry out ambulation, ease of omitting ambulation, and believing that ambulation was the job of a physical therapist. Barriers to ambulation most frequently cited by nurses were related to patients' physical symptoms such as weakness, pain, and fatigue; presence of devices such as intravenous line and urinary catheters; concerns about falls; and lack of staff to assist with out-of-bed activity.12 A recent study showed that 83% of patient time is spent lying in bed,13 and during one observational study, 73% of patients considered able to walk did not walk.14 Ambulation should be viewed as a priority and as a vital component of quality nursing care.15 Considering the deleterious effects of bed rest, the emerging literature on ambulation of patients with acute illness, and the potential for nursing staff to engage in ambulation activities with their patients, the Move to Improve team decided to develop a quality improvement study. We hypothesized that implementation of a mobility program would increase the likelihood of early mobilization in our ICU and intermediate care unit (IMCU) patients. Method Three months of data (January- March 2010) were collected before implementation of the mobility program to conrm consistency of baseline information. Postimplementation data were collected for 6 months (March-August 2011). To evaluate the impact of this initiative, we compared the frequency of ambulation for patients admitted to the ICU and IMCU, or who were transferred from the ICU to the IMCU, during these time periods. Volume 93 Number 2 Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 February 2013 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings In February 2010, nursing management gave approval to begin the quality improvement project. A multidisciplinary team consisting of advanced practice nurses, registered nurses, physical therapists, a critical care pharmacist, a respiratory therapist, and a critical care physician was assembled in April 2010. The team adopted the Plan-Do-Check-Act framework for the development and implementation of the Move to Improve mobility program; the \"Plan\" stage ran from January 2010 to April 2010 (see Appendix 1 for complete time line). Two units were selected for the pilot study. The rst unit was the IMCU, a 26-bed unit with an average daily census of 21.6 patients and a nurseto-patient ratio of 1:4. The patient population included patients with complex medical and surgical conditions as well as patients who were hemodynamically stable with a tracheostomy on a ventilator and had potential for respiratory insufciency. These patients often required frequent vital sign monitoring and respiratory therapy management. The second pilot unit was an adult ICU, a 16-bed unit designed to provide intensive medical/surgical care to patients with acute and chronic medical diagnoses. Its average daily census was 11.3 patients and a 1:2 nurse-to-patient ratio. During the study, from March through August 2011, this ICU had a standard mortality ratio of 0.726 (observed deaths/expected deaths) utilizing the APACHE IV scoring system.16 The average length of stay was 3.2 days. For patients admitted directly to the IMCU, the average length of stay was 4.95 days. In April 2010, the Move to Improve team reviewed current evidence and exemplary protocols to determine whether the adult ICUs were utilizing best practices for mobilizing patients. The literature review was February 2013 expanded to include ambulating patients in the non-ICU areas, weaning patients from ventilators safely and efciently, and sedation and pain management guidelines.17-19 The team divided into small groups to focus on the multiple facets of the program. The \"Do\" stage of the project ran from April through November of 2010. Multiple order sets and protocols were developed for the pilot study. A mobility order set was created that included a screening tool based on the exclusion criteria from the Critical Care Physical Medicine and Rehabilitation Program at Johns Hopkins Medical Center.20 The exclusion criteria were modied to address the needs of our patient population based on recommendations from the intensivists and medical staff chairpersons. The mobility algorithm developed by the physical therapist on the planning team was embedded in the order set to guide the assessment and allowed the nurse to consult physical therapists and occupational therapists when appropriate (Appendix 2). The ventilator weaning order set was developed by ICU respiratory therapists. This order set included a protocol for pain management with appropriate sedation determined by clinical pharmacists and implemented by bedside nurses, use of the Richmond Agitation Sedation Scale,21,22 and more frequent readiness trials to determine whether patients were capable of ventilator discontinuation.23-28 A primary objective was to remove mechanical ventilation as soon as possible, as it is easier and safer to mobilize patients without the burden of an articial airway. Pain that could worsen with movement was addressed to avoid patient resistance, and sedation was modied so that patients were alert enough to mobilize. The sedation protocol for ICU patients was modied from a practice of continuous infusions to a preferred practice of using intermittent dosing of sedation medications when possible to maintain goal sedation. After careful review of the multiple order sets, approval for the 4-week pilot study was granted by the hospital's Medical Executive Committee in September 2010. The team received approval from the hospital's institutional review board in November 2010. Data would be collected on patients 18 years of age or older who were hospitalized for 72 hours or longer. During November 2010, in preparation for the pilot study, nurses and patient care technicians completed an education program developed by the Move to Improve team. The education included verbal presentations by the advanced practice nurses and physical therapists at unit staff meetings. The staff was instructed on the