Abstract WP7: Critical Importance Of Enrollment Hours For Successful Recruitment In Acute Stroke Trials

Broderick, Joseph P.; Adeoye, Opeolu; Barreto, Andrew D; Grotta, James C.; Deeds, S Iris; Bentho, Oladi; Streib, Christopher; Staugaitis, Abbey; Demel, Stacie L; Vollmer, Abigail; Franklin, Jamey D; Janis, L. Scott; Khatri, Pooja

doi:10.1161/str.53.suppl_1.wp7

Cited by 3 publications

(5 citation statements)

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“…For example, in the ongoing MOST (Multiarm Optimization of Stroke Trial), sites open for enrollment 7 days a week recruited participants at twice the rate of those sites open for enrollment only during business hours, Monday through Friday. 3,16 Sites who enroll in acute stroke trials only during business hours cite the challenge of paying extra for after-hour coverage and the identification, training, and retention of study coordinators to do after-hour work.…”

Section: Participant Enrollmentmentioning

confidence: 99%

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Broderick,

Silva,

Selim

et al. 2023

Stroke

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The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community’s understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials’ efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.

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Section: Participant Enrollmentmentioning

confidence: 99%

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Broderick,

Silva,

Selim

et al. 2023

Stroke

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“…14 Efficiency gains at the micro and macro level shorten clinical trial timelines accelerating meaningful clinical practice change. 3,6 Our findings are retrospective and may be confounded by selection bias or indication.…”

Section: Discussionmentioning

confidence: 91%

“…14 Efficiency gains at the micro and macro level shorten clinical trial timelines accelerating meaningful clinical practice change. 3,6…”

Section: Discussionmentioning

confidence: 99%

“…However, due to the emergency nature of cerebrovascular disease, clinician investigators, research coordinators, patients, and LARs, are often not in the same physical location when a potential trial candidate is identified, especially after hours. 1,[4][5][6] To overcome these physical barriers to enrollment, some programs utilize remote research practices (RRPs) in which ECTE processes are supported off-site. 1 Hybrid remote and in-person clinical research has been proposed as a new standard for randomized control trials in order to address barriers related to cost, diversity, recruitment, and efficiency.…”

Section: Introductionmentioning

confidence: 99%

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Remote Research Practices Enhance Acute Stroke Clinical Trial Enrollment

Streib

Staugaitis

Tessmer

et al. 2023

Preprint

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Background: <break> Many acute stroke clinical trials (ASCTs) are underpowered or terminated early due to poor recruitment. A pervasive challenge to ASCT recruitment is the physical separation of patients, their legally authorized representatives, research coordinators, and clinician investigators when trial-eligible patients are identified. Remote research practices (RRPs) can facilitate time-critical ASCT enrollment and follow-up assessments, however, the feasibility and effectiveness are unknown.<break><break> <break><break>Methods<break><break>This case-control study retrospectively reviewed ASCT enrollment at two institutions. When conventional in-person clinical research was not possible, completion of study specific essential clinical trial events (ECTEs) were attempted via RRPs utilizing telemedicine evaluation or telephone communication. The primary outcome was successful execution of ECTEs by modality: in-person, telemedicine evaluation, or telephone communication. The secondary outcome was protocol violation rate by modality. We utilized Fishers Exact Test for primary and secondary outcomes and descriptive statistics to report RRP utilization.<break><break> <break><break>Results<break> A total of 1603 individual ECTEs were attempted for 171 subjects. RRPs were utilized for 53.9% of ECTEs (19.3% telemedicine, 34.6% telephone communication). ECTEs were more likely to be completed successfully via telemedicine (100%) than in-person (98.2%) or telephone (92.3%), (p<0.01). Additionally, protocol deviations were less common with telemedicine (0.0%) than in-person (2.6%), or telephone (2.8%) (p=0.04). More than half (53.4%) of randomized ASCT enrollments were dependent upon RRPs. Randomization (94.7%) and outpatient assessments (84.6%) were more frequently completed via RRPs compared to eligibility screening (40.7%), informed consent (40.4%), supervision of study intervention (44.6%), and inpatient assessments (18.8%).<break><break><break> Conclusion:<break> Remote research practices were effective and doubled randomized ASCT enrollments in comparison to conventional research models that are restricted to in-person interaction alone.<break><break>Telemedicine was associated with the highest rate of successful ECTE execution and the lowest rate of protocol deviations. These findings may be confounded by indication and further definitive study is indicated.

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“…Those sites that were open for enrollment every day recruited participants at twice the rate of those sites who were only open for enrollment during business hours, Monday through Friday. 13 Thus, projection of recruitment rates must account for when sites are able to enroll. One potential solution is to provide financial support for weekend and after-hour calls, not only for those sites who currently do have after-hours call but to support efforts at sites that currently do not to encourage adding this capacity.…”

Section: Enhancement Of Trial Infrastructure and Availability Of Inve...mentioning

confidence: 99%

Recruitment in Acute Stroke Trials: Challenges and Potential Solutions

Broderick

Aziz

Adeoye

et al. 2023

Stroke

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Randomized clinical trials of acute stroke have led to major advances in acute stroke therapy over the past decade. Despite these successes, recruitment in acute trials is often difficult. We outline challenges in recruitment for acute stroke trials and present potential solutions, which can increase the speed and decrease the cost of identifying new treatments for acute stroke. One of the largest opportunities to increase the speed of enrollment and make trials more generalizable is expansion of inclusion criteria whose impact on expected recruitment can be assessed by epidemiologic and registry databases. Another barrier to recruitment besides the number of eligible patients is availability of study investigators limited to business hours, which may be helped by financial support for after-hours call. The wider use of telemedicine has accelerated quicker stroke treatment at many hospitals and has the potential to accelerate research enrollment but requires training of clinical investigators who are often inexperienced with this approach. Other potential solutions to enhance recruitment include rapid prehospital notification of clinical investigators of potential patients, use of mobile stroke units, advances in the process of emergency informed consent, storage of study medication in the emergency department, simplification of study treatments and data collection, education of physicians to improve equipoise and enthusiasm for randomization of patients within a trial, and clear recruitment plans, and even potentially coenrollment, when there are competing trials at sites. Without successful recruitment, scientific advances and clinical benefit for acute stroke patients will lag.

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Abstract WP7: Critical Importance Of Enrollment Hours For Successful Recruitment In Acute Stroke Trials

Cited by 3 publications

References 0 publications

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Remote Research Practices Enhance Acute Stroke Clinical Trial Enrollment

Recruitment in Acute Stroke Trials: Challenges and Potential Solutions

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