Developing and implementing new safe practices: voluntary adoption through statewide collaboratives.

BACKGROUND: Disseminating new safe practices has proved challenging. In a statewide initiative we developed a framework for (1) selecting two safe practices, (2) developing operational details of implementation, (3) enlisting hospitals to participate, and (4) facilitating implementation. METHODS: Potential topics were selected by a multistep process to identify candidate practices, review the evidence for efficacy and feasibility, and then select them on the basis of importance, efficacy, feasibility, and impact. A multi-stakeholder advisory group representing all constituencies selected two practices: reconciling medications (RM) and communicating critical test results (CTR). Operational details and strategies for implementation were then developed for each practice using a consensus process of discipline stakeholders led by content experts. Hospital CEOs were solicited to participate by the Massachusetts Hospital Association which made the project a "flagship" initiative. A collaborative model was used to facilitate implementation, following the IHI Model for Improvement. In addition to providing exposure to content and method experts, we gave teams a "toolkit" containing recommendations, a change package, and implementation strategies. Each collaborative met four times over an 18 month period. Results were assessed using the IHI team assessment scale and surveys of teams and hospital leaders. RESULTS: Hospital participation rate was high with 88% of hospitals participating in one or both collaboratives. Partial implementation of the practices was achieved by 50% of RM teams and 65% of CTR teams. Full implementation was achieved by 20% of teams for each. CONCLUSIONS: Major factors leading to hospital participation included the intrinsic appeal of the practices, access to experts, and the availability of implementation strategies. Team success was correlated with active engagement of a senior administrator, engagement of physicians, increased use of PDSA cycles, and attendance at collaborative meetings. The prior development of subpractices, recommendations and implementation strategies was essential for the hospital teams. These should be well worked out before hospitals are required to implement any guideline.

Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. 1991.

BACKGROUND: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS: We reviewed 30121 randomly selected records from 51 randomly selected acute care, non-psychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi(2) = 21.04, p<0.0001). Using weighted totals we estimated that among the 2671863 patients discharged from New York hospitals in 1984 there were 98609 adverse events and 27179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence. CONCLUSIONS: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Comparison of use of medications after acute myocardial infarction in the Veterans Health Administration and Medicare.

BACKGROUND: There is concern that care provided in the Veterans Health Administration (VA) may be of poorer quality than non-VA health care. We compared use of medications after acute myocardial infarction in the VA with that in non-VA healthcare settings under fee-for-service (FFS) Medicare financing. METHODS AND RESULTS: We used clinical data from 2486 VA and 29 249 FFS men >65 years old discharged with a confirmed diagnosis of acute myocardial infarction from 81 VA hospitals and 1530 non-VA hospitals. We reported odds ratios (ORs) for use of thrombolytics, beta-blockers, ACE inhibitors, or aspirin among ideal candidates adjusted for age, sample design (hospital academic affiliation, availability of cardiac procedures, and volume), and within-hospital clustering. Ideal VA candidates were more likely to undergo thrombolytic therapy at arrival (OR [VA relative to Medicare] 1.40 [1.05, 1.74]) or to receive ACE inhibitors (OR 1.67 [1.12, 2.45]) or aspirin (OR 2.32 [1.81, 3.01]) at discharge and equally likely to receive beta-blockers (OR 1.09 [1.03, 1.40]) at discharge. CONCLUSIONS: Ideal candidates in VA were at least as likely as those in FFS to receive medical therapies of known benefit for acute myocardial infarction.

Racial differences in cardiac revascularization rates: does "overuse" explain higher rates among white patients?