exclusion criteria, the mobility algorithm, and the use of gait belts when transferring and ambulating patients. The nurses and patient care technicians also received self-learning packets, and posters were placed on the 2 units as reminders of the study. The nurses and patient care technicians had 1 month to complete the education. Respiratory therapists received mandatory education in both written and classroom formats on the use of the portable ventilator, ventilator weaning, sedation, and the mobility protocols. Physical therapists were educated on use of a custom-designed walker with folddown seat, funded by the hospital foundation, and intravenous pole that supported the portable ventilator (Fig. 1). They also received specic instructions on handling patients who are critically ill and ventilated for safety during ambulation. Beginning the rst week of December 2010, education was provided to the medical staff at their quarterly Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 199 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings no longer be mandatory but would now need a physician's order to implement. The Medical Executive Committee also approved hospitalwide implementation to begin in July 2011. Figure 1. Custom-designed walker and intravenous pole (purchased from Spectrum Surgical Instruments Co, Stow, Ohio, www. spectrumsurgical.com) with ventilator (Versamed Ivent 201, GE Healthcare, www.gehealthcare.com). meeting along with posters outlining the program and pilot study. The physicians were made aware that the mobility protocol would be mandatory for all patients in the adult ICU and IMCU during the pilot project, which was to run from December 14, 2010, through January 11, 2011. The physicians were informed that the nurse would have the ability to order physical therapy or occupational therapy when appropriate. Decisions about ability or appropriateness of activity were made by the nurse based on the mobility algorithm coupled with the assessment of exclusion criteria. All patients in both the ICU and the IMCU were screened using the same process. Upon completion of the pilot project, the team returned to the Medical Executive Committee in February 2011 to complete the \"Check\" process. Approval was granted to proceed with the program in the ICU and the IMCU with the understanding that the mobility protocol would 200 f Physical Therapy The \"Act\" process began in March 2011 at the beginning of the postimplementation period with the objective of increasing the number of adult patients ambulating during the rst 72 hours of their hospital stay. For the purpose of this study, we dened ambulation as the act of walking with or without an assistive device, moving self from point A to point B. Distance was measured for each patient's ambulation efforts. Multiple assessments were performed daily by the nurse to determine activity readiness.3 Ambulation was recorded before and after implementation of the mobility protocol for patients admitted to the ICU and the IMCU, or transferred from the ICU to the IMCU. Patients who were discharged in less than 72 hours or transferred to another unit (other than the IMCU) during that time frame were excluded. Due to these exclusions, the patient census during the study period appears to be less than that seen during the preimplementation period. Nurses and patient care technicians were encouraged to ambulate all patients regardless of their length of stay in the ICU or IMCU. Collected data captured only nurse or patient care technician documentation of ambulation and did not include activity performed by the physical therapist. Aggregated and de-identied data were reviewed. Monthly collection and analysis of data were reported to the nurse managers and staff at unit meetings. The retrospective chart reviews revealed little improvement in ambulation compared with preimplementation data. For this reason, an ambulation status report (Appendix 3) was developed that would provide real-time data for the nurses. This report was distributed to the units daily, noting each patient's length of stay and the distance the patient had ambulated on a given day. The ambulation status report was embraced by the IMCU staff and reviewed at multidisciplinary rounds each morning. With the creation and use of this daily report, there was an immediate increase in the number of patients ambulating in the IMCU. However, we did not see regular use of the ambulation status report in the ICU until several months into the study. Patient demographics such as age and sex were tracked across both departments studied. Data are presented as means (standard deviation) for descriptive variables. Comparisons of preimplementation and postimplementation data were performed using an unpaired, 2-tailed t test. Signicance was set at P.05. Analyses were performed with Microsoft Excel 2007 software (Microsoft Corporation, Redmond, Washington). Results Data were collected for 193 ICU patients and 349 IMCU patients during the 3-month preimplementation period and for 426 ICU patients and 358 IMCU patients during the 6-month postimplementation period (Table). During the preimplementation period, patients in the ICU had an average (SD) age of 67.0 (15.7) years; 42% were female. In the IMCU, the average (SD) patient age was 65.7 (17.5) years; 55% were female. Patients followed in the ICU during the postimplementation period had an average (SD) age of 64.4 (17.0) years of age; 48% were female. In the IMCU, the average (SD) patient age was 68.0 (16.1) years; 51% were female. There were no differences in average patient age or sex distribution between the 2 data collection periods. Volume 93 Number 2 Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 February 2013 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings Table. Summary of Patient Demographicsa ICU Variable Total population Preimplementation 193 Age (y), X (SD) 67.0 (15.7) Female, n (%) 81 (42) IMCU Postimplementation P 426 64.4 (17.0) 204 (48) Preimplementation 349 .07 .17 P 358 