Avoiding Unintended Consequences of Pediatric Blood Order Set Updates through In Situ Usability Testing.

Background Blood product ordering is a complex process, and mistakes can lead to patient harm and poor outcomes. Orders and order sets can be designed to help mitigate errors, but major changes in design can unintentionally cause new errors. Objectives (1) Utilize formative in situ usability testing to iteratively improve the design of a redesigned blood product order set prior to go-live, (2) implement changes based on feedback derived from this testing, and (3) Compare the error rate, System Usability Scale (SUS) score, time to task completion, and click counts between the prior order set in use at the time and the revised redesigned order set. Methods A multidisciplinary project team convened to redesign blood product orders and order sets from scratch based on a review of literature and benchmarking against four pediatric academic institutions with the goal of addressing prior ordering errors. The new redesigned blood product order set was iteratively updated via in situ formative usability testing performed with available clinical users using a concurrent think-aloud protocol in real clinical environments. Errors, SUS scores, time to task completion, and click counts were assessed for the revised redesigned order set using summative testing. Results Formative usability testing with 20 participants led to seven design changes in the redesigned order set which reduced the error rate at go-live. Summative usability testing showed that even though the usability scores were only slightly improved for the revised redesigned order set, the error rates in blood orders were significantly decreased. Conclusion Usability testing can identify design errors early in the process which can be rectified prior to implementation, thus avoiding unintended consequences of changes.

Development and evaluation of trigger tools to identify pediatric blood management errors.

BACKGROUND: Pediatric patient blood management (PBM) programs require continuous surveillance of errors and near misses. However, most PBM programs rely on passive surveillance methods. Our objective was to develop and evaluate a set of automated trigger tools for active surveillance of pediatric PBM errors. MATERIALS AND METHODS: We used the Rand-UCLA method with an expert panel of pediatric transfusion medicine specialists to identify and prioritize candidate trigger tools for all transfused blood products. We then iteratively developed automated queries of electronic health record (EHR) data for the highest priority triggers. Two physicians manually reviewed a subset of cases meeting trigger tool criteria and estimated each trigger tool's positive predictive value (PPV). We then estimated the rate of PBM errors, whether they reached the patient, and adverse events for each trigger tool across four years in a single pediatric health system. RESULTS: We identified 28 potential triggers for pediatric PBM errors and developed 5 automated trigger tools (positive patient identification, missing irradiation, unwashed products despite prior anaphylaxis, transfusion lasting >4 hours, over-transfusion by volume). The PPV for ordering errors ranged from 38-100%. The most frequently detected near miss event reaching patients was first transfusions without positive patient identification (estimate 303, 95% CI: 288-318 per year). The only adverse events detected were from over-transfusions by volume, including 4 adverse events detected on manual review that had not been reported in passive surveillance systems. DISCUSSION: It is feasible to automatically detect pediatric PBM errors using existing data captured in the EHR that enable active surveillance systems. Over-transfusions may be one of the most frequent causes of harm in the pediatric environment.

Influence of user-centered clinical decision support on pediatric blood product ordering errors.

BACKGROUND: Children are at increased risk from transfusion-related medical errors. Clinical decision support (CDS) can enhance pediatric providers' decision-making regarding transfusion practices including indications, volume, rate, and special processing instructions. Our objective was to use CDS in a pediatric health system to reduce:blood product-related safety events from ordering errors;special processing ordering errors for patients with T-cell dysfunction, sickle cell disease (SCD), or thalassemia;transfusions administered faster than 5 mL/kg/h. MATERIALS AND METHODS: In this single-center before and after quality improvement study, we evaluated how user-centered design of pediatric blood product orders influenced pediatric transfusion practices and outcomes. Safety events were identified through active and passive surveillance. Other clinically relevant outcomes were identified through electronic health record queries. RESULTS: Blood product-related safety events from ordering errors did not change significantly from the baseline period (6 events, 0.4 per month, from 1/1/2018-3/27/2019) to the intervention period (1 event, 0.1 per month, from 3/28/2019-12/31/2019; rate ratio: 0.27 [0.01-2.25]). Packed red blood cell (PRBC) and platelet orders for patients with T-cell dysfunction that did not specify irradiation decreased significantly from 488/12,359 (3.9%) to 204/6,711 (3.0%, risk ratio: 0.77 [0.66-0.90]). PRBC orders for patients with SCD or thalassemia that did not specify phenotypically similar units fell from 386/2,876 (13.4%) to 57/1,755 (3.2%, risk ratio: 0.24 [0.18-0.32]). Transfusions administered faster than 5 mL/kg/h decreased from 4,112/14,641 (28.1%) to 2,125/9,263 (22.9%, risk ratio: 0.82 [0.78-0.85]). DISCUSSION: User-centered design of CDS for pediatric blood product orders significantly reduced special processing ordering errors and inappropriate transfusion rates. Larger studies are needed to evaluate the impact on safety events.

