A pilot study of trained ICU doulas providing early psychological support to critically ill patients

Background Over a third of critical illness survivors suffer from mental health problems following hospitalization. Memories of delusional experiences are a major risk factor. In this project, ICU doulas delivered a unique positive suggestion intervention targeting the vulnerable time period during critical illness when these memories are formed. Methods Adult critically ill patients were recruited for this single-arm, prospective pilot study. These ICU patients received a positive suggestion intervention daily during their ICU stay in parallel with their medical treatment. The intervention was designed to be delivered over a minimum of two sessions. Feasibility was defined as intervention delivery on ≥ 70% of ICU days after patient enrollment. As a secondary analysis, psychometric questionnaires were compared to those of a historic control cohort of patients receiving standard care in the ICU using adjusted linear regression models. Results Of the 97 patients who received the intervention and were alive at the end of their ICU course, 54 were excluded from analyses mostly for having received only one session because of a short ICU length of stay of < 2 days, transitioning to comfort care or not wanting to answer the study questionnaires. Forty-three patients who completed 2 or more sessions of the positive therapeutic suggestion intervention provided by two trained ICU doulas received it for a median of 4 days (IQR 3, 5), with each session lasting for a median of 20 min (IQR 14, 25). The intervention was delivered on 71% of days, meeting our pre-determined feasibility goal. Compared to historical controls (N = 299), patients receiving the intervention had higher severity of illness and longer length of stay. When adjusted for baseline differences, patients both with and without mechanical ventilation who received the intervention scored lower on the Hospital Anxiety and Depression Scale (HADS)—Depression subscale. The intervention was also associated with reduced HADS-Anxiety subscale among ventilated patients. Conclusions Positive therapeutic suggestion delivered by ICU doulas is feasible in the ICU setting. A randomized trial is warranted to better delineate the role that positive suggestion and ICU doulas may play in ongoing interprofessional efforts to humanize critical care medicine. The study was registered on clinicaltrials.gov (NCT03736954) on 03/14/2018 prior to the first patient enrollment https://clinicaltrials.gov/ct2/show/NCT03736954?cond=ICU+Doulas+Providing+Psychological+Support&draw=2&rank=1.

The Attitude of Patients from a Romanian Tertiary Cardiology Center Regarding Participation in Biomarker-Based Clinical Trials

Background and Objectives: biomarker-based studies are the cornerstone of precision medicine, providing key data for tailored medical care. Enrollment of the planned number of patients is a critical determinant of a successful clinical trial. Moreover, for inclusive medical care, patients from different socio-demographic backgrounds must be recruited. Still, a significant number of trials fail to reach these prerequisites. Designing the informed consent forms based on the patients’ feedback could optimize accrual. We aimed to explore the attitudes of patients from a Romanian tertiary cardiology center towards participation in biomarker-based clinical trials. Materials and Methods: three hundred forty inpatients were interviewed based on a semi-structured questionnaire which included four sections: demographics, personal medical history, attitudes and trust. Results: Roughly, 62.5% of the respondents were interested in enrolling, while altruistic reasons were the most frequently expressed. Clear exposure of the possible risks was most valued (37.78%), followed by the possibility of directly communicating with the research team (23.78%). The most frequently chosen answer by acutely ill patients was improvement of their health, whereas chronically ill individuals indicated the possibility of withdrawal without affecting the quality of medical care. Importantly, the participation rate could be improved if the invitation to enrollment were made by both the current physician and the study coordinator (p = 0.0001). The level of trust in researchers was high in more than 50% of the respondents, and was correlated with therapeutic compliance and with the desire to join a biomarker study. Conclusions: the information gained will facilitate a tailored approach to patient enrollment in future biomarker-based studies in our clinic.

Factors Associated With the Acceleration of Patient Enrollment in Clinical Studies: A Cross-Sectional Study

Under-recruitment in clinical trials is an issue worldwide. If the number of patients enrolled is lower than expected, based on the required sample size, then the reliability of the study results and their validation tend to be impaired. The current study therefore evaluated factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective cohort study. The researchers encouraged research institutions to accelerate patient enrollment via e-mail, newsletters, telephone calls, and site visits. We analyzed the relationship between several potential factors associated with acceleration of patient enrollment including site visits and patient enrollment in a real clinical study. Data were collected from 106 research institutions that participated in a multicenter prospective cohort study. Results showed that the following parameters differed in terms of patient enrollment and non-enrollment: urban area (47.2 vs. 67.6%, p = 0.04), clinical research coordinator (CRC) participation in data input to electronic data capture (EDC) (41.7 vs. 11.8%, p &lt; 0.01), and site visit (38.9 vs. 11.8%, p &lt; 0.01). A multivariate analysis revealed that patient enrollment was significantly associated with urban area (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.12–0.86, p = 0.02), CRC participation in data input to EDC (OR 5.02; 95% CI 1.49–16.8; p &lt; 0.01), and site visit (OR 4.54, 95% CI 1.31–15.7, p = 0.01). In conclusion, site visits and CRC participation in data input to EDC had a significant effect on patient enrollment promotion. Moreover, hospitals in rural areas were more effective in promoting patient enrollment than those in urban areas.

