Medical errors (all errors in medicine), harmful errors (medical errors that specifically lead to patient harm), and adverse events (harms due to medical care) are leading causes of death and harm in patients in the hospital setting.^1,2 Communication failures are a common root cause of sentinel events, which are the most serious harmful errors.³ Minimal research has investigated whether efforts to reduce communication failures across healthcare providers, patients, and families could improve patient safety.⁴ This intervention sought to determine whether patient safety and communication processes could be improved via a family-centered communication program. Harvard Medical School and Boston Children’s Hospital designed a prospective, multicenter before-and-after intervention study in which families, nurses, and physicians coproduced an intervention to standardize healthcare provider-family communication on ward rounds in hospitals. This approach is also known as family-centered rounds.⁴

The intervention was conducted on seven pediatric units across the United States and Canada from December 2014 to January 2017. Before the intervention, most sites did not have a formal structure for rounds.⁴ This intervention, known as Patient and Family Centered I-PASS, was based off of the I-PASS Resident Handoff Study.5 It was adapted for the current study. A team of parents and healthcare professionals adapted the I-PASS framework⁵ to provide a formal structure for family-centered rounds. I-PASS stands for Illness severity (family reports if child was better, worse, or the same), Patient summary (brief summary of patient presentation, overnight events, plan), Action list (to-dos for the day), Situation awareness and contingency planning (what family and staff should look out for and what might happen), and Synthesis by receiver (family reads back key points of plan for the day, prompted by presenter and supported by nurse as needed).⁴ In addition to structuring communication on rounds around the I-PASS framework, the intervention sought to engage families in rounds by having them share their questions and concerns first and ensuring providers used simple language instead of medical jargon. The intervention engaged nurses to be present and speak early on rounds and support families. Finally, it involved a written summary of rounds filled out in real time, known as the Rounds Report.

The study team reviewed 3,106 patient admissions (1,574 preintervention and 1,532 postintervention), or a total of 13,171 patient days (6,326 preintervention and 6,845 postintervention) for medical errors, harmful errors, and nonpreventable adverse events.⁴ After the standardized family-centered rounds intervention was implemented, harmful errors decreased by 38% (20.7 per 1,000 patient days preintervention to 12.9 per 1,000 days postintervention; p=0.01).⁴ The overall rate of medical errors and nonharmful medical errors did not change.⁴

The study also had an unexpected decrease in nonpreventable adverse events. They decreased from 12.6 per 1,000 preintervention to 5.2 per 1,000 postintervention (p=0.003).⁴ This unexpected improvement may be due to improved engagement and communication with families, which prevented some adverse events from occurring in ways not apparent in the normal determination of adverse events.⁴ The reduction in harmful events occurred without significantly increasing the duration of rounds.⁴ Additionally, the intervention was found to improve key communication behaviors, like family and nurse engagement on rounds, and several measures of family experience.⁴

Per the innovator, Patient and Family Centered I-PASS is a novel approach in the patient safety movement. This innovation can be applied in many other settings of care, such as nursing homes and rehabilitation centers. Patient and Family Centered I-PASS has the potential to significantly reduce medical errors.

The Patient and Family Centered I-PASS innovation aimed to improve patient safety by improving health literacy, family engagement, and bidirectional structured communication between healthcare providers and patients’ families through the use of the modified I-PASS framework to standardize family-centered rounds.⁴

• Institutional support: Leadership support for the intervention
• Buy-in from families and the patient’s team of healthcare providers
• Unit physician and nursing champions who can help support implementation and training
• Support from families in sustaining the innovation
• Time and finances to properly train families and the patient’s healthcare team on the intervention. This includes a family orientation via brochures (for families, training on the content in the brochures is conducted by nurse staff), training modules (for healthcare providers), and the review of an implementation guide (for healthcare providers).⁴
• The implementation of observational tools (including core items and modules on activating and engaging the family and interprofessional team, patient-centered conversation and written information, use of structured communication techniques, and teaching) to ensure intervention adherence and improvement through audit and feedback⁴
• Disseminate campaign materials to encourage adoption of the intervention⁴
• Conduct meetings and teleconferences across sites, if the intervention is implemented across multiple sites, to track innovation progress and to address any challenges discovered during implementation⁴
• Conduct statistical analyses to assess changes in patient safety (medical errors and adverse events) and communication processes⁴
• Interpretation and translation resources for those who speak languages other than English

Per the innovator, engaging families in rounds has traditionally been done in the pediatric setting. Understanding where family-centered rounds could fit into the adult care setting has the potential to make a major impact. This innovation has the potential to improve health equity by ensuring standardized, clear communication and a partnership with patients and families.

Addressing diagnostic errors to improve outcomes and patient safety has long been a problem in the US healthcare system.¹ Many methods of reducing diagnostic error focus on individual factors and single cases, instead of focusing on the contribution of system factors or looking at diagnostic errors across a disease or clinical condition. Instead of addressing individual cases, KP sought to improve the disease diagnosis process and systems. The goal was to address the systemic root cause issues in systems that lead to diagnostic errors. In 2010, KP developed the e-Autopsy/e-Biopsy (eA/eB) methodology, an innovation designed to compile cases of specific populations of patients and diagnoses that have quality, safety, and diagnostic issues.² The goal of the innovation is to improve outcomes by identifying patterns of error for specific diagnoses. e-Autopsy denotes the eA methodology review process used among patients who died. e-Biopsy denotes the non-mortality eB methodology review process.

The eA/eB methodology is a three-part process involving reviewing cases, analyzing results, and implementing system changes. The case review process consists of two steps: electronic filtering of patient records and manual chart review. For electronic filtering of patient records, patients are electronically identified with the defined diagnosis to obtain a pool of charts from which cases are randomly selected for review. The manual review process is conducted by physician reviewers using an electronic review tool with questions relevant to their area of expertise. After the review process is completed, the data from the review tool are analyzed by the eA/eB team, which includes physicians who oversee each eA/eB study, as well as specialty experts, to identify patterns of variations in care, diagnostic accuracy, and failure to provide evidence-based care. The specialty experts are clinicians (e.g., gynecologists) who have expertise in the specific condition being studied (e.g., ectopic pregnancy). The results of the review and suggested system improvement opportunities are then presented to subject matter experts and leaders. Lastly, after the results and recommendations have been shared, the eA/eB team works with specialty and senior organizational leadership teams to implement the system changes.¹

KPSC’s September 2022³ study discusses the use of eA/eB to improve patient safety with three diagnoses: ectopic pregnancy, advanced colon cancer, and abdominal aortic aneurysms (AAA). Multiple systemic problems were found from the three-part process for each diagnosis. For example, in the eB review for ectopic pregnancy, the review of care found that only 56% of patients who had bloodwork indicating a risk of ectopic pregnancy were offered a repeat diagnostic ultrasound. Only 38% of patients were offered a conclusive procedure, such as an endometrial biopsy, to clarify the diagnosis, as recommended in guidelines. Inconsistent use of screening guidelines was an issue identified in the eA process for advanced colon cancer. KPSC identified that about 15% of patients had a delay in diagnosis of colon cancer due to failure to work up rectal bleeding and microcytic anemia. They noted that they were not measuring adenoma detection rates during colonoscopy. A lack of screening was a significant issue identified in the eA process for AAA.¹

Based on the eA/eB review findings, KPSC implemented several system changes that improved care across the three diagnoses. The updated system found eight patients with an ectopic pregnancy with possible early delays in care which were flagged in the SureNet system that led to clear communication with the involved clinicians to reduce the chance of significant diagnostic delays. Without this system, these patients likely would not have been identified, because, by their nature, diagnostic errors are not routinely identified. Due to the new system’s updates, intervention and appropriate care was provided to these eight patients between October 2021 and April 2022, with many more patients having been identified and appropriately cared for since then. The system changes for AAA, including a Best Practice Alert in the electronic health record (EHR), greatly increased the screening rate to identify early AAA, and decreased the rate of failure to recognize and follow up diagnosed AAA. This and other system improvements reduced the number and rate of AAA ruptures (average of 1.03/100,000 members at baseline to 0.5/100,000 postimplementation). KPSC implemented an electronic surveillance system⁴ to identify patients with rectal bleeding and/or with microcytic anemia who were not worked up, which resulted in their having testing done for colon cancer and reducing potential delays in diagnosis. Finally, between 2016 and 2018, colon cancer adenoma detection rates increased from 30% to 34% among women and from 42% to 47% among men.⁵

Since 2010, KPSC has conducted a total of 12 eA/eB studies on a wide variety of topics, identifying many needed system improvements. The key to success is in selecting the right topic for the study (i.e., objective criteria exist to diagnose the condition and there are evidence-based guidelines to clarify optimal care) with an identified need for improvements in diagnosis, having the support of leadership, creating actionable results that are implemented in the system itself to support buy-in, and obtaining internal funding to implement the actionable results in the system.

The innovation focused on reducing diagnostic errors for certain diagnoses to improve patient safety.

The intervention requires both physician and non-physician resources.

• For the physician resources, of the 50 charts reviewed, doctors spend about 15 minutes per chart. KPSC typically uses two research physicians and four to six specialists in the particular condition being studied.
• For non-physician resources, the intervention requires a project manager who does not need a clinical background, at 25% full-time equivalent per project. The project manager manages the manual review process and data collection completed by the physicians.
• The innovation requires the ability to create the electronic review tool, which standardizes the manual chart reviews to ensure accuracy.

Per the innovating organization, the innovation can be replicated at other organizations, but those organizations must have the minimum required resources. The organizations need the ability to review 50 charts, which is equivalent to 12 hours of physician time per study. There must be enough cases of the disease (minimum 50 for chart review) in the system that the organization can study. There should also be leadership support for the goal of identifying system issues amendable to improvement and for the necessary implementation of those changes.

In smaller hospitals or organizations, fewer staff can be used, and designated staff can spend more time reviewing more charts.