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

Research output: Contribution to journalArticleResearchpeer-review

6 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)1371-1380
Number of pages10
JournalJournal of Stroke and Cerebrovascular Diseases
Volume25
Issue number6
DOIs
Publication statusPublished - Jun 2016

Keywords

  • Stroke
  • patient retention
  • recruitment
  • pilot study
  • feasibility study
  • methodology

Cite this