Thayabaranathan, T and Cadilhac, DA and Srikanth, VK and Fitzgerald, SM and Evans, RG and Kim, J and Gerraty, RP and Phan, TG and Bladin, CF and Nelson, MR and Frayne, JH and Thrift, AG, Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study, Journal of Stroke and Cerebrovascular Diseases, 25, (6) pp. 1371-1380. ISSN 1052-3057 (2016) [Refereed Article]
Copyright 2016 National Stroke Association
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.
|Item Type:||Refereed Article|
|Keywords:||Stroke, patient retention, recruitment, pilot study, feasibility study, methodology|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Cardiovascular medicine and haematology|
|Research Field:||Cardiology (incl. cardiovascular diseases)|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Srikanth, VK (Dr Velandai Srikanth)|
|UTAS Author:||Nelson, MR (Professor Mark Nelson)|
|Web of Science® Times Cited:||5|
|Deposited By:||Menzies Institute for Medical Research|
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