Simplified vs Full-Length Consent Forms for Clinical Trials

(SIMPLY-SNAP Trial)

Recruiting at 8 trial locations

Overseen By Sean WX Ong, MBBS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Systemic antibacterials

Disqualifiers: Polymicrobial bacteremia, Previous SNAP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

346 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a shorter, simpler consent form improves understanding of a clinical study compared to the usual detailed form. It is part of a larger trial focused on treating Staphylococcus aureus bloodstream infections, which are serious bacterial infections. Participants will receive either the Simplified Layered Consent Form or the Full-length Consent Form to determine which makes the consent process easier and more satisfying. Ideal candidates for this trial are those admitted to a participating hospital, with a blood test confirming a Staphylococcus aureus infection, and who can read and speak either English or French. As an unphased study, this trial offers an opportunity to enhance the consent process for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on a systemic antibacterial agent that cannot be stopped, you may not be eligible to participate.

What prior data suggests that these consent forms are safe for use in clinical trials?

This trial aims to improve how clinical trials are explained to participants by comparing a simplified consent form to a traditional one.

Research has shown that people prefer the simplified consent form. One study found that participants appreciated having choices about how much information to read before deciding to join a trial. This suggests that the simplified form is safe and easy to use.

No safety concerns exist because this trial does not involve testing a drug or treatment. It only tests how information is shared, so participants are not at risk from the consent forms themselves. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's testing a new way to simplify the consent process for clinical trials. Unlike the traditional full-length consent forms that are often lengthy and complex, the simplified layered consent form is concise, using easy-to-understand language in a four-page document. This approach aims to make it easier for participants to comprehend the trial's details and make informed decisions. By streamlining the consent process, researchers hope to improve participant understanding and engagement, potentially enhancing the overall efficiency and ethical standards of clinical trials.

What evidence suggests that the simplified layered consent form is effective for improving recruitment and understanding in clinical trials?

This trial will compare the effectiveness of a Simplified Layered Consent Form with a Full-Length Consent Form. Research has shown that simpler consent forms can improve understanding and satisfaction during the consent process. Studies have found that allowing individuals to choose how much information to read makes them feel more comfortable and informed. This approach might also increase participation in clinical trials. By using clear and simple language, the form helps people understand the trial's purpose. Early findings suggest this method respects individuals' preferences for detail before making a decision. ^{1 2 3 4 6}

Who Is on the Research Team?

Sean WX Ong, MBBS

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults with a Staphylococcus aureus blood infection, who speak English or French well enough to understand the consent process. They must be in a participating hospital and not have multiple bacteria in their blood, nor be on certain antibiotics they can't stop. Patients already enrolled in SNAP or treated for S. aureus recently cannot join.

Inclusion Criteria

Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages)

Admitted to participating hospital of SIMPLY-SNAP

S. aureus complex grown from ≥1 blood culture

Exclusion Criteria

My blood test shows infection with more than one type of bacteria.

I am on a long-term antibacterial treatment that cannot be stopped.

Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Consent Process

Participants undergo either a simplified layered consent process or a full-length consent process to understand the SNAP trial

1 day

1 visit (in-person)

Evaluation

Participants are evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire

Within 3 days after the consent process

Follow-up

Participants' diversity and recruitment rates are assessed as part of the trial outcomes

End of the entire SIMPLY-SNAP study

What Are the Treatments Tested in This Trial?

Interventions

• Full-length Consent Form
• Simplified Layered Consent Form

Trial Overview The SIMPLY-SNAP trial tests if a simplified layered consent form improves recruitment rates, understanding of the study, and satisfaction compared to a full-length form during informed consent for treating Staph infections. Participants will receive either the detailed or simplified form randomly.

How Is the Trial Designed?

Group I: Simplified layered consent process Experimental Treatment 1 Intervention

For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.

Group II: Full-length consent form Active Control 1 Intervention

For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

Consumers, including survivors of Staphylococcus aureus bloodstream infection and their carers, support a layered approach to participant information sheets/consent forms (PICFs), which allows them to choose how much information to read before consenting to a trial.

The study highlighted the importance of prioritizing participants' information needs and providing clear details about the benefits of a trial, suggesting that a concise 3-page PICF could be effective for decision-making if additional information is readily accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial. Symons, TJ., Straiton, N., Gagnon, R., et al.[2023]

In a study involving 284 participants across six clinical trials, an interview-style video intervention significantly improved participants' understanding of the informed consent process compared to the standard consent form, with a p-value of 0.020.

Participants who viewed the video also reported higher satisfaction with the consent process, while the fact sheet intervention did not show any improvement in understanding or satisfaction compared to the standard method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Taylor, HA., Washington, D., Wang, NY., et al.[2023]

In a study involving 34 cancer patients, it was found that most patients preferred key risk information, such as the fact that a study drug has not been tested in humans, to be presented early in consent forms for first in human (FIH) trials.

For window of opportunity (Window) trials, patients preferred information about potential delays in standard of care surgery to be placed before the risks section, highlighting the need for tailored consent forms that reflect patient preferences for different trial types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback. Avinger, AM., Sibold, HC., Campbell, G., et al.[2023]

A study involving 82 parents from advocacy groups found that a shortened informed consent form (ICF) was perceived as more concise and straightforward compared to a conventional ICF, with 76% of parents preferring the shortened version.

Despite the preference for brevity, both groups showed no significant differences in understanding key components of the study, indicating that simplifying the ICF did not enhance comprehension of the clinical trial details.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a shortened informed consent form for pediatric research: a pilot study. Murray, PD., Bierer, BE., Hirschfeld, S., et al.[2023]

A study of 315 consent forms from cancer clinical trials revealed that the median word count was 5129 words, indicating that many consent forms are excessively lengthy, which may hinder patient understanding.

Consent forms from pharmaceutical company trials were the longest, and the study found that the length of consent forms increased over time, highlighting the need for more concise and clear consent documents to improve patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials. Duong, Q., Mandrekar, SJ., Winham, SJ., et al.[2022]

A review of 64 informed consent forms from drug development trials revealed that while they were lengthy (averaging 22 pages), many lacked critical information, particularly about experimental aspects of the research and post-trial provisions.

Despite including most required elements, significant gaps were found in areas such as whole-genome sequencing and commercial profit sharing, highlighting ongoing challenges in ensuring comprehensive and clear informed consent in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials. Dukaew, N., Na Takuathung, M., Sakuludomkan, W., et al.[2023]

The highlights version of the informed consent document, which follows the revised US Federal Common Rule, significantly improved participants' retention of high-relevance enrollment information compared to the original full-length document (65% vs. 59% correct answers).

Other revised versions of the consent document did not show a significant improvement in knowledge retention compared to the full-length version, indicating that the structure and prioritization of information are crucial for effective communication in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients. Yu, M., Fischhoff, B., Krishnamurti, T.[2020]

Patient representatives highlighted that the complexity of written information in clinical trial consent forms can hinder fully informed consent, emphasizing the need for clearer communication.

The study suggests that simplifying and improving the layout of informed consent forms, using plain language and illustrations, could enhance patient understanding and increase enrollment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient representatives' views on patient information in clinical cancer trials. Dellson, P., Nilbert, M., Carlsson, C.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06168474

Evaluating Simplified Layered Consent for Clinical Trials Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10806654/

Evaluating the impact of a SIMPlified LaYered consent ... A SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-07023-z

Consumer perspectives on simplified, layered consent ... - Trials Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5543760/

Informed consent process: A step further towards making it ... Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714416300854

Paving the way to a more effective informed consent process Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin.

6. ctti-clinicaltrials.org ctti-clinicaltrials.org/about/ctti-projects/informed-consent/

Informed Consent - CTTI - Clinical Trials Transformation Initiative Use CTTI's recommendations and resources – an informed consent discussion tool and tiered informed consent document – to optimize your informed consent process.