Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

Americans' Attitudes Toward COVID-19 Preventive and Mitigation Behaviors and Implications for Public Health Communication.

PURPOSE: Identifying drivers of behavior is essential to develop effective messaging around COVID-19 prevention and mitigation. Our study assessed for behavioral antecedents of social distancing, wearing face coverings, and sheltering in place during the onset of the COVID-19 pandemic. Although ours is an early assessment, understanding motivation for behavior will remain critical as U.S. vaccination uptake has stalled and variants continue to pose a health threat. DESIGN: Cross-sectional survey; Setting: Online assessments in April 10-13 and 17-20, 2020; Subjects: 2,279 U.S. adults identified through a national, probability-based web panel (34% response rate). Measures: self-reported behavior, perceived effectiveness and risk, worry, social norms, and knowledge. ANALYSIS: Multivariable regression analyses. RESULTS: Most Americans reported social distancing (91%) and sheltering in place (86%). Just over half reported wearing face coverings (51%), whereas more (77%) said they intended to do so. Perceived effectiveness of the behavior was consistently associated with each outcome (OR = 2.34, 1.40, 2.11, respectively; all P < .01). Perceptions about the extent to which others should comply with behavior (social norms) were strongly associated with intentions to wear a face covering only (OR = 6.30, 95% CI 4.34-9.15; P < .001) and worry about getting COVID-19 was associated with sheltering in place and social distancing (OR = 2.63, 95% CI 1.15-5.00; 4.91, 95% CI 1.66, 14.50, respectively; all P < .05). CONCLUSION: Behavioral constructs were strongly associated with COVID-19 preventive and mitigation behaviors and have implications for communication.

Effects of additional context information in prescription drug information sheets on comprehension and risk and efficacy perceptions.

OBJECTIVE: To determine how additional explanatory text (context) about drug side effects in a patient medication information handout affected comprehension and perceptions of risk and efficacy. METHODS: We conducted an online experiment with a national sample of 1,119 U.S. adults with rheumatoid arthritis and related conditions, sampled through random-digit dialing, address-based sampling, and online ads. We randomized participants to receive one of several versions of a patient information handout for a fictitious drug, either with or without additional context, then measured comprehension and other outcomes. RESULTS: Additional qualitative context about warnings and side effects resulted in lower comprehension of side effect information, but not information about uses of the drug or warnings. The effect of additional context on risk perceptions depended on whether the medication handout was delivered online or through the mail. Those who received a hardcopy of the handout with additional context had higher perceived risk of side effects than those who saw the version without additional context. CONCLUSION: More clarifying information is not always better and may lead to cognitive overload, inhibiting comprehension. PRACTICE IMPLICATIONS: Additional research should further explore effects of context in online vs. hard-copy formats before practice implications can be determined.

Predictors of willingness to get a COVID-19 vaccine in the U.S.

BACKGROUND: As COVID-19 vaccine distribution efforts continue, public health workers can strategize about vaccine promotion in an effort to increase willingness among those who may be hesitant. METHODS: In April 2020, we surveyed a national probability sample of 2279 U.S. adults using an online panel recruited through address-based sampling. Households received a computer and internet access if needed to participate in the panel. Participants were invited via e-mail and answered online survey questions about their willingness to get a novel coronavirus vaccine when one became available. The survey was completed in English and Spanish. We report weighted percentages. RESULTS: Most respondents were willing to get the vaccine for themselves (75%) or their children (73%). Notably, Black respondents were less willing than White respondents (47% vs. 79%, p < 0.001), while Hispanic respondents were more willing than White respondents (80% vs. 75%, p < 0.003). Females were less likely than makes (72% vs. 79%, p < 0.001). Those without insurance were less willing than the insured (47% vs. 78%, p < 0.001). Willingness to vaccinate was higher for those age 65 and older than for some younger age groups (85% for those 65 and older vs. 75% for those 50-64, p < 0.017; 72% for those 35-49, p < 0.002; 70% for those 25-34, p = NS and 75% for ages 18-24, p = NS), but other groups at increased risk because of underlying medical conditions or morbid obesity were not more willing to get vaccinated than their lower risk counterparts. CONCLUSIONS: Most Americans were willing to get a COVID-19 vaccine, but several vulnerable populations reported low willingness. Public health efforts should address these gaps as national implementation efforts continue.

