Patient safety issues and medical errors are less likely to occur when treating a typical 24-year-old with seasonal allergies in the community, but add 40 years to the patient’s age, a complex neurocognitive disorder, a severe behavioral problem, a high risk of falls, several medical issues, complicating family dynamics, and a multilayered health care system, and patient safety becomes a critical yet complex focus for both competent clinicians working within the health care system and for the patients and families served. Patients with complex illnesses in complex settings are at higher risk for the occurrence of medical errors.
Case Vignette
Walter Smith has been brought to the emergency department (ED) by his wife three times in the past week because of falls. This Friday night visit is the fourth time. His wife is angry and wants him admitted to the hospital. The ED is extremely busy. The ED physician is considering a psychiatric admission for Mr. Smith, and a consult is obtained. The second-year psychiatry resident has been called to the ED. When the resident psychiatrist arrives, the patient flow manager comments that an ED bed is needed but that there is no psychiatric bed left in the hospital; there is also no psychiatric bed available in the region. The patient’s previous ED doctor has gone off shift, and the new ED physician has a large number of new patients to see.
Mr. Smith is 64 years old and was previously employed as a mathematics professor at a nearby college. He has not taught in the past two years because of his declining memory, his worsening confusion, and his inability to function in many areas of his life. His wife has cared for him at home but now asserts, “I just can’t do it anymore. He doesn’t recognize me and has started to hit me. He started kicking and hitting me in his sleep about five years ago (
3), but his hitting is much worse now and happens during the day. He was not an abusive man.”
A nurse practitioner at Mr. Smith’s primary care group has been taking care of his medical issues, which include benign prostatic hypertrophy, seasonal allergies, osteoporosis, and the recent onset of parkinsonism symptoms. The patient received a diagnosis of Alzheimer’s dementia. However, the neurocognitive decline has been progressively worsening, with a five- week history of visual hallucinations. The nurse practitioner had prescribed haloperidol 2 mg at night to target the agitation and aggression in a setting of visual hallucinations. Mr. Smith’s other medications include tamsulosin for benign prostatic hypertrophy.
Mr. Smith’s wife states, “He’s taken the new and old medication every night for over a week, but he’s worse now. He sleeps all the time, is more confused, and can hardly walk anymore. He has fallen about eight times this week and hit his head twice falling down the steps. We live in a split-level house. I can’t pick him up and carry him up the stairs! I need help. This isn’t what we wanted for our retirement. He was such a smart, kind husband.” While the resident is reconciling Mr. Smith’s medication, his wife adds, “He’s also been taking Benadryl [diphenhydramine] for hay fever every summer.”
In the ED as Mr. Smith waits 16 hours for an inpatient bed, he becomes more agitated. He is given 1 mg haloperidol i.m. and 1 mg lorazepam i.m. He becomes physically aggressive, attempts to hit his wife, and takes a swing at a staff nurse, during which he stumbles and falls. He requires 2 mg haloperidol and 1 mg lorazepam i.m. and restraint for violent behavior. He is then transferred to a psychiatric bed.
Admission evaluation occurs on Saturday evening. Three nursing staff members have been pulled from another unit to cover the inpatient psychiatric unit, which has been understaffed since two staff members called in sick and one worked another shift earlier to fill a scheduling gap. Mr. Smith, arriving on the unit severely sedated and with an unsteady gait, falls as nursing staff are performing admission assessment. The physician is notified of the fall but is curt, explaining that she is in the ED seeing another patient. One of the pulled nursing staff who usually works as a medical-surgical nurse asks to perform a post-fall huddle, but the psychiatric charge nurse informs her that “they only do huddles after restraint.” An Edmonson Psychiatric Falls Risk Assessment is administered, and Mr. Smith receives a score of 101, at high risk for falls (≥90). Mr. Smith is then escorted to bed. He is provided a low bed with a bed exit alarm. Several hours later he awakes, tries to go to the bathroom, and experiences urinary incontinence. The alarm sounds, but within the 30 seconds it takes for staff to arrive, he falls again, hitting his head. He suffers a right-sided subdural hematoma and dies one day later.
The clinicians are devastated by the event and ask themselves, “What did I miss? Will I be sued? Could I have prevented this? What do I do now? How do I tell his wife and family?”
Questions
The following questions are based on facts obtained from the Centers for Disease Control and Prevention (CDC) (
6). Answer True or False for each:
1.
