Facilitators and Barriers to ICU Study Recruitment for a Future Post-Traumatic Epilepsy Trial: Preliminary Analysis of a Researcher Perspective Survey
Abstract number :
1.354
Submission category :
13. Health Services (Delivery of Care, Access to Care, Health Care Models)
Year :
2021
Submission ID :
1826639
Source :
www.aesnet.org
Presentation date :
12/4/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:55 AM
Authors :
Daniel Correa, MD, MSc - , Albert Einstein College of Medicine and Montefiore Medical Center, Montefiore/Einstein Epilepsy Center, Bronx, New York, USA; Churl-Su Kwon, MD, MPH – 2. Division of Health Outcomes and Knowledge Translation Research, Department of Neurology, Icahn School of Medicine at Mount Sinai, NY, USA; Jen No – Princeton University; Solomon Moshé, MD – Charles Frost Chair, and Professor of Neurology, Isabelle Rapin Division of Child Neurology, Dominick P. Purpura Department of Neuroscience, Bronx, New York, USA and Department of Pediatrics, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, USA; Nathalie Jetté, MD, MSc – Vice Chair, Neurology Clinical Research and Professor of Neurology, Division of Health Outcomes and Knowledge Translation Research, Department of Neurology, Icahn School of Medicine at Mount Sinai, NY, USA and Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Public Engagement Core Co- Investigators – EpiBioS4Rx
Rationale: Recruitment for a PTE trial about anti-epileptogenesis in the intensive care unit (ICU) poses challenges including consent from surrogate-decision-makers in a stressful environment. The Public Engagement Core of the Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx) used a cross-sectional survey of researchers involved in critical care research, to evaluate their perspective about participant recruitment for a future PTE prevention trial.
Methods: Using iterative feedback we adapted a prior validated survey of barriers and facilitators to recruitment in clinical trials. We included factors affecting recruitment, stratified into groups (i.e. trial design, study site, patient factors, surrogate factors, and informational/consent related items). Each item was rated on a Likert scale from strong barrier (–3) to strong facilitator (+ 3). The survey was sent to the 14 EpiBioS4Rx ICU research site and 25 NeuroNext site teams. Eligibility required ≥ 11 months experience in ICU clinical trial recruitment. Univariate analysis using Mann-Whitney U test was done to compare clinical researcher and research staff perspectives.
Results: This analysis includes 27 clinical researchers and 25 research staff responses. Top patient level factors rated as facilitators were: Good communication between research team and patient, receptive attitude towards taking experimental treatment or placebo, prior clinical research participation, intervention available only in the trial, minimal language or cultural barriers and minimal additional travel or costs. The only patient level factor rated as a barrier and ranked in the top 5 was patient's concerns about side effects of experimental treatment. Top surrogate factors rated as facilitators were: Good communication between research team and surrogate, clear perspective about the patient’s preferences, receptive attitude towards patient taking experimental treatment or placebo and minimal additional travel or costs. Minimal additional travel ranked in the top 5 by significantly fewer clinical researchers (25.9%) than research support staff (47.6%) (p < 0.05). The only family level factor rated as a substantial barrier and ranked in the top 5 was surrogate’s concerns about side effects of experimental treatment.
Health Services (Delivery of Care, Access to Care, Health Care Models)