Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III).

Autor: Kolls BJ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. kolls001@mc.duke.edu.; Department of Neurology, Duke University School of Medicine, Duke Box 2900 Bryan Research Building, 311 Research Drive, Durham, NC, 27710, USA. kolls001@mc.duke.edu., Muir KW; School of Psychology & Neuroscience, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, Scotland, UK., Savitz SI; Institute for Stroke and Cerebrovascular Disease, University of Texas Health Science Center, Houston, TX, USA., Wechsler LR; Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Pilitsis JG; Department of Neuroscience and Experimental Therapeutics, Albany Medical College, Albany, NY, USA., Rahimi S; Department of Neurosurgery, Medical College of Georgia, Augusta, GA, USA., Beckman RL; ReNeuron Limited., Pencoed, Bridgend, UK., Holmes V; ReNeuron Limited., Pencoed, Bridgend, UK., Chen PR; The Vivian L. Smith Department of Neurosurgery, The University of Texas Health Science Center, Houston, TX, USA., Albers DS; ReNeuron Limited., Pencoed, Bridgend, UK., Laskowitz DT; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Department of Neurology, Duke University School of Medicine, Duke Box 2900 Bryan Research Building, 311 Research Drive, Durham, NC, 27710, USA.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Feb 28; Vol. 25 (1), pp. 150. Date of Electronic Publication: 2024 Feb 28.
DOI: 10.1186/s13063-024-07988-z
Abstrakt: Background: Recruitment of participants is the greatest risk to completion of most clinical trials, with 20-40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous system (CNS) therapies such as intervention for chronic stroke. The PISCES III trial was an invasive trial of stereotactically guided intracerebral injection of CTX0E03, a fetal derived neural stem cell line, in patients with chronic disability due to ischemic stroke. We report on the experience using a novel hybrid recruitment approach of a patient-facing portal to self-identify and perform an initial screen for general trial eligibility (tier 1), followed by phone screening and medical records review (tier 2) prior to a final in-person visit to confirm eligibility and consent.
Methods: Two tiers of screening were established: an initial screen of general eligibility using a patient-facing web portal (tier 1), followed by a more detailed screen that included phone survey and medical record review (tier 2). If potential participants passed the tier 2 screen, they were referred directly to visit 1 at a study site, where final in-person screening and consent were performed. Rates of screening were tracked during the period of trial recruitment and sources of referrals were noted.
Results: The approach to screening and recruitment resulted in 6125 tier 1 screens, leading to 1121 referrals to tier 2. The tier 2 screening resulted in 224 medical record requests and identification of 86 qualifying participants for referral to sites. The study attained a viable recruitment rate of 6 enrolled per month prior to being disrupted by COVID 19.
Conclusions: A tiered approach to eligibility screening using a hybrid of web-based portals to self-identify and screen for general eligibility followed by a more detailed phone and medical record review allowed the study to use fewer sites and reduce cost. Despite the difficult and narrow population of patients suffering moderate chronic disability from stroke, this strategy produced a viable recruitment rate for this invasive study of intracranially injected neural stem cells.
Trial Registration: ClinicalTrials.gov Identifier: NCT03629275.
(© 2024. The Author(s).)
Databáze: MEDLINE
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