Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

OBJECTIVE: Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. STUDY SETTING: In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. STUDY DESIGN: Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. DATA COLLECTION METHODS: Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. PRINCIPAL FINDINGS: Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all P<0.001). Mean days between laboratory test date and evidence of completed action/treatment plan decreased by 19.4 days (P<0.001). Staff surveys showed modest but nonsignificant improvement for intervention practices relative to controls overall and for the 3 high-risk domains that were the focus of PROMISES. CONCLUSIONS: A consortium of stakeholders, quality improvement tools, coaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

Nonemergency PCI at hospitals with or without on-site cardiac surgery.

BACKGROUND: Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. METHODS: We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). RESULTS: A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. CONCLUSIONS: Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).

Evaluating ambulatory practice safety: the PROMISES project administrators and practice staff surveys.

BACKGROUND: Ambulatory practices deliver most health care services and contribute to malpractice risk. Yet, policymakers and practitioners often lack information about safety and malpractice risk needed to guide improvement. OBJECTIVE: To assess staff and administrator perceptions of safety and malpractice risk in ambulatory settings. RESEARCH DESIGN: We administered surveys in small-sized to medium-sized primary care practices in Massachusetts as part of a randomized controlled trial to reduce ambulatory malpractice risk. SUBJECTS: Twenty-five office practice managers/administrators and 482 staff, including [physicians, physician assistants, and nurse practitioners (MD/PA/NPs)], nurses, other clinicians, managers, and administrators. MEASURES: Surveys included structured questions about 3 high-risk clinical domains: referral, test result, and medication management, plus communication with patients and among staff. The 30-item administrator survey evaluated the presence of organizational safety structures and processes; the 63-item staff survey queried safety and communication concerns. RESULTS: Twenty-two administrators (88%) and 292 staff (61%) responded. Administrators frequently reported important safety systems and processes were absent. Suboptimal or incomplete implementation of referral and test result management systems related to staff perceptions of their quality (P<0.05). Staff perceptions of suboptimal processes correlated with their concern about practice vulnerability to malpractice suits (P<0.05). Staff was least positive about referral management system safety, talking openly about safety problems, willingness to report mistakes, and feeling rushed. MD/PA/NPs viewed high-risk system reliability more negatively (P<0.0001) and teamwork more positively (P<0.03) than others. CONCLUSIONS: Results show opportunities for improvement in closing informational loops and establishing more reliable systems and environments where staff feels respected and safe speaking up. Initiatives to transform primary care should emphasize improving communication among facilities and practitioners.

Utilitarian walking, neighborhood environment, and risk of outdoor falls among older adults.

OBJECTIVES: We examined the roles of utilitarian and recreational walking in relation to occurrence of outdoor falls in older adults. METHODS: We analyzed data on walking habits, falls, and fall injuries among participants of MOBILIZE Boston, a prospective cohort study of 765 community-dwelling women and men, mainly aged 70 years or older, in Boston, Massachusetts. Neighborhood socioeconomic status (SES) indicators were assessed at census block group level. Falls were recorded during a total of 2066.5 person-years of follow-up (September 2005-December 2009), and the median length of follow-up was 2.9 years (range = 0.04-4.3). RESULTS: . Lower neighborhood SES indicators were associated with more utilitarian walking and higher rates of falls on sidewalks, streets, and curbs. Falls on sidewalks and streets were more likely to result in an injury than were falls in recreational areas. Utilitarian-only walkers tended to live in neighborhoods with the lowest neighborhood SES and had the highest rate of outdoor falls despite walking 14 and 25 fewer blocks per week than the recreational-only and dual walkers, respectively. CONCLUSIONS: . Improving the safety of walking environments in areas where older adults shop and do other errands of necessity is an important component of fall prevention.

Primary care closed claims experience of Massachusetts malpractice insurers.

IMPORTANCE: Despite prior focus on high-impact inpatient cases, there are increasing data and awareness that malpractice in the outpatient setting, particularly in primary care, is a leading contributor to malpractice risk and claims. OBJECTIVE: To study patterns of primary care malpractice types, causes, and outcomes as part of a Massachusetts ambulatory malpractice risk and safety improvement project. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of pooled closed claims data of 2 malpractice carriers covering most Massachusetts physicians during a 5-year period (January 1, 2005, through December 31, 2009). Data were harmonized between the 2 insurers using a standardized taxonomy. Primary care practices in Massachusetts. All malpractice claims that involved primary care practices insured by the 2 largest insurers in the state were screened. A total of 551 claims from primary care practices were identified for the analysis. MAIN OUTCOMES AND MEASURES: Numbers and types of claims, including whether claims involved primary care physicians or practices; classification of alleged malpractice (eg, misdiagnosis or medication error); patient diagnosis; breakdown in care process; and claim outcome (dismissed, settled, verdict for plaintiff, or verdict for defendant). RESULTS: During a 5-year period there were 7224 malpractice claims of which 551 (7.7%) were from primary care practices. Allegations were related to diagnosis in 397 (72.1%), medications in 68 (12.3%), other medical treatment in 41 (7.4%), communication in 15 (2.7%), patient rights in 11 (2.0%), and patient safety or security in 8 (1.5%). Leading diagnoses were cancer (n = 190), heart diseases (n = 43), blood vessel diseases (n = 27), infections (n = 22), and stroke (n = 16). Primary care cases were significantly more likely to be settled (35.2% vs 20.5%) or result in a verdict for the plaintiff (1.6% vs 0.9%) compared with non-general medical malpractice claims (P < .001). CONCLUSIONS AND RELEVANCE: In Massachusetts, most primary care claims filed are related to alleged misdiagnosis. Compared with malpractice allegations in other settings, primary care ambulatory claims appear to be more difficult to defend, with more cases settled or resulting in a verdict for the plaintiff.