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.

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.

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).

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.

Influence of patient medication information format on comprehension and application of medication information: A randomized, controlled experiment.

OBJECTIVE: To examine patients' comprehension and application of alternative versions of patient medication information handouts for a fictitious drug, and whether patient characteristics influence patients' ability to understand the handouts. METHODS: A web-based experiment was conducted in which 1397 adults with rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis were randomly assigned to one of three conditions: (1) a one-page "Bubbles" format; (2) a one-page "Over-The-Counter" (OTC) format; and (3) a four-page document modeled after MedGuides used in 2009 which served as the control arm. Comprehension and application of information in the handouts were the key outcomes of interest. RESULTS: Participants who viewed either the Bubbles or OTC formats had greater comprehension than participants who viewed the MedGuide, but did not have better application scores. No significant differences were noted between the Bubbles and OTC formats. Patient characteristics did not moderate the results. CONCLUSION: Both formats resulted in better comprehension than the MedGuide format used in the study. PRACTICE IMPLICATIONS: Results provide valuable information on how to design patient information to improve patients' understanding of the risks and benefits of the drugs they are prescribed. Results could be extended to inform the content of other types of patient education materials.

Preferences for patient medication information: what do patients want?

This study investigated respondent preferences on how best to display patient medication information (PMI) that accompanies prescription medications to promote comprehension and appropriate usage. The authors identified 30 individuals diagnosed with select immune disorders, 30 with other chronic diseases, and 30 from the general public and had them review one of two PMI handouts that varied by format, organization, and content. The authors explored preferences for the PMI handout using one-on-one interviews. The authors analyzed the qualitative data to identify relevant themes and patterns using NVivo9 qualitative software. The majority of respondents noted that the formats of the two PMI handouts were more informative than those they currently receive from the pharmacist, with a preference for the 2-column, segmented design. However, respondent PMI preferences varied by age, education, and health status. Patients need simpler and more concise drug information to make better decisions about their health. Current PMI handouts are dense and complex, which can be confusing and not reader friendly. To improve PMI understandability and usefulness, the U.S. Food and Drug Administration is working with stakeholders, consumer advocates, and academics. Findings from this study may help inform future development of more user-friendly PMI.

Health literacy measurement: an inventory and descriptive summary of 51 instruments.

This article aimed to provide a descriptive review of the psychometric properties and conceptual dimensions of published health literacy measurement tools. PsycINFO and PubMed search from 1999 through 2013, review of the grey literature, and an environmental scan was conducted to identify health literacy measurement tools. For each tool, we evaluated the conceptual dimensions assessed, test parameters, and psychometric properties. Of the 51 tools identified, 26 measured general health literacy, and 15 were disease or content specific, and 10 aimed at specific populations. Most tools are performance based, require in-person administration, and are exclusively available in a pencil and paper testing mode. The tools assess 0 (proxy measure) to 9 of the 11 defined dimensions of health literacy. Reported administration times vary, from less than 1 to 60 minutes. Validation procedures for most of the tools are limited by inadequate power to ensure reliability across subgroups (i.e., race, age, ethnicity, and gender). The health literacy measurement tools currently available generally represent a narrow set of conceptual dimensions with limited modes of administration. Most of the tools lack information on key psychometric properties. Significant work is needed to establish important aspects of the construct, convergent, and predictive validity for many tools. As researchers develop new measures, inclusion of a full range of conceptual dimensions of health literacy, more representative sampling for testing, and additional modes of administration will allow a more refined and flexible approach to research in this field.