Clinical features and neurological outcomes in pediatric immune-mediated thrombotic thrombocytopenic purpura: A report from a large pediatric hematology center.

BACKGROUND: Thrombotic thrombocytopenic purpura (TTP) is a potentially life-threatening disorder characterized by microangiopathic hemolytic anemia, thrombocytopenia, and severely reduced or absent ADAMTS13 (A disintegrin and metalloprotease with thrombospondin type 1 repeats, member 13) activity, with varying degrees of organ dysfunction. As TTP is rare in pediatrics, most of the medical and scientific literature has largely reported on adult patients. As a result, limited data exist regarding the clinical features, comorbidities, treatment response, and long-term outcomes in pediatric patients with immune-mediated TTP. METHODS: A single-center retrospective cohort study was conducted of all children and adolescents presenting to Children's Healthcare of Atlanta, Atlanta, Georgia, between the years 2001 and 2021 with immune-mediated TTP (iTTP). Clinical features, treatments, and outcomes, including long-term neurocognitive function, were analyzed. RESULTS: Eighteen individuals were identified, six of whom had a total of 10 relapses, amounting to 28 episodes overall. Thirty-eight percent of the patients experienced exacerbations but, ultimately, 85% achieved a clinical response and clinical remission. Only one in-hospital death occurred (mortality rate 5.5%). Seventy-three percent of analyzed patients demonstrated long-term neurocognitive abnormalities, including cognitive delay, learning difficulties, and severe depression. CONCLUSIONS: Children and adolescents recovering from iTTP are at high risk for neurocognitive deficits from initial and possibly ongoing microvascular disease. Due to risk for long-term neurological deficits, we recommend neuropsychological testing in addition to monitoring of other organ functions in all children with TTP, as well as long-term surveillance of ADAMTS13 activity during remission to detect and promptly treat early relapse.

Adverse events of red blood cell transfusions in patients with sickle cell disease.

Blood transfusion is a common medical intervention for patients with sickle cell disease (SCD) and disease related complications. While patients with SCD are at risk for all transfusion related adverse events defined by the National Healthcare Safety Network (NHSN) Biovigilance Component Hemovigilance Module Surveillance Protocol, they are uniquely susceptible to certain adverse events. This review discusses risk factors, mitigation strategies, and management recommendations for alloimmunization, hemolytic transfusion reactions, hyperviscosity and transfusion-associated iron overload in the context of SCD.

Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study.

BACKGROUND: Individuals with sickle cell disease (SCD) and their caregivers may benefit from technology-based resources to improve disease self-management. OBJECTIVE: This study explores the preferences regarding a mobile health (mHealth) app to facilitate self-management in adults with SCD and their caregivers living in urban and rural communities. METHODS: Five community listening sessions were conducted in 2 urban and rural communities among adults with SCD and their caregivers (N=43). Each session comprised 4 to 15 participants. Participants were asked questions on methods of finding information about SCD self-care, satisfaction with current methods for finding SCD management information, support for SCD management, important features for development of an mHealth app, and areas of benefit for using an mHealth app for SCD self-management. An inductive-deductive content analysis approach was implemented to identify the critical themes. RESULTS: Seven critical themes emerged, including the current methods for receiving self-management information, desired information, recommendations for communicating sickle cell self-management information, challenges of disease management, types of support received for disease management, barriers to and facilitators of using an mHealth app, and feature preferences for an mHealth app. In addition, we found that the participants were receptive to using mHealth apps in SCD self-management. CONCLUSIONS: This study expands our knowledge on the use of mHealth technology to reduce information access barriers pertaining to SCD. The findings can be used to develop a patient-centered, user-friendly mHealth app to facilitate disease self-management, thus increasing access to resources for families of patients with SCD residing in rural communities.

