Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

Is tailored messaging more effective? An analysis of a digital health intervention to promote HPV vaccination intent among Latinx.

Latinx populations have unique barriers to HPV vaccination. In the current study, we assessed the effectiveness of an online intervention to increase HPV vaccination intentions among patients of clinics that principally serve a Latinx population (n = 85%) as part of a randomized control trial (RCT). Participants viewed on an iPad either an individually tailored educational website (CHiCOS) or untailored information derived from the Vaccine Information Sheet (VIS) for HPV. Vaccination intention and related covariates were assessed via survey items administered before (pre-test) and after (post-test) viewing the material. No statistically significant differences were seen in changes of intention to vaccinate between groups (N = 1294). However, 16% of all (tailored and untailored combined) participants increased in their intention to vaccinate, while 7% decreased in intention. Overall 72% of participants had high intentions to vaccinate, yet far fewer actually received a vaccine dose. The current study explores implications of the demonstrated intention-behavior gap. As such, it presents opportunities to improve future interventions-specifically those that employ tailored messaging.

Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial.

BACKGROUND: Social vulnerability indicators are associated with health care inequities and may similarly impede ongoing participation in research studies. We evaluated the association of social vulnerability indicators and research participant attrition in a trial focused on reducing health disparities. METHODS: Self-identified White or Black adults enrolled in the HYVALUE trial (Hypertension and VALUEs), a randomized trial testing a values-affirmation intervention on medication adherence, from February 2017 to September 2019 were included. The self-reported measures of social vulnerability indicators included: (1) Black race; (2) female gender; (3) no health insurance; (4) unemployment; (5) a high school diploma or less; and (6) financial-resource strain. Full attrition was defined as not completing at least one 3- or 6-month follow-up study visit. Log-binomial regression models adjusted for age, gender, race, medical comorbidities, and the other social vulnerability indicators to estimate the relative risk of each social vulnerability indicator with study attrition. RESULTS: Among 825 participants, the mean age was 63.3 years (±11.7 years), 60% were women, 54% were Black, and 97% reported at least one social vulnerability. Overall, 21% participants had full attrition after study enrollment. After adjustment for all other social vulnerabilities, only financial-resource strain remained consistently associated with full attrition (relative risk, 1.71 [95% CI, 1.28-2.29]). In a secondary analysis of partial attrition (completed only one follow-up visit), financial-resource strain (relative risk, 1.40 [95% CI, 1.09-1.81]) and being uninsured (relative risk, 1.54 [95% CI, 1.01-2.34]) were associated with partial attrition. CONCLUSIONS: In a trial aimed at reducing disparities in medication adherence, participants who reported financial-resource strain had a higher risk of participant attrition independent of race or gender. Our findings suggest that efforts to retain diverse populations in clinical trials should extend beyond race and gender to consider other social vulnerability indicators. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03028597.

Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial.

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions. Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race. Design, Setting, and Participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis. Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values. Main Outcomes and Measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured. Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]). Conclusions and Relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03028597.

A stakeholder engagement method navigator webtool for clinical and translational science.

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects.

Parental involvement in decision making about intracranial pressure monitor placement in children with traumatic brain injury.

OBJECTIVE: Little is known about how parents of children with traumatic brain injury (TBI) participate or feel they should participate in decision making regarding placing an intracranial pressure (ICP) monitor. The objective of this study was to identify the perspectives and decisional or information needs of parents whose child sustained a TBI and may require an ICP monitor. METHODS: This was a qualitative study at one US level I pediatric trauma center. The authors conducted in-depth semistructured interviews with 1) parents of critically injured children who have sustained a TBI and 2) clinicians who regularly care for children with TBI. RESULTS: The authors interviewed 10 parents of 7 children (60% were mothers and 80% were white) and 28 clinicians (17 ICU clinicians and 11 surgeons). Overall, the authors found concordance between and among parents and clinicians about parental involvement in ICP monitor decision making. Parents and clinicians agreed that decision making about ICP monitoring in children who have suffered TBI is not and should not be shared between the parents and clinicians. The concordance was represented in 3 emergent themes. Parents wanted transparency, communication, and information (theme 2), but the life-threatening context of this decision (theme 1) created an environment where all involved reflected a clear preference for paternalism (theme 3). CONCLUSIONS: The clear and concordant preference for clinician paternalistic decision making coupled with the parents' needs to be informed suggests that a decision support tool for this decision should be clinician facing and should emphasize transparency in collaborative decision making between clinicians.

