Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

Abstract WP333: Clinical Research Coordinators' Barriers and Best Practices to Minority Recruitment in Stroke Clinical Trials

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Jazmin Rivera ◽  
Lauren Southwick ◽  
Nina S Parikh ◽  
Sean Haley ◽  
Bernadette Boden-Albala
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Focus Groups ◽  
Team Building ◽  
Patient Centered ◽  
Organizational Barriers ◽  
Internet Resources ◽  
Clinical Research Coordinators ◽  
Recruitment Challenges

Background: Poor recruitment and retention of clinical trial participants continues to be a major contributor to the early termination of many clinical trials. Specifically, low racial-ethnic minority and female participation rates can limit scientific, economic, and ethical value of a clinical trial. Previous literature has explored patient-centered enrollment barriers, while research has yet to investigate recruitment challenges facing clinical research coordinators (CRCs). Aim: To gain insight of the barriers facings CRCs with particular attention to minority and female recruitment efforts. Methods: Two semi-structured focus groups were conducted with a purposive sample of stroke CRCs in 2013 (N=17) and 2014 (N=23). Discussion topics included: 1) integrating NIH Inclusion Policy into trial design and recruitment strategies; 2) experiences recruiting minorities and women in stroke/neurological trials; and 3) strategies to enhance minority and female involvement. Two reviewers independently developed an initial set of base codes (n=6). Reviewers met and reconciled their independent coding using the 2013 transcript before applying the same process to the 2014 transcript. Codes and sub-codes were used to identify thematic areas. Results: Both focus groups included majority female participants with nearly half holding nursing degree. Codes informed three thematic areas: administration, enrollment and “other.” Administrative findings highlight organizational barriers. Enrollment findings identified challenges related to the severity of condition and time limitations. The “other” theme cut across administration and enrollment, often informed by coordinators’ personal experiences. Personal barriers include biases and uncertainty approaching patients from diverse backgrounds. Participants identified coordinator conferences, trainings, Internet resources, direct support from PIs and team building between hospital and research staff as key strategies. Conclusion: Our findings identified multi-dimensional organizational, administrative and resource barriers and the need for more focused CRC support to enhance participant recruitment efforts in stroke clinical research.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1543-1543
Author(s):  
Peter Blankenship ◽  
David DeLaRosa ◽  
Marc Burris ◽  
Steven Cusson ◽  
Kayla Hendricks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tissue Sample ◽  
High Volume ◽  
Trial Participation ◽  
Fresh Tissue ◽  
Oncology Clinical Trials ◽  
The Status ◽  
Unique Source

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

scholarly journals Clinical Trial Units in Italy: the perception of the Clinical Research Coordinators

2016 ◽  
Vol 27 ◽  
pp. iv111 ◽  
Author(s):  
C. Cagnazzo ◽  
O. Nanni ◽  
S. Campora ◽  
P. Frati ◽  
R. Camisa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Research Coordinators

scholarly journals A Text Message Alcohol Intervention for Young Adult Emergency Department Patients: A Randomized Clinical Trial

2014 ◽  
Vol 64 (6) ◽  
pp. 664-672.e4 ◽  
Author(s):  
Brian Suffoletto ◽  
Jeffrey Kristan ◽  
Clifton Callaway ◽  
Kevin H. Kim ◽  
Tammy Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Young Adult ◽  
Randomized Clinical Trial ◽  
Text Message ◽  
Alcohol Intervention ◽  
Emergency Department Patients

scholarly journals Estimands: bringing clarity and focus to research questions in clinical trials

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052953
Author(s):  
Timothy Peter Clark ◽  
Brennan C Kahan ◽  
Alan Phillips ◽  
Ian White ◽  
James R Carpenter
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recent Work ◽  
Treatment Effect ◽  
Research Question ◽  
Probability Of Success ◽  
Research Questions

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

scholarly journals TEXT messages to improve MEDication adherence and Secondary prevention (TEXTMEDS) after acute coronary syndrome: a randomised clinical trial protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019463 ◽  
Author(s):  
Clara K Chow ◽  
Aravinda Thiagalingam ◽  
Karla Santo ◽  
Cindy Kok ◽  
Jay Thakkar ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Medication Adherence ◽  
Text Message ◽  
Randomised Clinical Trial ◽  
Text Messages ◽  
Improve Medication Adherence ◽  
Coronary Syndrome ◽  
Secondary Outcomes

BackgroundIdentifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important.ObjectiveThe TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS).Study designA single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness.SummaryThe study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors.Ethics and disseminationPrimary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences.Trial registration numberACTRN12613000793718; Pre-results.

Using Social Media to Increase the Recruitment of Clinical Research Participants

2018 ◽  
pp. 7181-7189
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recruitment Strategies ◽  
Primary Role ◽  
Trial Recruitment ◽  
Recruitment Methods ◽  
Pros And Cons ◽  
Clinical Trial Recruitment

Research has shown that clinical research continues to have difficulty recruiting participants. This problem is expected to increase as the number of clinical trials increases and as there continues to be more focus on complex diseases and treatments. Researchers have typically relied on traditional recruitment methods to recruit participants, which revolve around the physicians and their support staff having the primary role to locate and recruit these participants. However, with individuals using online platforms such as social media to retrieve information, this creates an opportunity for research site personnel to use it as a way to relay information on clinical trial opportunities. Studies that have used social media as a way to recruit participants are discussed. Furthermore, pros and cons of social media for recruitment, along with recommendations that future researchers should consider when deciding whether to implement this type of strategy in their clinical trials will be shared. In general, clinical trial recruitment strategies need to shift to an approach that is not only more targeted, but also has a larger reach. By evaluating the success of studies that have used social recruitment strategies so far, it is evident that future researchers can also achieve recruitment success through social media. Moreover, social media could be a promising new avenue for clinical trial recruitment that allows for a more positive experience for both investigative site personnel and potential participants.

Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial

2019 ◽  
Vol 58 (4) ◽  
pp. 428-436 ◽  
Author(s):  
Peter G. Szilagyi ◽  
Stanley Schaffer ◽  
Cynthia M. Rand ◽  
Nicolas P. N. Goldstein ◽  
Mary Younge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Elementary Schools ◽  
Influenza Vaccination ◽  
Intervention Group ◽  
Text Message ◽  
Text Messages ◽  
Urban Elementary Schools ◽  
Vaccination Rates ◽  
Flu Vaccination ◽  
Percentage Points

Half of US school children receive influenza vaccine. In our previous trials, school-located influenza vaccination (SLIV) raised vaccination rates by 5 to 8 percentage points. We assessed whether text message reminders to parents could raise vaccination rates above those observed with SLIV. Within urban elementary schools we randomized families into text message + SLIV (intervention) versus SLIV alone (comparison). All parents were sent 2 backpack notifications plus 2 autodialer phone reminders about SLIV at a single SLIV clinic. Intervention group parents also were sent 3 text messages from the school nurse encouraging flu vaccination via either primary care or SLIV. Among 15 768 children at 32 schools, vaccination rates were text + SLIV (40%) and SLIV control (40%); 4% of students per group received influenza vaccination at SLIV. Text message reminders did not raise influenza vaccination rates above those observed with SLIV alone. More intensive interventions are needed to raise influenza vaccination rates.

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