True or False? One out of five falls causes a serious injury such as broken bones or a head injury.
2.
True or False? Approximately 35% of hip fractures are caused by falling.
3.
True or False? Falls are the third most common cause of traumatic brain injuries (TBIs).
4.
True or False? Adjusted for inflation, the direct medical costs for fall injuries are $31 billion annually. Hospital costs account for two-thirds of the total.
5.
True or False? Unintentional falls are the leading cause of nonfatal injury in the United States for all age groups combined, not only for those 65 or older.
Although there might be many causes for any serious safety event, root causes are those whose removal from the problem-fault sequence means that the sentinel event would not have occurred. Other causes may contribute to the event, but their removal might not necessarily have prevented the outcome with certainty. It helps to determine the underlying root causes for health care sentinel events in order to learn about them and to improve the system. With its history in the field of engineering (
7), root cause analysis (RCA) is a methodical, structured process of analysis designed to identify and thereby correct the underlying root cause of adverse events. This retrospective process can help improve future systems and prevent recurrence of such adverse events for other patients (
8).
6.
Some potential root causes of the adverse falls event for Mr. Smith include which of the following? (Note all those that apply.)
A.
The misdiagnosis of a patient as having Alzheimer’s dementia in a clinical picture more consistent with a diagnosis of Lewy body dementia, that is, major neurocognitive disorder with Lewy bodies
B.
The staffing factors of overworked nursing staff being pulled from other units to work on the psychiatric unit and of extremely busy ED staff on a Friday night
C.
The institutional-regulatory factor of the utilization of restraint for violent behavior, which is not a recovery-based intervention approved by the Substance Abuse and Mental Health Services Administration
D.
The organizational-management factor of the post-fall huddle being recommended by the nurse but not supported by the charge nurse and thus not occurring
Diagnostic errors are receiving more attention, given their impact on patient safety, and can include not only an incorrect diagnosis but a missed or delayed one. Misdiagnosis-related harm has been viewed as preventable, yet it results in an estimated 40,000 to 80,000 U.S. hospital deaths annually (
9). The misdiagnosis of Lewy-body disease has been recognized as a risk when formulating a differential diagnosis for persons with neurocognitive decline (
10–
12). Missing the correct diagnosis of a neurocognitive disorder with Lewy bodies can also increase risk for harm, given the severe neuroleptic sensitivity involved, especially when combined with first-generation antipsychotics, resulting in behavioral worsening, parkinsonism, somnolence, orthostatic hypotension (
13), and falls risk. The provision of diphenhydramine was likely a contributing cause to Mr. Smith’s worsening cognition yet not a root cause of the hospital falls. Thorough medication reconciliation, another patient safety strategy (
14,
15), helped to elicit this cause.
A naturalistic decision-making strategy to improve patient safety in health care is the use of after-action reviews, one type of which is the post-fall huddle. The post-fall huddle, which allows providers to learn from errors in a culture of safety and immediately to apply lessons learned to prevent a patient’s next fall, has shown success in decreasing both noninjurious and injurious falls (
16). Use of this tool has been supported by the Joint Commission to prevent falls and fall-related injuries with the following recommendation (
17):
“Conduct a post-fall huddle as soon as possible after the fall. Involve staff at all levels and, if possible, the patient, to discuss the fall—what happened, how it happened, and why (such as physiological factors due to medication or medical condition) [
18–
20]. In addition, the huddle should include:
• Whether appropriate interventions were in place
• Specific considerations as to why the fall might have occurred, including but not limited to: whether the call light was on and for how long, staffing at the time of the fall, and which environment of care factors were in play (such as toilet height and design, and slip and trip hazards)
• How similar outcomes can be avoided
• How the care plan will change
The huddle should incorporate a standard post-fall huddle tool. A standard script ensures that all elements are covered” [
21].
7.
An analysis by the Joint Commission of RCA data on falls with injury revealed that the most common contributing factors pertained to which of the following? (Note all those that apply.) (
22)
C.
Lack of adherence to protocols and safety practices
E.
Inadequate staff orientation, staff supervision, staffing levels, or staff skill mix
F.
Deficiencies in the physical environment
G.
