Reducing Assessment Barriers for Patients With Low Literacy

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

Detailed Description
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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.

Official Title
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Reducing Assessment Barriers for Patients With Low Health Literacy

Conditions
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Health Literacy

Intervention / Treatment
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* Other: Computerized Talking Touchscreen
* Other: Phone Administration of Questionnaires


Participation Criteria
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Eligibility Criteria
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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: Enrollment in the in-person protocol (including all inclusion/exclusion criteria from in-person protocol) Access to reliable phone connection Be willing to participant in three phone-based sessions Exclusion criteria: Unable to complete the consent process Inadequate hearing for phone-based assessments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a two-group, three time-point experimental design. The two study groups are paper-and-pencil questionnaires versus a computerized talking touchscreen interface. The three time points are baseline, 3-month follow-up, and 6-month follow-up. Additionally, due to the COVID-19 pandemic, participants can optionally enroll in a phone-based assessment that includes 3 time-points over 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pen-and-paper format<br>Based on randomization, participants in this group will receive traditional pen-and-paper questionnaires about health. | Other: Phone Administration of Questionnaires<br>* This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.<br>|
| Experimental: Computerized Talking Touchscreen<br>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. | Other: Computerized Talking Touchscreen<br>* The intervention is a computerized talking touchscreen designed to aid people with low health literacy. All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand.<br>Other: Phone Administration of Questionnaires<br>* This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention. This method was used during the COVID-19 pandemic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Anxiety Subscale | A primary outcome of this study will be the degree of DIF in NIH PROMIS questionnaire Anxiety subscale observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. The pseudo R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the US population mean. Items are aggregated using item response theory, but aggregation is not relevant here because the McFadden pseudo-R2 is evaluated for each item. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with anxiety determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF. | 6 months | 
| Patient Health Questionnaire (PHQ-9) | A primary outcome of this study will be the degree of DIF observed in the Patient Health Questionnaire (PHQ-9), a questionnaire used to measure depression across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. Pseudo-R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R2 is evaluated for each item, not for aggregate scores. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with depression determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF. | 6 months | 
| The Degree of Differential Item Functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Depression Subscale | A primary outcome will be the degree of DIF in NIH PROMIS questionnaire Depression subscale observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square (R2), which captures the degree to which health-literacy group determines probability of response type for each item. The pseudo R2 is an analogue to R2 used in linear regression. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the US population mean. Items are aggregated using item response theory, but aggregation is not relevant here because the McFadden pseudo-R2 is evaluated for each item. We report the maximum DIF value across items by condition. Pseudo-R2 values express how much health literacy and/or health literacy's interaction with depression determine the probability of response. Higher values correspond to higher DIF; lower values correspond to lower DIF. | 6 months |