Gaps in Knowledge About COVID-19 Among US Residents Early in the Outbreak.

OBJECTIVES: The novel coronavirus disease 2019 (COVID-19) resulting from severe acute respiratory syndrome coronavirus 2 began to affect the United States in early 2020. This study aimed to assess the US public's initial understanding about the disease and virus to inform public health communication efforts. METHODS: We conducted a survey of US households from February 28 through March 2, 2020, using a probability-based web-panel survey of 1021 US residents. To assess knowledge about COVID-19, we asked respondents a series of 16 true/false questions. We conducted descriptive statistics and linear regression analyses to examine differences in knowledge scores based on demographic and background characteristics. RESULTS: Knowledge about COVID-19 and the virus was relatively low overall at the beginning of the outbreak, with average scores of 62% on a 16-item knowledge index (ie, answers for 6 of the 16 questions were incorrect or unknown). Knowledge was especially low among people who had low education and income levels, were unemployed, were Hispanic, were non-Hispanic Black, were aged 18-24 and 35-49, indicated having "other" health insurance, and had limited exposure to information about the pandemic. Non-Hispanic Black respondents were less knowledgeable about COVID-19 and the virus at every education level compared with non-Hispanic White respondents at higher education levels. Non-Hispanic Black respondents with

Mental Models of Infectious Diseases and Public Understanding of COVID-19 Prevention.

The emergence of viral diseases such as Ebola virus disease, Zika virus disease, and the coronavirus disease (COVID-19) has posed considerable challenges to health care systems around the world. Public health strategy to address emerging infectious diseases has depended in part on human behavior change and yet the perceptions and knowledge motivating that behavior have been at times inconsistent with the latest consensus of peer-reviewed science. Part of that disjuncture likely involves the existence and persistence of past ideas about other diseases. To forecast and prepare for future epidemic and pandemic response, we need to better understand how people approach emerging infectious diseases as objects of public opinion during the periods when such diseases first become salient at a population level. In this essay, we explore two examples of how existing mental models of past infectious diseases appear to have conditioned and constrained public response to novel viral diseases. We review previously reported experiences related to Zika virus in Central America and discuss public opinion data collected in the early months of the COVID-19 pandemic. In the case of Zika virus disease, we assess how thinking about earlier mosquito-borne disease seems to have affected public consideration of the virus in Guatemala. In the case of COVID-19, we assess how previous vaccination behavior for a different disease is associated with intention to obtain vaccination for COVID-19 in the future.

Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability.

BACKGROUND: Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. METHODS: Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consenting information provided via the digital decision support tool), or the comparison group (information provided via standard practice). Participants were assessed on four aspects of decisional capacity (Understanding, Appreciating, Reasoning, and Expressing a choice). We used regression analyses to test the impact of the tool on each outcome, repeating the analyses on the higher functioning subsample. RESULTS: No differences existed in any domain of decisional capacity for the sample in full. However, participants in the higher IQ subsample who used the tool scored better on Understanding after adjustment (ß = 0.25, p = 0.04), but not on Appreciating or Reasoning. No differences by experimental group existed in the decision to join the hypothetical trial for the full sample or higher functioning subsample. CONCLUSIONS: A decision support tool shows promise for individuals with fragile X syndrome with higher cognitive abilities. Future studies should examine the level of cognitive ability needed for sufficient understanding, whether these findings can be translated to other clinical populations, and the impact of the tool in larger trials and on trial retention.

