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The goal of this randomized clinical trial is to learn if participants are better able to understand medical handouts written at below a sixth grade reading level compared to those written at above a sixth grade reading level. The main question it aims to answer is:
• Do participants score higher on a knowledge test after reading a handout written at below a sixth grade reading level compared to after reading a handout written at above a sixth grade reading level?
Researchers will compare knowledge scores on pelvic organ prolapse after participants read a handout written at an eight grade reading level compared to the same handout re-written to be at a fifth grade reading level.
Participants will:
The secondary objective is to determine characteristics of patients whose knowledge levels are higher after reading educational material written below a sixth grade reading level compared to material written above a sixth grade reading level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Below Sixth Grade Reading Level | Experimental | Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level. |
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| Above Sixth Grade Reading Level | Active Comparator | Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handout Written at Below a Sixth Grade Reading Level | Other | Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level. |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge Assessment Score | Mean number of correct answers from 0 to 12 on the validated Prolapse Knowledge Questionnaire where 0 indicates 0 correct answers (worst knowledge score) and 12 indicates all correct answers (best knowledge score). | Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes |
| Participant-reported Handout Utility | Percentage of participants who respond "Yes" that reading the handout increased their understanding of pelvic organ prolapse on a Yes/No/Don't know scale. | Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertie Geng, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX | Raleigh | North Carolina | 27607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18480958 | Background | Shah AD, Massagli MP, Kohli N, Rajan SS, Braaten KP, Hoyte L. A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1283-9. doi: 10.1007/s00192-008-0631-x. Epub 2008 May 15. |
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Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 12 months following publication until 36 months following publication.
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| Handout Written at Above a Sixth Grade Reading Level | Other | Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level. |
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