An interventional study of Decision Aid (DA) in Health Literacy, Health Insurance and Health Services Accessibility, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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.
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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Behavioral: Decision Aid (DA)
Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
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.
Knowledge Score (% Correct)
8 questions developed in researchers' past work. Assessed health insurance knowledge.
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
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.
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
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.
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
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.
Time frame: Pre-intervention and post-intervention
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.
Time frame: Pre-intervention and post-intervention
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).
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Recruitment occurred between 10/2015 - 1/2016 via community events, online advertisements, social service organizations, and the recruitment/retention arm of our Center for Community-Engaged Research.
| Milestone | Decision Aid (DA) | Control |
|---|---|---|
| Started | 165 | 163 |
| Completed | 164 | 163 |
| Not completed | 1 | 0 |
| Withdrew: Technical failure | 1 | 0 |
8 questions developed in researchers' past work. Assessed health insurance knowledge.
| percentage of 8 items correctly answered | Decision Aid (DA) | Control |
|---|---|---|
| Knowledge Score (% Correct) | 77.6 ± 18.2 | 58.8 ± 21.0 |
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.
| units on a scale | Decision Aid (DA) | Control |
|---|---|---|
| Decision Self-efficacy | 81.5 ± 22.5 | 73.0 ± 20.4 |
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.
| units on a scale | Decision Aid (DA) | Control |
|---|---|---|
| Confidence in Choice | 3.5 ± 0.9 | 2.9 ± 1.3 |
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.
| participants | Decision Aid (DA) | Control |
|---|---|---|
| Yes | 66 | 49 |
| No | 98 | 113 |
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.
| participants | Decision Aid (DA) | Control |
|---|---|---|
| Yes | 88 | 51 |
| No | 76 | 111 |
Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).
| participants | Decision Aid (DA) | Control |
|---|---|---|
| Catastrophic | 0 | 5 |
| Bronze | 41 | 108 |
| Silver | 121 | 30 |
| Gold | 0 | 9 |
| Platinum | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decision Aid (DA) | — | 0/165 (0%) | 0/165 (0%) |
| Control | — | 0/163 (0%) | 0/163 (0%) |
| Age, Continuous(years) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| Mean | 43.1 ± 13.2 | 41.4 ± 12.5 | 42.3 ± 12.9 |
| Sex: Female, Male(Participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| Female | 97 | 94 | 191 |
| Male | 67 | 69 | 136 |
| Race/Ethnicity, Customized(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| Not Hispanic | 156 | 159 | 315 |
| Hispanic | 8 | 4 | 12 |
| Race/Ethnicity, Customized(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| African American only | 96 | 107 | 203 |
| Caucasian only | 46 | 41 | 87 |
| Other (Including Mixed) | 22 | 15 | 37 |
| Education(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| Less than HS | 12 | 15 | 27 |
| HS or GED | 111 | 99 | 210 |
| College + | 41 | 49 | 90 |
| % Federal Poverty Line(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| < 100 | 72 | 94 | 166 |
| 100-249 | 64 | 47 | 111 |
| 250-399 | 15 | 10 | 25 |
| 400+ | 13 | 8 | 21 |
| Urbanicity(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| Rural | 9 | 11 | 20 |
| Suburban | 97 | 99 | 196 |
| Urban | 58 | 53 | 111 |
| Total number covering(participants) | Decision Aid (DA) | Control | Total |
|---|---|---|---|
| 1 | 97 | 106 | 203 |
| 2 | 32 | 21 | 53 |
| 3+ | 35 | 36 | 71 |
8 further baseline measures are reported on the registry.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine