Viewing Study NCT02915003


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Study NCT ID: NCT02915003
Status: COMPLETED
Last Update Posted: 2018-04-10
First Post: 2016-09-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: A Partnership Approach to Enhance Health Care Literacy
Sponsor: University of Michigan
Organization:

Study Overview

Official Title: A Partnership Approach to Enhance Health Care Literacy
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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. 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."
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: