Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study

Tharshanah Thayabaranathan; Dominique A Cadilhac; Velandai K Srikanth; Sharyn M Fitzgerald; Roger G Evans; Joosup Kim; Richard P Gerraty; Thanh G Phan; Christopher F Bladin; Mark R Nelson; Judith H Frayne; Amanda G Thrift

doi:10.1016/j.jstrokecerebrovasdis.2016.02.020

Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study

J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1371-80. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.020. Epub 2016 Apr 20.

Affiliations

¹ 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: [email protected].
² 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.
³ Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia; Menzies Research Institute Tasmania, Hobart, Tasmania, Australia.
⁴ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁵ Department of Physiology, Monash University, Melbourne, Victoria, Australia.
⁶ Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.
⁷ Department of Medicine, Epworth Healthcare, Monash University, Richmond, Victoria, Australia.
⁸ 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.
⁹ 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.
¹⁰ Department of Neurology, The Alfred Hospital, Prahran, Victoria, Australia.
¹¹ 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.

PMID: 27009610
DOI: 10.1016/j.jstrokecerebrovasdis.2016.02.020

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.

Conclusion: 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.

Keywords: Stroke; feasibility study; methodology; patient retention; pilot study; recruitment.

MeSH terms

Clinical Trials, Phase II as Topic / methods*
Clinical Trials, Phase III as Topic / methods*
Health Knowledge, Attitudes, Practice
Humans
Informed Consent
Interviews as Topic
Patient Dropouts
Patient Participation
Patient Selection*
Pilot Projects
Randomized Controlled Trials as Topic / methods*
Recurrence
Research Subjects / psychology
Retrospective Studies
Sample Size
Secondary Prevention / methods*
Stroke / prevention & control*
Time Factors
Treatment Outcome
Workflow