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Hospital Disclosure Practices: Results Of A National Survey
New patient safety standards from JCAHO that require hospitals to disclose to patients all unexpected outcomes of care took effect 1 July 2001. In an early 2002 survey of risk managers at a nationally representative sample of hospitals, the vast majority reported that their hospitals practice was to disclose harm at least some of the time, although only one-third of hospitals actually had board-approved policies in place. More than half of respondents reported that they would always disclose a death or serious injury, but when presented with actual clinical scenarios, respondents were much less likely to disclose preventable harms than to disclose nonpreventable harms of comparable severity. Reluctance to disclose preventable harms was twice as likely to occur at hospitals having major concerns about the malpractice implications of disclosure.
Telling patients about unanticipated outcomes of care is an established ethical expectation for physicians and nurses.1 However, decisions about the appropriateness, timing, and content of disclosure have traditionally remained a private matter, left to the preferences of individual clinicians and health care institutions. Advances in informed-consent law and patients rights over the past thirty years appear to have had little demonstrable impact on providers willingness to disclose information about errors and adverse outcomes.2 Today providers face new constraints in the area of disclosure. The Institute of Medicines (IOMs) 1999 report, To Err Is Human, prompted calls for greater transparency in health care.3 In July 2001 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) responded by introducing new patient safety standards, including a requirement that all unanticipated outcomes of care be disclosed.4 Although the requirement itself does not specify the need to disclose pooroutcomes, JCAHO has clarified that accredited organizations must tell patients when harms occur to them in the course of treatment.5 To investigate how hospitals are dealing with this standard, we surveyed risk managers from a nationally representative sample of hospitals. We sought information on how and what hospitals were disclosing six months after the JCAHO standards took effect. We also sought to gauge the importance of several potential barriers to disclosure, including fear of litigation.
Survey design. We developed the survey instrument through extensive consultation with physicians, risk managers, senior hospital administrators, patients, and experts in patient safety and quality improvement. A draft version was pre-tested on chief medical officers and risk managers at four different hospitals to determine validity and the type of respondent best able to answer the questions. We judged risk managers to be the most knowledgeable and appropriate respondents. The survey comprised three sections.6 The first section asked respondents about their institutional policies and practices related to disclosure. We defined disclosure as "honestly telling patients or their families about unexpected harm that occurs as a result of treatment or care, not directly because of a patients illness or underlying condition." Section two elicited specific information on disclosure practices, including respondents propensity to disclose harms of varying severity levels, the elements commonly included in disclosures (for example, explanation, apology, acknowledgement of harm, and undertaking to investigate), and actions that commonly accompany a disclosure (for example, pay costs of associated care, pay compensation, and provide details of support groups). We also asked respondents to estimate the likelihood that each of four different clinical scenarios would be disclosed at their institution. The scenarios mixed combinations of severity and preventability.7 Section three elicited information about the actual frequency of disclosure, trends in disclosure practice, barriers to disclosure, and perceptions of malpractice risk. Sampling and administration. We used a stratified random sampling approach to select 500 hospitals from the American Hospital Association (AHA) database of 1,218 medical/surgical hospitals with 200 or more beds. One stratum was based on facility size, with half of the sample coming from hospitals with 200399 beds and the other half from hospitals with 400 or more beds. A second stratum, based on region, ensured a representative geographic spread. Exclusion of Veterans Affairs (VA) hospitals and several other ineligible institutions resulted in a sample of 493 hospitals (245 hospitals with 200399 beds; 248 hospitals with 400 or more beds).8 We derived sampling weights to allow adjustment of the survey results to represent the larger sample of AHA hospitals with 200 or more beds. Finally, using AHA contact information, we mailed the survey to risk managers at each of the sampled hospitals in January 2002. Two weeks later a second copy of the survey was sent to nonrespondents, with intensive telephone follow-up. Analysis. We used existing descriptive data on the sampled hospitals from the AHAs annual survey for 2000 to categorize them by ownership (for-profit, not-for-profit, and government), whether or not they were academic medical centers (AMCs), number of admissions, and region (using the four census regions). We created a binary variable separating the hospitals situated in the sixteen states with mandatory reporting laws in place at the time of our survey from those in states without such laws.9 We used the STATA statistical package to conduct weighted analyses of the survey response data. We calculated descriptive statistics summarizing disclosure policies, practices, and experience. We also used chi-square tests to test for statistically significant differences in responses to the clinical scenarios based on respondents malpractice perceptions and beliefs. Finally, we used logistic regression to investigate factors associated with divergent reporting practices among respondents.
Of the 479 surveys mailed, we received 338 replies, yielding 245 usable responses for analysis: a completion rate of 51 percent.10 The hospital characteristics for this respondent group closely resembled those of the nonrespondents with two exceptions: For-profit hospitals were underrepresented among respondents (p = .05) and AMC hospitals were overrepresented (p < .001) (Exhibit 1
Disclosure policies and practices. Approximately one in three hospitals had board-approved disclosure policies in place, and nearly half were in the process of developing a formal policy (Exhibit 2
With respect to the types of harms generally disclosed, 65 percent of hospitals reported always disclosing death or serious injury. A smaller proportion always disclosed in the case of serious, short-term harms (Exhibit 2 The most common elements of disclosures were an explanation, an undertaking to investigate the incident, an apology, and an acknowledgement of harm. Relatively few respondents reported that a typical disclosure included a declaration of responsibility for the harm or a promise to share investigation results with the patients or their families. However, thirty-seven respondents (17 percent) indicated that disclosures at their hospitals routinely included all six of the elements we queried them about. The majority of hospitals also met the costs of health care associated with the harm, but few paid compensation or provided details of outside support groups, regulatory agencies, or lawyers.
Seventy percent of respondents said that the number of disclosures made in their hospitals had increased in the past two years, but half still reported fewer than five disclosures per 10,000 annual admissions (Exhibit 3
Media coverage. News media coverage did not appear to affect hospitals willingness to tell patients about harm (Exhibit 3
Litigation risk.
Respondents were divided in their beliefs about whether disclosure increased, decreased, or did not alter the disclosing clinicians or institutions probability of being sued (Exhibit 3
Disclosing preventable harms.
Exhibit 4
Exhibit 4 Multivariate analysis confirmed that malpractice concerns were associated with hospitals being significantly less likely to disclose preventable harms than nonpreventable ones (odds ratio 2.03, p =.03).11 No other hospital characteristics had a statistically significant association with reluctance to disclose preventable injury.
The explosion of public interest in medical error following the 1999 IOM report galvanized attention on consumers expectations around disclosure of medical error. Several years later it is timely to ask what has changed for patients. If one measure of the reports success is the extent to which hospitals own up to error, then our study provides some encouraging results. Virtually all (98 percent) of the respondents in our study reported disclosing harms to patients at least some of the time, and 80 percent had disclosure policies in place or under development. The fact that 44 percent of surveyed hospitals were in the process of developing disclosure policies at the time of our survey suggests that the IOMs message, together with the patient safety initiatives it has sparked at JCAHO and other agencies, is driving substantial reform. Follow-up investigation of the final form and content of the many institutional policies that were budding at the time of this survey would add greatly to our knowledge in this area. Disclosure frequency. Our study also suggests that there is still a long way to go before serious harm is consistently and thoroughly disclosed to patients. For example, our respondents reported considerably fewer disclosures than would be expected from epidemiologic estimates of general rates of iatrogenic injury. Leading studies of medical injury from Utah/Colorado and New York, which were used as the basis of the IOM estimates, found that adverse events occurred in 2.9 percent and 3.7 percent of hospitalizations, respectively.12 These rates imply 290370 potentially disclosable harms per 10,000 admissions. Adjusting the estimates of adverse events to include only the most serious incidents suggests approximately 4466 medical injuries per 10,000 admissions that should be disclosed. Only two hospitals in our study were in this range. In fact, only sixteen hospitals (less than 10 percent) reported making more than twenty disclosures per year. Alternative explanations certainly exist for the gap between these estimates and the number of disclosures reported in our survey. Specifically, the risk managers we surveyed may not be aware of all disclosures in their hospitals, and rates of injury in our national sample of hospitals may be lower than those previously identified in New York, Utah, and Colorado. Nevertheless, it seems likely that disclosure of the most serious events would come to risk managers attention. Hence, the relatively low rate of disclosure reported in our study raises questions about both the extent to which harms are recognized by hospital staff and the frequency with which known harms are disclosed. The malpractice barrier. Hospitals heightened reluctance to disclose preventable harms raises further questions. Of all hospital and respondent characteristics we examined, fear of litigation was most strongly associated with this reluctance. The challenge that the medical malpractice environment poses for patient safety efforts has been well documented, as have the fears of physicians.13 Some conclude that the cultural change necessary for major safety improvements cannot occur against the backdrop of a litigation system that induces secrecy and silence, and they stress the need for malpractice reform.14 A different, and increasingly prominent, twist on the malpractice issue