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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MD008808-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid (DA) | Experimental | The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid (DA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary C Politi, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Washington University in St. Louis School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26880251 | Derived | 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. |
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482 participants were assessed for eligibility. Participants were excluded (n=154) if they did not meet the inclusion criteria (n=82) or could not be reached (n=65).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Aid (DA) | The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. 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. |
| FG001 | Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Aid (DA) | The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge Score (% Correct) | 8 questions developed in researchers' past work. Assessed health insurance knowledge. | Posted | Mean | Standard Deviation | percentage of 8 items correctly answered | Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Aid (DA) | The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary C. Politi, PhD | Washington University's School of Medicine | 314-747-1968 | politim@wudosis.wustl.edu |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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 |
| 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. |
| Control |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Education | Number | participants |
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| % Federal Poverty Line | Four participants in the healthcare.gov condition did not report FPL (n=159) | Number | participants |
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| Urbanicity | Number | participants |
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| Total number covering | Number | participants |
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| Smoking status - Participant | Number | participants |
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| Smoking status - Dependent (n=124) | n=124 | Number | participants |
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| Chronic Conditions - Participant (n=207) | Only participants specifying they have a chronic condition were asked to provide the number of chronic conditions. | Mean | Standard Deviation | Number chronic conditions |
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| Chronic Conditions - Participant + Dependents (n=107) | Only participants with dependents were asked to provide the number of chronic conditions anyone in their household had (if any). | Mean | Standard Deviation | Number chronic conditions |
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| Insurance Status (Uninsured) | Number | participants |
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| Health Literacy (SILS) | The Single Item Literacy Screener (SILS) assessed broader health literacy. The SILS is a single item question intended to identify adults in need of help with printed health material scored on a scale from 1-5 (1 indicating never needing help with printed health material; 5 indicating always needing help with printed health material). Participants with scores greater than 2 were categorized into the "limited" health literacy category; remaining participants were categorized into "adequate" category. One participant in the healthcare.gov condition did not complete the SNS or SILS (n=162) | Number | participants |
|
| Subjective Numeracy (SNS) | Three items from the Subjective Numeracy Scale (SNS) assessed numeracy skills. The SNS is a self-report measure scored from 1-6, with larger values indicating greater perceived ability with mathematical tasks. Scores from each of the three items were summed and averaged to obtain a composite score. Values for Range are the actual score range obtained from the study's participants. One participant in the healthcare.gov condition did not complete the SNS or SILS (n=162) | Mean | Full Range | units on a scale |
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| Objective Numeracy (Lipkus) | Four items from a validated objective numeracy scale assessed numeracy skills. Each of the open-ended responses to the four items were scored correct or incorrect. The number of correct items were summed to obtain a summary score. Values for Range are the actual score range obtained from the study's participants.The mean of the summary score was obtained to provide average scores for the DA and Control groups. | Mean | Full Range | units on a scale |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete. |
|
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete. |
|
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|
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| 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. | One participant in healthcare.gov (Control) condition did not finish HILM (n=162) | Posted | Number | participants | Pre-intervention and post-intervention |
|
|
|
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| 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. | One participant in healthcare.gov (Control) condition did not finish HILM (n=162) | Posted | Number | participants | Pre-intervention and post-intervention |
|
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|
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| 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). | Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152) | Posted | Number | participants | Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete. |
|
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|
|
| 0 |
| 165 |
| 0 |
| 165 |
| EG001 | Control | 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. | 0 | 163 | 0 | 163 |
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| Regression, Linear |
| 0.30 |
| Superiority or Other |
| Controlling for Numeracy. | Regression, Linear | 0.82 | Superiority or Other |
| Regression, Linear |
| 0.82 |
| Superiority or Other |
| Controlling for Numeracy. | Regression, Linear | 0.15 | Superiority or Other |
Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).
| Regression, Logistic |
| 0.26 |
| Superiority or Other |
| Controlling for Numeracy. | Regression, Linear | 0.58 | Superiority or Other |
Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).
| Regression, Logistic |
| 0.39 |
A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power. |
| Superiority or Other |
| Controlling for Numeracy. | Regression, Linear | 0.57 | Superiority or Other |
| Silver |
|
| Gold |
|
| Platinum |
|
Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).
| Regression, Logistic |
| 0.001 |
A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power. |
| Superiority or Other |
| Controlling for numeracy. | Regression, Linear | 0.46 | Superiority or Other |