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Findings from the SafeCare Study Underscore Importance of Patient Safety, Need for Continued Improvement

Study led by Boston area hospitals demonstrates a need for better tools, increased measurement of patient harm and improved implementation systems

More than 30 years ago, findings from the Harvard Medical Practice Study (HMPS) helped bring public awareness to the problem of patient safety. Since the publication of the HMPS results, new strategies for preventing specific types of adverse events have been put into place, but it has been challenging to measure the impact on patient care. To better understand what progress has been made in the last few decades, a team from Boston area hospitals conducted the SafeCare Study, which evaluated 11 hospitals in the region. Led by investigators from Mass General Brigham and sponsored by CRICO, the medical professional liability insurer for the Harvard medical community and its affiliated organizations, the study provides an estimate of adverse events in the inpatient environment, shedding light on the progress of two decades of work focused on improving patient safety and highlighting the need for continued improvement. Results are published in The New England Journal of Medicine.

“The study clearly demonstrates a need for better tools, increased measurement of patient harm, and better implementation systems,” said corresponding author David Westfall Bates, MD, medical director of Clinical and Quality Analysis for Mass General Brigham and chief of General Internal Medicine at Brigham and Women’s Hospital. “While we looked at hospitals in Massachusetts, improving the delivery of safe care is a national issue, not one that is specific to one hospital, system, state, or region. It’s valuable to know how much harm there is and for every institution to be aware of trends in adverse events so that they can take steps to mitigate and address issues within their walls.”

“Our work is a call to action for those from board to bedside to ensure reducing preventable patient harm is a top priority,” said Elizabeth Mort, MD, senior vice president of Quality and Safety at Massachusetts General Hospital and a co-author of the study. “Keep in mind that our study looked at patient safety before the COVID-19 pandemic. We know that our industry is now facing economic, workforce and wellness challenges nationally. Given these pressures, remaining focused and committed to patient safety is more important than ever.”

The SafeCare study followed a similar methodology to the HMPS, performed in 1984, although ways of capturing levels of harm have improved in the ensuing decades. Through review of 2,800 inpatient charts from patient visits in 2018 to hospitals ranging from large to small, the research team identified at least one adverse event in 23.6 percent of admissions. Overall, 23 percent of these adverse events were judged to be preventable given what is known today, and 32 percent had serious or higher clinical severity.

The leading causes of harm were medication related (39% of adverse events); surgery/procedural (30%); patient care, including falls and pressure ulcers (15%); and healthcare-associated infections (12%).

The rates of harm detected in the new study were higher than those from the HMPS, though different definitions were used. The authors note that the healthcare delivery system itself has changed dramatically since HMPS was conducted, with the advent of electronic health records and movement of complex care to ambulatory sites, leaving the most severely ill patients in our acute care hospitals. These changes present both challenges and opportunities.

“Because records are now computerized in nearly all hospitals, it should be possible to search them to make identification of these events much easier, which should in turn make it easier for hospitals to manage this area more effectively,” said Bates. “Based on our study, we are now taking steps to ensure that key findings do not get lost. We are also evaluating technological solutions that may help us better detect changes in respiratory rates, a patient’s pulse, and other early warning signs so that we can take steps to prevent or mitigate adverse events before they can cause harm.”

Bates and co-authors recommend that health care providers improve tracking of adverse drug effects, increase reliable and routine collection of data, deliver consistent and reliable care for healthcare-associated infections and work toward a culture that prioritizes safe, high-quality care.

“It’s important to do the work to identify adverse events if we’re going to work to improve them,” said Bates. “All organizations should have approaches for monitoring these things on a regular basis.”

Disclosures: Bates reports grants and personal fees from EarlySense; personal fees from CDI Negev; equity from Valera Health, Clew, and MDClone; personal fees and equity from AESOP and FeelBetter; and grants from IBM Watson Health, outside the submitted work. Co-author David Levine reports a grant and co-development with Biofourmis, grant from IBM, and fees from The MetroHealth System, all outside the submitted work. Co-authors Ania Syrowatka, Lynn Volk, Sevan Dulgarian, Mary Amato, and Heba Edrees received partial salary support from grants funded by IBM Watson Health, outside of the submitted work.

This study was supported by a grant from CRICO/Risk Management Foundation of the Harvard Medical Institutions.

Paper cited: Bates, DW et al. “The Safety of Inpatient Health Care” NEJM DOI: 10.1056/NEJMsa2206117

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