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

Developing Strategies to Facilitate Consent of Legally Authorized Representatives to Clinical Trials - a Prospective, Single-arm, Open-label Exploratory Trial

This study aims to gather insights into the perceptions of legal representatives regarding the recruitment process for clinical trials in the intensive care setting when the patients cannot decide for themselves. With this information, effective strategies will be developed to increase involvement and the feeling of ownership of LARs of (potential) participants in clinical trials and thus enhance and facilitate patient recruitment for clinical trials. The single-arm study design does not include a choice of comparator, as the focus of this trial is to explore the perceptions of the participants at first hand without comparing different cohorts or strategies.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Loss of Consciousness
• Intervention / Treatment: Other: interview

Detailed Description

The evidence for specific therapies and treatment strategies, particularly for critically ill patients, remains limited. A significant difficulty for the planning, initiation and implementation of clinical trials in these patients is the urgency of the necessary medical measures, which leaves patients and their relatives, as well as the treating clinicians, little time and opportunities to present necessary studies and to inform the patients or their legal guardians about them. Critically ill patients are a particularly vulnerable group of patients. The measures required as part of a study can mean additional efforts for these patients over and above the burden of the disease and the necessary diagnostic and therapeutic measures, which are only justified if special duties of care are observed. In addition to an ethical assessment of the study, this also includes providing comprehensive information to patients or their legal representatives.

In this study, the process of informing and educating patients or their legal representatives will be examined in more detail. The aim of the study is to gain a better understanding of this process, in particular the perceptions and views of the persons to be informed, and specifically to investigate which aspects are particularly important to patients and their legal representatives in an information and education discussion and what information they need in order to be able to consider participating in a study or what reasons exist that would prevent them from giving their consent. The overall aim of this study is to improve the information and education process.

For some years now, the involvement of patients and relatives in individual aspects of the planning and conduct of clinical trials has been increasingly demanded and promoted. For example, large public funders often require the involvement of patient and/or family representatives at an early stage in the planning of trials. The objectives of this study are based on these expectations.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Supady, MD; Phone Number: +4976127034010; Email: alexander.supady@uniklinik-freiburg.de

Study Locations

• Germany
  • Freiburg, Germany, 79106
    • Recruiting
    • Freiburg University Medical Center
    • Contact: Alexander Supady, MD; Phone Number: +4976127034010; Email: alexander.supady@uniklinik-freiburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient relative/LAR interview; Study intervention: interview with patient relative/LAR	Other: interview; patient relatives or legal authorized representatives will be interviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relative/LAR perception	The primary aim of the study is to evaluate the perceptions of LARs towards the recruitment process for clinical trials. This is an exploratory examination. All findings are considered merely hypothesis generating and will be used for designing further trials based on sound hypotheses following the findings from this trial.	actual day

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Investigators: Principal Investigator: Alexander Supady, MD, Freiburg University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Consciousness Disorders; Critical Illness; Unconsciousness
• Other Study ID Numbers: 23-1162-S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No