BACKGROUND: Coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty (PTCA) are well-established treatments for symptomatic coronary artery disease. Previous studies have documented racial differences in rates of use of these cardiac revascularization procedures. Other studies suggest that these procedures are overused: that is, they are done for patients with clinically inappropriate indications. OBJECTIVE: To test the hypothesis that the higher rate of cardiac revascularization among white patients is associated with a higher prevalence of overuse (revascularization for clinically inappropriate indications) among white patients than among African-American patients. DESIGN: Observational cohort study using Medicare claims and medical record review. SETTING: 173 hospitals in five U.S. states. PARTICIPANTS: A stratified, weighted, random sample of 3960 Medicare beneficiaries who underwent coronary angiography during 1991 and 1992; 1692 of these patients underwent 1711 revascularization procedures within 90 days. MEASUREMENTS: The proportion of CABG and PTCA procedures rated appropriate, uncertain, and inappropriate according to RAND criteria, and the multivariate odds of undergoing inappropriate revascularization among African-American patients and white patients. RESULTS: After angiography, rates of PTCA (23% vs. 19%) and CABG surgery (29% vs. 17%) were significantly higher among white patients than among African-American patients. The respective rates of inappropriate PTCA and CABG surgery were 14% and 10%. Among the study states, rates of inappropriate use ranged from 4% to 24% for PTCA and 0% to 14% for CABG surgery. White patients were more likely than African-American patients to receive inappropriate PTCA (15% vs. 9%; difference, 6 percentage points [95% CI, -0.4 to 12.7 percentage points]), and difference by race was statistically significant among men (20% vs. 8%; difference, 12 percentage points [CI, 1.2 to 21.7 percentage points]). Rates of inappropriate CABG surgery did not differ by race (10% in both groups). CONCLUSIONS: Among a large and diverse sample of Medicare beneficiaries in five U.S. states, overuse of PTCA was greater among white men than among other groups, but this difference did not fully account for racial disparities in revascularization. Overuse of cardiac revascularization varied significantly by geographic region.

Sensitivity and specificity of the RAND/UCLA Appropriateness Method to identify the overuse and underuse of coronary revascularization and hysterectomy.

There is no empirical evidence on the sensitivity and specificity of methods to identify the possible overuse and underuse of medical procedures. To estimate the sensitivity and specificity of the RAND/UCLA Appropriateness Method. Parallel three-way replication of the RAND/UCLA Appropriateness Method for each of two procedures, coronary revascularization and hysterectomy. Maximum likelihood estimates of the sensitivity and specificity of the method for each procedure. These values were then used to re-calculate past estimates of overuse and underuse, correcting for the error rate in the appropriateness method. The sensitivity of detecting overuse of coronary revascularization was 68% (95% confidence interval 60-76%) and the specificity was 99% (98-100%). The corresponding values for hysterectomy were 89% (85-94%) and 86% (83-89%). The sensitivity and specificity of detecting the underuse of coronary revascularization were 94% (92-95%) and 97% (96-98%), respectively. Past applications of the appropriateness method have overestimated the prevalence of the overuse of hysterectomy, underestimated the prevalence of the overuse of the coronary revascularization, and provided true estimates of the underuse of revascularization. The sensitivity and specificity of the RAND/UCLA Appropriateness Method vary according to the procedure assessed and appear to estimate the underuse of procedures more accurately than their overuse.

Reducing the frequency of errors in medicine using information technology.

BACKGROUND: Increasing data suggest that error in medicine is frequent and results in substantial harm. The recent Institute of Medicine report (LT Kohn, JM Corrigan, MS Donaldson, eds: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999) described the magnitude of the problem, and the public interest in this issue, which was already large, has grown. GOAL: The goal of this white paper is to describe how the frequency and consequences of errors in medical care can be reduced (although in some instances they are potentiated) by the use of information technology in the provision of care, and to make general and specific recommendations regarding error reduction through the use of information technology. RESULTS: General recommendations are to implement clinical decision support judiciously; to consider consequent actions when designing systems; to test existing systems to ensure they actually catch errors that injure patients; to promote adoption of standards for data and systems; to develop systems that communicate with each other; to use systems in new ways; to measure and prevent adverse consequences; to make existing quality structures meaningful; and to improve regulation and remove disincentives for vendors to provide clinical decision support. Specific recommendations are to implement provider order entry systems, especially computerized prescribing; to implement bar-coding for medications, blood, devices, and patients; and to utilize modern electronic systems to communicate key pieces of asynchronous data such as markedly abnormal laboratory values. CONCLUSIONS: Appropriate increases in the use of information technology in health care- especially the introduction of clinical decision support and better linkages in and among systems, resulting in process simplification-could result in substantial improvement in patient safety.

