Reading Level Adjustment for Health Literacy

Overseen By Christine M Chu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Unable to read English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if people understand medical information better when written in simpler language. Participants will read a handout about pelvic organ prolapse, written at either a fifth-grade or eighth-grade level. After reading, they will take a short quiz to assess their understanding. This study is ideal for those who can read and understand English and are comfortable completing a paper questionnaire. As an unphased study, it offers participants the opportunity to contribute to improving patient education materials.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe?

This study involves no new treatments or safety concerns for participants. The goal is to understand written materials, not to test a new drug or procedure. Participants will read a handout about pelvic organ prolapse, which will be either simple or more detailed.

Research has shown that simplifying medical information can enhance understanding of health topics. This study examines whether using simpler language improves comprehension. There are no risks, as the only activity is reading. No reports of problems have arisen from reading educational materials.

Overall, the study is safe because it only involves reading different versions of a handout. There is no physical or medical treatment involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tackles health literacy by adjusting the reading level of medical handouts for pelvic organ prolapse. Unlike standard handouts that might be too complex for some patients, this approach uses simpler language, making it more accessible to individuals with lower literacy skills. By ensuring that everyone can understand their health information, this method could empower more patients to make informed decisions about their care.

What evidence suggests that this handout is effective for improving understanding of pelvic organ prolapse?

Research shows that health information is often too complicated for many people to understand. Studies find that online health materials, such as those about pelvic organ prolapse, are usually written above a sixth-grade reading level, making them difficult for most people to follow. In this trial, participants will be randomized to receive either a simplified handout written below a sixth-grade level or a standard handout written above a sixth-grade level. Simplified handouts help people understand better by using easier words and clearer explanations. This method is expected to improve performance on knowledge tests by making information more accessible. By creating materials at a lower reading level, the aim is to help more people understand and make informed health decisions. ^{2 6 7 8 9}

Who Is on the Research Team?

Bertie Geng, MD

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who are being evaluated on their ability to understand medical information. There's no specific health condition required, but participants should be able to read and comprehend handouts in English to take a knowledge test afterwards.

Inclusion Criteria

Must be able to complete pen and paper questionnaire

Exclusion Criteria

Unable to understand or read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants read a one-page handout on pelvic organ prolapse and complete a multiple-choice test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for understanding and knowledge retention after reading the handout

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Handout

Trial Overview The study is testing if there's a difference in understanding when medical handouts are written at different reading levels: one below sixth grade level and another above it. Participants will be randomly assigned to read about pelvic organ prolapse at one of these levels and then tested on the material.

How Is the Trial Designed?

Group I: Below Sixth Grade Reading Level Experimental Treatment 1 Intervention

Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level.

Group II: Above Sixth Grade Reading Level Active Control 1 Intervention

Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9562075/

Patient-Centered Goals for Treatment of Pelvic Floor ... The English handouts from both IUGA and AUGS exceeded the sixth-grade level, with average readability of 10.5 grade level and 9.9 grade level ...

2. researchgate.net researchgate.net/publication/231223807_Readability_Assessment_of_Online_Urology_Patient_Education_Materials

Readability Assessment of Online Urology Patient ... Many studies have found that most online health information does not follow the protocol of creating health materials at a 6th-grade reading ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1089/jwh.2024.0160?icid=int.sj-full-text.similar-articles.1

Decision-Making Interventions for Pelvic Organ Prolapse Overall quality was low with a mean DISCERN of 48.2/80, and the mean reading grade level was 10.0. ... “There is little conversation about pelvic organ prolapse ...

4. chbrp.org chbrp.org/sites/default/files/bill-documents/AB1904/ab1904-FullReport_1.pdf

Analysis of California Assembly Bill 1904 Pelvic Floor ... Symptoms of PFD include urinary incontinence, fecal incontinence, pelvic organ prolapse, and pelvic pain. Primary risk factors for PFD include ...

5. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-020-01264-1

Pelvic organ prolapse and treatment decisions– developing ... This study formed the developmental phase of a larger study to develop and test an online tool to support shared decision-making.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12325106/

Generative AI/LLMs for Plain Language Medical ... AI-based models have the potential to act as a convenient, customizable and easy-to-access source of information that can improve patients' self ...

7. yourpelvicfloor.org yourpelvicfloor.org/media/Pelvic_Organ_Prolapse_RV2.pdf

Pelvic Organ Prolapse A Guide for Women. 1. What is pelvic organ prolapse? 2. What causes pelvic organs to prolapse? 3. Where can prolapse occur? 4. How bad is my prolapse?

8. hartfordhealthcare.org hartfordhealthcare.org/File%20Library/Services/PDFs/Pelvic-Organ-Prolapse-Patient-Education.pdf

PELVIC ORGAN PROLAPSE Pelvic Organ Prolapse (POP) refers to dissension or “falling” of the pelvic organs into the vagina. This occurs when the pelvic floor muscles, connective tissue ...

9. mayoclinic.org mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/symptoms-causes/syc-20360557

Pelvic organ prolapse - Symptoms and causes Pelvic organ prolapse is when one or more pelvic organs drop from their position. This makes a bulge in the vagina, called a prolapse.