Formative Usability Testing Reduces Severe Blood Product Ordering Errors.

BACKGROUND: Medical errors in blood product orders and administration are common, especially for pediatric patients. A failure modes and effects analysis in our health care system indicated high risk from the electronic blood ordering process. OBJECTIVES: There are two objectives of this study as follows:(1) To describe differences in the design of the original blood product orders and order sets in the system (original design), new orders and order sets designed by expert committee (DEC), and a third-version developed through user-centered design (UCD).(2) To compare the number and type of ordering errors, task completion rates, time on task, and user preferences between the original design and that developed via UCD. METHODS: A multidisciplinary expert committee proposed adjustments to existing blood product order sets resulting in the DEC order set. When that order set was tested with front-line users, persistent failure modes were detected, so orders and order sets were redesigned again via formative usability testing. Front-line users in their native clinical workspaces were observed ordering blood in realistic simulated scenarios using a think-aloud protocol. Iterative adjustments were made between participants. In summative testing, participants were randomized to use the original design or UCD for five simulated scenarios. We evaluated differences in ordering errors, time on task, and users' design preference with two-sample t-tests. RESULTS: Formative usability testing with 27 providers from seven specialties led to 18 changes made to the DEC to produce the UCD. In summative testing, error-free task completion for the original design was 36%, which increased to 66% in UCD (30%, 95% confidence interval [CI]: 3.9-57%; p = 0.03). Time on task did not vary significantly. CONCLUSION: UCD led to substantially different blood product orders and order sets than DEC. Users made fewer errors when ordering blood products for pediatric patients in simulated scenarios when using the UCD orders and order sets compared with the original design.

Towards remote assessment and screening of acute abdominal pain using only a smartphone with native accelerometers.

Smartphone-based telehealth holds the promise of shifting healthcare from the clinic to the home, but the inability for clinicians to conduct remote palpation, or touching, a key component of the physical exam, remains a major limitation. This is exemplified in the assessment of acute abdominal pain, in which a physician's palpation determines if a patient's pain is life-threatening requiring emergency intervention/surgery or due to some less-urgent cause. In a step towards virtual physical examinations, we developed and report for the first time a "touch-capable" mHealth technology that enables a patient's own hands to serve as remote surrogates for the physician's in the screening of acute abdominal pain. Leveraging only a smartphone with its native accelerometers, our system guides a patient through an exact probing motion that precisely matches the palpation motion set by the physician. An integrated feedback algorithm, with 95% sensitivity and specificity, enabled 81% of tested patients to match a physician abdominal palpation curve with <20% error after 6 attempts. Overall, this work addresses a key issue in telehealth that will vastly improve its capabilities and adoption worldwide.

Differences in pain management between hematologists and hospitalists caring for patients with sickle cell disease hospitalized for vasoocclusive crisis.

OBJECTIVES: Sickle cell disease (SCD) is a chronic disease characterized by multiple vaso-occlusive complications and is increasingly cared for by hospitalists. The purpose of this study is to examine differences in pain management between hematologists and hospitalists. METHODS: We performed a single-institution, retrospective review of pain management patterns and outcomes in adult SCD patients hospitalized for vaso-occlusive crisis. RESULTS: Over 26 months, we found a total of 298 patients (120 cared for by the hematologists and 178 by hospitalists), with a mean age of 32 (range 19-58). Patients cared for by hospitalists had a lower total number of hours on a patient controlled analgesia (PCA) device (171 vs. 212 hours, P=0.11). Hospitalists also were significantly more likely to utilize demand only PCA (42% vs. 23%, P=0.002) and had a significantly lower rate of using both continuous and demand PCA (54% vs. 67%, P=0.04). In addition, patients cared for by hospitalists had a significantly shorter hospitalization (8.4 days) compared to hematologists (10 days, P=0.04) with a non-significant difference in 7 and 30 day readmission rates (7.2% vs. 6.7% and 40% vs. 35% respectively). CONCLUSION: We found patients cared for by hospitalists more frequently utilized home oral pain medication during admission, had shorter lengths of hospitalization, and did not have a significant increase in readmission rates.