General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization.

BACKGROUND: Blood transfusions can serve as a life-saving treatment, but inappropriate blood product transfusions can result in patient harm and excess costs for health systems. Despite published evidence supporting restricted packed red blood cell (pRBC) usage, many providers transfuse outside of guidelines. Here, we report a novel prospective, randomized control trial to increase guideline-concordant pRBC transfusions comparing three variations of clinical decision support (CDS) in the electronic health record (EHR). METHODS: All inpatient providers at University of Colorado Hospital (UCH) who order blood transfusions were randomized in a 1:1:1 fashion to the three arms of the study: (1) general order set improvements, (2) general order set improvements plus non-interruptive in-line help text alert, and (3) general order set improvements plus interruptive alert. Transfusing providers received the same randomized order set changes for 18 months. The primary outcome of this study is the guideline-concordant rate of pRBC transfusions. The primary objective of this study is to compare the group using the new interface (arm 1) versus the two groups using the new interface with interruptive or non-interruptive alerts (arms 2 and 3, combined). The secondary objectives compare guideline-concordant transfusion rates between arm 2 and arm 3 as well as comparing all of arms of the study in aggregate to historical controls. This trial concluded after 12 months on April 5, 2022. DISCUSSION: CDS tools can increase guideline-concordant behavior. This trial will examine three different CDS tools to determine which type is most effective at increasing guideline-concordant blood transfusions. TRIAL REGISTRATION: Registered on ClinicalTrials.gov 3/20/21, NCT04823273 . Approved by University of Colorado Institutional Review Board (19-0918), protocol version 1 4/19/2019, approved 4/30/2019.

User-Centered Design to Reduce Inappropriate Blood Transfusion Orders.

BACKGROUND: To improve blood transfusion practices, we applied user-centered design (UCD) to evaluate potential changes to blood transfusion orders. OBJECTIVES: The aim of the study is to build effective transfusion orders with different designs to improve guideline adherence. METHODS: We developed three different versions of transfusion orders that varied how information was presented to clinicians ordering blood transfusions. We engaged 14 clinicians (residents, advanced practice providers [APPs], and attending physicians) from different specialties. We used the think aloud technique and rapid qualitative analysis to generate themes to incorporate into our modified orders. RESULTS: Most end-users who participated in the semi-structured interviews preferred the interruptive alert design plus behavioral nudges (n = 8/14, 57%). The predominant rationale was that the in-line alert was not visually effective in capturing the end-user's attention, while the interruptive alert forced a brief stop in the workflow to consider the guidelines. All users supported the general improvements, though for different reasons, and as a result, the general improvements remained in the designs for the forthcoming trial. CONCLUSION: The user experience uncovered through the think aloud approach produced a clear and rich understanding of potentially confounding factors in the initial design of different intervention versions. Input from end-users guided the creation of all three designs so each was addressing human factors with parity, which ensured that the results of our study reflected differences in interruptive properties of the alerts and not differences in design.

Differences in cardiac testing resource utilization using two different risk stratification schemes.

OBJECTIVE: Assess whether changing an emergency department (ED) chest pain pathway from utilizing the Thrombolysis in Myocardial Infarction (TIMI) score for risk stratification to an approach utilizing the History, EKG, Age, Risk, Troponin (HEART) score was associated with reductions in healthcare resource utilization. METHODS: A retrospective, quasi-experimental study using difference-in-differences and interrupted time series specifications evaluated all ED patients with a chest pain encounter from 8/2015 to 7/2019 at a large academic medical center. We included patients age ≥ 18 with negative troponin testing discharged from the ED. Our standardized care pathway utilized TIMI for risk stratification until 09/2017 and HEART thereafter. We evaluated patients undergoing hospital-based cardiac diagnostic testing (CDT), length of stay (LOS), and 30-day Major Adverse Cardiovascular Events (MACE) at the intervention site before and after the pathway change and compared these outcomes to a similar control site within the health system for the difference-in-differences specification. RESULTS: During the study period, 6.3% (450 of 7117) of patients in the TIMI cohort and 7.2% (546 of 7623) in the HEART cohort among 400,965 total ED visits underwent CDT. In a multivariable analysis, transition to the HEART pathway was associated with greater odds of receiving CDT (odds ratio 2.88 [95% CI 1.21 to 6.86]), a reduction in LOS of 34 min (95% CI 2.2 to 67.6), and no significant difference in 30-day MACE. CONCLUSION: The transition from TIMI to HEART was associated with mixed consequences for healthcare resource utilization, including increased CDT but reduced length of stay.

Dig Deeper: A Case Report of Finding (and Fixing) the Root Cause of Add-On Laboratory Failures.

BACKGROUND: Venipunctures and the testing they facilitate are clinically necessary, particularly for hospitalized patients. However, excess venipunctures lead to patient harm, decreased patient satisfaction, and waste. OBJECTIVES: We sought to identify contributors to excess venipunctures at our institution, focusing on electronic health record (EHR)-related factors. We then implemented and evaluated the impact of an intervention targeting one of the contributing factors. METHODS: We employed the quality improvement (QI) methodology to find sources of excess venipunctures, specifically targeting add-on failures. Once an error was identified, we deployed an EHR-based intervention which was evaluated with retrospective pre- and postintervention analysis. RESULTS: We identified an error in how the EHR evaluated the ability of laboratories across a health system to perform add-on tests to existing blood specimens. A review of 195,263 add-on orders placed prior to the intervention showed that 165,118 were successful and 30,145 failed, a failure rate of 15.4% (95% confidence interval [CI]: 15.1-15.6). We implemented an EHR-based modification that changed the criteria for add-on testing from a health-system-wide query of laboratory capabilities to one that incorporated only the capabilities of laboratories with feasible access to existing patient samples. In the 6 months following the intervention, a review of 87,333 add-on orders showed that 77,310 were successful, and 10,023 add-on orders failed resulting in a postintervention failure rate of 11.4% (95% CI: 11.1, 11.8) (p < 0.001). CONCLUSION: EHR features such as the ability to identify possible add-on tests are designed to reduce venipunctures but may produce unforeseen negative effects on downstream processes, particularly as hospitals merge into health systems using a single EHR. This case report describes the successful identification and correction of one cause of add-on laboratory failures. QI methodology can yield important insights that reveal simple interventions for improvement.

Anti-seizure therapy with a long-term, implanted intra-cerebroventricular delivery system for drug-resistant epilepsy: A first-in-man study.

BACKGROUND: A clinical feasibility study was undertaken at a single center of long-term intra-cerebroventricular drug delivery of the anti-seizure medication valproic acid, into the cerebrospinal fluid (CSF) in order to treat drug resistant focal seizures, using an implantable infusion system. The primary objective was to establish the dose range of VPA administered in this manner. Secondarily, safety, pharmacokinetics (PK) and a preliminary estimate of effectiveness were evaluated. METHODS: In this single arm study, five adult subjects, with 29-234 focal onset seizures per month from a seizure focus involving the mesial temporal lobe were implanted with the system (clinicaltrials.gov identifier NCT02899611). Oral valproic acid (VPA) had previously been ineffective in all subjects. Post-surgery, pharmacokinetic studies of CSF infused VPA were performed. Valproic acid doses were increased stepwise in a standardised protocol. FINDINGS: The procedure and implantation were well-tolerated by all subjects. Four subjects responded with > 50% seizure reduction at the highest tested dose of 160 mg/day. Two subjects experienced extended periods of complete seizure freedom. All five subjects reported significant quality of life improvement. No clinical dose limiting side effects were encountered and there was no evidence of local periventricular toxicity in three subjects who were evaluated with imaging (T2 MRI). Side effects included nausea and appetite loss but were not dose-limiting. Mean CSF valproic acid levels were 45 µg per ml (range 20-120 µg per ml), with corresponding serum levels of 4-14 µg per ml.  Subjects have received therapy for up to 2.5 years in total . The efficacy analysis presented focuses on the period of time with the current pump with a mean 12.5 months, range 11.5-15 months. Pump failure requiring reimplantation was a significant initial issue in all subjects but resolved with use of pumps suitably compatible with long-term exposure to valproic acid. INTERPRETATION: The study demonstrated that chronic intraventricular administration of valproic acid is safe and effective in subjects with medically refractory epilepsy over many months. The procedure for implanting the infusion system is safe and well-tolerated. High CSF levels are achieved with corresponding low serum levels and this therapy is shown to be effective despite unsuccessful earlier use of oral valproate preparations. Drug side effects were minimal. FUNDING: The study was funded by Cerebral Therapeutics Inc., Suite 137 12635 East Montview Blvd Aurora CO 80045.