Opinion
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Does Improving Handoffs Reduce Medical Error Rates? Leora I. Horwitz, MD, MHS
In 1965, the American Medical Association declared that “An intern’s duties and responsibilities are not discharged on a ‘nine-to-five’ basis. While an acceptable internship provides for a reasonable amount of free time, [the Viewpoint page 2247 intern’s] thought for and contact with his patients should be on a ‘round-the-clock’ Related article page 2262 basis.”1 In the intervening 45 years, the advent of the hospitalist movement fragmented inpatient and outpatient care, payment by diagnosis reduced length of stay, hospitalization rates per capita increased by 15%, 2 and more than 1000 new drug applications were approved.3 In short, inpatient care is now more fragmented, more frantic, and more complicated than in the 1960s. At the same time, the science of sleep and cognition matured enough to make the risks of working while fatigued unequivocally clear, and the influx of women into medical training made it increasingly difficult to sustain the fiction that house staff have no obligations outside the hospital. The medical establishment reacted accordingly by restricting work hours of house staff. Thus, in 2013 not only is the “round the clock” internship a relic of the past, but in Europe internships are approaching the “nine to five” standard, with work-hours restricted to 48 hours a week.4 Despite an anticipated reduction in fatigue-related errors, work-hour regulations have been associated with little to no improvement in patient outcomes either in the United States or in Europe.5 Many commentators ascribe this disappointing outcome to an offsetting increase in discontinuity and in handoff-related errors. Numerous anecdotal and systematic studies have demonstrated that handoffs are associated with medical errors. There are also numerous reports of programs and tools to increase the safety and effectiveness of handoffs.6-8 To date, however, almost no evidence suggests that improvements in handoffs reduce the rate of subsequent errors.6 The report by Starmer et al9 in this issue of JAMA is by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale. The authors conducted an uncontrolled, before-and-after study of the effectiveness of a multifaceted “handoff bundle” on medical errors and preventable adverse events. They studied 642 admissions cared for by 42 house staff on 2 pediatric units at a single hospital from July through September 2009, implemented a handoff bundle in October, and then studied 613 admissions cared for by 42 house staff on the same units from November 2009 through January 2010. The authors found a
decline in medical errors from 33.8 per 100 admissions in the preintervention period to 18.3 per 100 admissions in the postintervention period (P < .001). Although far from a gold-standard design, this study has numerous strengths. The handoff bundle was multifaceted and included team training (which is not usually considered a handoff intervention per se but has been shown to improve outcomes10), structural changes in team organization and electronic documentation (which have been shown to improve handoff quality8,11), and didactic training in handoff standardization. Adverse events were identified prospectively in real time and were later characterized according to standard definitions. The authors assessed a variety of important outcomes beyond adverse events, including direct observation of time spent with patients and assessment of written handoff materials. Among the most provocative and intriguing findings of the study is that time spent with patients significantly increased in the postintervention period, even though time spent creating computerized handoff documents and conducting verbal handoffs did not change. Nevertheless, results of this study should be considered preliminary because of numerous limitations. First, the authors used an uncontrolled, before-and-after design, making the results vulnerable to the effects of the steep early year intern learning curve; changes in patient demographics, comorbidity, and diagnoses over time; the Hawthorne effect of observation; and other quality improvement initiatives. Moreover, the nurses collecting adverse event data in real time could not be blinded to preintervention or postintervention period and were therefore another important potential source of bias. Even though all events were adjudicated by blinded physicians, their agreement on categorization and preventability was only moderate and they were reliant on the study nurses to bring adverse events to their attention. The brief and reasonably light touch nature of the intervention seems disproportional to the large effect size (46% reduction in medical error rate), increasing concern for unmeasured confounding or random variation. The authors did not attempt to characterize events as handoff related or not and largely did not measure the uptake of the intervention, such as improved teamwork, use of unified team handoff, supervision by senior clinicians, or quality of verbal handoffs. The follow-up time period of 3 months was relatively brief, raising questions as to long-term sustainability of improved outcomes. Moreover, the authors implemented the entire bundle wholesale, making it impossible to determine which, if any, elements were more effective than others. Although quality improvement studies are difficult to perform in truly randomized fashion, options are available to make
jama.com
JAMA December 4, 2013 Volume 310, Number 21
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/30/2015
2255
Opinion Editorial
them more rigorous. Bundled interventions, for example, can be implemented in a step-wise fashion rather than simultaneously, enabling estimates of additive effects. Interventions on multiple units can be implemented at different times, in different orders, or both, thereby allowing for concurrent controls and more effective blinding of data collection.12 Longerterm follow-up can be conducted. Data from the same time period of a prior year can be added as a separate seasonal control, although such comparisons are also more vulnerable to secular trends. Many of these features are present in a follow-up multi-institutional pediatric handoff study that recently completed data collection; results are expected soon.13 Given the known problems of discontinuity, the strong face validity of the handoff bundle, the reasonably minimal effort it involved to implement, and these promising albeit preliminary results, it would be difficult to argue that handoff bundles should not be widely adopted. Indeed, the TeamSTEPPS program that the investigators adapted has already been implemented by more than 1500 organizations, and residency programs nationally are now standardizing handoffs and evaluating handoff competency in response to new Accreditation Council for Graduate Medical Education regulations.14 Nevertheless, additional study is still needed to replicate these results, better characterize essential elements, refine the interventions, and determine sustainability. Furthermore, other ARTICLE INFORMATION Author Affiliations: Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. Corresponding Author: Leora Horwitz, MD, MHS, Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT 06520-8093 (leora [email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Essentials of an approved internship. JAMA. 1965;194(13):117-127.
2256
means of improving safety at transitions should be considered as additional or alternate components of the handoff bundle. As Dhaliwal and Hauer15 suggest in their Viewpoint in this issue of JAMA, the very structure and purpose of handoff presentations should be reconsidered in response to changes in workflow, degree of supervision, and penetration of electronic records. As electronic data become more prevalent and readily accessible, the next frontier of improving safety at times of transition may be data manipulation rather than communication skills. There is now promising work in automatically aggregating data to characterize patients’ clinical condition, identify early deterioration, or prospectively identify patients who have not yet received standard of care,16 potentially enabling clinicians to convert the existing static handoff process to a real-time dynamic reassessment of clinical condition and patient care. As hospitals and residency programs seek to manage increasing complexity and fragmentation without reverting to an archaic model of round-the-clock care, the focus will be on safe handoffs and mitigating discontinuity. The study by Starmer et al9 presents tantalizing evidence that improving handoffs can actually reduce harm to patients. In the meantime, while awaiting results from larger multi-institutional studies, it is reasonable to ensure that at least basic elements of safe handoffs are in place.
/WhatWeDo/History/ProductRegulation /SummaryofNDAApprovalsReceipts1938tothepresent /default.htm. Accessed October 28, 2013. 4. European Union. Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time. Offi J Eur Communities. 2003;137(2):299(9). 5. Moonesinghe SR, Lowery J, Shahi N, Millen A, Beard JD. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients’ outcomes: systematic review. BMJ. 2011;342:d1580. 6. Cohen MD, Hilligoss PB. The published literature on handoffs in hospitals: deficiencies identified in an extensive review. Qual Saf Health Care. 2010;19(6):493-497. 7. Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009;24(3):196-204.
2. CMS.gov. Medicare & Medicaid statistical supplement, Table 5.1—discharges, total days of care, total charges, and program payments for Medicare beneficiaries discharged from short-stay hospitals, by type of entitlement: calendar years 1972-2010. http://www.cms.gov/Research -Statistics-Data-and-Systems/Statistics-Trends-and -Reports/MedicareMedicaidStatSupp/2011.html. Accessed October 28, 2013.
8. Li P, Ali S, Tang C, Ghali WA, Stelfox HT. Review of computerized physician handoff tools for improving the quality of patient care. J Hosp Med. 2013;8(8):456-463.
3. US Food and Drug Administration. Summary of NDA approvals & receipts, 1938 to the present. http://www.fda.gov/AboutFDA
10. Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training
9. Starmer AJ, Sectish TC, Simon DW, et al. Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle. JAMA. doi:10.1001/jama.2013.281961.
program and surgical mortality. JAMA. 2010;304(15):1693-1700. 11. Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255. 12. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006;6:54. 13. I-PASS. Better handoffs; safer care. http://www.ipasshandoffstudy.com/. Accessed October 20, 2013. 14. Accreditation Council for Graduate Medical Education. Common Program Requirements. http://www.acgme-2010standards.org/pdf /Common_Program_Requirements_07012011.pdf. Accessed August 23, 2011. 15. Dhaliwal G, Hauer KE. The oral patient presentation in the era of night float admissions: credit and critique. JAMA. doi:10.1001 /jama.2013.282322. 16. Escobar GJ, LaGuardia JC, Turk BJ, Ragins A, Kipnis P, Draper D. Early detection of impending physiologic deterioration among patients who are not in intensive care: development of predictive models using data from an automated electronic medical record. J Hosp Med. 2012;7(5):388-395.