Decision-Making About Intracranial Pressure Monitor Placement in Children With Traumatic Brain Injury.

OBJECTIVES: Little is known about how clinicians make the complex decision regarding whether to place an intracranial pressure monitor in children with traumatic brain injury. The objective of this study was to identify the decisional needs of multidisciplinary clinician stakeholders. DESIGN: Semi-structured qualitative interviews with clinicians who regularly care for children with traumatic brain injury. SETTING: One U.S. level I pediatric trauma center. SUBJECTS: Twenty-eight clinicians including 17 ICU nurses, advanced practice providers, and physicians and 11 pediatric surgeons and neurosurgeons interviewed between August 2017 and February 2018. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Participants had a mean age of 43 years (range, 30-66 yr), mean experience of 10 years (range, 0-30 yr), were 46% female (13/28), and 96% white (27/28). A novel conceptual model emerged that related the difficulty of the decision about intracranial pressure monitor placement (y-axis) with the estimated outcome of the patient (x-axis). This model had a bimodal shape, with the most difficult decisions occurring for patients who 1) had a good opportunity for recovery but whose neurologic examination had not yet normalized or 2) had a low but uncertain likelihood of neurologically functional recovery. Emergent themes included gaps in medical knowledge and information available for decision-making, differences in perspective between clinical specialties, and ethical implications of decision-making about intracranial pressure monitoring. Experienced clinicians described less difficulty with decision-making overall. CONCLUSIONS: Children with severe traumatic brain injury near perceived transition points along a spectrum of potential for recovery present challenges for decision-making about intracranial pressure monitor placement. Clinician experience and specialty discipline further influence decision-making. These findings will contribute to the design of a multidisciplinary clinical decision support tool for intracranial pressure monitor placement in children with traumatic brain injury.

Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and Values (HYVALUE) Trial.

BACKGROUND: Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient's ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies. OBJECTIVE: The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat. METHODS: The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients' adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients' prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes. RESULTS: This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes. CONCLUSIONS: The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition-hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12498.

A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos.

Human papillomavirus (HPV) causes a number of cancers that disproportionally affect Latinos yet there is a paucity of research on interventions to increase HPV vaccination among this population. We sought to evaluate the efficacy of a web-based, individually customizable intervention, called CHICOs (Combatting HPV Infection and Cancers, tailored intervention) for its impact on HPV vaccine utilization. We conducted a three-armed, randomized, controlled trial in the waiting rooms of five family medicine practices from June 2014-February 2016 where CHICOS was compared to an iPad-based version of the Vaccine Information Sheet from the Centers for Disease Control and Prevention (untailored intervention), and usual care. Pair-wise comparisons between study arms of 6 different measures of HPV vaccine uptake were assessed, with analyses stratified by adolescents versus young adults. Of the 1,294 participants enrolled in the study, 1,013 individuals could be assessed for vaccination. Across study arms, 265 adolescents, but only 18 young adults, received an HPV vaccine dose during the study period. In both intention-to-treat and per-protocol analyses there were essentially no differences between the CHICOS and untailored arms in any vaccination measure, or between the untailored or CHICOS arms and usual care. Our study suggests that a tailored educational intervention may not be effective for increasing HPV vaccine uptake among Latino adolescents or young adults. However, the higher than expected baseline levels of positive vaccination attitudes of study participants could have diminished the statistical power of the study. Trial Registration Number: ClinicalTrials.gov (NCT02145156).

Using Community Engagement to Develop a Web-Based Intervention for Latinos about the HPV Vaccine.

