title: Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.
abstract: BACKGROUND
  Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke.
  
  
  METHODS
  Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention.
  
  
  RESULTS
  All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home.
  
  
  CONCLUSIONS
  Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention.
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia; Department of Physiology, Monash University, Melbourne, Victoria, Australia. Electronic address: tharshanah.thayabaranathan@monash.edu.
authors.forename: Tharshanah
authors.initials: T
authors.lastname: Thayabaranathan
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia; Department of Medicine (Austin Health), The University of Melbourne, Heidelberg, Victoria, Australia.
authors.forename: Dominique A
authors.initials: DA
authors.lastname: Cadilhac
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia; Menzies Research Institute Tasmania, Hobart, Tasmania, Australia.
authors.forename: Velandai K
authors.initials: VK
authors.lastname: Srikanth
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Sharyn M
authors.initials: SM
authors.lastname: Fitzgerald
authors.affiliation: Department of Physiology, Monash University, Melbourne, Victoria, Australia.
authors.forename: Roger G
authors.initials: RG
authors.lastname: Evans
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.
authors.forename: Joosup
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Medicine, Epworth Healthcare, Monash University, Richmond, Victoria, Australia.
authors.forename: Richard P
authors.initials: RP
authors.lastname: Gerraty
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.
authors.forename: Thanh G
authors.initials: TG
authors.lastname: Phan
authors.affiliation: Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia; Department of Neurosciences, Box Hill Hospital, Monash University, Box Hill, Victoria, Australia; Department of Medicine, Box Hill Hospital, Monash University, Box Hill, Victoria, Australia.
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Bladin
authors.affiliation: Menzies Research Institute Tasmania, Hobart, Tasmania, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Nelson
authors.affiliation: Department of Neurology, The Alfred Hospital, Prahran, Victoria, Australia.
authors.forename: Judith H
authors.initials: JH
authors.lastname: Frayne
authors.affiliation: Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia; Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia.
authors.forename: Amanda G
authors.initials: AG
authors.lastname: Thrift
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D010352:Patient Dropouts; D010358:Patient Participation; D018579:Patient Selection; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012008:Recurrence; D035842:Research Subjects / Q000523:psychology; D012189:Retrospective Studies; D018401:Sample Size; D055502:Secondary Prevention / Q000379:methods*; D020521:Stroke / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D057188:Workflow
keywords: Stroke; feasibility study; methodology; patient retention; pilot study; recruitment