65.7 (17.5) 193 (55) Postimplementation 68.0 (16.1) 184 (51) .07 .30 a ICUintensive care unit, IMCUintermediate care unit. Preimplementation of Move to Improve early mobility program: January-March 2010; postimplementation of Move to Improve early mobility program: March-August 2011. During the preimplementation period, only 6.2% (12 of 193) of the ICU patients and 15.5% (54 of 349) of the IMCU patients ambulated within 72 hours of hospital admission. In contrast, following implementation of the Move to Improve program, 20.2% (86 of 426) of the ICU patients (P.001) and 71.8% (257 of 358) of the IMCU patients (P.001) ambulated within 72 hours of admission (Fig. 2). Discussion This quality improvement study was undertaken to determine whether routine patient care could be modied to include mobility. The project utilized current evidence that a signicant change in clinical practice could be effected, as demonstrated in a quality research study by Needham et al.29 The Move to Improve project was a vision of health care professionals who knew more needed to be done to improve patients' ability to overcome illness. The mobility initiative has enabled nurses to drive the care for the patient through an evidence-based protocol. Within our institution, patient activity levels were frequently not addressed until many days into their hospital stay. Some patients became deconditioned, which led to the cancellation of discharges or transfer to a rehabilitation facility. Upon realization of this hospital-wide problem, it was brought to the attention of the ICU leadership and the quality committee in the IMCU. February 2013 The Move to Improve committee met biweekly from April through November 2010 to develop order sets and algorithms to formulate a mobility pathway to be used across the continuum of care. A major lesson learned was that in order to implement practice changes, the leadership and staff needed an environment and culture that supported learning and a commitment to best practice.30 Initially, the ICU staff and physicians felt the patients with critical illness were too sick to move, that it was too risky to mobilize them, or that it was the role of the physical therapist to do the required exercises. During the pilot study in the adult ICU, there was a change in the leadership structure and a higher than normal staff turnover rate. These factors posed additional challenges to the implementation of change. Despite the challenges, after focusing on the topic in staff meetings and through education, nurses realized the importance of the mobility program, and it became a priority. The Figure 2. Patient ambulation in the intensive care unit (ICU) and the intermediate care unit (IMCU) before and after implementation of the Move to Improve early mobility program. Preimplementation of Move to Improve early mobility program: January-March 2010; postimplementation of Move to Improve early mobility program: March-August 2011. Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 201 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings staff of the IMCU and ICU gathered to discuss the successes and obstacles of the program. During the open discussion, the nurses stressed the importance of teamwork and making ambulation a priority as they provided care to patients. It is now a daily expectation to discuss the mobility plan for patients who are critically ill. Upon completion of the pilot study, the data were presented to the hospital's Medical Executive Committee to obtain approval for a house-wide Move to Improve initiative, which began in July 2011. After receiving approval, the committee focused on implementation to all remaining adult patient care units. The marketing department facilitated communication and organizational support for this project through posters and Intranet communications. The Move to Improve team encouraged physicians to order the mobility protocol on admission orders so that nurses would become familiar with the exclusion criteria and begin to think of mobility as part of the daily clinical routine. The physicians supported this change, as it streamlined care for their patients and reduced the number of telephone calls for the nurses and medical staff. The outcomes of our initial data collection were as expected. We predicted that with nurses assessing the patient's ability to ambulate, more patients will be walking during their hospital stay. Our data support Bailey and colleagues' ndings in patients with respiratory failure that early activity is feasible and can be used to prevent or treat neuromuscular complications of critical illness.31 We have determined that modications to our protocol are not needed at this time; however, it is critical to maintain protocol use in daily routine patient care. 202 f Physical Therapy In our study, we showed that implementing a practice and culture change led to an improvement in the number of patients ambulating within 72 hours of their admission in both the ICU and the IMCU. Our data indicate that it is feasible to ambulate these patients. Limitations One limitation of this study is that it was carried out at only one center. There is a lack of detailed data on patient demographics and illness severity. However, all patients were screened for appropriateness of mobility using the criteria presented in Appendix 2; therefore, all patients in this study met these physiologic parameters. Applicability of our results may be limited by changes made to the practice of sedation management in the ICU to support the mobility initiative, which posed a challenge to nursing and physician staff. Inconsistent practice patterns as well as variations in levels of sedation may have affected the patients' ability to participate in mobility and subsequent ambulation trials. Conclusion A nurse-driven protocol signicantly increased the number of patients who ambulated in the adult ICU and IMCU during the rst 72 hours of their hospital stay. The health care team consisting of nurses, physicians, physical therapists, respiratory