Clinical trial NCT02522624: Supporting Decisions About Health Insurance to Improve Care for the Uninsured
Official title: Supporting Decisions About Health Insurance to Improve Care for the Uninsured
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Health Insurance
Health Services Accessibility
Informed Decision Making
Keywords: Health insurance
Health services accessibility
Decision making
Health literacy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2015-08-13
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall purpose of the study is to better understand how the investigators previously developed decision support (DS) tool can help people make decisions about health insurance plans available through the federal exchanges created by the Affordable Care Act (ACA). The investigators will evaluate the DS tool compared to the federal government website. The investigators will also evaluate the feasibility of disseminating this tool. There are two primary aims to be completed in this project: (1) examine the reach and effectiveness of the health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of implementation of the DS tool.

Detailed description: First, for Aim 1 part 1, the investigators will recruit 40 key stakeholders (uninsured participants, health providers, community advisors, and health policy experts) to refine the DS tool through a series of individual semi-structured interviews. Next, the investigators will use their feedback to program the DS strategies into an online DS tool. After its initial production, the tool will be pilot tested with 30 individuals to assess readability, message clarity, format, and function of the tool as well as to test the randomized trial study procedures. Then, for Aim 1 part 2, the investigators will test the DS tool in a randomized trial with 362 participants eligible for the Affordable Care Act (ACA) exchanges. Half will use the DS tool and the other half will use the federal government site to learn about the exchanges. The investigators will use computerized random assignment to assign participants to study condition, after which they will all complete the same short survey. For Aim 2, the investigators will collect 40 stakeholders' feedback on likelihood of adoption and implementation of the DS tool to plan for dissemination and implementation. Stakeholders will be asked both open-ended and closed-ended questions in order to gather feedback about delivering the DS tool. These stakeholders will be different from those who were interviewed in Aim 1 as to ensure broader applicability of the DS tool.

Eligibility criteria: Inclusion Criteria:

* Must be without health insurance currently; or
* Must be enrolled in one of the ACA exchange plans in the past 1 year; and
* Must speak English

Exclusion Criteria:

* Currently has health insurance that was not provided by being enrolled in one of the ACA exchange plans in the past year
* Currently has health insurance that is provided through public insurance or private employer-based insurance
* Does not speak English

Primary outcomes:
measure: Knowledge Score (% Correct)
timeFrame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
measure: Decision Self-efficacy
timeFrame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
measure: Confidence in Choice
timeFrame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Secondary outcomes:
measure: Improvements in HILM 1 (Health Insurance Literacy Measure)
timeFrame: Pre-intervention and post-intervention
measure: Improvements in HILM 2 (Health Insurance Literacy Measure)
timeFrame: Pre-intervention and post-intervention
measure: Intended Choice Metal Level
timeFrame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: The Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary C Politi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.