Evaluation of a Pharmacists' Patient Care Process Approach for Hypertension.

INTRODUCTION: An estimated 116 million American adults (47.3%) have hypertension. Most adults with hypertension do not have it controlled-3 in 4 (92.1 million) U.S. adults with hypertension have a blood pressure ≥130/80 mmHg. The Pharmacists' Patient Care Process is a standardized patient-centered approach to the provision of pharmacist care that is done in collaboration with other healthcare providers. Through the Michigan Medicine Hypertension Pharmacists' Program, pharmacists use the Pharmacists' Patient Care Process to provide hypertension management services in collaboration with physicians in primary care and community pharmacy settings. In 2019, the impact of Michigan Medicine Hypertension Pharmacists' Program patient participation on blood pressure control was evaluated. METHODS: Propensity scoring was used to match patients in the intervention group with patients in the comparison group and regression analyses were then conducted to compare the 2 groups on key patient outcomes. Negative binomial regression was used to examine the number of days with blood pressure under control. The findings presented in this brief are part of a larger multimethod evaluation. RESULTS: More patients in the intervention group than in the comparison group achieved blood pressure control at 3 months (66.3% vs 42.4%) and 6 months (69.1% vs 56.5%). The intervention group experienced more days with blood pressure under control within a 3-month (18.6 vs 9.5 days) and 6-month period (57.0 vs 37.4 days) than the comparison group did. CONCLUSIONS: Findings support the effectiveness of the Michigan Medicine Hypertension Pharmacists' Program approach to implementing the Pharmacists' Patient Care Process to improve blood pressure control.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

BACKGROUND: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective. OBJECTIVE: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows. METHODS: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68). RESULTS: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics. CONCLUSIONS: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.

Exposure to Potentially Harmful E-Cigarette Emissions via Vape Tricks: Protocol for a Mixed-Methods Study.

BACKGROUND: The number of adolescents and adults using e-cigarettes, referred to as vaping, has dramatically increased. E-cigarettes can be used to perform vape tricks by inhaling and exhaling the e-cigarette aerosol in patterns to create visual effects or large clouds. To create these effects, the puffing patterns associated with vape tricks may be different than standard ad-lib e-cigarette usage. The prevalence of vape tricks and the harm associated with exposure to e-cigarette emissions when performing vape tricks is currently unknown. OBJECTIVE: Our objectives are to characterize duration, heart rate, respiratory rate, tidal volume, minute volume, and physical activity metrics associated with the performance of vape tricks and to characterize the emission of e-cigarettes when performing vape tricks in a manner suitable to inform novel exposure modeling. METHODS: The study will recruit e-cigarette users with a history of performing vape tricks. Data collection will occur in two different sessions. In the first session, participants will be asked to puff on their e-cigarette as they normally would for 20 minutes. The second session will be a vape tricks session, where users will be asked to perform a series of up to five different vape tricks with their e-cigarette. Data will be collected through screener surveys, in-person interviews, video recordings, a personal exposure monitor, and a biometric garment. RESULTS: Data analysis is pending and scheduled to take place in the fall of 2019. CONCLUSIONS: This study will be used to assess the feasibility of using a biometric garment to complement environmental and observational data. The approach may provide greater insight into the health risks of performing vape tricks compared to typical e-cigarette use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12304.

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).

Establishing Linkages Between Distributed Survey Responses and Consumer Wearable Device Datasets: A Pilot Protocol.

BACKGROUND: As technology increasingly becomes an integral part of everyday life, many individuals are choosing to use wearable technology such as activity trackers to monitor their daily physical activity and other health-related goals. Researchers would benefit from learning more about the health of these individuals remotely, without meeting face-to-face with participants and avoiding the high cost of providing consumer wearables to participants for the study duration. OBJECTIVE: The present study seeks to develop the methods to collect data remotely and establish a linkage between self-reported survey responses and consumer wearable device biometric data, ultimately producing a de-identified and linked dataset. Establishing an effective protocol will allow for future studies of large-scale deployment and participant management. METHODS: A total of 30 participants who use a Fitbit will be recruited on Mechanical Turk Prime and asked to complete a short online self-administered questionnaire. They will also be asked to connect their personal Fitbit activity tracker to an online third-party software system, called Fitabase, which will allow access to 1 month's retrospective data and 1 month's prospective data, both from the date of consent. RESULTS: The protocol will be used to create and refine methods to establish linkages between remotely sourced and de-identified survey responses on health status and consumer wearable device data. CONCLUSIONS: The refinement of the protocol will inform collection and linkage of similar datasets at scale, enabling the integration of consumer wearable device data collection in cross-sectional and prospective cohort studies.

Biometrics and Policing: A Protocol for Multichannel Sensor Data Collection and Exploratory Analysis of Contextualized Psychophysiological Response During Law Enforcement Operations.

BACKGROUND: Stress experienced by law enforcement officers is often extreme and is in many ways unique among professions. Although past research on officer stress is informative, it is limited, and most studies measure stress using self-report questionnaires or observational studies that have limited generalizability. We know of no research studies that have attempted to track direct physiological stress responses in high fidelity, especially within an operational police setting. The outcome of this project will have an impact on both practitioners and policing researchers. To do so, we will establish a capacity to obtain complex, multisensor data; process complex datasets; and establish the methods needed to conduct idiopathic clinical trials on behavioral interventions in similar contexts. OBJECTIVE: The objective of this pilot study is to demonstrate the practicality and utility of wrist-worn biometric sensor-based research in a law enforcement agency. METHODS: We will use nonprobability convenience-based sampling to recruit 2-3 participants from the police department in Durham, North Carolina, USA. RESULTS: Data collection was conducted in 2016. We will analyze data in early 2017 and disseminate our results via peer reviewed publications in late 2017. CONCLUSIONS: We developed the Biometrics & Policing Demonstration project to provide a proof of concept on collecting biometric data in a law enforcement setting. This effort will enable us to (1) address the regulatory approvals needed to collect data, including human participant considerations, (2) demonstrate the ability to use biometric tracking technology in a policing setting, (3) link biometric data to law enforcement data, and (4) explore project results for law enforcement policy and training.

ActiviTeen: A Protocol for Deployment of a Consumer Wearable Device in an Academic Setting.

BACKGROUND: Regular physical activity (PA) can be an important indicator of health across an individual's life span. Consumer wearables, such as Fitbit or Jawbone, are becoming increasingly popular to track PA. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. OBJECTIVE: The primary objective of the described study is to evaluate the feasibility of individual data collection from the selected consumer wearable device (the Fitbit Zip). The rate of user attrition and barriers preventing the use of consumer wearable devices will also be evaluated as secondary objectives. METHODS: The pilot study will occur in two stages and employs a long-term review and analysis with a convenience sample of 30 students attending Research Triangle High School. For the first stage, students will initially be asked to wear the Fitbit Zip over the course of 4 weeks. During which time, their activity data and step count will be collected. Students will also be asked to complete a self-administered survey at the beginning and conclusion of the first stage. The second stage will continue to collect students' activity data and step count over an additional 3-month period. RESULTS: We are anticipating results for this study by the end of 2016. CONCLUSION: This study will provide insight into the data collection procedures surrounding consumer wearable devices and could serve as the future foundation for other studies deploying consumer wearable devices in educational settings.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

BACKGROUND: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. OBJECTIVE: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. METHODS: The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. RESULTS: This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. CONCLUSIONS: These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.