Preventable medical injuries in older patients.

Injuries associated with hospitalization are more common in older (>/=65 years) than in younger patients (<65 years), and they may be more severe and more often preventable. The increasing age of the population magnifies the importance of this problem. In this review, we first consider medical injuries in general and then review the literature for 6 categories: adverse drug events, falls, nosocomial infections, pressure sores, delirium, and surgical and perioperative complications. For each of these categories, older patients appear to be at higher risk, ranging from a 2.2-fold increase for perioperative complications to a 10-fold increase for falling, based on Harvard Medical Practice Study rates. The main cause of these increased risks appears to be the diminished physiological reserve of elderly patients; however, age alone is a less important predictor of adverse events than comorbidities and functional status. Furthermore, many of these complications appear to be preventable, although the proportion preventable varies by type of complication. While some prevention strategies are specifically beneficial in older patients, many apply to all age groups. Geriatric care units and consultation systems have improved outcomes in some instances, although the data are mixed. The success of intervention varies by type of complications. For medications, various interventions have been successful, and fall prevention programs have been demonstrated to be effective in the nursing home and home.

Reducing adverse drug events: lessons from a breakthrough series collaborative.

BACKGROUND: In January 1996, 38 hospitals and health care organizations (for a total of 40 hospitals) in the United States came together in an Institute for Healthcare Improvement (IHI; Boston) Breakthrough Series collaborative to reduce adverse drug events-injuries related to the use or nonuse of medications. METHODS: The participants were taught the Model for Improvement, a method for rapid-cycle change and evaluation, and were then coached on how to identify their own problem areas and develop changes in practice for rapid-cycle testing. These changes could be implementation of one or more known medication error prevention practices or new practices developed. RESULTS: During a 15-month period the 40 hospitals conducted a total of 739 tests of changes. Process changes accounted for 63% of the cycles; the remainder consisted of preliminary data gathering, consensus-building, or education cycles. Eight types of changes were implemented by seven or more hospitals, with a success rate of 70%. These changes included non-punitive reporting, ensuring documentation of allergy information, standardizing medication administration times, and implementing chemotherapy protocols. DISCUSSION: Success in making significant changes was associated with strong leadership, effective processes, and appropriate choice of intervention. Successful teams were able to define, clearly state, and relentlessly pursue their aims, and then chose practical interventions and moved early into changing a process. They did not spend months collecting data before beginning a change. Changes that were most successful were those that attempted to change processes, not people. Health care organizations committed to patient safety need not regard current performance limits as inevitable.

Effect of variability in the interpretation of coronary angiograms on the appropriateness of use of coronary revascularization procedures.

BACKGROUND: Evidence from numerous studies of coronary angiography show differences between observers' assessments of 15% to 45%. The implication of this variation is serious: If readings are erroneous, some patients will undergo revascularization procedures unnecessarily and others will be denied an essential treatment. We evaluated the variation in interpretation of angiograms and its potential effect on appropriateness of use of revascularization procedures. METHODS AND RESULTS: Angiograms of 308 randomly selected patients previously studied for appropriateness of angiography, coronary artery bypass grafting (CABG), and percutaneous transluminal coronary angioplasty (PTCA) were interpreted by a blinded panel of 3 experienced angiographers and compared with the original interpretations. The potential effect on differences on the appropriateness of revascularization was assessed by use of the RAND criteria. Technical deficiencies were found in 52% of cases. Panel readings tended to show less significant disease (none in 16% of vessels previously read as showing significant disease), less severity of stenosis (43% lower, 6% higher), and lower extent of disease (23% less, 6% more). The classification of CABG changed from necessary/appropriate to uncertain/inappropriate for 17% to 33% of cases when individual ratings were replaced by panel readings. CONCLUSIONS: The general level of technical quality of coronary angiography is unsatisfactory. Variation in the interpretation of angiograms was substantial in all measures and tended to be higher in individual than in panel readings. The effect was to lead to a potential overestimation of appropriateness of use of CABG by 17% and of PTCA by 10%. These findings indicate the need for increased attention to the technical quality of studies and an independent second reading for angiograms before recommending revascularization.

