eCite Digital Repository

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

Citation

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 Statement

Copyright 2016 National Stroke Association

DOI: 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.

Item Details

Item Type:Refereed Article
Keywords:Stroke, patient retention, recruitment, pilot study, feasibility study, methodology
Research Division:Medical and Health Sciences
Research Group:Cardiorespiratory Medicine and Haematology
Research Field:Cardiology (incl. Cardiovascular Diseases)
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Cardiovascular System and Diseases
Author:Srikanth, VK (Dr Velandai Srikanth)
Author:Nelson, MR (Professor Mark Nelson)
ID Code:109412
Year Published:2016
Deposited By:Menzies Institute for Medical Research
Deposited On:2016-06-15
Last Modified:2017-02-15
Downloads:0

Repository Staff Only: item control page