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Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III Trial

  • Amanda L. Porter
  • James Ebot
  • Karen Lane
  • Lesia H. Mooney
  • Amy M. Lannen
  • Eugene M. Richie
  • Rachel Dlugash
  • Steve Mayo
  • Thomas G. Brott
  • Wendy Ziai
  • William D. FreemanEmail author
  • Daniel F. Hanley
Take a Closer Look at Trials

Abstract

Background

The process of informed consent in National Institutes of Health randomized, placebo-controlled trials is poorly studied. There are several issues regarding informed consent in emergency neurologic trials, including a shared decision-making process with the patient or a legally authorized representative about overall risks, benefits, and alternative treatments.

Methods

To evaluate the informed consent process, we collected best and worst informed consent practice information from a National Institutes of Health trial and used this in medical simulation videos to educate investigators at multiple sites to improve the consent process. Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) (clinicaltrials.gov, NCT00784134) studied the effect of intraventricular alteplase (n = 251) versus saline (placebo) injections (n = 249) for intraventricular hemorrhage reduction. Reasons for ineligibility (including refusing to consent) for all screen failures were analyzed. The broadcasted presentation outlined best practices for doctor–patient interactions during the consenting process, as well as anecdotal, study-specific reasons for consent refusal. Best and worst consent elements were then incorporated into a simulation video to enhance the informed consent process. This video was disseminated to trial sites as a webinar around the midpoint of the trial to improve the consent process. Pre- and post-intervention consent refusals were compared.

Results

During the trial, 10,538 patients were screened for eligibility, of which only three were excluded due to trial timing. Pre-intervention, 77 of 5686 (1.40%) screen eligible patients or their proxies refused consent. Post-intervention, 55 of 4849 (1.10%) refused consent, which was not significantly different from pre-intervention (P = 0.312). The incidence of screen failures was significantly lower post-intervention (P = 0.006), possibly due to several factors for patient exclusion.

Conclusion

The informed consent process for prospective randomized trials may be enhanced by studying and refining best practices based on trial-specific plans and patient concerns particular to a study.

Keywords

Best practice Consent Randomized controlled trial Simulation 

Notes

Author contributions

AL Porter contributed to analysis and interpretation of data, drafting and critical revision of the manuscript, and collection/generation of visual components. J Ebot contributed to experiments, collection of data, and critical revision of the manuscript. K Lane contributed to experiments, collection of data, and critical revision of the manuscript. LH Mooney contributed to conception and design, experiments, and collection of data. AM Lannen contributed to conception and design, experiments, collection of data, and critical revision of the manuscript. EM Richie contributed to conception and design, experiments, and collection of data. R Dlugash contributed to conception and design; experiments; collection, analysis, and interpretation of data; drafting and critical revision of the manuscript; and generation of figures. S Mayo contributed to conception and design; experiments; collection, analysis, and interpretation of data; and collection/generation of visual components. TG Brott contributed to conception and design, experiments, and collection of data. W Ziai contributed to conception and design; experiments; collection, analysis, and interpretation of data; drafting and critical revision of the manuscript; and collection/generation of visual components. WD Freeman contributed to conception and design; experiments; collection, analysis, and interpretation of data; drafting and critical revision of the manuscript; and collection/generation of visual components. DF Hanley contributed to conception and design; experiments; collection, analysis, and interpretation of data; drafting and critical revision of the manuscript; and collection/generation of visual components.

Source of support

The authors received no funding for the study described in this article.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval/informed consent

This study was performed under the CLEAR III NIH trial. No informed consent was required.

Supplementary material

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Supplementary material 1 (DOCX 18 kb)
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Supplementary material 2 (DOCX 19 kb)

Supplementary material 3 (MPG 251440 kb)

Supplementary material 4 (MPG 237888 kb)

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Supplementary material 5 (WMV 53508 kb)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society 2019

Authors and Affiliations

  • Amanda L. Porter
    • 1
  • James Ebot
    • 2
  • Karen Lane
    • 7
  • Lesia H. Mooney
    • 3
  • Amy M. Lannen
    • 4
  • Eugene M. Richie
    • 6
  • Rachel Dlugash
    • 7
  • Steve Mayo
    • 7
  • Thomas G. Brott
    • 5
  • Wendy Ziai
    • 8
  • William D. Freeman
    • 2
    • 5
    • 6
    Email author
  • Daniel F. Hanley
    • 7
  1. 1.Department of Neurology, Mayo Clinic Alix School of MedicineMayo ClinicJacksonvilleUSA
  2. 2.Department of Neurologic SurgeryMayo ClinicJacksonvilleUSA
  3. 3.Department of NursingMayo ClinicJacksonvilleUSA
  4. 4.J. Wayne and Delores Barr Weaver Simulation CenterMayo ClinicJacksonvilleUSA
  5. 5.Department of NeurologyMayo ClinicJacksonvilleUSA
  6. 6.Department of Critical Care MedicineMayo ClinicJacksonvilleUSA
  7. 7.Brain Injury Outcomes (BIOS) DivisionJohns Hopkins UniversityBaltimoreUSA
  8. 8.Department of Neurology, Anesthesiology and Critical Care MedicineJohns Hopkins UniversityBaltimoreUSA

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