A Framework for Usable and Effective Clinical Decision Support: Experience from the iCPR Randomized Clinical Trial.

INTRODUCTION: The promise of Clinical Decision Support (CDS) has always been to transform patient care and improve patient outcomes through the delivery of timely and appropriate recommendations that are patient specific and, more often than not, are appropriately actionable. However, the users of CDS-providers-are frequently bombarded with inappropriate and inapplicable CDS that often are not informational, not integrated into the workflow, not patient specific, and that may present out of date and irrelevant recommendations. METHODS: The integrated clinical prediction rule (iCPR) project was a randomized clinical trial (RCT) conducted to determine if a novel form of CDS, i.e., clinical prediction rules (CPRs), could be efficiently integrated into workflow and result in changes in outcomes (e.g., antibiotic ordering) when embedded within a commercial electronic health record (EHR). We use the lessons learned from the iCPR project to illustrate a framework for constructing usable, useful, and effective actionable CDS while employing off-the-shelf functionality in a production system. Innovations that make up the framework combine the following: (1) active and actionable decision support, (2) multiple rounds of usability testing with iterative development for user acceptance, (3) numerous context sensitive triggers, (4) dedicated training and support for users of the CDS tool for user adoption, and (5) support from clinical and administrative leadership. We define "context sensitive triggers" as being workflow events (i.e., context) that result in a CDS intervention. DISCUSSION: Success of the framework can be measured by CDS adoption (i.e., intervention is being used), acceptance (compliance with recommendations), and clinical outcomes (where appropriate). This framework may have broader implications for the deployment of Health Information Technology (HIT). RESULTS AND CONCLUSION: iCPR was well adopted(57.4% of users) and accepted (42.7% of users). Usability testing identified and fixed many issues before the iCPR RCT. The level of leadership support and clinical guidance for iCPR was key in establishing a culture of acceptance for both the tool and its recommendations contributing to adoption and acceptance. The dedicated training and support lead to the majority of the residents reporting a high level of comfort with both iCPR tools strep pharyngitis (64.4 percent) and pneumonia (62.7 percent) as well as a high likelihood of using the tools in the future. A surprising framework addition resulted from usability testing: context sensitive triggers.

Integrating usability testing and think-aloud protocol analysis with "near-live" clinical simulations in evaluating clinical decision support.

PURPOSE: Usability evaluations can improve the usability and workflow integration of clinical decision support (CDS). Traditional usability testing using scripted scenarios with think-aloud protocol analysis provide a useful but incomplete assessment of how new CDS tools interact with users and clinical workflow. "Near-live" clinical simulations are a newer usability evaluation tool that more closely mimics clinical workflow and that allows for a complementary evaluation of CDS usability as well as impact on workflow. METHODS: This study employed two phases of testing a new CDS tool that embedded clinical prediction rules (an evidence-based medicine tool) into primary care workflow within a commercial electronic health record. Phase I applied usability testing involving "think-aloud" protocol analysis of 8 primary care providers encountering several scripted clinical scenarios. Phase II used "near-live" clinical simulations of 8 providers interacting with video clips of standardized trained patient actors enacting the clinical scenario. In both phases, all sessions were audiotaped and had screen-capture software activated for onscreen recordings. Transcripts were coded using qualitative analysis methods. RESULTS: In Phase I, the impact of the CDS on navigation and workflow were associated with the largest volume of negative comments (accounting for over 90% of user raised issues) while the overall usability and the content of the CDS were associated with the most positive comments. However, usability had a positive-to-negative comment ratio of only 0.93 reflecting mixed perceptions about the usability of the CDS. In Phase II, the duration of encounters with simulated patients was approximately 12 min with 71% of the clinical prediction rules being activated after half of the visit had already elapsed. Upon activation, providers accepted the CDS tool pathway 82% of times offered and completed all of its elements in 53% of all simulation cases. Only 12.2% of encounter time was spent using the CDS tool. Two predominant clinical workflows, accounting for 75% of all cases simulations, were identified that characterized the sequence of provider interactions with the CDS. These workflows demonstrated a significant variation in temporal sequence of potential activation of the CDS. CONCLUSIONS: This study successfully combined "think-aloud" protocol analysis with "near-live" clinical simulations in a usability evaluation of a new primary care CDS tool. Each phase of the study provided complementary observations on problems with the new onscreen tool and was used to refine both its usability and workflow integration. Synergistic use of "think-aloud" protocol analysis and "near-live" clinical simulations provide a robust assessment of how CDS tools would interact in live clinical environments and allows for enhanced early redesign to augment clinician utilization. The findings suggest the importance of using complementary testing methods before releasing CDS for live use.

Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR) randomized trial in primary care.

BACKGROUND: Clinical prediction rules (CPRs) represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR) has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR) trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. METHODS: A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS) tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149) were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated) groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters) and chest x-rays (pneumonia iCPR only) between intervention and control providers. DISCUSSION: Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative process will lead to higher rates of utilization and EBM guided use of antibiotics and chest x-ray's in primary care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01386047.