JAMA December 4, 2013 Volume 310, Number 21
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/30/2015
jama.com
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
EDITORIAL
Does Improving Handoffs Reduce Medical Error Rates? Leora I. Horwitz, MD, MHS
In 1965, the American Medical Association declared that “An intern’s duties and responsibilities are not discharged on a ‘nine-to-five’ basis. While an acceptable internship provides for a reasonable amount of free time, [the Viewpoint page 2247 intern’s] thought for and contact with his patients should be on a ‘round-the-clock’ Related article page 2262 basis.”1 In the intervening 45 years, the advent of the hospitalist movement fragmented inpatient and outpatient care, payment by diagnosis reduced length of stay, hospitalization rates per capita increased by 15%, 2 and more than 1000 new drug applications were approved.3 In short, inpatient care is now more fragmented, more frantic, and more complicated than in the 1960s. At the same time, the science of sleep and cognition matured enough to make the risks of working while fatigued unequivocally clear, and the influx of women into medical training made it increasingly difficult to sustain the fiction that house staff have no obligations outside the hospital. The medical establishment reacted accordingly by restricting work hours of house staff. Thus, in 2013 not only is the “round the clock” internship a relic of the past, but in Europe internships are approaching the “nine to five” standard, with work-hours restricted to 48 hours a week.4 Despite an anticipated reduction in fatigue-related errors, work-hour regulations have been associated with little to no improvement in patient outcomes either in the United States or in Europe.5 Many commentators ascribe this disappointing outcome to an offsetting increase in discontinuity and in handoff-related errors. Numerous anecdotal and systematic studies have demonstrated that handoffs are associated with medical errors. There are also numerous reports of programs and tools to increase the safety and effectiveness of handoffs.6-8 To date, however, almost no evidence suggests that improvements in handoffs reduce the rate of subsequent errors.6 The report by Starmer et al9 in this issue of JAMA is by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale. The authors conducted an uncontrolled, before-and-after study of the effectiveness of a multifaceted “handoff bundle” on medical errors and preventable adverse events. They studied 642 admissions cared for by 42 house staff on 2 pediatric units at a single hospital from July through September 2009, implemented a handoff bundle in October, and then studied 613 admissions cared for by 42 house staff on the same units from November 2009 through January 2010. The authors found a
decline in medical errors from 33.8 per 100 admissions in the preintervention period to 18.3 per 100 admissions in the postintervention period (P < .001). Although far from a gold-standard design, this study has numerous strengths. The handoff bundle was multifaceted and included team training (which is not usually considered a handoff intervention per se but has been shown to improve outcomes10), structural changes in team organization and electronic documentation (which have been shown to improve handoff quality8,11), and didactic training in handoff standardization. Adverse events were identified prospectively in real time and were later characterized according to standard definitions. The authors assessed a variety of important outcomes beyond adverse events, including direct observation of time spent with patients and assessment of written handoff materials. Among the most provocative and intriguing findings of the study is that time spent with patients significantly increased in the postintervention period, even though time spent creating computerized handoff documents and conducting verbal handoffs did not change. Nevertheless, results of this study should be considered preliminary because of numerous limitations. First, the authors used an uncontrolled, before-and-after design, making the results vulnerable to the effects of the steep early year intern learning curve; changes in patient demographics, comorbidity, and diagnoses over time; the Hawthorne effect of observation; and other quality improvement initiatives. Moreover, the nurses collecting adverse event data in real time could not be blinded to preintervention or postintervention period and were therefore another important potential source of bias. Even though all events were adjudicated by blinded physicians, their agreement on categorization and preventability was only moderate and they were reliant on the study nurses to bring adverse events to their attention. The brief and reasonably light touch nature of the intervention seems disproportional to the large effect size (46% reduction in medical error rate), increasing concern for unmeasured confounding or random variation. The authors did not attempt to characterize events as handoff related or not and largely did not measure the uptake of the intervention, such as improved teamwork, use of unified team handoff, supervision by senior clinicians, or quality of verbal handoffs. The follow-up time period of 3 months was relatively brief, raising questions as to long-term sustainability of improved outcomes. Moreover, the authors implemented the entire bundle wholesale, making it impossible to determine which, if any, elements were more effective than others. Although quality improvement studies are difficult to perform in truly randomized fashion, options are available to make
jama.com
JAMA December 4, 2013 Volume 310, Number 21
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/30/2015
2255
Opinion Editorial
them more rigorous. Bundled interventions, for example, can be implemented in a step-wise fashion rather than simultaneously, enabling estimates of additive effects. Interventions on multiple units can be implemented at different times, in different orders, or both, thereby allowing for concurrent controls and more effective blinding of data collection.12 Longerterm follow-up can be conducted. Data from the same time period of a prior year can be added as a separate seasonal control, although such comparisons are also more vulnerable to secular trends. Many of these features are present in a follow-up multi-institutional pediatric handoff study that recently completed data collection; results are expected soon.13 Given the known problems of discontinuity, the strong face validity of the handoff bundle, the reasonably minimal effort it involved to implement, and these promising albeit preliminary results, it would be difficult to argue that handoff bundles should not be widely adopted. Indeed, the TeamSTEPPS program that the investigators adapted has already been implemented by more than 1500 organizations, and residency programs nationally are now standardizing handoffs and evaluating handoff competency in response to new Accreditation Council for Graduate Medical Education regulations.14 Nevertheless, additional study is still needed to replicate these results, better characterize essential elements, refine the interventions, and determine sustainability. Furthermore, other ARTICLE INFORMATION Author Affiliations: Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. Corresponding Author: Leora Horwitz, MD, MHS, Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT 06520-8093 (leora [email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Essentials of an approved internship. JAMA. 1965;194(13):117-127.
