Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials

Abstract

BackgroundPatient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions.MethodsThe Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD).ResultsIn Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61).ConclusionsEvidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population.Trial registrationCurrent Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users.

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

“…In this group of patients with severe mental health problems, the overall rates of response and participation were low, although this was in line with similar studies [18]. For our primary outcome, we found that being sent the intervention was not effective for improving recruitment rates.…”

“…The addition of the PPIR recruitment intervention may, therefore, have been irrelevant since the PPIR undertaken in EQUIP may have been sufficient to promote participant recruitment. However, the overall enrolment rates in EQUIP were low, with rates similar to other trials recruiting from similar populations [18, 81], so this does not suggest that the significant PPIR in EQUIP improved recruitment when compared with other trials. This contrasts with an observational study which found that studies that involved patients to a greater extent were more likely to have achieved recruitment targets [46].…”

“…We have developed methodological, logistical and reporting frameworks for embedded recruitment trials [12, 17] and assessed their feasibility using interventions such as an improved Participant Information Sheet and a multimedia decision aid [18, 19]. The eventual aim is to make delivery of embedded recruitment trials a routine activity, to assist the rapid development of recruitment to meet health and policy goals [20].…”

Collaborative case management to aid return to work after long-term sickness absence: a pilot randomised controlled trial

“…However, the modest nature of these methods meant that such changes (for example, better wording of an information sheet) are unlikely to have a profound effect, given the very low rates of response to the initial invitations. 77 If our package of changes had led to an increase in recruitment of 25% (which would be a very large increase), the impact on recruitment targets would have been small. One innovation that might be expected to have a large impact involved CRN staff calling patients, 78 where there is a reasonable evidence base already, including a study testing this approach using employees on a sick list.…”

An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

“…The results of this MRC START substudy have now been published. 305 Next, as difficulties with motivation and concentration are at the heart of depression, this is a difficult patient group to keep engaged in research, especially over the course of a 12-month study. Therefore, we attempted three different methods to increase response rates with these participants at follow-up.…”