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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial). The main questions it aims to answer are: * Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial? * Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process? Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.

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 data supports the effectiveness of simplified vs full-length consent forms for clinical trials?

Research shows that a simplified consent form, designed to meet new US Federal Common Rule requirements, helps participants better understand important information for enrolling in clinical trials compared to traditional full-length forms. ^{1 2 3 4 5}

Is the simplified or full-length consent form safe for use in clinical trials?

The research does not provide specific safety data for the use of simplified or full-length consent forms in clinical trials. ^{2 5 6 7 8}

Research Team

Sean WX Ong, MBBS

Principal Investigator

University of Toronto

Eligibility Criteria

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

Admitted to a participating hospital at the time of eligibility assessment

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Patient representatives' views on patient information in clinical cancer trials. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Randomized comparison of two interventions to enhance understanding during the informed consent process for research. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of a shortened informed consent form for pediatric research: a pilot study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback. [2023]