Every physician fears being sued. Almost half of primary care doctors are subject to a malpractice lawsuit at some point in their careers. In some quarters, physicians are fatalistic about this fact. I have heard colleagues say: “It’s going to happen at some point, I know it.”
But since the publication of the Institute of Medicine’s landmark To Err is Human [PDF] report, there is more awareness of patient safety in medicine and that the vast majority of harm done to patients is avoidable. Recognizing the opportunity to reduce ambulatory malpractice and improve the safety of primary care, a large group of stakeholders ranging from researchers in the Division of General Internal Medicine at Brigham and Women’s Hospital to the Institute for Healthcare Improvement collaborated to perform a multimethod randomized controlled trial, recently published in Medical Care, entitled: Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk.
As the researchers point out, primary care providers face numerous barriers to safe patient care, including high volume, high pressure practice environments, fragmentation of care with patients seeking care in multiple healthcare systems, and difficulties with diagnosis and health IT. The study focused on three domains of care malpractice suits frequently focus on: management of lab results, referrals, and medications. Additionally, the study focused on workplace culture and communication as a factors that may contribute to malpractice suits.
Researchers recruited 25 small-to-medium-sized primary care practices throughout the state of Massachusetts (16 intervention and 9 control practices). Intervention practices received 15 months of Quality Improvement support through a learning network, interactive didactic webinars, quarterly face-to-face learning sessions, and coaching from a practice improvement advisor that provided on-site advising over the course of 2 years.
The intervention was evaluated with retrospective chart review pre- and post-intervention, staff surveys, and patient surveys. The chart reviews assessed whether specific, common abnormal labs were appropriately acknowledged and managed. The staff surveys assessed a range of topics, including: access to service and care, medication management, referral management, test result management, and teamwork. The patient surveys were compiled from previously validated instruments, such as the Patients Perceptions of Integrated Care survey.
The researchers found a significant reduction in the rate of potential patient safety risks arising from abnormal lab tests from 155 per 1000 patients to 54 per 1000 patients [incidence rate ratio, 0.35 (95% confidence interval, 0.24-0.50)]. Researchers also found significant improvements in documentation of abnormal results in the chart (absolute improvement 1.4%, P=0.001), patient notification (5.8%, p<0.001), documentation of an action or treatment plan (6.1%, P<0.001), and evidence of a completed action plan (8.6%, P<0.001). Staff surveys revealed small improvements in the intervention group compared to control practices but none were statistically significant. Patient surveys showed no statistically significant differences.
As a practicing primary care physician, these results make sense to me. In a high-volume practice, it is extremely challenging to keep track of abnormal lab results, and I imagine that a targeted intervention that provided me specific education on the malpractice risks of delaying follow-up and poor documentation would lead me to become more fastidious in my follow-up and documentation, referrals, and medication reconciliation.
It is not at all surprising to me that patients did not report differently after the intervention. The changes that the practices in the study made were fairly granular in nature – how abnormal labs and referrals were documented and communicated to patients, and the process of medication reconciliation. But while abnormal labs are a fairly common occurrence in primary care, a patient having more than one of the abnormal labs that were specifically tracked in this study over the course of the two years is pretty unlikely; and for any intervention to have such a profound effect that patients note a difference in how the labs were handled would be surprising.
With regard to the staff surveys, you might think at first glance that such a broad, multi-pronged intervention over the course of two years should result in significant changes — but it didn’t. For those of us in primary care, this is also not surprising. Primary care is extremely busy. Simply moving forward and getting through each day requires significant staff energy – implementing meaningful reform that truly changes the culture and filters through an entire practice is a herculean task. I’ve heard people compare it to building a spaceship while already hurtling through space.
Also, as the authors point out, primary care is rife with turnover – one practice in the study experienced nearly 100% turnover during the study period. Changing workplace culture while employees constantly rotate through the clinic requires consistent structural changes from the leadership in how workers are recruited and trained as well as assiduous attention to the operations of the clinic. This consumes significant resources, which simply are not available in primary care in our current payor environment.
All of that said, we must provide safer care. There is no excuse for failing to follow up abnormal labs appropriately. The three central domains that the intervention targeted (following up abnormal labs, referrals, and medications) are basic functions of primary care. The fact that we still struggle to perform those functions should be shocking to non-clinicians – but to anyone who works in primary care, I am sure this comes as no surprise.
I don’t think that these changes necessarily need to be seen through the lens of trying to reduce risk of malpractice. If that motivates some clinicians to make changes to improve care, fine. But virtually all of the interventions provided to the study practices are congruent with the criteria for Patient-Centered Medical Home [PDF] certification, as laid out by the National Committee for Quality Assurance. Making care more accountable, better coordinated, patient-centered, and team-oriented will improve patient care and reduce the risk of malpractice for clinicians. We must keep moving forward.