RecruitingNAINTERVENTIONAL

Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials

This research aims to understand how to best involve family members, known as Legal Representatives, in decisions about joining clinical trials when a critically ill patient can't make choices for themselves. Researchers want to find out what's important to these family members when they are given information about a trial and what might stop them from agreeing. There are many benefits to taking part in clinical trials, but also some risks. By listening to their experiences, the study hopes to create better ways to explain trials, making it easier for families to give their consent and help more patients participate in important medical research. This will ultimately help improve treatments for critically ill patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Freiburg

Enrolment target

Start

18 Jun 2024

Estimated completion

31 Dec 2026

Critical Illness Loss of Consciousness

What is this study about?

When someone is very poorly in hospital and can't make decisions for themselves, their family member or a close legal representative often has to make choices about their medical care. This also includes decisions about whether they should take part in important research studies, called clinical trials. These trials help doctors find better ways to treat illnesses and save lives.

However, it can be really difficult to talk about research at such a stressful time. This study wants to understand this process better. It's asking family members who have been in this situation what information they needed, what helped them make a decision, and what concerns they had. The main goal is to find the best ways to explain clinical trials so families feel fully informed and comfortable with their decision, whether they say yes or no.

Ultimately, by improving how we talk to families, this study hopes to make it easier for more patients to participate in vital clinical trials. This will lead to new and improved treatments for critically ill people, which is incredibly important for everyone.

Key takeaways

This study wants to improve how families are told about clinical trials.
It focuses on families of very ill patients who can't make their own decisions.
You would share your thoughts and experiences in an interview.
The goal is better communication to help research and patient care.
Participation helps future families facing similar tough choices.

Who may be eligible?

This study is looking for family members or legal guardians of patients aged 18 or older who are currently in hospital in Freiburg, Germany.

You would not be able to take part if you have already said you do not want to be involved in the study or have concerns about what the study involves.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a legal representative or close family member of a critically ill patient?
Is the patient 18 years old or older?
Is the patient currently in hospital in Freiburg, Germany?
Are you willing to share your experiences in an interview?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would share your experiences and thoughts in an interview. This interview would focus on your perceptions and views regarding the recruitment process for clinical trials in the intensive care unit. There are no medications involved, and there would be no long follow-up appointments after your interview.

Potential risks and benefits

The main benefit of taking part is helping to improve how critical medical information and research opportunities are communicated to families in difficult times. This could lead to better research and better care for very ill patients in the future. The risks are very low, mostly relating to the time committed and potentially discussing sensitive topics. You have the right to withdraw from the study at any time, for any reason, without it affecting your loved one's care.

Locations (1)

Freiburg University Medical Center
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is a 'Legal Representative'?

This is usually a family member or a close person who has the legal right to make decisions for someone who cannot make them for themselves, often because they are very ill.

Why is this study important?

It's important because it aims to make it easier for families to understand research trials and decide if their loved one should take part. This helps more people get cutting-edge treatments.

Will my loved one get special treatment if I take part?

No, your loved one's care will not be affected by whether or not you choose to take part in this study.

Do I have to share really personal details?

The study will ask about your experiences and thoughts on the process of being asked to consider a clinical trial, not deep personal medical details about your loved one.

How long will the interview take?

The study details don't specify the exact length, but generally, interviews for studies like this aim to be thorough while respecting your time.

How to find out more

Alexander Supady, MD

alexander.supady@uniklinik-freiburg.de +4976127034010 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.