AzTrials
AzTrials

Insurance, HealthNCT02915003

A Partnership Approach to Enhance Health Care Literacy

A study testing E-health website in people with Insurance, Health, run by University of Michigan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

With the help of local focus groups, the investigators are designing and testing a website to help urban people have better access to health care through understanding their insurance options better. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Insurance, Health
What is being tested?
E-health website
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
No sites listed yet
Study dates
20 Sep 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

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

  • ages 18-64
  • identify as African American, Latino/Hispanic, or Arab American
  • access to a telephone

Who cannot join

  • -

About this study

With the help of local focus groups, the investigators are designing and testing a website to help urban people have better access to health care through understanding their insurance options better. They hypothesize that once individuals engage with the website and go through all of its modules, they will: 1) become more informed consumers of the ACA and its health insurance options; 2) enroll in an insurance plan; and 3) better leverage the benefits of their existing plans."

Read the detailed description

The Affordable Care Act (ACA) has afforded millions of Americans with both greater access to and greater affordability of health insurance and its associated benefits. However, limited resources have been devoted for effective ACA outreach and enrollment - especially in states that did not create their own health insurance exchanges such as Michigan. Federally Qualified Health Centers (FQHCs) in Detroit are vital to meeting the health and medical care needs of the local community. However, they face long-term sustainability challenges, particularly related to their financial capacity, which can be augmented by increasing the number of insured patients that they serve.

The goal of the proposed project is to establish a new community-based participatory research (CBPR) partnership aimed at enhancing health care literacy of community residents of Detroit as it relates to the implementation of the ACA, through the design, implementation and evaluation of the effectiveness of an intervention trial. In accordance with the principles of CBPR, a Steering Committee will be established, involving four FQHCs and social service agencies working in Detroit, four community partner organizations, and academic members of the research team. The investigators will first conduct 9 focus groups with Detroit residents who use the local FQHCs and social service agencies and 1 focus group with health care navigators in order to inform the development of the e-Health intervention and better ascertain the healthcare literacy challenges residents face accessing information about the ACA. The investigators propose to develop and evaluate a healthcare literacy, e-Health intervention embedded with short, culturally and locally-tailored videos informed by behavior change principles that will teach patients/families about: the importance and benefits of health insurance, ACA coverage provisions and local insurance options available to them, the specifics of the new law and how it affects them, and how to navigate local systems and resources to obtain and maintain health insurance. They will recruit 240 patients/families seen at 4 local-area FQHC and social service sites to examine whether patient use of the website increases health care literacy and encourages individuals to enroll in health insurance plans. They will employ a randomized cross-over lagged research design where 120 patient/families seen at 2 FQHC and social service sites will be approached to use the website. The investigators will also identify 120 patients/families seen at 2 other sites who will serve as a lagged control group in the first segment of the study. Both the 120 intervention patients/families and the lagged control patient/families will be asked to complete a questionnaire about the ACA and other pertinent issues at the onset of the study. Six months later, they will again survey the patients in both groups (using the same survey instrument) to see whether any differences between the groups can be detected after 6 months. At that time, the 100 patient/families in the lagged control group will then be given the website (treatment) and they will follow them for 3 months. The investigators hypothesize that once individuals engage with the website and go through all of its modules, they will: 1) become more informed consumers of the ACA and its health insurance options; 2) enroll in an insurance plan; and 3) better leverage the benefits of their existing plans.

Being tested
E-health website
Keywords
health care navigation, health literacy, Affordable Care Act

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-health websiteBehavioural

    e-Health website embedded with short, culturally and locally-tailored videos informed by behavior change principles that will teach patients/families about: the importance and benefits of health insurance, ACA coverage provisions and local insurance options available to them, the specifics of the new law and how it affects them, and how to navigate local systems and resources to obtain and maintain health insurance.

Study groups in NCT02915003
Study groupRoleWhat they receive
E-health website interventionExperimentale-Health website embedded with short, culturally and locally-tailored videos informed by behavior change principles that will teach patients/families about: the importance and benefits of health insurance, ACA coverage provisions and local insurance options available to them, the specifics of the new law and how it affects them, and how to navigate local systems and resources to obtain and maintain health insurance.
Receives: Behavioral: E-health website
ControlNo interventionusual health insurance navigation, and ACA materials provided by social service agencies and clinics where individuals seek services.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline questionnaire measures of self-efficacy in navigating health insurance options at 6 and 9 months

    self-reported assessment of confidence in navigating several facets of health insurance that will be summed for a single score

    Measured: baseline, 6 months, 9 months

Secondary outcomes (3)
  1. Change from baseline questionnaire measure of behavioral intention with health insurance navigation at 6 and 9 months

    participants will be asked if they intend to enroll in a health insurance plan or seek help at the time of assessment

    Measured: baseline, 6 months, 9 months

  2. Change from baseline measure questionnaire measure of Knowledge about the Affordable Care Act at 6 and 9 months

    participants will be asked a series of true/false statements about key provisions of the Affordable Care Act. A knowledge score will be generated based on the sum of responses from the knowledge questionnaire

    Measured: baseline, 6 months, 9 months

  3. Change from baseline use of questionnaire measures of beliefs around preventative health services use at 6 and 9 months

    participants will be asked if they have a usual source of care and have seen a doctor for routine care. Each item will be analyzed individually, and scores will be created for a sum of responses.

    Measured: baseline, 6 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study start20 Sep 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915003
Sponsor's protocol ID
HUM00116683
Status last verified
Apr 2018
First submitted
20 Sep 2016
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing E-health website in people with Insurance, Health, run by University of Michigan.

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 1 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline questionnaire measures of self-efficacy in navigating health insurance options at 6 and 9 months (time frame: baseline, 6 months, 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Apr 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in