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Gaps in Strength of Evidence

Evidence Gap 1: Few Well-Evaluated Studies on Patient Engagement To Improve Patient Safety in Primary Care

The evidence base for improving patient safety in primary care settings by engaging patients and families is overall suggestive or modest at best. Our team identified several gaps in evidence that could serve for further study and attention in further developing the Guide. Of note is how few of the interventions we reviewed were carefully evaluated. Only 33 (35.1%) of the peer-reviewed literature and 68 (20.7%) of the grey literature reports described an evaluated intervention. The lack of rigorous evaluation and the limited approaches to standardized evaluation through validated surveys or other means represent gaps in the literature.

In terms of safety issues addressed, the grey literature is much more focused on studies addressing fragmentation of the care system (75.3%) and communication between patients and providers (85.4%). The corresponding percentages for the peer-reviewed literature are 25.5% and 36.2%, respectively. This suggests a gap in the peer-reviewed literature addressing fragmentation and communication between patients and providers.

On the other hand, medication prescription, management, drug interactions, and adherence (57.4%) and antibiotic, opioid, and other medication overuse (10.6%) are relatively more common in the peer-reviewed literature; the corresponding percentages for the grey literature are 36.3% and 2.1%, respectively.

Gaps in Practice Patient Safety Infrastructure

Infrastructure Gap 1: Limited Evidence on Infrastructure To Support Safety in Primary Care

The environmental scan revealed gaps in primary care practices to identify, review, and disclose medical errors.^262,263 Organizational and operational structures that exist in hospital settings such as patient safety event reporting systems, patient safety officers, peer review committees, and other structures for safety are rare in individual primary care practices. Instances of these structures appear limited to those practices affiliated with large health care systems, but attention within these systems often focuses on acute care settings.

AHRQ's efforts on consumer reporting may be one strategy to support primary care practices in identifying common causes of error in the practice environment. However, a practice's inability to support the infrastructure of a robust safety program may limit detecting, addressing, and learning from medical errors in primary care. Future research is needed to address optimal approaches to event review/root cause analysis, and failure modes and effects analyses, as well as the costs associated with safety improvements in primary care.

Gaps in Measurement

Measurement Gap 1: Limited Evidence of Measures To Assess Patient Safety in Primary Care

While not a focus of our environmental scan, our work did reveal a dearth of outcome measures for patient safety in primary care. Assessment of patient safety in primary care is limited not only in the small number of validated measures of safety but also by practices’ inability to conduct routine measurement of traditional safety outcomes. Discrete tests of change in patient safety in primary care are rare.²⁶⁴ With few measures of patient safety available specific to primary care, evidence of improvement in patient safety within primary care settings is inherently anecdotal, case based, and ripe for transformation.

AHRQ's survey on medical office safety is one of the strongest and most widely used assessment tools currently available to measure safety culture in practices.²⁶⁵ Another surrogate measure of safety has been through the evaluation of malpractice claims.¹³⁵ As attention in the field of patient safety continues to shift focus to the ambulatory care setting, several new measures of safety have recently emerged. One promising measure is the Patient Measure of Safety for use within the acute and primary care settings.^266,267 Until these measures are implemented to scale, surrogate measures of patient safety such as patient satisfaction and claims will continue to dominate the field.^165,268

Measurement Gap 2: Limited Measures To Assess the Impact of Engagement on Patient Safety

Another gap identified during our environmental scan was in the assessment of patient and family engagement. Most of the literature assessed engagement of patients and families using surrogate measures such as health outcome improvements and patient satisfaction, and through qualitative reports of satisfaction with engagement approaches.^7,58,67,269 To this end, the evidence base for improving patient safety by engaging patients and families is thin.

Publication of the psychometric properties of the Patient Health Engagement Scale is a good first step in improving measures of engagement.²⁷⁰ Assessment of patient activation is also a potential measure that may be linked to patient safety improvements. However, widespread adoption of measures of activation have not yet been described in primary care.^{181,271–273} Whether these measures are directly related to improvements in patient safety is also an area requiring further study.

Gaps in Usability of the Tools Identified

Usability Gap 1: Limited Evidence of Patient Involvement in Intervention Development

The peer-reviewed and grey literature demonstrates a significant number of tools, resources, and interventions targeting patient engagement in health care. Many of these tools, however, have limited evidence of end-user (i.e., patient) input into development of the tool or involvement in usability and dissemination activities. The scan revealed little information on usability of common tools such as medication lists or tools that support patient readiness for doctor visits.

Instructions for how to use and get started using the interventions were also limited. In addition, many of the tools, toolkits, and resources reviewed appeared appropriate for patients who were already activated, engaged, and empowered. We found cases of minimal attention to less engaged patients. This gap has significant implications for the Guide and the Guide development process.

Usability Gap 2: Culturally Sensitive and Culturally Appropriate Tools

Overall, our environmental scan revealed that despite the diversity of health care settings and recipients of care across the Nation, there is a general lack of culturally appropriate or culturally specific tools for patients and families. We found few tools that were tailored to specific populations or that addressed or acknowledged the need to accommodate specific cultural, racial, ethnic, or religious needs of patients and families. There is also little evidence to suggest the effectiveness of existing tools for differing cultural needs.

Specific gaps in the tools reviewed include little attention to interventions addressing limited English proficiency, the need for translators or other language support services within primary care settings, and barriers to health literacy. Few of the patient-focused tools catered to patients and families with lower or limited health literacy. Related to this issue, there does not seem to be a consensus on what would be an appropriate way to test or assess the health literacy level of existing tools in order to modify them appropriately.