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Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

ABSTRACT: BACKGROUND/AIMS:In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS:Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5?years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p?

SUBMITTER: Brubaker L

PROVIDER: S-EPMC7197014 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

Brubaker Linda L Jelovsek J Eric JE Lukacz Emily S ES Balgobin Sunil S Ballard Alicia A Weidner Alison C AC Gantz Marie G MG Whitworth Ryan R Mazloomdoost Donna D

Clinical trials (London, England) 20190726 5

<h4>Background/aims</h4>In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.<h4>Methods</h4>Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants ...[more]

PMID: 31347384

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Project description:IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.

Project description:BACKGROUND:We investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. METHODS:We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. RESULTS:A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention (72.57?±?16.21 (SD)) than in the control (61.67?±?18.39) group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores (coefficient: 7.646, 95% CI: 3.381-11.911). Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients' perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. CONCLUSIONS:Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. TRIAL REGISTRATION:The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Project description:ObjectivesTo explore trial site staff's perceptions regarding barriers and facilitators to local recruitment.DesignQualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.Participants11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).SettingEmbedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.ResultsOur study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.ConclusionsOur paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this 'work'. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.Trial registration numberISRCTN No 92289221; Pre-results.

Dataset Information

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

Publications

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

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