therapists, and pharmacists approached this project with enthusiasm and a commitment to provide outstanding care. When this project was introduced to hospital leadership 2 years previously, there was little thought given to patients' activity level. Today it has become a priority throughout the hospital. Although this study was conducted in a single community hospital setting without additional stafng, we feel strongly that it could be replicated in other settings. The ancillary staff utilized at our hospital for this program is present at other hospitals, and the biases our staff had regarding mobility of patients are likely to be common at other institutions. As only initial ambulation was investigated in this study, future studies may be useful in determining overall distance improvements, impact on length of stay, the number of inappropriate physical therapist evaluation orders, incidence of falls, and the number of patients discharged to rehabilitation facilities. Ms Drolet, Ms Harkless, Ms Henricks, Ms Kamin, Dr Leddy, Ms Waters, and Ms Williams provided concept/idea/research design. Ms Drolet, Ms DeJuilio, Ms Harkless, Ms Henricks, Dr Leddy, Ms Waters, and Ms Williams provided writing. Ms Drolet, Ms Harkless, Ms Henricks, and Ms Waters provided data collection. Ms Drolet, Ms Henricks, and Ms Lloyd provided data analysis. Ms Drolet provided project management and facilities/equipment. Ms Drolet, Ms Harkless, and Dr Leddy provided consultation (including review of manuscript before submission). The authors thank the following individuals for their expertise, guidance, and assistance in the design and performance of the study and in preparation and editing of the manuscript: Jeffrey Huml, MD; David Cooke, MD; Jeffrey Hinchman, BS, MS; Patricia Raetz, APN, CNRN; Alice Siehoff, RN, MSN, DNP; and Julie Stielstra, MLS. The project was presented at the International ICU Physical Medicine & Rehabilitation meeting, May 14, 2011; Denver, Colorado. DOI: 10.2522/ptj.20110400 References 1 Dean E. Mobilizing patients in the ICU: evidence and principles of practice. Acute Care Perspectives. 2008;17:3-9. 2 Allen C, Glasziou P, Del Mar C. Bed rest: a potentially harmful treatment needing more careful evaluation. Lancet. 1999; 354:1229 -1233. 3 Timmerman R. A mobility protocol for critically ill adults. Dimens Crit Care Nurs. 2007;26:175-179. 4 Schweikart W, Pohlman M, Pohlman A, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373:1874 -1882. Volume 93 Number 2 Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 February 2013 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings 5 Needham D. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008;300:1685-1690. 6 Convertino VA, Bloomeld SA, Greenleaf JE. An overview of the issues: physiological effects of bed rest and restricted physical activity. Med Sci Sports Exerc. 1997; 29:187-190. 7 Kleinpell R, Fletcher K, Jennings B. Reducing functional decline in hospitalized elderly. In: Hughes RG, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, MD: Agency for Healthcare Research and Quality; 2008. Available at: http://www.ncbi.nlm. nih.gov/books/NBK2629/. Accessed November 7, 2011. 8 Flanders S, Harrington L, Fowler R. Falls and patient mobility in critical care. AACN Adv Crit Care. 2009;20:267-276. 9 Stiller K. Safety issues that should be considered when mobilizing critically ill patients. Crit Care Clin. 2007;23:35-53. 10 Doherty-King B, Bowers B. How nurses decide to ambulate hospitalized older adults: development of a conceptual model. Gerontologist. 2011;51:786 -797. 11 Kalisch BJ. Missed nursing care: a qualitative study. J Nurs Care Qual. 2006;21: 306 -313. 12 Brown C, Williams B, Woodby L, et al. Barriers to mobility during hospitalization from the perspectives of older patients and their nurses and physicians. J Hosp Med. 2007;2:305-313. 13 Brown C, Redden D, Flood K, et al. The underrecognized epidemic of low mobility during hospitalization of older adults. J Am Geriatr Soc. 2009;57:1660 -1665. 14 Callen B, Mahoney J, Grieves C, et al. Frequency of hallway ambulation by hospitalized older adults on medical units of an academic hospital. Geriatr Nurs. 2004;25: 212-217. February 2013 15 Padula C, Hughes C, Baumhover L. Impact of a nurse-driven mobility protocol on functional decline in hospitalized older adults. J Nurs Care Qual. 2009;24:325- 331. 16 Zimmerman JE, Kramer AA, McNair DS, et al. Acute Physiology and Chronic Health Evaluation (APACHE) IV: hospital mortality assessment for today's critically ill patients. Crit Care Med. 2006;34:1297- 1310. 17 Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009;18:212-221. 18 Fisher S, Kuo Y, Graham J, et al. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010;170:1942-1943. 19 Jacobi J, Fraser G, Coursin DB, et al. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002;30: 119 -141. 20 Korupolu R, Gifford J, Needham D. Early mobilization of critically ill patients: reducing neuromuscular complications after intensive care. Contemporary Critical Care. 2009;6:1-11. 21 Ely EW, Truman B, Shintani A, et al. Monitoring sedation status over time in ICU patients: the reliability and validity of the Richmond Agitation Sedation Scale (RASS). JAMA. 2003;289:2983-2991. 22 Stawicki S. Sedation scales: very useful, very underused. OPUS 12 Scientist. 2007; 1:10 -12. 23 Chittawatanarat K, Thongchai C. Spontaneous breathing trial with low pressure support protocol for weaning respirator in surgical ICU. J Med Assoc Thai. 2009;92: 1306 -1312. 24 Cook D, Meade M, Guyatt G, et al. Evidence report on criteria for weaning from mechanical ventilation. In: AHRQ Evidence Report Summaries. Rockville, MD: Agency for Healthcare Research and Quality; 1999. Available at: http://www.ncbi. nlm.nih.gov/books/NBK11921/. Accessed November 7, 2011. 25 Girault C, Daudenthun I, Chevron V, et al. Noninvasive ventilation as a systematic extubation and weaning technique in acute-on-chronic respiratory failure: a prospective, randomized controlled study. Am J Resp Crit Care Med. 1999;160:86 - 92. 