Unintended Effects of Communicating About Drug Safety Issues: A Critical Review of the Literature.

Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about safety issues with prescription and over-the-counter drugs. We searched PubMed for peer-reviewed studies published from 1990 to 2017 where study authors reported probable unintended effects of communicating drug safety. The types of communications included in these studies were news reports, direct-to-consumer advertisements, and those released by government agencies. Among the 26 studies identified, the most commonly reported unintended effects were decreased drug use or discontinuation. Other unintended effects included spillover to populations not targeted by the communications (e.g., discontinuation of antidepressants among adults following communications concerning use among youth), shifts in clinical diagnoses (e.g., fewer diagnoses of depression), increased use of alternative therapies, and other undesirable behaviors (e.g., possible increased suicide attempts because antidepressants were discontinued). Limitations to the literature include the inability to establish causation or to isolate the effects of multiple communication sources and messages. Further, because the intended effect of many communications was not known, our study was limited by challenges in defining some effects as unintended. Most studies used health insurer claims data to identify unintended effects of communications, which provide an incomplete picture; few used self-reported or other methodologies that could help illuminate the reasons underlying the effects observed in the claims data. Best practices for communicating about the potential benefits and harms of drugs in a manner that minimizes negative unintended effects are needed to protect and improve public health.

Impact of messages about scientific uncertainty on risk perceptions and intentions to use electronic vaping products.

BACKGROUND: The science surrounding e-cigarettes and other electronic vaping products (EVPs) is rapidly evolving, and the health effects of vaping are unclear. Little research has explored how individuals respond to information acknowledging scientific uncertainty. The aim of the present study was to understand the impact of messages about scientific uncertainty regarding the health effects of vaping on risk perceptions and behavioral intentions. METHODS: Adults in an online experiment (n = 2508) were randomly exposed to view either a control message (a short factual statement about EVPs) or an uncertainty message (the control message plus additional information describing why EVP-related research is limited or inconclusive). Participants rated the risks of vaping and their intentions to try or stop vaping. RESULTS: Individuals who viewed the uncertainty message rated vaping as less risky than those who viewed the control message. Message exposure did not impact intentions to try vaping soon or intentions to stop vaping in the next 6 months. CONCLUSIONS: Acknowledging scientific uncertainty made EVP use seem less risky. Future research should explore possible drivers of this response, such as deeper message processing or emotional reactions. Researchers and practitioners designing public health campaigns about vaping might consider a cautious approach to presenting information about scientific uncertainty.

A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.

BACKGROUND: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. OBJECTIVE: The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. METHODS: A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. RESULTS: Data analysis will be completed by late 2018. CONCLUSIONS: By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.

A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

BACKGROUND: Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. OBJECTIVE: We describe the design and development process of a tablet-based decision support tool. METHODS: Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. RESULTS: We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. CONCLUSIONS: The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW).

Zika Virus Prevention: U.S. Travelers' Knowledge, Risk Perceptions, and Behavioral Intentions-A National Survey.

Limited data exist about U.S. travelers' knowledge, risk perceptions, and behaviors related to the Zika virus (ZIKV). Using an internet research panel, in March 2017, we surveyed 1,202 Americans in the continental United States and Puerto Rico who planned to travel to a ZIKV-affected country, state, or U.S. territory in 2017. We compared levels of knowledge and perceived risk of ZIKV, and intentions to practice ZIKV prevention behaviors across respondents from three regions: Puerto Rico, at-risk states, and other states. More than 80% of respondents correctly understood that a person could acquire ZIKV through a bite from an infected mosquito, and over 64% of respondents knew that a pregnant woman could pass the virus to her fetus. Less than half of the respondents from at-risk states and other states knew that ZIKV could be transmitted sexually, as compared with three-quarters of respondents from Puerto Rico. Compared with respondents from at-risk and other states, respondents from Puerto Rico were the most knowledgeable for almost all types of knowledge assessed. Knowledge about post-travel precautions was low across all three regions. Differences in perceived risk and intentions to practice specific prevention behaviors also varied among regions. Significant gaps exist in U.S. travelers' knowledge about how to prevent ZIKV transmission both during and after travel. Input and collaboration from the travel industry, health care providers, and the media are needed to help educate travelers about how to prevent ZIKV infection and transmission.

Factors affecting the communication experiences of newly diagnosed colorectal cancer patients.

OBJECTIVE: This study assessed patient-centered communication (PCC) among newly diagnosed colorectal cancer patients. PCC, a key part of patient-centered care, contributes directly and indirectly to health-related quality of life, satisfaction with care, and other outcomes. METHODS: We conducted a survey of patients in North Carolina, using a theoretically-based and validated measure that provides an overall PCC score and subscale scores for six PCC functions. RESULTS: A total of 501 patients participated. The highest scores were for the PCC functions of Fostering Healing Relationships, Exchanging Information, and Making Decisions. The lowest scores were for the functions of Managing Uncertainty and Enabling Self-Management, yet these were functions respondents rated as most important. Respondents who thought about more than one health professional (versus oncologist) reported better communication. PCC also varied by treatment type, mental and physical health status, age, race, and education. CONCLUSION: Most patients reported good communication overall, however patients in poor physical health and mental health reported worse communication. The quality of communication varied across the PCC functions. PRACTICE IMPLICATIONS: Health professionals need to use a PCC approach that builds trust, respects the patient, provides salient information that patients can understand, provides emotional support, and facilitates the patient's engagement in care.

Laparoscopic-Assisted Transgastric ERCP: A Single-Institution Experience.

Background: Laparoscopic-assisted transgastric endoscopic retrograde cholangiopancreatography (LAERCP) is used for treatment in patients after Roux-en-Y gastric bypass (RYGB), where transoral access to the biliary tree is not possible. We describe our technique and experience with this procedure. Methods: Electronic medical record search was performed from September 2012 to January 2016, identifying patients who underwent LAERCP per operative records. Charts were reviewed for demographic, clinical, and outcomes data. Results: Sixteen patients were identified. Average time since bypass was 6.9 years, and length of stay was 3.7 days. Five patients underwent simultaneous cholecystectomy. Eleven patients, or 43%, had cholecystectomy more than 2 years previously. ERCP with sphincterotomy was completed in 15 of 16 patients (94%). Our technique involves access to the bypassed stomach via a laparoscopically placed 15 mm port. We observed one major complication of post-ERCP necrotizing pancreatitis. No minor complications nor mortalities were seen in our series. Conclusion: Biliary obstruction can occur many years after RYGB and cholecystectomy. Our findings suggest that RYGB patients may be at a higher risk of primary CBD stone formation. LAERCP is a reliable option for common bile duct (CBD) clearance; our technique of LAERCP is technically simple and associated with low complication rate, making it appealing to surgeons not trained in advanced laparoscopy.

United States Travelers' Concern about Zika Infection and Willingness to Receive a Hypothetical Zika Vaccine.

The ongoing Zika pandemic has affected many countries that are common travel destinations. We assessed the willingness to receive a prophylactic Zika virus (ZIKV) vaccine, currently under development, among travelers to areas with reported autochthonous ZIKV transmission. We surveyed United States (U.S.) residents aged 18-44 years who had ever heard of ZIKV and planned to travel to Florida and/or Texas (N = 420) or a U.S. territory or foreign country (N = 415) in 2017, using a nationally representative internet panel. Travelers to Florida and/or Texas reported less concern about ZIKV infection than travelers to other destinations (27% versus 36%, P = 0.01). Female sex, Hispanic ethnicity, discussing ZIKV with medical professionals, ZIKV risk perception, and self-efficacy for ZIKV prevention predicted concern about ZIKV infection in both groups. Travelers to Florida and/or Texas (43%) and other destinations (44%) were equally willing to receive a ZIKV vaccine. Hispanic ethnicity, discussing ZIKV with medical professionals, and concern about ZIKV infection predicted vaccine willingness in both groups. Likelihood of using existing ZIKV prevention methods, confidence in the U.S. government to prevent ZIKV spread, self-efficacy for ZIKV prevention, and knowledge about ZIKV symptoms further predicted vaccine willingness in travelers to other destinations. In multivariable analyses, only concern about ZIKV infection was associated with vaccine willingness in both groups (prevalence ratio [95% confidence interval]: Florida and/or Texas: 1.34 [1.06, 1.69]; other: 1.82 [1.44, 2.29]). Targeted communications can educate travelers, particularly travelers who are pregnant or may become pregnant, about ZIKV risk to generate ZIKV vaccine demand.