Patient risk factors for adverse drug events in hospitalized patients. ADE Prevention Study Group.

BACKGROUND: Adverse drug events (ADEs) are common in hospitalized patients, but few empirical data are available regarding the strength of patient risk factors for ADEs. METHODS: We performed a nested case-control study within a cohort that included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary care hospitals during a 6-month period. Analyses were conducted on 2 levels: (1) using a limited set of variables available for all patients using computerized data available from 1 hospital and (2) using a larger set of variables for the case patients and matched controls from both hospitals. Case patients were patients with an ADE, and the matched control for each case patient was the patient on the same unit as the case patient with the most similar prevent length of stay. Main outcome measures were presence of an ADE, preventable ADE, or severe ADE. RESULTS: In the cohort analysis, electrolyte concentrates (odds ratio [OR], 1.7), diuretics (OR, 1.7), and medical admission (OR, 1.6) were independent correlates of ADEs. Independent correlates of preventable ADEs in the cohort analysis were low platelet count (OR, 4.5), antidepressants (OR, 3.3), antihypertensive agents (OR, 2.9), medical admission (OR, 2.2), and electrolyte concentrates (OR, 2.1). In the case-control analysis, exposure to psychoactive drugs (OR, 2.1) was an independent correlate of an ADE, and use of cardiovascular drugs (OR, 2.4) was independently correlated with severe ADEs. For preventable ADEs, no independent predictors were retained after multivariate analysis. CONCLUSIONS: Adverse drug events occurred more frequently in sicker patients who stayed in the hospital longer. However, after controlling for level of care and preevent length of stay, few risk factors emerged. These results suggest that, rather than targeting ADE-prone individuals, prevention strategies should focus on improving medication systems.

Pharmacist participation on physician rounds and adverse drug events in the intensive care unit.

CONTEXT: Pharmacist review of medication orders in the intensive care unit (ICU) has been shown to prevent errors, and pharmacist consultation has reduced drug costs. However, whether pharmacist participation in the ICU at the time of drug prescribing reduces adverse events has not been studied. OBJECTIVE: To measure the effect of pharmacist participation on medical rounds in the ICU on the rate of preventable adverse drug events (ADEs) caused by ordering errors. DESIGN: Before-after comparison between phase 1 (baseline) and phase 2 (after intervention implemented) and phase 2 comparison with a control unit that did not receive the intervention. SETTING: A medical ICU (study unit) and a coronary care unit (control unit) in a large urban teaching hospital. PATIENTS: Seventy-five patients randomly selected from each of 3 groups: all admissions to the study unit from February 1, 1993, through July 31, 1993 (baseline) and all admissions to the study unit (postintervention) and control unit from October 1, 1994, through July 7, 1995. In addition, 50 patients were selected at random from the control unit during the baseline period. INTERVENTION: A senior pharmacist made rounds with the ICU team and remained in the ICU for consultation in the morning, and was available on call throughout the day. MAIN OUTCOME MEASURES: Preventable ADEs due to ordering (prescribing) errors and the number, type, and acceptance of interventions made by the pharmacist. Preventable ADEs were identified by review of medical records of the randomly selected patients during both preintervention and postintervention phases. Pharmacists recorded all recommendations, which were then analyzed by type and acceptance. RESULTS: The rate of preventable ordering ADEs decreased by 66% from 10.4 per 1000 patient-days (95% confidence interval [CI], 7-14) before the intervention to 3.5 (95% CI, 1-5; P<.001) after the intervention. In the control unit, the rate was essentially unchanged during the same time periods: 10.9 (95% CI, 6-16) and 12.4 (95% CI, 8-17) per 1000 patient-days. The pharmacist made 366 recommendations related to drug ordering, of which 362 (99%) were accepted by physicians. CONCLUSIONS: The presence of a pharmacist on rounds as a full member of the patient care team in a medical ICU was associated with a substantially lower rate of ADEs caused by prescribing errors. Nearly all the changes were readily accepted by physicians.