26 Jubran A, Tobin MJ. Pathophysiological basis of acute respiratory distress in patients who fail a trial of weaning from mechanical ventilation. Am J Respir Crit Care Med. 1997;155:906 -915. 27 MacIntyre N, Cook D, Ely E, et al. Evidence-based guidelines for weaning and discontinuing ventilatory support. Chest. 2001;120:375S-395S. 28 Cohen CA, Zagelbaum G, Gross D, et al. Clinical manifestations of inspiratory muscle fatigue. Am J Med. 1982;73:308 -316. 29 Needham D, Korupolu R, Zanni J, et al. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010;91:536 -542. 30 Hopkins R, Spuhler V, Thomsen G. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007;23:81-96. 31 Bailey P, Thomsen G, Spuhler V, et al. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007;35:139 -145. Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 203 204 ICUintensive care unit, IMCUintermediate care unit, IRBinstitutional review board. a Move to Improve Early Mobility Protocol Time Linea Appendix 1. An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings f Physical Therapy Volume 93 Number 2 Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 February 2013 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings Appendix 2. Non-Intensive Care Unit Mobililty Order and Mobility Protocola Non-ICU Mobility Order 1. 2. 3. 4. 5. 6. 7. 8. 9. Evaluate patient for presence of any exclusion criteria (see #2). If exclusion criteria are present, do not initiate mobility protocol until cleared by physician. Exclusion Criteria a. Respiratory Criteria i. FIO2 greater than 0.6 ii. PEEP greater than 5 cm H2O iii. Hypoxemia: pulse oximeter less than 88% iv. Tachypnea: respiratory rate greater than 35 v. Acidosis: Arterial pH less than 7.25 b. Circulatory Criteria i. Continuous infusion of a vasodilator medication ii. Addition of a new anti-arrhythmic agent within previous 24 hours iii. Unstable arrhythmia within previous 24 hours iv. New cardiac ischemia within 24 hours v. MAP greater than 140 mm Hg or less than 65 mm Hg vi. New DVT/pulmonary emboli (rst 24 hours) vii. Compartment syndrome c. Neurologic Criteria i. Acute stroke (rst 24 hours) ii. CSF leak d. Orthopedic Criteria i. Acute fracture e. Hematologic Criteria i. Hemoglobin less than 7 g/dL ii. Platelet count less than 20,000 iii. INR greater than 5.0 Prevent Excessive Work of Breathing-Desaturation a. Increase baseline FIO2 up to 20% as needed to keep SaO2 greater than 90% with maximum FIO2 80% b. If trached and not on ventilator during activity, have BVM with 100% oxygen available c. If newly extubated: NO AMBULATION ON DAY OF EXTUBATION Document patient's previous level of mobility and exercise capacity (prior to admission). If patient does not progress through the activity algorithm, consult PT and OT for evaluation and treatment. If PT/OT are consulted, the nursing staff/PCTs are to mobilize the patient 1-2 times daily in addition to physical therapy/occupational therapy as tolerated. If patient tolerates chair activity, then patient should be up in chair for all meals as tolerated. Patients requiring airborne or AFB precautions may not participate in physical activity outside their room. Patients in isolation, please refer to isolation policy for preparation of patients prior to ambulating outside their room. Signature: Provider Number: Date: Time: [PLACE PATIENT LABEL HERE] (Continued) February 2013 Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 205 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings Appendix 2. Continued a ICUintensive care unit, FIO2fraction of inspired oxygen, PEEPpositive end-expiratory pressure (cm H2O), MAPmean arterial pressure, DVTdeep vein thrombosis, CSFcerebrospinal uid, INRinternational normalized ratio, SaO2arterial oxygen saturation, BVMbag value mark, PTphysical therapist, OToccupational therapist, PCTpatient care technician, AFBacid fast bacilli, WOBwork of breathing. 1 ft0.3048 m. 206 f Physical Therapy Volume 93 Number 2 Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 February 2013 An Early Mobility Protocol to Increase Ambulation in Intensive and Intermediate Care Settings Appendix 3. Intermediate Care Unit (IMCU) Ambulation Status Reporta a LOSlength of stay. 1 ft0.3048 m. February 2013 Volume 93 Number 2 Physical Therapy f Downloaded from http://ptjournal.apta.org/ by Kimber Gerlich on February 27, 2013 207 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. JAN JOURNAL OF ADVANCED NURSING ORIGINAL RESEARCH A before and after study assessing the impact of a new model for recognizing and responding to early signs of deterioration in an acute hospital Ann McDonnell, Angela Tod, Kate Bray, Derek Bainbridge, Dawn Adsetts & Stephen Walters Accepted for publication 19 February 2012 Correspondence to A. McDonnell: e-mail: a.mcdonnell@shu.ac.uk Ann McDonnell MSc PhD RN Reader Centre for Health and Social Care Research, Shefeld Hallam University, Shefeld, UK Angela Tod MSc PhD RN Principal Research Fellow Centre for Health and Social Care Research, Shefeld Hallam University, Shefeld, UK Kate Bray BA MSc RN Honorary Research Associate The Rotherham NHS Foundation Trust, Rotherham Hospital, Rotherham, UK Derek Bainbridge BA RN Dip Nurs Nurse Consultant Critical Care, The Rotherham NHS Foundation Trust, Rotherham Hospital, Rotherham, UK Dawn Adsetts BA MSc RN Nurse Specialist Critical Care, The Rotherham NHS Foundation Trust, Rotherham Hospital, Rotherham, UK Stephen Walters MSc PhD Professor Medical Statistics and Clinical Trials, School of Health and Related Research, University of Shefeld, Shefeld, UK MCDONNELL A., TOD A., BRAY K., BAINBRIDGE D., ADSETTS D. & WALTERS S . ( 2 0 1 3 ) A before and after study assessing the impact of a new model for recognizing and responding to early signs of deterioration in an acute hospital. Journal of Advanced Nursing 69(1), 41-52. doi: 10.1111/j.1365-2648.2012.05986.x Abstract Aim. To evaluate the impact of a new model for the detection and management of deteriorating patients on knowledge and condence of nursing staff in an acute hospital. Background. International evidence shows that clinical deterioration is not always recognized or acted on by nurses. The use of physiological track and trigger scoring systems accompanied by a graded response strategy has been recommended to monitor all adult patients in acute UK hospitals. However, little is known about the impact of these new systems in practice. Design. A single centre, mixed methods before-and-after study. Methods. A mixed methods before-and-after study, set in a district general hospital in England, in 2009, including a survey (n = 213) and qualitative interviews (n = 15) with nursing staff. The questionnaire examined knowledge and condence in recognition and management of deteriorating patients 6 weeks before and after an intervention which included training, new observation charts and a new track and trigger system. Interviews further explored participants' perspectives. Comparisons were made between registered and unregistered nurses. Results. Following the intervention, knowledge, and condence to recognize and manage deteriorating patients increased; the number of concerns were reduced. Scores were higher for registered than unregistered nurses before and after the intervention. Interviews conrmed these ndings and provided detail on how nurses felt the new system had improved practice. Conclusion. The new model had a positive impact on the self-assessed knowledge and condence of registered and unregistered nurses. Similar initiatives should take into account the clinical context and tailor training packages accordingly. Keywords: acute care, nurses, nursing assessment, qualitative approaches, survey design 2012 Blackwell Publishing Ltd 41 A. McDonnell et al. Introduction Hospitalized patients are at risk of clinical deterioration at many points during their in-patient stay. Observational studies have demonstrated that catastrophic events such as cardiopulmonary arrest are often preceded by abnormalities in vital signs (Hillman et al. 2001, Kause et al. 2004). However, a growing body of evidence including studies from the UK (McQuillan et al. 1998, National Patient Safety Agency 2007) the USA (Rich 1999) and Australia (Daffurn et al. 1994) suggests that deterioration is not recognized or acted on by hospital staff. This may result in adverse outcomes including delayed or avoidable admission to critical care and increased mortality (Buist et al. 2004, Kause et al. 2004). Growing concern over these shortcomings in care has led to a variety of initiatives including Critical Care Outreach Teams (CCOT) in the UK (Department of Health 2000) Rapid Response Teams in the USA (Berwick et al. 2006) and Medical Emergency Teams in Australia (Lee et al. 1995). Tied to these initiatives is the use of physiological track and trigger systems (T&Ts) which seek to ensure timely recognition of patients with potential or established critical illness and timely attendance from appropriately skilled staff (Department of Health and National Health Services (NHS) Modernisation Agency 2003). Although nurses are responsible for completing T&Ts, little is known about the impact of T&Ts on nurses or their utility in clinical settings. Background A national survey indicated that most T&Ts in use in the UK are aggregate scoring systems - where weighted scores are assigned to vital signs such as pulse and blood pressure and then compared with predened trigger thresholds (McDonnell et al. 2007). While recording vital signs is a cornerstone of nursing practice, in many UK hospitals routine observations are now delegated to unregistered nurses (UN) working under the guidance of registered nurses (RN), such as support workers or healthcare assistants. Recent work by the National Patient Safety Agency (NPSA) indicates that observations may now be seen as tasks with a low priority (National Patient Safety Agency 2007). In 2007, guidance from the UK National Institute of Health and Clinical Excellence (NICE) recommended that some form of T&T should be used to monitor all adult patients in acute hospitals (National Institute for Health and Clinical Excellence 2007). NICE further recommended that physiological observations should be monitored at least every 12 hours and that a graded response strategy with three levels 42 should be implemented. Further evidence-based guidance included recommendations on training to ensure that observations were recorded and acted on by staff who understood the clinical relevance of physiological changes (National Patient Safety Agency 2008). These recommendations taken together represent a complex intervention requiring major changes in practice for many UK hospitals (Medical Research Council 2000). Whether these changes improve patient outcomes, will depend not just on the introduction of T&Ts that are valid, but on staffs' response to T&Ts (Subbe 2010). Since nurses are responsible for monitoring observations, education, and training has been identied as crucial if T&Ts are to be utilized to their full potential. While the aim of T&Ts is not to increase the condence of nurses, if T&T systems are put in place and education and training provided on how to use them, nurses may well feel more empowered, condent, and knowledgeable in their clinical decisionmaking about deteriorating patients. This is supported by a theoretical argument that educational interventions can improve nurses' clinical decision-making and judgement (Thompson & Stapley 2011) and expert opinion that anxiety and lack of condence when dealing with sick patients is highly likely to affect performance (Featherstone et al. 2005). In the study hospital, before 2008, only those patients who were at high risk of deterioration, were monitored using a T&T. These included trauma patients and patients undergoing major surgery. For these patients, observations (including uid balance) and T&T scores were recorded on a Patient at Risk (PAR) chart. In 2008, in response to evidence based guidance (National Institute for Health and Clinical Excellence 