A Permissioned Blockchain-Based Clinical Trial Service Platform to Improve Trial Data Transparency

The clinical research faces numerous challenges, from patient enrollment to data privacy concerns and regulatory requirements to spiraling costs. Blockchain technology has the potential to overcome these challenges, thus making clinical trials transparent and enhancing public trust in a fair and open process with all stakeholders because of its distinct features such as data immutability and transparency. This paper proposes a permissioned blockchain platform to ensure clinical data transparency and provides secure clinical trial-related solutions. We explore the core functionalities of blockchain applied to clinical trials and illustrate its general principle concretely. These clinical trial operations are automated using the smart contract, which ensures traceability, prevents a posteriori reconstruction, and securely automates the clinical trial. A web-based user interface is also implemented to visualize the data from the blockchain and ease the interaction with the blockchain network. A proof of concept is implemented on Hyperledger Fabric in the case study of clinical management for multiple clinical trials to demonstrate the designed approach’s feasibility. Lastly, the experiment results demonstrate the efficiency and usability of the proposed platform.

Tele-dermatology Recruitment during COVID-19: An Application of Behavioral Economic Principles

In the ever-changing state of healthcare during the recent COVID-19 pandemic, our system has innovated rapidly using tele-dermatology in acute and chronic patient management. To combat barriers such as low patient enrollment, behavioral economics theories were implemented. Underlying principles in choice architecture, include choice inertia, the way in which humans favor the status quo; and choice overload, where humans fail to make an optimal choice when presented with multiple options. Using these theories, we modified support-staff scripts in our dermatology clinic used when rescheduling appointments. Our baseline script group allowed for patients to choose from a list of options whereas our improvement script applied behavioral economic principles and used tele-dermatology as the default. This quality improvement initiative was employed with the hypothesis that the “improvement” group would lead to an increase in tele-dermatology enrollment over an 8-week period. Our results are clinically significant and demonstrate the effect behavioral economics has on patient enrollment in tele-dermatology, which will serve as an asset during the COVID-19 pandemic and beyond.

Phenotyping Cardiogenic Shock

Background Cardiogenic shock (CS) is a heterogeneous syndrome with varied presentations and outcomes. We used a machine learning approach to test the hypothesis that patients with CS have distinct phenotypes at presentation, which are associated with unique clinical profiles and in‐hospital mortality. Methods and Results We analyzed data from 1959 patients with CS from 2 international cohorts: CSWG (Cardiogenic Shock Working Group Registry) (myocardial infarction [CSWG‐MI; n=410] and acute‐on‐chronic heart failure [CSWG‐HF; n=480]) and the DRR (Danish Retroshock MI Registry) (n=1069). Clusters of patients with CS were identified in CSWG‐MI using the consensus k means algorithm and subsequently validated in CSWG‐HF and DRR. Patients in each phenotype were further categorized by their Society of Cardiovascular Angiography and Interventions staging. The machine learning algorithms revealed 3 distinct clusters in CS: "non‐congested (I)", "cardiorenal (II)," and "cardiometabolic (III)" shock. Among the 3 cohorts (CSWG‐MI versus DDR versus CSWG‐HF), in‐hospital mortality was 21% versus 28% versus 10%, 45% versus 40% versus 32%, and 55% versus 56% versus 52% for clusters I, II, and III, respectively. The "cardiometabolic shock" cluster had the highest risk of developing stage D or E shock as well as in‐hospital mortality among the phenotypes, regardless of cause. Despite baseline differences, each cluster showed reproducible demographic, metabolic, and hemodynamic profiles across the 3 cohorts. Conclusions Using machine learning, we identified and validated 3 distinct CS phenotypes, with specific and reproducible associations with mortality. These phenotypes may allow for targeted patient enrollment in clinical trials and foster development of tailored treatment strategies in subsets of patients with CS.

Implementation of a clinical pharmacist-led service to optimize management of refractory chemotherapy-induced nausea and vomiting in adult hematology/oncology clinic

Objective Chemotherapy-induced nausea and vomiting (CINV) is a common and potentially debilitating adverse effect of chemotherapy. Refractory CINV can be particularly difficult to control. This report provides details on the implementation and evaluation of a pharmacist-led program for the management of refractory CINV in hematology and oncology clinics. Methods A pharmacist-led program open to adult outpatients with refractory CINV was implemented at University of Wisconsin. Pharmacists conducted baseline and follow-up assessments, provided patient education, and started, discontinued, and/or adjusted antiemetics as clinically necessary for all enrolled patients. Retrospective chart review was used to describe the proportion of patients whose CINV improved through pharmacist intervention, effect of the program on antiemetic adherence, categorization of pharmacist interventions, and duration of patient enrollment. Results Forty-six patients were enrolled between February 2019 and January 2020. Forty-one patients (89.1%) had an overall reduction in their nausea and vomiting from baseline. Eleven patients (23.9%) met criteria for nonadherence to prescribed antiemetics at baseline; all patients were adherent at unenrollment. A total of 111 pharmacist interventions were made. The most common intervention was addition of new breakthrough antiemetic. The least common intervention was dose escalation of a previously prescribed antiemetic. The average number of interventions made per patient was 2.5. On average, patients were enrolled in the program for 16.6 days and met with a pharmacist three times. Conclusion Implementation of this program standardized and streamlined pharmacist involvement with refractory CINV. Enrollment resulted in a measurable reduction in nausea and/or vomiting for patients with refractory CINV.