Improving Consent Experiences in Clinical Trials

Washington University School of Medicine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Cancer

Interventions

Standard Consent FormBEHAVIORAL

The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.

Visual Key Information (VKI) pageBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient's knowledge of consent

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.

Time frame: Time of consent completion for parent study (day 1)

Patient's anxiety about enrolling

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.

Time frame: Time of consent completion for parent study (day 1)

Secondary Outcomes

Patient's trust in information

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.

Time frame: Time of consent completion for parent study (day 1)

Patient's perceptions of patient centered care

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.

Data from ClinicalTrials.gov

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