Human papillomavirus (HPV) infection is pervasive among sexually active women and men, and Hispanic women are at particularly high risk as they have higher rates of invasive cervical cancer compared to other racial or ethnic groups in the United States. There is a need for interventions to increase HPV vaccination among this high-risk population. This study investigated how to modify a previously developed web-based intervention that provided individually tailored information about HPV to improve its use among the Latino population. A community-oriented modification approach incorporated feedback from a community advisory committee, and focus groups among the Latino population, to modify the intervention. Several themes emerged including a need for basic information about HPV and HPV vaccination, changes to make the intervention appear less clinical, and incorporation of information addressing barriers specific to the Latino community. This work was done in preparation for a randomized trial to assess the impact of this modified intervention on HPV vaccination attitudes and uptake among Latino young adults and parents of adolescents. If effective, our intervention could be a resource for reducing HPV vaccination concerns, improving immunization rates, and educating Latinos about HPV and the HPV vaccine outside of the time boundaries of the traditional clinical encounter.

Reporting Data Quality Assessment Results: Identifying Individual and Organizational Barriers and Solutions.

INTRODUCTION: Electronic health record (EHR) data are known to have significant data quality issues, yet the practice and frequency of assessing EHR data is unknown. We sought to understand current practices and attitudes towards reporting data quality assessment (DQA) results by data professionals. METHODS: The project was conducted in four Phases: (1) examined current DQA practices among informatics/CER stakeholders via engagement meeting (07/2014); (2) characterized organizations conducting DQA by interviewing key personnel and data management professionals (07-08/2014); (3) developed and administered an anonymous survey to data professionals (03-06/2015); and (4) validated survey results during a follow-up informatics/CER stakeholder engagement meeting (06/2016). RESULTS: The first engagement meeting identified the theme of unintended consequences as a primary barrier to DQA. Interviewees were predominantly medical groups serving distributed networks with formalized DQAs. Consistent with the interviews, most survey (N=111) respondents utilized DQA processes/programs. A lack of resources and clear definitions of how to judge the quality of a dataset were the most commonly cited individual barriers. Vague quality action plans/expectations and data owners not trained in problem identification and problem-solving skills were the most commonly cited organizational barriers. Solutions included allocating resources for DQA, establishing standards and guidelines, and changing organizational culture. DISCUSSION: Several barriers affecting DQA and reporting were identified. Community alignment towards systematic DQA and reporting is needed to overcome these barriers. CONCLUSION: Understanding barriers and solutions to DQA reporting is vital for establishing trust in the secondary use of EHR data for quality improvement and the pursuit of personalized medicine.

Characteristics of users of a tailored, interactive website for parents and its impact on adolescent vaccination attitudes and uptake.

BACKGROUND: We examined the characteristics of parents using an iPad-based intervention about vaccines, and its impact on vaccination attitudes and behavior. METHODS: Interventions were implemented in three primary care clinics from June 2012-September 2013. Baseline and follow up surveys assessed vaccination attitudes and intentions. Medical records were used to examine adolescent vaccine uptake. RESULTS: During the study, 42 parents viewed tailored educational content. Users were generally positive about vaccines, though one out of five worried that vaccines caused more harm than good. Among the 16 parents completing the post-intervention survey, there was a slightly higher, non-statistically significant, mean vaccination intention after viewing the website than prior to viewing it for three of the four adolescent vaccines (all except tetanus-diphtheria-acellular pertussis). Using the intervention did not increase the likelihood of adolescent vaccination. CONCLUSIONS: Providing educational material via iPads in clinic waiting rooms does not appear to be an effective strategy for engaging parents about vaccines. Overall, parents' interaction with TeenVaxScene was low, and had little impact on their vaccination attitudes and beliefs. However, use of TeenVaxScene did not appear to worsen parents' attitudes about vaccines. New and creative ideas for engaging parents to use such educational materials are needed.

Understanding how different recruitment strategies impact parent engagement with an iPad-based intervention to provide personalized information about adolescent vaccines.

PURPOSE: Inadequate provider time for addressing parents' questions and concerns about adolescent vaccines is a barrier to vaccine utilization. We sought to determine how different recruitment strategies impact the degree of engagement with an intervention that provided this information via an iPad placed in a clinical setting. METHODS: We provided to three pediatric practices in the Denver area the "Teen VaxScene" web site that generates individually customized information for parents about adolescent vaccines. Three recruitment strategies were assessed for their impact on parental use of the intervention as follows: passive recruitment using posters to advertise a "kiosk" version of the intervention; posters plus a $10 incentive for using the kiosk; and posters plus a $10 incentive plus decoupling the iPad from the kiosks to enable "roving." We assessed the engagement with the intervention at multiple levels including log in, consent, and completion of a baseline survey and viewing individually tailored web pages. Surveys were used to assess barriers to using the intervention. RESULTS: During the 14-month study period, 693 people had contact with the iPad, 199 consented, and 48 completed the survey to enable creation of tailored content; and 42 used the tailored site. Five times as many parents (n = 40) consented to participation during the 2 months when the intervention was "roving" than during the 10-month "passive" recruitment period. Engagement with the tailored material was low, with most users viewing only the "table of contents" pages. Utilizers and nonutilizers of the intervention had similar demographic characteristics. CONCLUSIONS: Enabling the iPad to "rove" in the clinic greatly increased the proportion of parents consenting to use the intervention. However, meaningful engagement with the material was low. Further research is needed to understand the most effective and time efficient ways to provide vaccine-related educational information to parents of adolescents.

Adapting practice-based intervention research to electronic environments: opportunities and complexities at two institutions.

BACKGROUND AND PURPOSE: Primary care practice-based research has become more complex with increased use of electronic health records (EHRs). Little has been reported about changes in study planning and execution that are required as practices change from paper-based to electronic-based environments. We describe the evolution of a pediatric practice-based intervention study as it was adapted for use in the electronic environment, to enable other practice-based researchers to plan efficient, effective studies. METHODS: We adapted a paper-based pediatric office-level intervention to enhance parent-provider communication about subspecialty referrals for use in two practice-based research networks (PBRNs) with partially and fully electronic environments. We documented the process of adaptation and its effect on study feasibility and efficiency, resource use, and administrative and regulatory complexities, as the study was implemented in the two networks. RESULTS: Considerable time and money was required to adapt the paper-based study to the electronic environment, requiring extra meetings with institutional EHR-, regulatory-, and administrative teams, and increased practice training. Institutional unfamiliarity with using EHRs in practice-based research, and the consequent need to develop new policies, were major contributors to delays. Adapting intervention tools to the EHR and minimizing practice disruptions was challenging, but resulted in several efficiencies as compared with a paper-based project. In particular, recruitment and tracking of subjects and data collection were easier and more efficient. CONCLUSIONS: Practice-based intervention research in an electronic environment adds considerable cost and time at the outset of a study, especially for centers unfamiliar with such research. Efficiencies generated have the potential of easing the work of study enrollment, subject tracking, and data collection.

Creating a measure of portion control self-efficacy.

OBJECTIVE: Over the last few decades, food portion sizes have steadily increased by as much as 700% (Young & Nestle, 2002). Food portions are often much larger than dietary guidelines recommend, leaving individuals to manage their food consumption on their own and making it necessary to understand individual factors impacting food consumption. In the current paper, we focus on self-efficacy for portion control. METHOD: Specifically, across three studies, we developed and validated a new measure of portion control self-efficacy (PCSE). RESULT: The PCSE measure yielded good fit statistics and had acceptable test-retest reliability using two cross-sectional surveys (Studies 1(a) and 1(b)). Results from Study 2 demonstrated construct and predictive validity of the PCSE using the Food Amount Rating Scale (FARS; Dohm, & Striegel-Moore, 2002). Study 3 offered additional support for reliability and validity with a sample of overweight and obese adults currently trying to lose weight. CONCLUSIONS: Overall, findings indicate that the new PCSE measure is reliable and valid. Individuals often make inaccurate food portion estimates (Slawson & Eck, 1997; Yuhas, Bolland, & Bolland, 1989) which can lead to overeating and weight-gain. Thus, the discussion centers on the need to incorporate PCSE in future research and intervention work targeting weight loss, health, and food consumption.