Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial : study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Informed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. In turn, this can influence trial recruitment, completion and external validity.
METHODS AND ANALYSIS: SIMPLY-SNAP is a pragmatic, multicentre, open-label, two-arm parallel-group superiority RCT, nested within a larger trial, the Staphylococcus aureus Network Adaptive Platform (SNAP) trial. We will randomise potentially eligible participants of the SNAP trial 1:1 to a full-length ICF or a SIMPlified LaYered (SIMPLY) consent process where basic information is summarised with embedded hyperlinks to supplemental information and videos. The primary outcome is recruitment into the SNAP trial. Secondary outcomes include patient understanding of the clinical trial, patient and research staff satisfaction with the consent process, and time taken for consent. As an exploratory outcome, we will also compare measures of diversity (eg, gender, ethnicity), according to the consent process randomised to. The planned sample size will be 346 participants.
ETHICS AND DISSEMINATION: The study has been approved by the ethics review board (Sunnybrook Health Sciences Research Ethics Board) at sites in Ontario. We will disseminate study results via the SNAP trial group and other collaborating clinical trial networks.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT06168474; www.
CLINICALTRIALS: gov).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
BMJ open - 14(2024), 1 vom: 18. Jan., Seite e083239 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ong, Sean W X [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial |
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| Anmerkungen: |
Date Completed 22.01.2024 Date Revised 01.02.2024 published: Electronic ClinicalTrials.gov: NCT06168474 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2023-083239 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Ong, Sean W X |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial |b study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial) |
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| 500 | |a Date Revised 01.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT06168474 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Informed consent forms (ICFs) for randomised clinical trials (RCTs) can be onerous and lengthy. The process has the potential to overwhelm patients with information, leading them to miss elements of the study that are critical for an informed decision. Specifically, overly long and complicated ICFs have the potential to increase barriers to trial participation for patients with mild cognitive impairment, those who do not speak English as a first language or among those with lower medical literacy. In turn, this can influence trial recruitment, completion and external validity | ||
| 520 | |a METHODS AND ANALYSIS: SIMPLY-SNAP is a pragmatic, multicentre, open-label, two-arm parallel-group superiority RCT, nested within a larger trial, the Staphylococcus aureus Network Adaptive Platform (SNAP) trial. We will randomise potentially eligible participants of the SNAP trial 1:1 to a full-length ICF or a SIMPlified LaYered (SIMPLY) consent process where basic information is summarised with embedded hyperlinks to supplemental information and videos. The primary outcome is recruitment into the SNAP trial. Secondary outcomes include patient understanding of the clinical trial, patient and research staff satisfaction with the consent process, and time taken for consent. As an exploratory outcome, we will also compare measures of diversity (eg, gender, ethnicity), according to the consent process randomised to. The planned sample size will be 346 participants | ||
| 520 | |a ETHICS AND DISSEMINATION: The study has been approved by the ethics review board (Sunnybrook Health Sciences Research Ethics Board) at sites in Ontario. We will disseminate study results via the SNAP trial group and other collaborating clinical trial networks | ||
| 520 | |a TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT06168474; www | ||
| 520 | |a CLINICALTRIALS: gov) | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Health Equity | |
| 650 | 4 | |a INFECTIOUS DISEASES | |
| 650 | 4 | |a MEDICAL ETHICS | |
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| 700 | 1 | |a Fowler, Robert A |e verfasserin |4 aut | |
| 700 | 1 | |a Mahar, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Pinto, Ruxandra L |e verfasserin |4 aut | |
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| 700 | 1 | |a Tong, Steven Y C |e verfasserin |4 aut | |
| 700 | 1 | |a Daneman, Nick |e verfasserin |4 aut | |
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