O'Hare, F and Flanagan, Z and Nelson, M and Curtis, A and Heritier, S and Spark, S and Zoungas, S, on behalf of the STAREE Investigator Group, Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach, Clinical Trials, 15, (6) pp. 610-615. ISSN 1740-7745 (2018) [Refereed Article]
Copyright 2018 The Authors
Aims: To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults.
Methods: In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated into two groups by age, gender and attending general practice location, to receive the trial information and consent form in the mail (Method 1) prior to the first baseline visit or in person (Method 2) at the visit where a comprehensive informed consent process took place.
Results: Compared with Method 1, potential participants assigned to Method 2 were more likely to agree to attend the first baseline screening visit (refusal rate 20% vs 13.5%, respectively, p = 0.05). However, there was no significant difference in the proportion of participants recruited into the trial by providing written informed consent at the first baseline screening visit. For each informed consent delivery method, similar proportions of participants refused to take part in the trial by the end of the screening phase. Randomisation rates in the two groups were also similar. Time to conduct the informed consent procedure took significantly longer with Method 2 compared with Method 1 (median time 20 vs 15 min, respectively, p < 0.01). Interest in the research trial topic was the main reason cited (33.4%) for considering trial participation.
Conclusion: Later delivery of informed consent documents to potential participants in this trial was associated with a small increase in attendance at the first, in person, screening visit. However, the randomisation rate of participants into the trial was not affected by the method and timing of delivery of informed consent information. Similar randomisation rates occurred whether potential participants were mailed informed consent documents prior to the first in person screening visit or were given the information at the screening visit.
|Item Type:||Refereed Article|
|Keywords:||informed consent, clinical trial, participant recruitment, elderly, primary care|
|Research Division:||Health Sciences|
|Research Group:||Health services and systems|
|Research Field:||Primary health care|
|Objective Group:||Public health (excl. specific population health)|
|Objective Field:||Behaviour and health|
|UTAS Author:||Nelson, M (Professor Mark Nelson)|
|Deposited By:||Menzies Institute for Medical Research|
Repository Staff Only: item control page