Health LiteracyNCT02522624
Supporting Decisions About Health Insurance to Improve Care for the Uninsured
A study testing Decision Aid (DA) in people with Health Literacy and Health Insurance, run by Washington University School of Medicine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Health Insurance, Health Services Accessibility
- What is being tested?
- Decision Aid (DA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Health Literacy, Health Insurance, Health Services Accessibility, Informed Decision Making
- Being tested
- Decision Aid (DA)
- Keywords
- Health insurance, Health services accessibility, Decision making, Health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid (DA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid (DA) | Experimental | The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. Receives: Behavioral: Decision Aid (DA) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Score (% Correct)
8 questions developed in researchers' past work. Assessed health insurance knowledge.
Measured: 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.
Measured: 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.
Measured: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Mary C Politi, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522624
- Sponsor's protocol ID
- 201407058
- Other IDs
- 5R01MD008808-02
- Status last verified
- Jan 2018
- First submitted
- 6 Aug 2015
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Decisions About Health Insurance to Improve Care for the Uninsured
- ClinicalTrials.gov ID
- NCT02522624
- Acronym / sponsor ID
- 201407058
- Conditions
- Health Literacy, Health Insurance, Health Services Accessibility, Informed Decision Making
- Keywords
- Health insurance, Health services accessibility, Decision making, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid (DA) | Experimental | Behavioral: Decision Aid (DA)The decision aid (DA) will be provided to participants randomized to the experimental/intervention group. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Decision Aid (DA) |
Primary outcome
Knowledge Score (% Correct)
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
8 questions developed in researchers' past work. Assessed health insurance knowledge.
Decision Self-efficacy
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
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.
Confidence in Choice
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
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.
3 secondary outcomes
Improvements in HILM 1 (Health Insurance Literacy Measure)
Time frame: Pre-intervention and post-intervention
Improvements in HILM 2 (Health Insurance Literacy Measure)
Time frame: Pre-intervention and post-intervention
Intended Choice Metal Level
Time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26880251Politi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary C Politi, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid (DA) in people with Health Literacy and Health Insurance, 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 3 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 28 Feb 2018. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (% Correct) (time frame: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.). 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 NCT02522624, which also lists 1 linked publication.
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 28 Feb 2018.