Sleep deprivation and fatigue of residents
Given the high cost in resources, morbidity, and lives, the Joint Commission and the Centers for Medicare and Medicaid Services (CMS) have set expectations for falls risk screening and assessment. Several standardized and validated tools exist that are used to provide screening for falls risk, including the Hendrich II Fall Risk Model, the Morse Fall Scale, and, for psychiatric settings, the Edmondson Psychiatric Fall Risk Assessment Tool (
23). These scales and risk assessment guidelines can be integrated into the electronic health record and built into clinical decision support. While many risk factor instruments have a quantitative component, some tools may also include qualitative assessment and even a functional component, as exemplified by the Timed Get-Up-and-Go test (
24). Training on using the tools should be provided to staff to ensure interrater reliability (the degree of consistency among raters). In addition to obtaining patient scores on formal tools, a comprehensive, individualized assessment for falls and injury risk should be performed for each patient. The patient’s age, gender, cognitive status, and level of function should be included in the assessment.
Falls risk assessment builds upon the results from these instruments and is a more thorough, individualized biopsychosocial assessment that elicits the static and the dynamic risk factors for falls, which include factors intrinsic to the individual (
Box 2) as well as the extrinsic and environmental risk factors that also exist in both home and health care settings (
Box 3).
The falls risk formulation should rationally integrate the risk factors, including those intrinsic and extrinsic to the patient. The clinical estimation of risk will most often rank the patient as at high risk for falls or at low risk for falls. Some formulation paradigms take into account not only risk grading as “high” or “low” for falls but also the patient’s risk for injury. Some patients are at high risk simultaneously for falls and for injury from falls given such additional risk factors as having osteoporosis, taking anticoagulant medication, or refusing to wear hip protectors or a helmet. This cohort would need to be the focus of the greatest attention from the treatment team.
The falls risk assessment will drive the falls risk reduction and harm risk reduction plans, which often target decreasing the modifiable, dynamic risk factors, increasing the risk reduction factors, addressing the environmental factors, and implementing harm risk reduction strategies (
29). Options are outlined in
Box 4.
One of the challenges for psychiatrists in managing falls risk is that psychoactive medications are listed as a modifiable risk in many assessment instruments. These medications can be a best-practice, standard-of-care treatment for persons with neurocognitive disorders and co-occurring problems. A challenge for psychiatrists working with patients with neurocognitive disorders is that the risk-benefit analysis must focus not only on falls prevention but also on the treatment of the psychiatric or behavioral problem, which may include a risk of violence. One of the frequent criteria for psychiatric admission of a person with a neurocognitive disorder is risk of harm to others. Ethically—with other factors being equal—the risk to the one is outweighed by the risk to the many. This responsibility makes it challenging for psychiatrists to mitigate the aggression risk to others without worsening the falls risk for the individual patient. Maximizing psychosocial interventions to target treatment of aggression is a key, initial step. However, for some patients, the utilization of psychopharmacologic treatment, including antipsychotic medication, may be clinically indicated (
30). The ECRI Institute’s Falls Prevention Plan recommends ensuring that pharmacists review medication regimens and communicate to physicians the benefits of reducing or eliminating drugs that can increase the risk of falling (
25). Lists of medications that increase the risk of falling are readily available to help inform this decision making (
31–
33). Pharmacist-psychiatrist collaboration can identify opportunities to reduce the medication dose, discontinue the medication, or substitute an alternative drug with less potential for falls risk and thereby help to inform the risk-benefit analysis for treatment efficacy in targeting the underlying psychiatric issue.
Throughout these complex processes, involvement of the patient as capacity allows, of the surrogate decision maker, and of the family is key. Not only are informed consent and assent essential, but shared decision making can help guide the decision maker(s) through the multifaceted and emotionally difficult issues, including falls prevention, in order to integrate a patient’s goals, concerns, and values when making choices ranging from allowing a patient to ambulate in support of autonomy to utilizing restraints when immediate safety is an issue (while targeting the psychiatric issues for which the patient is being treated).
8.
What medications were a contributing factor to Mr. Smith’s falls risk in the community, in the ED, and on the psychiatric unit?