2007, National Patient Safety Agency 2008), the hospital moved to the new model that is evaluated here. The new model involved several major changes including: modication of the existing T&T to include new parameters e.g. oxygen saturation replacement of the original algorithm accompanying the T&T with a graded response algorithm modication of the standard observation chart to include the T&T Thus the hospital moved to a two-tier system where all patients were monitored with a T&T, using one of two different observation charts - the detailed PAR chart and the standard observation chart. Patients could be 'stepped up' to the PAR chart (if they 'triggered' on the algorithm on the standard chart), or 'stepped down' to the standard chart. (Having two different charts was part of the hospital's response to the guidance, rather than part of the evidencebased guidance itself.) These changes were introduced 2012 Blackwell Publishing Ltd JAN: ORIGINAL RESEARCH throughout the hospital alongside a rolling training programme for all nurses. The training was delivered by the CCOT nurse specialist and lasted approximately 30-45 minutes. The content of the session included information on the recognition and response to deteriorating patients and an overview of the new charts, new T&T and graded response algorithm. Approximately 2 weeks later, the new charts were introduced to the ward. Over the next 4 weeks daily visits were made by the CCOT to the ward to deal with problems or queries relating to the new charts. To learn lessons which could inform the introduction of changes in other hospitals, it was important not only to measure impact of the intervention on nurses' knowledge and condence to detect and manage deteriorating patients, but to develop an understanding of the reasons behind any observed changes, therefore a mixed-methods approach using a before-and-after survey and qualitative interviews was undertaken. The study Aim The aims of this study were: to evaluate the impact of a new T&T and observation charts on the knowledge and condence of nurses to recognize and manage deteriorating patients to gain an understanding of the reasons for any observed changes to explore the perceptions of nurses on the impact of the new system on day to day practice Design A single centre, mixed-methods, before-and-after study using a survey to measure changes in nurses' knowledge and condence and semi-structured interviews to explore the reasons for observed changes and gain a richer understanding of the issues involved. Sample The study site was a district general hospital with >500 beds, providing a range of services including high dependency, intensive care, and coronary care. The study was conducted in 12 wards (all in-patient areas excluding day surgery, ophthalmic, and care of the elderly wards). These wards covered a range of clinical specialities including medicine, surgery, orthopaedics, gynaecology, and stroke services. For 2012 Blackwell Publishing Ltd Before-and-after study patient deterioration the quantitative survey, all nursing staff who undertook observations on the 12 study wards and were therefore eligible to attend the training were included (n = 322). The sample size for the study was determined a priori based on a previous study of the impact of the ALERT (acute life-threatening events: recognition, and treatment) course which reported a mean (SD ) score of 604 (180) pre-course and 771 (119) post-course for condence to recognize a critically ill patient scored on a 1 (little condence) to 10 (very condent) scale (Featherstone et al. 2005). Assuming the SD of the difference in scores is 20 and that a mean change of 05 points in condence scores is of clinical and practical importance, then to have an 80% power of detecting this change as statistically signicant at the 5% (two-sided) level would require 128 paired responses (preand post-training) to the survey. This is equivalent to a standardized effect of 025 which is regarded as a small but important change (Cohen 1988). Assuming there were approximately 320 eligible staff, 40% of whom would complete the survey, this would ensure the required number of respondents (n = 128). For the qualitative arm, a purposive sample of 15 staff was selected to ensure a range of participants in terms of ward, grade, and length of time since qualifying. As a single site study covering 12 wards a sample of 15 was anticipated to be adequate to give insight into staff expectations and experience of the intervention. Data collection Data collection took place in 2009. For the survey, data were collected using a questionnaire, based on an existing instrument with established face and content validity, which had been used to detect changes in condence levels in the recognition and management of acutely ill patients, 6 weeks following an educational intervention (Featherstone et al. 2005). The questionnaire was adapted and piloted with 17 staff on a ward not included in the main study. This resulted in minor modications to the questionnaire to clarify areas of ambiguity. The questionnaire comprised a series of questions asking respondents to rate their condence, skills, and knowledge in the recognition and management of deteriorating patients on a 1-10 scale, for example, 'how condent are you that you are able to recognize a patient on your ward who is deteriorating clinically?' It also included closed and open questions and collected demographic information about respondents. For the 'before' and 'after' surveys, evidence-based data collection strategies were used to maximize the response rate (Edwards et al. 2002). Questionnaires were given to all staff 43 A. McDonnell et al. immediately before the start of each training session. All staff completing before and after questionnaires were entered into a prize draw to receive shopping vouchers for 25. Approximately 6 weeks after the introduction of the charts, 'after' questionnaires were sent to all staff. Written reminders and another copy of the questionnaire were sent to