Cancer
Conditions
Keywords
Informed Consent, Key information, Research Ethics
Brief summary
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
Interventions
BEHAVIORALStandard Consent Form
The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.
BEHAVIORALVisual Key Information (VKI) page
A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Eligibility Criteria: * Patient must be 18 years or older * Patients must be English-speaking * Able to understand an IRB-approved written consent document * Must go through the consent process for one of the parent studies Research Team Eligibility Criteria: * Member of a parent study research team * Engaged in the study consent processes, including creating and reviewing consents or enrolling participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's knowledge of consent | Time of consent completion for parent study (day 1) | Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests. |
| Patient's anxiety about enrolling | Time of consent completion for parent study (day 1) | Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's trust in information | Time of consent completion for parent study (day 1) | Patient's trust in information will be measured by a single-item on the patient consent experience survey adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The item is a 5-point scale with answers as follows: Not at all, Slightly, Moderately, Very, and Extremely. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests. |
| Patient's perceptions of patient centered care | Time of consent completion for parent study (day 1) | Perception of patient-centered care (PCC) will be measured by three items on the patient consent experience survey which are adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The items are a 4-point scale as follows: Always, Usually, Sometimes, and Never. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests. |
| Parent study enrollment rates | Completion of enrollment (estimated total time is 9-13 months) | Enrollment rates will be measured by total number of patients enrolled in each parent study. Responses will be reported via descriptive statistics and between group differences will be examined via t-tests. |
Outcome results
None listed