Feasibility of Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial

Background: Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. Objective: The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. Methods: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. Results: Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. Conclusions: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. Trial Registration: ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon) International Registered Report Identifier (IRRID): DERR1-10.2196/1245

Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Technology Target Studies: Technology Solutions to Make Patient Care Safer and More Efficient

Presents findings on technologies that could enhance care delivery, including patient records and medication processes; features and functionality nurses require, including tracking, interoperability, and hand-held capability; and best practices

eConsent Forms on Ancillary Applications with Electronic Medical Record Integration – Reducing Consent Error

Purpose of Project: The purpose of this project is to utilize electronic consents (eConsents) with ancillary applications as an evidence-based intervention to reduce consent errors. Background: Studies show that paper-based handwritten forms have an error rate of up to 50%. Consent errors, especially in the preparation of surgery, are not merely documentation errors but patient safety pitfalls that allow for incorrect surgeries or financial loss due to aborted or delayed interventional cases. Internal organizational evidence indicates the implementation of an evidence-based opportunity as there was no use of electronic tools for consents utilized in the inpatient setting. Methods: Inpatient departments were provided tablets that contain a consent application connected with the electronic medical record (EMR). Only blood and surgical consents were transformed into eConsent format. The electronic form is automatically attached to patient’s EMR to prevent misplacement and ease of access for all treatment team members. System-wide education was provided to nursing staff on how to access eConsents when preparing the patient for surgery as well as associated policy implications. Collaboration with analysts, leadership, and clinicians was essential to ensuring successful inpatient operational use when launched in May 2021. Metrics were tracked over an additional five months post-intervention. Results: The primary outcome of reducing the eConsent error rate per patient day indicated an overall decrease of 42% from January 2021 to October 2021. However, this decrease comparing 5 months pre-intervention versus 5 months post-intervention and the associated result of the two-tailed independent samples t-test was not significant based on an alpha value of .05, t(8) = -0.42, p = .686. Secondary outcomes showed a steadily increase in eConsent usage between May 2021 to October 2021. Evaluation: eConsents have proven worthy for surgical consents and in the reduction of consent error and continued use. Considerations should be made to expand eConsents to other types of consent forms not only for the consolidation of patient documentation and enhanced workflow but to further pursue safe patient practices and prevent documentation error. Nursing informatics is essential to coordinating evidence-based interventions on electronic healthcare platforms that also marry well with bedside operations and workflows

Factors Impacting Clinicians’ Adoption of a Clinical Photo Documentation App and its Implications for Clinical Workflows and Quality of Care: Qualitative Case Study

Background: Mobile health (mHealth) tools have shown promise in clinical photo and wound documentation for their potential to improve workflows, expand access to care, and improve the quality of patient care. However, some barriers to adoption persist. Objective: This study aims to understand the social, organizational, and technical factors affecting clinicians’ adoption of a clinical photo documentation mHealth app and its implications for clinical workflows and quality of care. Methods: A qualitative case study of a clinical photo and wound documentation app called imitoCam was conducted. The data were collected through 20 in-depth interviews with mHealth providers, clinicians, and medical informatics experts from 8 clinics and hospitals in Switzerland and Germany. Results: According to the study participants, the use of mHealth in clinical photo and wound documentation provides numerous benefits such as time-saving and efficacy, better patient safety and quality of care, enhanced data security and validation, and better accessibility. The clinical workflow may also improve when the app is a good fit, resulting in better collaboration and transparency, streamlined daily work, clinician empowerment, and improved quality of care. The findings included important factors that may contribute to or hinder adoption. Factors may be related to the material nature of the tool, such as the perceived usefulness, ease of use, interoperability, cost, or security of the app, or social aspects such as personal experience, attitudes, awareness, or culture. Organizational and policy barriers include the available clinical practice infrastructure, workload and resources, the complexity of decision making, training, and ambiguity or lack of regulations. User engagement in the development and implementation process is a vital contributor to the successful adoption of mHealth apps. Conclusions: The promising potential of mHealth in clinical photo and wound documentation is clear and may enhance clinical workflow and quality of care; however, the factors affecting adoption go beyond the technical features of the tool itself to embrace significant social and organizational elements. Technology providers, clinicians, and decision makers should work together to carefully address any barriers to improve adoption and harness the potential of these tools

Implementing Electronic Tablet-Based Education of Acute Care Patients

Poor education-related discharge preparedness for patients with heart failure is believed to be a major cause of avoidable rehospitalizations. Technology-based applications offer innovative educational approaches that may improve educational readiness for patients in both inpatient and outpatient settings; however, a number of challenges exist when implementing electronic devices in the clinical setting. Implementation challenges include processes for "on-boarding" staff, mediating risks of cross-contamination with patients' device use, and selling the value to staff and health system leaders to secure the investment in software, hardware, and system support infrastructure. Strategies to address these challenges are poorly described in the literature. The purpose of this article is to present a staff development program designed to overcome challenges in implementing an electronic, tablet-based education program for patients with heart failure

Addendum to Informatics for Health 2017: Advancing both science and practice

This article presents presentation and poster abstracts that were mistakenly omitted from the original publication

Formative Evaluation to Determine Facilitators and Barriers to Nurse-driven Implementation: Designing an Inpatient mHealth Intervention to Support Smoking Cessation

The inpatient setting is often a missed opportunity for the introduction of technology to promote health using behavioral techniques. Nurses are stakeholders in the implementation of technology for patients in the inpatient setting and are essential for the determination of feasibility and relevance. The objective of this study was to identify facilitators and barriers for introduction of health-related patient technology, and specifically the appropriateness of mobile health (mHealth) technology in the hospital setting as identified by nurse leaders and staff. Methods of formative evaluation included nurse leader and staff semi-structured interviews and qualitative analysis. Nurses are comfortable with patients using mHealth technology in the inpatient setting. Facilitators for the introduction of technology to hospitalized patients were identified. Based on the formative evaluation findings, we developed an Implementation Program for mHealth technology introduction in the inpatient setting

The Use of Online Applications to Improve Chronic Wound Care in Primary Care; A Literature Review

Abstract Background: Chronic wounds are a major burden on patients, health care professionals, and the healthcare system. Primary care professionals need to be prepared with the information and skills that will help them perform high-quality wound care. Objective: The purpose of this manuscript is to assess the use of mobile applications to support health care providers in primary care who care for patients with chronic wounds. Data Sources: A review of the evidence was performed using CINAHL, Cochrane/ DARE, PubMed, Ovid, and Evidence-Based Journals to explore the consequences of using online wound care applications by primary care practitioners. Conclusions: The literature showed that using smartphone applications in wound management had positive outcomes. The professionals who access the software apps were better equipped to provide wound management than those who were not. Implications for practice: Wound care smartphone applications would allow primary care providers to overcome time stress by accessing resources needed for evaluating, recognizing, and treating wounds. Keywords: Wound care, wound management, wound assessment, measurement, documentation, mobile application