The State of the Science of Health Literacy Measurement.

Advancing health literacy (HL) research requires high-quality HL measures. This chapter provides an overview of the state of the science of HL measurement: where the field started, currently is, and should be going. It is divided into eight key sections looking at (1) the history of HL measurement, (2) the relationship between HL definitions and measurement, (3) the HL conceptual domains most and least frequently measured, (4) the methods used to validate HL measures, (5) the characteristics of the participants in the measurement validation studies, (6) the practical considerations related to administering HL measures, (7) the advantages and disadvantages of using objective versus subjective HL measures, and (8) future directions for HL measurement. Based on the material presented in this chapter, the following conclusions can be drawn. First, there is an enormous proliferation of HL measures and this growth presents both opportunities and challenges for the field. Second, to move the field forward, there is an urgent need to better align HL measurement with definitions of HL. Third, some HL domains, such as numeracy, are measured more often than others, such as speaking and listening. Consequently, it is important to think about novel mechanisms to measure HL domains that are rarely measured. Fourth, HL measures are most often developed, validated, and refined using classical measurement approaches. However, strong empirical and practical rationales suggest making an assertive shift toward using modern measurement approaches. Fifth, most HL measures are not well validated for use in minority populations; consequently, future validation studies should be mindful of validation samples. Sixth, HL measures can be administered using multiple modes, most frequently via paper-and-pencil surveys. Identifying which mode of administration is most suitable requires reflecting on the underlying measurement purpose and the characteristics of the participants being measured. These considerations should also be made when deciding between a subjective versus objective HL measure. Cumulatively, this chapter provides tools to help readers select and use the most appropriate measures of HL for their needs. It also provides rationale and strategies for moving the science of HL measurement forward.

Psychometric evaluation and design of patient-centered communication measures for cancer care settings.

OBJECTIVE: To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). METHODS: Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. RESULTS: Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). CONCLUSION: This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. PRACTICE IMPLICATIONS: The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives.

Improving low health literacy and patient engagement: A social ecological approach.

OBJECTIVE: This article posits four principal objectives related to the overarching goal of broadening the conceptualization of health literacy. We propose a social ecological approach to health literacy and patient engagement by illustrating how this multilevel approach offers an array of strategic options for interventions. DISCUSSION: A social ecological approach supports a broader understanding of health literacy that aligns with increased patient engagement. The ecological model highlights the importance of context, demonstrates how health literacy and patient engagement are inextricably connected, and gives rise to strategies to enhance them both. We illustrate the five multilevel intervention strategies for addressing low health literacy and promoting patient engagement: accumulation, amplification, facilitation, cascade, and convergence strategies. In addition, we provide a theoretical foundation to facilitate the development of interventions to enhance health literacy and ultimately increase patient engagement. CONCLUSIONS: The practice implications of adopting a broader social ecological perspective to address low health literacy shifts the field from thinking about individual educational interventions to how individual interventions may be augmented or supported by interventions at additional levels of influence. The potential benefit of adopting a multilevel intervention approach is that combining interventions could produce synergies that are greater than interventions that only utilize one level of influence.