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The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

ABSTRACT: BACKGROUND:Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates. METHODS:We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS. RESULTS:In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR?=?1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR?=?1.103, 95% CI, 0.778 to 1.565). CONCLUSIONS:Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

SUBMITTER: Parker A

PROVIDER: S-EPMC6145341 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

Parker Adwoa A Knapp Peter P Treweek Shaun S Madhurasinghe Vichithranie V Littleford Roberta R Gallant Stephanie S Sullivan Frank F Schembri Stuart S Rick Jo J Graffy Jonathan J Collier David J DJ Eldridge Sandra S Kennedy Anne A Bower Peter P

Trials 20180918 1

<h4>Background</h4>Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to ...[more]

PMID: 30227890

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Project description:BackgroundFew interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART.Methods/designWe conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate.ResultsWe recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to have been randomised using the audit reports. Respondents frequently reported resource and time pressures as being key barriers to running the audit reports.ConclusionThe PRIME complex intervention did not significantly improve the recruitment rate to RESTART. Further research is needed to establish if PRIME might be beneficial at an earlier stage in a prevention trial or for prevention dilemmas that arise more often in clinical practice.

Project description:BackgroundThe information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment.MethodsSeven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part.ResultsSix SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%).ConclusionsParticipant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies.Trial registrationHealthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Project description:BackgroundRecruitment into clinical trials is challenging and there is a lack of evidence on effective recruitment strategies. Personalisation of invitation letters is a potentially pragmatic and feasible way of increasing recruitment rates at a low-cost. However, there is a lack of evidence concerning the effect of personalising of study invitation letters on recruitment rates.MethodsWe undertook a Study Within A Trial (SWAT) to investigate the effect of personalised versus non-personalised study invitation letters on recruitment rates into the host feasibility trial ENGAGE, a feasibility study of an internet-administered, guided, Low Intensity Cognitive-Behavioural Therapy based self-help intervention for parents of children previously treated for cancer. An intervention group (n = 254) received a personalised study invitation letter and the control group (n = 255) received a non-personalised study invitation letter. The primary outcome was the proportion of participants in the intervention group and the control group enrolled into the ENGAGE host feasibility trial. Secondary outcomes relating to the recruitment and screening process, and retention were examined. Differences in proportions between groups for the primary and secondary outcomes were estimated using logistic regression.ResultsOf the 509 potential participants, 56 (11.0%) were enrolled into the ENGAGE host feasibility trial: personalised: 30/254 (11.8%) and non-personalised: 26/255 (10.2%). No statistically significant effect on personalisation of enrolment was found (OR 1.18, 95% CI 0.68-2.06). No statistically significant differences were found for any secondary outcome.ConclusionsPersonalisation of study invitations had no effect on recruitment. However, given the small study sample size in the present SWAT, and lack of similar embedded recruitment RCTs to enable a meta-analysis, additional SWATs to examine the personalisation of study invitation letters are warranted.Trial registrationISRCTN57233429 ; ISRCTN18404129 ; SWAT 112, Northern Ireland Hub for Trials Methodology Research SWAT repository (2018 OCT 1 1231) ( https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,939618,en.pdf ).

Project description:BackgroundLarge randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it.MethodsParticipants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2-THRIVE is registered at ClinicalTrials.gov (NCT00461630).ResultsThe commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94-1.17) and 1.10 (95% CI 0.94-1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33).ConclusionsMany reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.

Dataset Information

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

Publications

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

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