Complexity Bias in the Prevention of Iatrogenic Injury: Why Specific Harms May Inhibit Performance

Introduction

Iatrogenic injury is a subject of great concern, fueled in part by research finding that medical error as the third leading cause of death worldwide.^1,2 The U.S. Agency for Healthcare Research & Quality (AHRQ) reported a 13% decrease between 2014 and 2017 across major patient safety events, most of which are related to iatrogenic injury in complex patients. These reductions in infections and injuries have saved $7.7 billion and averted 20,500 deaths.³

But hospitals and the U.S. Centers for Medicare and Medicaid Services (CMS) are missing a chance for even greater impact, particularly among patients who remain bedridden after complicated procedures. Hospitals need to reduce the complexity that builds from trying to reduce harms individually rather than systematically, and CMS needs to recognize that its incentives for harm reduction are not functioning properly to address the safety needs of different patients across all key areas simultaneously.

Problem: Complexity Bias

These challenges could be thought of as a system-wide “complexity bias,” whereby healthcare organizations tend to over-complicate the reduction of iatrogenic injuries by breaking it down into many parts that address limited components of the greater problem.⁴ Thus, organizations may invest in separate initiatives to improve outcomes of infections such as ventilator-acquired pneumonia, or fall- and pressure-related injuries, while failing to realize that individual outcomes have overlapping risk factors that could be addressed in a more efficient, unified and replicable manner.

There is little doubt that CMS penalties have spurred some reductions in iatrogenic injuries overall with the intent of addressing this complexity bias. In 2014, CMS installed a 1% reimbursement penalty on lowest-performing healthcare systems in addition to withholding payment on composite rates of eleven outcomes, termed Patient Safety Indicator 90 (PSI90).⁵ AHRQ attributed much of the observed reduction across these iatrogenic injuries to CMS payment changes, as do independent analyses exploring these associations over time.⁶

However, the rate reductions have not been equal across all iatrogenic injuries. In fact, some hospitalized patients may be less safe as a result of these reimbursement policies.^7,8

Pressure injuries increased 6% between 2014 and 2017, representing more than $25 billion in waste and potentially causing nearly 60,000 deaths each year.^3,9 Likewise, catheter-associated urinary tract infections (CAUTI) increased 4% between 2014–2016, costing an additional $170 million for 12,000 new cases per year.^3,10 These concerning statistics are analogous to findings by Gupta and colleagues that critically ill, malnourished or frail patients are not necessarily safer as a result of CMS payment restructuring.¹¹

Beginning in 2008, when CMS initiated payment reductions for iatrogenic injuries, hospitals had to decide which conditions to prevent first based on best available evidence and cost-minimization.¹² Established guidelines such as the Surgical Safety Checklist for preventing surgical site infection and Michigan Keystone Initiative for preventing central line-associated bloodstream infection were already backed by good evidence.^13,14 Hospitals took steps to integrate these new checklists with practice, one or two at a time. At the same time, most evidence to support pressure injury or CAUTI prevention was still in a phase of experimentation; the international guidelines for pressure injury prevention, for instance, were not published until 2009. Additionally, efforts to suppress these particular injuries required continuous implementation during admission, drawing down sizable assets to deploy skilled labor and technological resources.

These factors may tempt medical directors with budget constraints to prioritize adoption of some guidelines over others if they have to be selective. And given the structure of PSI90, why would healthcare systems worry about reducing rates of all iatrogenic injuries equally? In the previous examples, PSI90 is illustrative of regression towards the mean. That is, hospitals can tackle high-return, low-risk tasks with simpler prevention guidelines. This tactic results in overall performance improvement, while harm could increase for certain conditions.⁶

The growing likelihood of some harmful outcomes increasing as health systems may prioritize some guidelines exemplifies concerns about a growing complexity bias across healthcare facilities.⁴ The result of this wasteful effort is an administrative and medical logjam.

Such an approach to selectively improve quality and performance may disregard overlapping clinical steps between prevention protocols. Waste is introduced as multiple response teams assemble to address separate patient needs to prevent negative outcomes. In turn, teams’ efforts are duplicated and prioritized based on the amount of financial commitment in order to achieve improvement. As a result, costly protocols with mixed evidence such as pressure injury and CAUTI prevention are deprioritized.

Clinical Solutions

A better way to prevent all PSI90 measures equally would explore factors that overlap between outcomes. For example, three key domains to effectively manage risk for pressure injury and CAUTI are mobility, moisture and nutrition. Managing these three risk factors could have overlapping benefits for other negative outcomes as well. Thus, centering a prevention program around these three domains, rather than specific outcomes, could potentially address the needs of patients at risk for most other infections, falls and other iatrogenic injuries included in PSI90 (Figure 1). While implementation of a unified model of quality improvement such as this has not yet been tested, there could be strong justification for deploying a model such as this hypothetical one on the likelihood of economic and performance gains. There may be overlapping risk factors for other types of negative outcomes as well that are not displayed here, such as risk for sepsis and C. difficile. Overall, the key to viewing quality improvement in health system is not to think of outcomes as isolated events, but events along a continuum of common risk factors that need to be addressed in tandem.

