Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Partnership Approach to Enhance Health Care Literacy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by University of Michigan
Sponsor:
Collaborator:
National Institute for Health Care Reform
Information provided by (Responsible Party):
Minal Patel, University of Michigan
ClinicalTrials.gov Identifier:
NCT02915003
First received: September 20, 2016
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
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."

Condition Intervention
Insurance, Health
Behavioral: E-health website

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Partnership Approach to Enhance Health Care Literacy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ]
    self-reported assessment of confidence in navigating several facets of health insurance that will be summed for a single score


Secondary Outcome Measures:
  • Change from baseline questionnaire measure of health insurance status at 6 and 9 months [ Time Frame: baseline, 6 months, 9 months ]
    participants will be asked if they are enrolled in a health insurance plan at the time of assessment

  • Change from baseline measure questionnaire measure of Knowledge about the Affordable Care Act at 6 and 9 months [ Time Frame: baseline, 6 months, 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

  • Change from baseline use of questionnaire measures of preventative health services at 6 and 9 months [ Time Frame: baseline, 6 months, 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.


Estimated Enrollment: 240
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E-health website intervention
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.
Behavioral: E-health website
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.
No Intervention: Control
usual health insurance navigation, and ACA materials provided by social service agencies and clinics where individuals seek services.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ages 18-64
  2. identify as African American, Latino/Hispanic, or Arab American
  3. access to a telephone

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02915003

Contacts
Contact: Minal R Patel, PhD, MPH 734-763-0087 minalrp@umich.edu

Sponsors and Collaborators
University of Michigan
National Institute for Health Care Reform
Investigators
Principal Investigator: Minal R Patel, PhD, MPH Univeristy of Michigan
  More Information

Responsible Party: Minal Patel, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02915003     History of Changes
Other Study ID Numbers: HUM00097758
Study First Received: September 20, 2016
Last Updated: September 22, 2016

Keywords provided by University of Michigan:
health care navigation
health literacy
Affordable Care Act

ClinicalTrials.gov processed this record on April 26, 2017