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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03592433
Other study ID # 201704045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date February 28, 2019

Study information

Verified date April 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.


Description:

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 263
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Ability to read English

- Diagnosed with cancer in the past 5 years

- Residing in Missouri or Illinois

Exclusion Criteria:

- Eligible for Medicaid or Medicare in Missouri or Illinois

- Enrolled in the following types of health insurance plans: Medicare, Medicaid, TRICARE or other military healthcare, or Indian Health Services

Study Design


Intervention

Behavioral:
I Can PIC
Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Housten AJ, Furtado K, Kaphingst KA, Kebodeaux C, McBride T, Cusanno B, Politi MC. Stakeholders' perceptions of ways to support decisions about health insurance marketplace enrollment: a qualitative study. BMC Health Serv Res. 2016 Nov 8;16(1):634. — View Citation

Politi MC, Barker AR, Kaphingst KA, McBride T, Shacham E, Kebodeaux CS. Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri. BMC Health Serv Res. 2016 Feb 16;16:55. doi: 10.1186/s12913-016-1314-9. — View Citation

Politi MC, Kuzemchak MD, Liu J, Barker AR, Peters E, Ubel PA, Kaphingst KA, McBride T, Kreuter MW, Shacham E, Philpott SE. Show Me My Health Plans: Using a Decision Aid to Improve Decisions in the Federal Health Insurance Marketplace. MDM Policy Pract. 2016 Jul;1. doi: 10.1177/2381468316679998. Epub 2016 Nov 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge Score The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions. Completed immediately after using I Can PIC
Primary Decision Self-efficacy The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions). Completed immediately after using I Can PIC.
Primary Certainty about Choice (Decisional Conflict Scale) The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice. Completed immediately after using I Can PIC
Secondary Health Insurance Literacy Measure Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms. Completed immediately after using I Can PIC
Secondary Health Insurance Literacy Measure Two items from the validated Health Insurance Literacy Measure will be used. This scale measures consumers' confidence in their ability to estimate their annual health care costs and their understanding of health insurance terms.
This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Secondary Choice of Health Insurance Plan Participants will be asked what health insurance plan they would choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses. Completed immediately after using I Can PIC
Secondary Choice of Health Insurance Plan Participants will be asked what health insurance plan they choose. Plan selections will be categorized by the type of plan, e.g., high deductible plan, PPO, silver-tier Marketplace plan, gold-tier Marketplace plan, and will be compared to our algorithmic prediction about good fit plans for users based on estimates of their health care expenses.
This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Secondary Healthcare Utlization Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization 3 month follow-up
Secondary Knowledge Score The percent correct out of eight questions that were created by the research team based on information that is considered vital to making health insurance decisions.
This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
Secondary Certainty about Choice (Decisional Conflict Scale) The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice, and feel they have enough support to make a choice.
This measure will be assessed at follow-up to see if differences observed between groups immediately post-intervention, remain at follow-up.
3 month follow-up
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