is that clinicians and hospitals perceptions about litigation risk may be worse than the reality.15 The experience of the VA Medical Center in Lexington, Kentucky, where a proactive disclosure policy has reportedly not resulted in higher liability payments at the institutional level, is widely cited.16 There is also growing anecdotal evidence from some nongovernmental hospitals, such as the Dana Farber Cancer Institute in Boston, that their policies to disclose have not been accompanied by a big increase in lawsuits.17 Another Massachusetts hospital, Sturdy Memorial, says that it found owning up to error a positive experience.18 These reports find support in studies suggesting that patients who are dealt with openly and honestly are less likely to sue.19 Our findings do not contradict any of this. However, they do suggest that regardless of whether or not providers concerns about malpractice are well founded, litigation fears continue to pose a serious obstacle to transparency about patient injury. Important breakthroughs in the openness of providers about error may thus depend on reforms of the malpractice system that can mitigate the blame, guilt, and fear it generates.20 Malpractice reforms are a top priority for policymakers at the federal and state levels.21 However, these proposals tend to focus on the immediate problem of claims volume and award size, not the more fundamental issue of the barriers the system creates for advances in the patient safety arena. Adverse publicity. There is ongoing debate about the impact of adverse publicity on patient safety advances, with some commentators arguing that it provides important impetus and others that it may cause inertia.22 Our survey results suggest that such coverage has little effect in the area of disclosure. Only two respondents indicated that their hospitals willingness to disclose had decreased as a result of prominent reporting of cases of harm. Study limitations. There are several limitations to our study. A survey completion rate of 51 percent introduces the possibility of nonresponse bias. The similarity in hospital characteristics between respondents and nonrespondents provides some comfort in this regard, although for-profit hospitals and non-AMCs were under-represented among respondents, and their disclosure behavior may have differed systematically.23 However, the fact that a substantial proportion (27 percent) of the ninety-three respondents who said that they would not complete the survey cited legal concerns as the reason bolsters rather than undercuts our findings about the impact of litigation fears on willingness to disclose. Second, the findings may also be limited because the survey is focused on risk managers. Our decision to target this group was based on a recognition that risk managers in many hospitals are at the center of efforts to develop formal written disclosure processes and policies to comply with the new JCAHO standards.24 Although physicians have not always viewed hospital risk managers as advocates of disclosure, a previous survey of 650 risk managers suggested that their personal support of disclosure is consistent with that of other managers and may even exceed the willingness of their organizations to disclose.25 Finally, we used only four injury scenarios to measure the willingness to disclose preventable versus non-preventable harm. These findings should be explored further by testing a wider range of possible clinical events. The results of this survey give some cause for optimism: A large proportion of hospitals appear to be telling patients about harms caused by medical care. Moreover, the far-reaching impact of the IOM report and the JCAHO standard are evident in the sizable number of hospitals that are in the process of developing disclosure policies. However, it is clear that the spread and execution of such policies and practices fall short of the standards that would be expected in a therapeutic model based on partnership and patient empowerment.26 There is still marked variation in the types of harm that hospitals are prepared to disclose and how they handle such disclosure. Malpractice concerns appear to be the most prominent foil to aspirations of openness. As malpractice insurance costs spiral for physicians in a number of states and pundits herald a fresh set of malpractice "crises," the litigation barrier looks set to grow.27
Rae Lamb is a health correspondent for Radio New Zealand in Wellington. David Studdert is an assistant professor of law and public health, Department of Health Policy and Management, Harvard School of Public Health, in Boston. Richard Bohmer is an assistant professor of technology and operations management at the Harvard Business School. Don Berwick is president and chief executive officer of the Institute for Healthcare Improvement in Boston. Troy Brennan is a professor of medicine at Harvard Medical School and a professor of law and public health at the Harvard School of Public Health The authors thank Shimon Shaykevich for programming support; Meghan Martino for data entry work and other logistical help; the chief medical officers, risk managers, and others who offered expertise in the survey development; and the respondents who took time to participate. This work was conducted while Rae Lamb was a 20012002 Harkness Fellow in Health Policy, based jointly at the Harvard School of Public Health and the Institute for Healthcare Improvement and supported by the Commonwealth Fund. David Studdert was supported in part by Grant no. K02HS11285 from the Agency for Healthcare Research and Quality. The views presented here are those of the authors and not necessarily those of the Commonwealth Fund.
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