Figure 1.

Venn diagram simplifying the “complexity bias” of patient safety programs by noting overlapping risk factors (i.e. mobility, moisture and nutrition) for the prevention of iatrogenic injuries included in the AHRQ PSI90 measure. Health systems should consider focused efforts first on outcomes with overlapping risk factors that are common to many other iatrogenic injuries. Considering, for example, the fact that the prevention of pressure injury and catheter-associated urinary tract infection (CAUTI) depend on successful management of mobility, moisture and nutrition. Centralizing quality improvement efforts on these outcomes and their risk factors can potentially have positive effects on stabilizing other conditions as well (e.g. other infections, falls, adverse events) which possess overlap in some of common risk factors. Key: ADE, Adverse Drug Event; CLABSI, central line-associated bloodstream infection; DVT, Deep-Vein Thrombosis; SSI, Surgical Site Infection; VAP, Ventilator-acquired Pneumonia.

As a result, health systems should no longer view iatrogenic injuries as mutually exclusive events. As Figure 1 implies, preventing PSI90 cases may require a unified set of guidelines and clinical change teams to reduce total PSI90 risk, not only separate prevention guidelines for each outcome. Creating transdisciplinary change teams in health systems of MDs, RNs, therapists and operations experts that are knowledgeable of these domains across the spectrum of outcomes, along with specific needs of patients, could lead to more successful reductions in iatrogenic injuries.

Such transdisciplinary change teams should be governed not just by their knowledge of preventive guidelines, but by measures of process improvement. This means prospectively collecting data on the processes that lead to better outcomes, such as daily adherence with risk assessment protocols for pressure injury prevention, or tracking time since catheterization for incontinent patients.¹⁵ Collecting data on processes alongside outcomes in a prospective nature enables such teams to respond to changes in patient risk caused by a shortfall in the implementation of preventive care, rather than reacting to an isolated injury with treatment.

Policy Solutions

The PSI90 measure and CMS payment structure created momentum for reducing iatrogenic injuries. Health systems now should consider a top-down approach to prevention. By better understanding the nature of prevention as illustrated in Figure 1, several steps at the system- and division-levels could lead to further reductions (Box 1).

Box 1.

Policy- and hospital-level steps to reduce iatrogenic injury in the U.S.

Resolution	Description
Common Risk Factors for Iatrogenic Injury	Creating transdisciplinary teams to reduce the risk of multiple harms can streamline practice and cut costs without risking additional harm to the patient.
Equal-sided Risk Payments	Reward Hospitals for Good Performance; Penalize Hospitals for Poor Performance. Also called “carrot-and-stick” payment model.
Short-term vs. Long-term Outcomes	Payers should weigh the short-term benefits of reduced reimbursements with the long-term consequences of increased morbidity in a population with conditions that could have been avoided.

First, CMS should consider rewarding health systems for good performance, rather than solely punitive measures. Currently, CMS penalizes hospitals −1% of total reimbursements if they fall into the bottom-quartile for PSI90 rates. An alternate solution could be an equal-sided risk model that rewards the top-quartile +1% of reimbursements for good performance, in addition to the penalty.¹⁶ Equal-sided risk for PSI90 could attract hospitals towards greater financial resources, which remain revenue-neutral for CMS. As CMS has seen in the past when partnering with accountable care organizations on novel payment models, equal-sided risk models have grown in popularity in the past decade and resulted in performance improvement.¹⁷

Second, CMS should recognize that it is not actually saving money or gaining financially by penalizing hospitals. The PSI90 penalties generate revenue from iatrogenic injuries that occur during the acute phase immediately following a procedure. Yet, the consequences of some iatrogenic injuries last far beyond a few weeks in the hospital. For instance, chronic wounds caused by pressure injuries can last months or years, and multiple follow-up procedures in the acute and post-acute settings that are fully reimbursable by CMS to the tune of $20 billion per year in chronic wound management.¹⁸

Conclusion

Ultimately, preventing iatrogenic injuries is important to patients and hospital performance. The existing model of prevention, by tackling each outcome separately, generates complexity bias that may not serve hospitals well. This existing model divides clinical change teams that specialize in overlapping practices, which if unified could achieve better outcomes with fewer labor-intensive resources. By bringing change teams together to serve patients through a common mission, they could deliver value to patients and health systems by improving all outcomes that matter simultaneous with the more efficient use of resources.

There are a number of incentives that influencers such as CMS could consider to adopt a unified model of care that reduces complexity bias, such as carrot-and-stick approaches like the equal-sided risk models that CMS has deployed effectively to improve outcomes in other areas. While financial constraints are usually rate-limiting factors to initiate new ideas, these novel payment models that create new hospital incentives and remain revenue-neutral for CMS could make the difference in future AHRQ Scorecards that see improvements in all iatrogenic injuries simultaneously.

Abbreviations:

AHRQ

Agency for Healthcare Research & Quality

CAUTI

Catheter-associated Urinary Tract Infection

CMS

Centers for Medicare & Medicaid Services

PSI

Patient Safety Indicator