non-responders after 2 weeks. For the qualitative arm, 'before' and 'after' semi-structured interview schedules were developed to complement the questionnaire and explore participants' perspectives in more depth. Participants were interviewed before the training and approximately 6 weeks after the introduction of the new charts. Interviews were arranged at a convenient time for staff, at their place of work and took approximately 15- 20 minutes. Interviews were audio-taped and transcribed for analysis. Ethical considerations Following consultation with the NHS Research Ethics Committee, the study was classed as service evaluation. Research governance approval was obtained from the participating organization. Participants were provided with an information sheet outlining the purpose of the study and given assurances that their data would be treated condentially. Written consent was obtained from participants prior to interview. Interview transcripts were checked against audio tapes for accuracy and transcripts analysed using thematic framework analysis (Ritchie & Spencer 1994). This approach allows the integration of pre-existing themes into the emerging data analysis and gives a clearly dened analytical structure that contributes to the transparency and validity of the results. The structure is developed through ve analysis techniques with associated methods of data ordering: familiarization, developing a thematic framework, indexing, charting, mapping, and interpretation. Validity and reliability/rigour For the survey, sampling error was avoided since all nursing staff on the study wards were included in the sample. Anonymizing the questionnaires reduced the possibility of staff giving socially desirable responses. For the qualitative interviews, analysis was conducted by one researcher (KB) and independent analysis of a sample of transcripts was conducted by another (AT) to verify interpretation and thematic analysis. In addition, during data analysis regular meetings of the research team were held to conrm shared understanding and ensure that interpretation of themes was consistent. NVIVO 7 was used to manage, store, and search the data. Results Data analysis Data were analysed in SPSS (SPSS Windows version 16). Differences between 'before' and 'after' responses were explored using paired t-tests for continuous data, for example, knowledge and condence scores and McNemar tests for categorical data. To explore differences between groups, the two independent samples ttest was used to compare mean scores. Parametric tests were justied in view of the large sample size (>200 respondents). Central Limit Theorem ensures that sample mean scores will be approximately Normally distributed provided the sample size is sufciently large (Walters 2009). When making judgements about what magnitude of change on a 10-point scale can be classed as clinically meaningful, the approach suggested by Cohen (1988) was used. The 'standardised effect size' was calculated by dividing the mean difference by the SD and then using the following rule to answer this question: Standardized effect size: <03 small 03-08 medium>08 large 44 Response rates Eighty-four per cent (271/322) of eligible staff attended the training and completed 'before' questionnaires. Seventy-seven per cent of (247/322) staff completed the 'after' questionnaire, not all of whom had completed 'before' questionnaires. The nal number of paired responses was 66% (213/322). All staff (n = 15) who were selected participated in 'before' and 'after' interviews. Characteristics of respondents Characteristics of survey respondents are shown in Table 1 and indicate that the staff were relatively mature and experienced in terms of years since registration. The sample of staff interviewed included RNs and UNs of varying grades, years of experience, hospital ward, and clinical specialty (Table 2). Key ndings from the survey and interviews are presented in an integrated form under three thematic headings - staff concerns, staff knowledge, and condence and differences between RNs and UNs. The qualitative ndings are presented using illustrative quotes to give insight into the survey responses. 2012 Blackwell Publishing Ltd JAN: ORIGINAL RESEARCH Before-and-after study patient deterioration Table 1 Characteristics of respondents. Staff concerns Gender, n (%) Male Female Band*, n (%) Unregistered Nurses 2 3 Registered Nurses, n (%) 5 6 7 8 Age (n = 211) Mean 19 (89) 194 (911) 69 (324) 2 (09) 100 30 11 1 (469) (141) (1) (05) 412 105 Range 19-64 Years since registration (Registered Nurses only, n = 138) Mean 96 SD 6 Range 0-36 SD *UK, NHS pay bands. Following the intervention the total numbers of concerns expressed was reduced from 43 (SD 26) out of 10 to 37(SD 23), a change of 06 points (95% CI 091 to 026, P < 00001). For all factors, the number of staff who expressed concern was reduced. These reductions were statistically signicant for two factors - 'lack of prior specic experience' (P = 005) and 'keeping calm' (P = 004). Prior to the intervention, factors which caused concern for most staff were 'rapid deterioration' (n = 139, 662%) and 'lack of information about the patient' (n = 131, 615%). The latter was also reected in the interviews. For all nurses 'knowing the patient' in addition to conducting observations was perceived as essential to understanding if a patient was deteriorating or not: You can see colour, whether they're drowsy, whether they're awake, you know, what they're normally like. Especially if they've been in a while you get used to them. It's harder to tell somebody that's just come in. But it's just like the more you care for them the more you get used to them and know what they're like (7) Table 2 Characteristics of interviewees. Speciality Band* Length of time as a Registered/ Unregistered Nurse(years) Surgery Surgery Surgery Surgery Surgery Orthopaedic Orthopaedic 7 6 5 5 2 5 2 >20 5-10 <10 1-5>10 5-10 <10 1-5 8 9 10 11 12 13 14 orthopaedic acute medicine 6 5 7 2 5-10>20 5-10 1-5 1-5 >20 5-10 1-5 1-5 <10 the