This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
430
Standard financial education resources will be provided to patients enrolled in the control arm. Financial education will be accessible via website and provided by the participating site.
The CARE Tool is a web-based tool provided to patients after enrollment. The CARE Tool provides patients with individualized information about cancer care costs, health insurance, and resources to assist with costs.
Members of the care team who have been identified as implementation champions will undergo training on cost conversations, how to use the CARE Tool, and how to implement the CARE Tool in their clinical workflow.
Alton Memorial Hospital
Alton, Illinois, United States
Delbert Day Cancer Institute at Phelps Health
Rolla, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Patient's comprehensive score for financial toxicity (COST)
COST will be calculated by the sum of 11-items according to the validated measure. The items are scored on a 5-point Likert scale as follows: 0-Not at all, 1-A little bit, 2-Somewhat, 3-Quite a bit, and 4-Very much. Total possible range is 0-44 and the lower the score indicates greater financial toxicity. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Patient's score of self-efficacy for communicating about care costs measured with the Decision Self-Efficacy Scale
The measure of self-efficacy for communicating about care costs is adapted from the validated tool Decision Self-Efficacy Scale. The Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making, including shared decision making. Three-items from the Decision Self-Efficacy Scale will be used to measure self-efficacy for communicating about care costs. The three items will be measured by a 3-point Likert scale as follows: 0-Not Confident, 2-A Little Confident, and 4-A lot confident. A higher score indicates greater self-efficacy in decision making. The total score will be calculated according to the validated measure. Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Patient's health insurance literacy measure (HILM) score
HILM score is calculated from a 6-item questionnaire according to the validated measure. Each item is measured by a 4-point Likert scale as follows: 1-Not at all confident, 2-Slightly confident, 3-Moderately confident, and 4-Very confident. Total possible range is 0-100 where 0 represents the lowest possible health insurance literacy level (more difficulty navigating insurance) and 100 represents the highest (more confidence in choosing/using insurance). Scores will be summarized using means and 95% confidence intervals. Changes between timepoints will be analyzed by a two-sample t-test.
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
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Patient's reported adherence to therapy & delayed care
Patient reported delayed care will be calculated from responses to three-items adapted from the National Health Interview Survey (NHIS). The three items have four categorical answers: Yes, No, I don't know, and Prefer not to answer. Scores will be summarized using frequencies. Changes between timepoints will be analyzed using sample proportions and 95% Clopper-Pearson Confidence Intervals. Changes between timepoints will be analyzed by a Pearson Chi-square test. .
Time frame: Completion of initial survey to completion of follow up survey (total estimated time is 3 months)
Feasibility of Intervention Measure (FIM) - Adapted
FIM will be assessed by implementation champions' response to a single item from the FIM measure on the initial and follow up survey. FIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater feasibility of the intervention in practice. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Acceptability of Intervention Measure (AIM) - Adapted
AIM will be assessed by implementation champions' response to a single item from the AIM measure on the initial and follow up survey. AIM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater acceptability by subjects of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)
Intervention Appropriateness Measure (IAM) - Adapted
IAM will be assessed by implementation champions' response to a single item from the IAM measure on the initial and follow up survey. IAM is measured by a 5-point Likert scale: 1-Completely disagree, 2-Disagree, 3-Neither agree nor Disagree, 4-Agree, or 5-Completely agree. A higher score indicates greater appropriateness of the intervention. Outcome will be summarized using means and 95% confidence intervals. Changes between surveys will be analyzed by a two-sample t-test.
Time frame: At start of recruitment and at completion recruitment (total estimated time is 2 years)