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)
Abstract 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 PISCE...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-024-07988-z |
| _version_ | 1827326341989531648 |
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| author | Brad J. Kolls Keith W. Muir Sean I. Savitz Lawrence R. Wechsler Julie G. Pilitsis Scott Rahimi Richard L. Beckman Vincent Holmes Peng R. Chen David S. Albers Daniel T. Laskowitz |
| author_facet | Brad J. Kolls Keith W. Muir Sean I. Savitz Lawrence R. Wechsler Julie G. Pilitsis Scott Rahimi Richard L. Beckman Vincent Holmes Peng R. Chen David S. Albers Daniel T. Laskowitz |
| author_sort | Brad J. Kolls |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-03-07T14:43:03Z |
| format | Article |
| id | doaj.art-c3732c3a4d014d00a0a506ffb4de9cef |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-07T14:43:03Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c3732c3a4d014d00a0a506ffb4de9cef2024-03-05T20:11:03ZengBMCTrials1745-62152024-02-0125111110.1186/s13063-024-07988-zExperience 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)Brad J. Kolls0Keith W. Muir1Sean I. Savitz2Lawrence R. Wechsler3Julie G. Pilitsis4Scott Rahimi5Richard L. Beckman6Vincent Holmes7Peng R. Chen8David S. Albers9Daniel T. Laskowitz10Duke Clinical Research Institute, Duke University School of MedicineSchool of Psychology & Neuroscience, University of Glasgow, Queen Elizabeth University HospitalInstitute for Stroke and Cerebrovascular Disease, University of Texas Health Science CenterDepartment of Neurology, Perelman School of Medicine, University of PennsylvaniaDepartment of Neuroscience and Experimental Therapeutics, Albany Medical CollegeDepartment of Neurosurgery, Medical College of GeorgiaReNeuron Limited.ReNeuron Limited.The Vivian L. Smith Department of Neurosurgery, The University of Texas Health Science CenterReNeuron Limited.Duke Clinical Research Institute, Duke University School of MedicineAbstract 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: NCT03629275https://doi.org/10.1186/s13063-024-07988-zInternet-based trial recruitmentTrial participant screeningInvasive trial recruitmentChronic ischemic strokeCell based interventionStem cell |
| spellingShingle | Brad J. Kolls Keith W. Muir Sean I. Savitz Lawrence R. Wechsler Julie G. Pilitsis Scott Rahimi Richard L. Beckman Vincent Holmes Peng R. Chen David S. Albers Daniel T. Laskowitz 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) Trials Internet-based trial recruitment Trial participant screening Invasive trial recruitment Chronic ischemic stroke Cell based intervention Stem cell |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Internet-based trial recruitment Trial participant screening Invasive trial recruitment Chronic ischemic stroke Cell based intervention Stem cell |
| url | https://doi.org/10.1186/s13063-024-07988-z |
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