2256
means of improving safety at transitions should be considered as additional or alternate components of the handoff bundle. As Dhaliwal and Hauer15 suggest in their Viewpoint in this issue of JAMA, the very structure and purpose of handoff presentations should be reconsidered in response to changes in workflow, degree of supervision, and penetration of electronic records. As electronic data become more prevalent and readily accessible, the next frontier of improving safety at times of transition may be data manipulation rather than communication skills. There is now promising work in automatically aggregating data to characterize patients’ clinical condition, identify early deterioration, or prospectively identify patients who have not yet received standard of care,16 potentially enabling clinicians to convert the existing static handoff process to a real-time dynamic reassessment of clinical condition and patient care. As hospitals and residency programs seek to manage increasing complexity and fragmentation without reverting to an archaic model of round-the-clock care, the focus will be on safe handoffs and mitigating discontinuity. The study by Starmer et al9 presents tantalizing evidence that improving handoffs can actually reduce harm to patients. In the meantime, while awaiting results from larger multi-institutional studies, it is reasonable to ensure that at least basic elements of safe handoffs are in place.
/WhatWeDo/History/ProductRegulation /SummaryofNDAApprovalsReceipts1938tothepresent /default.htm. Accessed October 28, 2013. 4. European Union. Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time. Offi J Eur Communities. 2003;137(2):299(9). 5. Moonesinghe SR, Lowery J, Shahi N, Millen A, Beard JD. Impact of reduction in working hours for doctors in training on postgraduate medical education and patients’ outcomes: systematic review. BMJ. 2011;342:d1580. 6. Cohen MD, Hilligoss PB. The published literature on handoffs in hospitals: deficiencies identified in an extensive review. Qual Saf Health Care. 2010;19(6):493-497. 7. Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009;24(3):196-204.
2. CMS.gov. Medicare & Medicaid statistical supplement, Table 5.1—discharges, total days of care, total charges, and program payments for Medicare beneficiaries discharged from short-stay hospitals, by type of entitlement: calendar years 1972-2010. http://www.cms.gov/Research -Statistics-Data-and-Systems/Statistics-Trends-and -Reports/MedicareMedicaidStatSupp/2011.html. Accessed October 28, 2013.
8. Li P, Ali S, Tang C, Ghali WA, Stelfox HT. Review of computerized physician handoff tools for improving the quality of patient care. J Hosp Med. 2013;8(8):456-463.
3. US Food and Drug Administration. Summary of NDA approvals & receipts, 1938 to the present. http://www.fda.gov/AboutFDA
10. Neily J, Mills PD, Young-Xu Y, et al. Association between implementation of a medical team training
9. Starmer AJ, Sectish TC, Simon DW, et al. Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle. JAMA. doi:10.1001/jama.2013.281961.
program and surgical mortality. JAMA. 2010;304(15):1693-1700. 11. Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. What are covering doctors told about their patients? analysis of sign-out among internal medicine house staff. Qual Saf Health Care. 2009;18(4):248-255. 12. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006;6:54. 13. I-PASS. Better handoffs; safer care. http://www.ipasshandoffstudy.com/. Accessed October 20, 2013. 14. Accreditation Council for Graduate Medical Education. Common Program Requirements. http://www.acgme-2010standards.org/pdf /Common_Program_Requirements_07012011.pdf. Accessed August 23, 2011. 15. Dhaliwal G, Hauer KE. The oral patient presentation in the era of night float admissions: credit and critique. JAMA. doi:10.1001 /jama.2013.282322. 16. Escobar GJ, LaGuardia JC, Turk BJ, Ragins A, Kipnis P, Draper D. Early detection of impending physiologic deterioration among patients who are not in intensive care: development of predictive models using data from an automated electronic medical record. J Hosp Med. 2012;7(5):388-395.
JAMA December 4, 2013 Volume 310, Number 21
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/30/2015
jama.com
