Patient materials are often written above the reading level of most adults. Tool 11 of the Health Literacy Universal Precautions Toolkit ("Design Easy-to-Read Material") provides guidance on ensuring that written patient materials are easy to understand. As part of a pragmatic demonstration of the Toolkit, we examined how four primary care practices implemented Tool 11 and whether written materials improved as a result. We conducted interviews to learn about practices' implementation activities and assessed the readability, understandability, and actionability of patient education materials collected during pre-and postimplementation site visits. Interview data indicated that practices followed many action steps recommended in Tool 11, including training staff, assessing readability, and developing or revising materials, typically focusing on brief documents such as patient letters and information sheets. Many of the revised and newly developed documents had reading levels appropriate for most patients and-in the case of revised documents-better readability than the original materials. In contrast, the readability, understandability, and actionability of lengthier patient education materials were poor and did not improve over the 6-month implementation period. Findings guided revisions to Tool 11 and highlighted the importance of engaging multiple stakeholders in improving the quality of patient materials.Address correspondence to Angela G. Brega, Department of Community and Behavioral Health, Colorado School of Public Health, 13055 East 17th Avenue, Mail Stop F800, Aurora, CO 80045, USA. angela.brega@ucdenver.edu. HHS Public AccessAuthor manuscript J Health Commun. Author manuscript; available in PMC 2016 October 28. Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptHealth literacy plays a critical role in comprehension of written health-related materials. And yet numerous studies show that the reading level of patient materials often exceeds the reading skills of many adults. It is estimated that the average U.S. adult can comprehend text written at the eighthto ninth-grade level (Doak, Doak, & Root, 1996; Institute of Medicine Committee on Health Literacy, 2004; National Work Group on Literacy and Health, 1998), although literacy skills are substantially lower among older and low-income adults (Doak et al., 1996;Kutner, Greenberg, Jin, & Paulsen, 2006;Weiss et al., 1994). In contrast, patient materials are often written at or above the 10th-grade level (Aliu & Chung, 2010;Helitzer, Hollis, Cotner, & Oestreicher, 2009;Kaphingst, Zanfini, & Emmons, 2006;Vallance, Taylor, & Lavallee, 2008;Wallace, Turner, Ballard, Keenum, & Weiss, 2005). These high reading levels, in addition to other features that can make documents difficult to understand (e.g., the use of medical terms), render many patient materials unusable for millions of Americans.The Agency for Healthcare Research and Quality developed the Health Literacy Universal Precautions Toolkit to support primary care practices in thei...