A culture of safety provides the foundation for high-quality care. The Agency for Healthcare Research and Quality (AHRQ) has noted that “the safety culture of an organization is the product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine the commitment to, and the style and proficiency of, an organization’s health and safety management. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures” (
34). The concept originated in companies that met high reliability with an awareness that it could only occur through a culture in which mindfulness of safety was nurtured and maintained at all levels, from the frontline worker to the C-suite. A culture of safety should span the depth and breadth of an organization—from the nurse aide and environmental service frontline employees to the organization’s C-suite, which includes the leadership of chief executive officer, chief operating officer, chief information officer, chief medical officer, and other top senior executives. AHRQ further noted that the commitment to establishing a culture of safety “encompasses these key features: acknowledgment of the high-risk nature of an organization’s activities and the determination to achieve consistently safe operations; a blame-free environment where individuals are able to report errors or near misses without fear of reprimand or punishment; encouragement of collaboration across ranks and disciplines to seek solutions to patient safety problems; organizational commitment of resources to address safety concerns” (
35. The U.S. Occupational Safety and Health Administration (OSHA [
36]) has observed that
in a strong safety culture, everyone feels responsible for safety and pursues it on a daily basis; employees go beyond “the call of duty” to identify unsafe conditions and behaviors, and intervene to correct them. . . . A company with a strong safety culture typically experiences few at-risk behaviors, consequently they also experience low incident rates, low turn-over, low absenteeism, and high productivity. They are usually companies who are extremely successful by excelling in all aspects of business and excellence. Creating a safety culture takes time. It is frequently a multiyear process. A series of continuous process improvement steps can be followed to create a safety culture. Employer and employee commitment are hallmarks of a true safety culture where safety is an integral part of daily operations.
9.
Evidence that the health care system was supporting a culture of safety after the death of Mr. Smith would include which of the following? (Note all those that apply.)
A.
In reporting the serious event, holding the nursing assistant who did not arrive in time as responsible for Mr. Smith’s death and seeking written counseling and possible termination for her
B.
Leadership taking a role in ensuring the right staffing and training for the staff on the psychiatric unit
C.
Due to the risk of a malpractice suit, instructing staff not to speak up if they see something again that may negatively affect patient care, including falls prevention
D.
Having staff on the unit work longer hours on weekends than is required for patient care because of recruitment and retention challenges and because leadership wants to minimize use of agency or temporary staff
E.
After a similar patient being admitted and falling but coming to no harm, still reporting the near miss
The AHRQ provides a Toolkit for the prevention of falls in hospitals (
19). Tools for improvement target not only improvement in clinicians’ practices but also system transformation via change management, checklists, reinforcements, implementation team development, stewardship of leaders, and various falls prevention options.
10.
Other organizations providing tools developed through research and quality improvement initiatives to decrease patient falls in health care include which of the following? (Note all those that apply.)
A.
U.S. Department of Veterans Affairs (VA)
E.
Institute for Healthcare Improvement
The VA National Center for Patient Safety developed one of the first toolkits in the country, designed to aid facilities in developing a comprehensive falls prevention program and offering a range of updated solutions on post-fall huddles, utilization of hip protectors, educational videos, environmental assessment templates, and other resources (
21). The Joint Commission Center for Transforming Healthcare has released a toolkit, the Targeted Solutions Tool (TST) for Preventing Falls. Its online web application offers support to subscribing organizations through a robust process-improvement approach to preventing falls by using Lean, Six Sigma, and change management methodology and tools (
37). In October 2008, CMS and, thereafter, other third-party payers stopped reimbursing U.S. hospitals for the treatment of falls injuries occurring during patients’ stays if the falls were considered preventable (
38). This financial disincentive has influenced change at the organization and health care system levels. The Institute for Healthcare Improvement has developed a “bedside how-to guide” that provides resources to reduce serious injuries from falls for hospitalized patients, step-by-step activities for implementation, and tools for falls risk assessment, nursing hand-off procedures, and post-fall safety huddles (
20). In March of 2016, the ECRI Institute offered tools to further support falls management program development, including action items for establishing a falls management team and policy, medication review, staff education, and environmental evaluation (
25).
Psychiatrists work within complex systems. Patients with neurocognitive disorders often have complex biopsychosocial presentations with high levels of comorbidity. Therefore, when the two meet— the psychiatrist within the complex health care system and the patient with the multifaceted neurocognitive disorder—patient safety risk is not additive but exponentially intensified, especially when dealing with prevention of falls and fall-related injuries. Not only can psychiatrists minimize the individual patient’s risk through risk assessment and falls prevention, but they can take a medical leadership role to minimize the system’s risk by using systems thinking and design and by creating a culture of safety. Multiple resources exist within the field to support psychiatrists in teaming with other clinicians and collaborating across organizations to improve safety for the patients they serve.