Reducing Assessment Barriers for Patients With Low Literacy

Northwestern University

Status: Completed

Conditions: Health Literacy

Treatments: Other: Computerized Talking Touchscreen; Other: Phone Administration of Questionnaires

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03584490

1R01MD010440-01A1 (U.S. NIH Grant/Contract)

STU00202907

Details and patient eligibility

About

The purpose of this study is to determine the effects of health literacy on questionnaire-based measurement.

Full description

Low health literacy as a barrier to healthcare. Health literacy is defined as "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions." A vast body of research shows that lower health literacy is associated with poorer outcomes, including higher hospitalization rates, worse health, and greater mortality. Approximately 75 million U.S. adults have low health literacy. Worse yet, racial and ethnic minorities and older individuals (age 65+) are more likely to have low health literacy, creating another mechanism for health disparities. These data indicate that many people will have difficulties adhering to treatment regimens that require health literacy, as well as completing questionnaires for public health and health research and care.

Improving self-report assessment. Health surveys are ubiquitous, but almost no questionnaires used across the country have been validated for use with people who have low health literacy. This is a glaring shortcoming in current survey validation methodology; inaccurate surveys lead to false conclusions and threaten the empirical foundation of everyone's efforts to understand and improve public health, healthcare, and health outcomes. Our goal is to rectify this shortcoming. This study will 1) determine the effect of health literacy on widely-used questionnaires, 2) determine the stability of psychometric properties of questionnaires over time, and 3) test various testing formats to determine which ones work best for people with low health literacy.

Due to the COVID-19 pandemic, the study will implement phone-based assessments in addition to the original in-person protocol described above. The phone-based assessments will only be available to enrolled or previously enrolled participants. Participants will be asked questionnaires over the phone by a research coordinator at 3 time-points over 6 months.

Enrollment: 729 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older
• Be willing to provide informed consent, including signing the consent form
• Be willing to be randomized to administration method
• Be willing to complete questionnaires and interviews
• Be fluent in English and/or Spanish
• Be willing to attend three face-to-face sessions
• Have no plans to move out of the study area in the next six months

Exclusion criteria

• Significant cognitive or neurologic impairment
• Being a prisoner, detainee, or in police custody
• Unable to complete the consent process
• Inadequate vision to see study materials (worse than 20/80 corrected)
• Inadequate hearing or manual dexterity to use the computer system

Phone-based protocol:

Inclusion criteria:

1. Enrollment in the in-person protocol (including all inclusion/exclusion criteria from in-person protocol)
2. Access to reliable phone connection
3. Be willing to participant in three phone-based sessions

Exclusion criteria:

1. Unable to complete the consent process
2. Inadequate hearing for phone-based assessments

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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729 participants in 2 patient groups

Pen-and-paper format

Active Comparator group

Description:

Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health.

Treatment:

Other: Phone Administration of Questionnaires

Computerized Talking Touchscreen

Experimental group

Description:

This group will receive the Computerized Talking Touchscreen intervention. Based on randomization, participants in this group will receive a computerized talking touchscreen version of our health questionnaires, which allows the participant to have questions and answer choices read aloud to them by the computer.

Treatment:

Other: Phone Administration of Questionnaires

Other: Computerized Talking Touchscreen