Disclosing Harmful Medical Errors to Patients - Harvard University

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T h e n e w e ng l a nd j o u r na l o f m e dic i n ethe expression of regret, not accompanying informationrelated to causality (“our care causedyour injury”) or fault (“this should not have happened”).In addition, plaintiffs’ attorneys, whomust sift through dozens of prospective claimsin choosing which ones to pursue, will prize informationgained from disclosures, whether ornot they are permitted to use that information asevidence in subsequent litigation. Thus, althoughapology laws are useful policy endorsements ofdisclosure, they will probably have little influenceon disclosure behavior.The potential for top-down regulation to havea meaningful effect on disclosure conversationsis limited. The most successful disclosure initiativesare likely to be those that emerge locally, aredriven by an institutional leadership and a workforcecommitted to transparency, and focus onproviding health care workers with the skills neededto conduct these difficult conversations well.There is considerable speculation and debateabout the impact of disclosure on litigation.Patient-safety experts and proponents of disclosuretout its litigation-reducing potential andpoint to several success stories (which we reviewbelow) as well as research linking poor communicationwith patients’ decisions to sue. 37-39 The actualeffect is not known and will not be evidentfor years. Overall, disclosure probably will nothave the chilling effect on litigation that someadvocates have claimed. Although disclosure mayquell some patients’ interest in litigating, it willignite interest in others, particularly those whowould never have known of their injury in the absenceof the disclosure. The net impact of disclosureon the size and cost of litigation ultimatelydepends on the balance between these twoeffects. 40Prominen t Discl osur e Pro gr a msAlthough many organizations are experimentingwith disclosure initiatives, relatively little is knownabout their effectiveness. In 1999, the VeteransAffairs Hospital in Lexington, Kentucky, issuedthe first published report of the effect of an opendisclosureprogram. There were no dramaticchanges in the volume of claims or the size ofpayouts after the hospital adopted the program. 14Recently, the University of Michigan Health Systemreported that the cost and frequency of litigationdecreased substantially in the 5 years afterthe implementation of an open-disclosure program,with annual litigation expenses reducedfrom $3 million to $1 million and the number ofclaims decreasing by more than 50%. 15 These twoinitiatives clearly spotlight institutions with a seriouscommitment to transparency. The data areprovocative but difficult to interpret because theyrely largely on historical comparison groups anddo not attempt to control for other factors thatinfluence litigation rates and outcomes over time.In addition, the generalizability of the results ata single Veterans Affairs hospital and a singleacademic institution is questionable.The best-known private-sector disclosure programis the “3Rs” program at COPIC, a liabilityinsurer directed by physicians in Colorado. COPICinsures approximately 6000 physicians and is thelargest insurer in Colorado. In 2000, the companydeveloped a program designed to facilitatetransparent communication about injuries and expeditecompensation in selected circumstances. 41The program’s key features and outcomes arelisted in Table 2.The 3Rs program links interventions to improvecommunication with a mechanism that providespatients with up to $30,000 in compensationfor out-of-pocket health care expenses and“loss of time.” The program is “no-fault” in thatit does not tie compensation to evidence of faulton the provider’s part. The payments are notmade in response to written demands, and patientsdo not waive their rights to sue, so 3Rspayments are not considered reportable to theNational Practitioner Data Bank.The 3Rs program has handled more than 3000events; approximately one quarter of the patientsinvolved received payments averaging $5,400 each.Seven cases in which patients were paid proceededto litigation. Two cases resulted in additionaltort payments. Sixteen 3Rs cases that closedwithout payments were subsequently litigated; sixof the patients secured tort compensation (LembitzA: personal communication). Although therange of cases handled by the COPIC program islimited, the outcomes suggest that these eventscan be resolved less adversarially than they mightbe by means of traditional litigation. In addition,the low average payment per incident reinforcesthe view that maximum compensation is frequentlynot the main objective for patients in the wakeof medical injury. 42Whether COPIC’s outcomes can be general2716n engl j med 356;26 www.nejm.org june 28, 2007Downloaded from www.nejm.org at HARVARD UNIVERSITY on June 29, 2007 .Copyright © 2007 Massachusetts Medical Society. All rights reserved.
current conceptsized is also not known. Colorado has enactedbroad tort reform that provides a fertile environmentfor the 3Rs program. COPIC has long fostereda strong culture of patient-safety awarenessand early incident reporting among its insuredphysicians; this culture also may have influencedthe program’s outcomes. The 3Rs program requiresclose relationships among COPIC, theColorado Board of Medical Examiners, and theColorado Insurance Commissioner; these connectionsmay be difficult to establish elsewhere.Whether initiatives like those in the 3Rs programare feasible outside of Colorado will soonbecome evident as other insurers such as MedicalMutual in Maryland and West Virginia Mutual InsuranceCompany embark on similar programs.F u t ur e De v el opmen t sTable 2. Key Elements of COPIC’s 3Rs Program.Key featuresDisclosure linked to no-fault compensation for patient’s out-of-pocket expenses(up to $30,000)Disclosure training for physiciansExclusion criteria: death, clear negligence, attorney involvement, complaint tostate board, written demand for paymentDisclosure coaching for physician and case management for patient providedby 3Rs administratorsPayments not reportable to National Practitioner Data BankKey outcomes (January 2000–October 2006)2853 Colorado physicians enrolled3200 events handled in program25% of patients received payments; average, $5,400 per caseSeven paid cases subsequently litigated, two of which resulted in tort compensation16 unpaid cases subsequently litigated, 6 of which resulted in tort compensationDisclosure programs and practices are in their infancy.The fast pace at which they have developedover the past 5 years appears to be set to continueand perhaps even accelerate during the next 5 years.There will be ongoing experimentation with disclosureby health care delivery organizations andsome malpractice insurers. This work will yielduseful information about the impact of variousdisclosure approaches on key outcomes such aspatient satisfaction and the rates and cost of litigation.Insights gained by institutions that usestandard quality-improvement techniques to track,test, and refine their disclosure strategies will beespecially valuable. Disclosure activities continueapace outside the United States. Canada’s recentlyformed Canadian Patient Safety Institute, for example,is set to release new national disclosureguidelines, and some Canadian provinces haveadopted legislation concerning apology and disclosure.43To many practicing clinicians, the concept ofdisclosing harmful errors to patients will remainnovel and raise concerns. Research is needed tobetter understand patients’ preferences in relationto specific components of the disclosure discussion.19 Sophisticated investigations involving multicentercontrolled trials of training interventionsare planned, but the results are several yearsaway. Similarly, evidence of the medical and legalimplications of disclosure will remain an openquestion for the foreseeable future. Although itmay be disconcerting to individual practitioners,the absence of such an evidence base will probablynot halt the widespread implementation ofdisclosure policies and procedures. The momentumfor change is now too great for any stakeholdergroup to brush aside demands for transparency.As organizations gain experience with disclosure,the challenges of conducting these conversationsand the need for provider education willbe increasingly apparent. 44 Eventually, most organizationswill probably provide introductory disclosuretraining for their health care workers andmore intensive skills training with the use oftechniques such as simulation for clinicians whoare likely to be on the frontlines of the disclosureprocess. Many organizations will also train riskmanagers or medical directors to be coaches whoprovide guidance at the time that disclosure iswarranted. Other organizations, troubled by thedifficulty of disclosures and the risks associatedwith conducting them poorly, will move the involvedclinicians to the periphery and will rely onrapid-response teams to conduct disclosures. Itremains to be seen whether the benefits of theuse of disclosure “pinch hitters” will outweighthe potential harm to the clinician–patient relationship.Additional national organizations and specialtysocieties may follow the NQF’s lead and disseminatedisclosure standards. Key uncertaintiesabout disclosure practice include the effect of disclosureon patient satisfaction and claiming behaviorand the role of apology and acceptance ofn engl j med 356;26 www.nejm.org june 28, 2007 2717Downloaded from www.nejm.org at HARVARD UNIVERSITY on June 29, 2007 .Copyright © 2007 Massachusetts Medical Society. All rights reserved.
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