Supporting Decisions About Health Insurance to Improve Care for the Uninsured

Health Literacy Clinical Trial

Official title:

Supporting Decisions About Health Insurance to Improve Care for the Uninsured

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522624
• Other study ID #: 201407058
• Secondary ID: 5R01MD008808-02
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: January 30, 2018
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Insurance
• Health Literacy
• Health Services Accessibility
• Informed Decision Making

Intervention

Behavioral:
• Decision Aid (DA)
Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care.

Locations

Country	Name	City	State
United States	The Washington University in St. Louis School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Score (% Correct)	8 questions developed in researchers' past work. Assessed health insurance knowledge.	Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Primary	Decision Self-efficacy	The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one's decision-making ability.	Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Primary	Confidence in Choice	The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice. The scale ranged from 0-4.	Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Secondary	Improvements in HILM 1 (Health Insurance Literacy Measure)	Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from "not confident" pre-intervention to "a little confident" or "very confident" post-intervention, or from "a little confident" pre-intervention to "very confident" post-intervention.	Pre-intervention and post-intervention
Secondary	Improvements in HILM 2 (Health Insurance Literacy Measure)	Assessed confidence understanding terms.Improvement in HILM was defined as moving from "not confident" pre-intervention to "a little confident" or "very confident" post-intervention, or from "a little confident" pre-intervention to "very confident" post-intervention.	Pre-intervention and post-intervention
Secondary	Intended Choice Metal Level	Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).	Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.