Clinical trial NCT06804837: Implement and Test Visual Consent Template and Process
Official title: Implement and Test Visual Consent Template and Process
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Alzheimer Disease
Keywords: Informed consent
Key information
Common Rule
Research ethics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2025-02-03
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.


Eligibility criteria: Eligibility Criteria for Patients:

* Adult participants (18+) eligible for one of three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill. The eligibility criteria for the main trials are below:

  * UNC:

    * Basal-like PDAC Treated with Gemcitabine, Erlotinib, and Nab-paclitaxel (PANGEA) trial inclusion criteria:

      * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
      * Participant is willing and able to comply with study procedures based on the judgment of the investigator.
      * Age ≥ 18 years at the time of consent.
      * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
      * Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
      * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  * Washington University:

    * Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)

      * Participants of the Knight Alzheimer Disease Research Center.
      * Participants with available results from an Alzheimer Disease blood biomarker test.
      * Participants who agreed to be contacted for additional research studies.
  * University of Utah:

    * Huntsman Cancer Institute Total Cancer Care

      * Participants who have been diagnosed with any type of tumor or cancer.
      * Participants with genetic predispositions or family history of cancer or tumors.
      * Participant volunteers willing to share samples and data for research.

Eligibility Criteria for Research Staff:

* Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.

Primary outcomes:
measure: Change in feasibility (FIM) of implementation (Research Staff only)
timeFrame: From baseline to end of study (estimated to be 4 months)
measure: Change in acceptability (AIM) of implementation measures (Research Staff only)
timeFrame: From baseline to end of study (estimated to be 4 months)
measure: Change in appropriateness (IAM) of implementation measure (Research Staff only)
timeFrame: From baseline to end of study (estimated to be 4 months)
measure: Change in organizational willingness and ability to implement strategies (Research staff only)
timeFrame: From baseline to end of study (estimated to be 4 months)
Secondary outcomes:
measure: Knowledge of information provided in the consent (Participant only)
timeFrame: At time of consent review (day 1)
measure: Satisfaction of information provided in the consent (Participant only)
timeFrame: At time of consent review (day 1)
measure: Decisional conflict (Participant only)
timeFrame: At time of consent review (day 1)
measure: Number of enrollments to clinical trials (Participant only)
timeFrame: At time of consent review (day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Medicine
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute (HCI)
state: Utah
Study officials:
References: