Improving consent processes for legal representatives in critical care clinical trials
Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials - a Prospective, Single-arm, Open-label Exploratory Trial
This study is trying to understand how legal representatives feel about the process of getting consent for clinical trials involving critically ill patients, to make it easier for them to help with patient recruitment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital Freiburg Academic / other |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT06471400 on ClinicalTrials.gov |
What this trial studies
This study aims to understand the perceptions of legally authorized representatives (LARs) regarding the recruitment process for clinical trials involving critically ill patients who cannot provide consent themselves. By conducting interviews with LARs, the study seeks to identify their needs and concerns during the information and education process about clinical trials. The insights gained will help develop effective strategies to enhance LAR involvement and facilitate patient recruitment in these urgent medical situations. The study employs a single-arm design focusing on qualitative data without a comparator group.
Who should consider this trial
Good fit: Ideal candidates for this study are legally authorized representatives of adult patients aged 18 years or older admitted to the Freiburg University Medical Center.
Not a fit: Patients who are not represented by a legally authorized representative or those who have expressed unwillingness to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recruitment processes for clinical trials, ultimately benefiting critically ill patients through better access to potentially life-saving therapies.
How similar studies have performed: While the approach of enhancing consent processes for LARs is not widely tested, similar studies have shown that improving communication can positively impact recruitment in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study will include LARs of adult patients aged 18 years or older who are admitted to the Freiburg University Medical Center in Germany. Exclusion Criteria: * LARs who have expressed their unwillingness to participate in the study or have objected to the measures implemented in the study will not be included.
Where this trial is running
Freiburg im Breisgau
- Freiburg University Medical Center — Freiburg im Breisgau, Germany (Recruiting)
Study contacts
- Principal investigator: Alexander Supady, MD — Freiburg University Medical Center
- Study coordinator: Alexander Supady, MD
- Email: alexander.supady@uniklinik-freiburg.de
- Phone: +4976127034010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.