AzTrials
AzTrials

CancerI Can PICNCT03592433

Improving Cancer Patients' Insurance Choices

A study testing I Can PIC in people with Cancer and Health Literacy, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Cancer, Health Literacy, Health Insurance
What is being tested?
I Can PIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
1 siteUnited States
Study dates
27 Jun 2018to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ability to read English
  • Diagnosed with cancer in the past 5 years
  • Residing in Missouri or Illinois

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Supporting Cancer Survivors' Health Insurance Marketplace Decisions

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.

Read the detailed 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.

Being tested
I Can PIC
Keywords
Decision Making, Decision Support, Health Literacy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I Can PICBehavioural

    Also called Decision Aid (DA)

    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.

Study groups in NCT03592433
Study groupRoleWhat they receive
I Can PICExperimentalThe I Can PIC website will be provided to participants randomized to the experimental/intervention group.
Receives: Behavioral: I Can PIC
Attention ControlNo interventionParticipants randomized to the attention control group will be provided a link to a website developed by the American Cancer Society Cancer Action Network.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Completed immediately after using I Can PIC

  2. 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).

    Measured: Completed immediately after using I Can PIC.

  3. 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.

    Measured: Completed immediately after using I Can PIC

Secondary outcomes (7)

  1. 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.

    Measured: Completed immediately after using I Can PIC

  2. 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.

    Measured: 3 month follow-up

  3. 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.

    Measured: Completed immediately after using I Can PIC

  4. 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.

    Measured: 3 month follow-up

  5. Healthcare Utlization

    Participants will be asked questions about how often they use healthcare services to see if their plan choice relates to their utilization

    Measured: 3 month follow-up

  6. 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.

    Measured: 3 month follow-up

  7. 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.

    Measured: 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start27 Jun 2018
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03592433
Sponsor's protocol ID
201704045
Acronym
I Can PIC
Status last verified
Apr 2019
First submitted
26 Jun 2018
Last updated
1 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1186/s12913-016-1890-8.

    PubMed 27821121

  • 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.

    PubMed 26880251

  • 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(1):2381468316679998. doi: 10.1177/2381468316679998. Epub 2016 Nov 16.

    PubMed 28804780

Questions about this trial

What is this clinical trial studying?

A study testing I Can PIC in people with Cancer and Health Literacy, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge Score (time frame: Completed immediately after using I Can PIC). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03592433, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

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