Mapping Theories, Models, and Frameworks to Evaluate Digital Health Interventions: Scoping Review.

BACKGROUND: Digital health interventions (DHIs) are a central focus of health care transformation efforts, yet their uptake in practice continues to fall short of their potential. In order to achieve their desired outcomes and impact, DHIs need to reach their target population and need to be used. Many factors can rapidly intersect between this dynamic of users and interventions. The application of theories, models, and frameworks (TMFs) can facilitate the systematic understanding and explanation of the complex interactions between users, practices, technology, and health system factors that underpin research questions. There remains a gap in our understanding of how TMFs have been applied to guide the evaluation of DHIs with real-world health system operations. OBJECTIVE: This study aims to map TMFs used in studies to guide the evaluation of DHIs. The objectives are to (1) describe the TMFs and the constructs they target, (2) identify how TMFs have been prospectively used (ie, their roles) in primary studies to evaluate DHIs, and (3) to reflect on the relevance and utility of our findings for knowledge users. METHODS: This scoping review was conducted in partnership with knowledge users using an integrated knowledge translation approach. We included papers (eg, reports; empirical quantitative, qualitative, and mixed methods studies; conference proceedings; and dissertations) if primary insights resulting from the application of TMFs were presented. Any type of DHI was eligible. Papers published from 2000 and onward were mainly identified from the following databases: MEDLINE (Ovid), CINAHL Complete (EBSCOhost), PsycINFO (Ovid), EBM Reviews (Ovid), and Embase (Ovid). RESULTS: A total of 156 studies published between 2000 and 2022 were included. A total of 68 distinct TMFs were identified across 85 individual studies. In more than half (85/156, 55%) of the included studies, 1 of following 6 prevailing TMFs were reported: Consolidated Framework for Implementation Research (n=39); the Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework (n=17); the Technology of Acceptance Model (n=16); the Unified Theory on Acceptance and Use of Technology (n=12); the Diffusion of Innovation Theory (n=10); and Normalization Process Theory (n=9). The most common intended roles of the 6 TMFs were to inform data collection (n=86), to inform data analysis (n=69), and to identify key constructs that may serve as barriers and facilitators (n=52). CONCLUSIONS: As TMFs are most often reported to be applied to support data collection and analysis, researchers should consider more clearly synthesizing key insights as practical use cases to both increase the relevance and digestibility of their findings. There is also a need to adapt or develop guidelines for better reporting DHIs and the use of TMFs to guide evaluation. Hence, it would contribute to ensuring ongoing technology transformation efforts are evidence and theory informed rather than anecdotally driven.

Integrating Behavioral Science and Design Thinking to Develop Mobile Health Interventions: Systematic Scoping Review.

BACKGROUND: Mobile health (mHealth) interventions are increasingly being designed to facilitate health-related behavior change. Integrating insights from behavioral science and design science can help support the development of more effective mHealth interventions. Behavioral Design (BD) and Design Thinking (DT) have emerged as best practice approaches in their respective fields. Until now, little work has been done to examine how BD and DT can be integrated throughout the mHealth design process. OBJECTIVE: The aim of this scoping review was to map the evidence on how insights from BD and DT can be integrated to guide the design of mHealth interventions. The following questions were addressed: (1) what are the main characteristics of studies that integrate BD and DT during the mHealth design process? (2) what theories, models, and frameworks do design teams use during the mHealth design process? (3) what methods do design teams use to integrate BD and DT during the mHealth design process? and (4) what are key design challenges, implementation considerations, and future directions for integrating BD and DT during mHealth design? METHODS: This review followed the Joanna Briggs Institute reviewer manual and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist. Studies were identified from MEDLINE, PsycINFO, Embase, CINAHL, and JMIR by using search terms related to mHealth, BD, and DT. Included studies had to clearly describe their mHealth design process and how behavior change theories, models, frameworks, or techniques were incorporated. Two independent reviewers screened the studies for inclusion and completed the data extraction. A descriptive analysis was conducted. RESULTS: A total of 75 papers met the inclusion criteria. All studies were published between 2012 and 2021. Studies integrated BD and DT in notable ways, which can be referred to as "Behavioral Design Thinking." Five steps were followed in Behavioral Design Thinking: (1) empathize with users and their behavior change needs, (2) define user and behavior change requirements, (3) ideate user-centered features and behavior change content, (4) prototype a user-centered solution that supports behavior change, and (5) test the solution against users' needs and for its behavior change potential. The key challenges experienced during mHealth design included meaningfully engaging patient and public partners in the design process, translating evidence-based behavior change techniques into actual mHealth features, and planning for how to integrate the mHealth intervention into existing clinical systems. CONCLUSIONS: Best practices from BD and DT can be integrated throughout the mHealth design process to ensure that mHealth interventions are purposefully developed to effectively engage users. Although this scoping review clarified how insights from BD and DT can be integrated during mHealth design, future research is needed to identify the most effective design approaches.

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients.

The pursuit of more efficient patient-friendly health systems and reductions in tertiary health services use has seen enormous growth in the application and study of remote patient monitoring systems for cardiovascular patient care. While there are many consumer-grade products available to monitor patient wellness, the regulation of these technologies varies considerably, with most products having little to no evaluation data. As the science and practice of virtual care continues to evolve, clinicians and researchers can benefit from an understanding of more comprehensive solutions capable of monitoring multiple biophysical parameters (eg, oxygen saturation, heart rate) continuously and simultaneously. These devices, herein referred to as continuous multiparameter remote automated monitoring (CM-RAM) devices, have the potential to revolutionise virtual patient care. Through seamless integration of multiple biophysical signals, CM-RAM technologies can allow for the acquisition of high-volume big data for the development of algorithms to facilitate early detection of negative changes in patient health status and timely clinician response. In this article, we review key principles, architecture, and components of CM-RAM technologies. Work to date in this field and related implications are also presented, including strategic priorities for advancing the science and practice of CM-RAM.

Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study.

BACKGROUND: Wearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. OBJECTIVE: Our aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. METHODS: Included participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. RESULTS: The validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time). CONCLUSIONS: We found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial.

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.

BACKGROUND: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04344665.

Identifying optimal frameworks to implement or evaluate digital health interventions: a scoping review protocol.

INTRODUCTION: Digital health interventions (DHIs) are defined as health services delivered electronically through formal or informal care. DHIs can range from electronic medical records used by providers to mobile health apps used by consumers. DHIs involve complex interactions between user, technology and the healthcare team, posing challenges for implementation and evaluation. Theoretical or interpretive frameworks are crucial in providing researchers guidance and clarity on implementation or evaluation approaches; however, there is a lack of standardisation on which frameworks to use in which contexts. Our goal is to conduct a scoping review to identify frameworks to guide the implementation or evaluation of DHIs. METHODS AND ANALYSIS: A scoping review will be conducted using methods outlined by the Joanna Briggs Institute reviewers' manual and will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Studies will be included if they report on frameworks (ie, theoretical, interpretive, developmental) that are used to guide either implementation or evaluation of DHIs. Electronic databases, including MEDLINE, EMBASE, CINAHL and PsychINFO will be searched in addition to grey literature and reference lists of included studies. Citations and full text articles will be screened independently in Covidence after a reliability check among reviewers. We will use qualitative description to summarise findings and focus on how research objectives and type of DHIs are aligned with the frameworks used. ETHICS AND DISSEMINATION: We engaged an advisory panel of digital health knowledge users to provide input at strategic stages of the scoping review to enhance the relevance of findings and inform dissemination activities. Specifically, they will provide feedback on the eligibility criteria, data abstraction elements, interpretation of findings and assist in developing key messages for dissemination. This study does not require ethical review. Findings from review will support decision making when selecting appropriate frameworks to guide the implementation or evaluation of DHIs.

Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study.

BACKGROUND: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure. OBJECTIVE: As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively. METHODS: Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews. RESULTS: A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems. CONCLUSIONS: User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.

Postoperative Remote Automated Monitoring: Need for and State of the Science.

Worldwide, more than 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to home, are inadequate. On the surgical ward, vital signs evaluation usually occurs only every 4-8 hours. Reduced in-hospital ward monitoring, followed by no vital signs monitoring at home, leads to thousands of cases of undetected/delayed detection of hemodynamic compromise. In this article we review work to date on postoperative remote automated monitoring on surgical wards and strategy for advancing this field. Key considerations for overcoming current barriers to implementing remote automated monitoring in Canada are also presented.

Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

BACKGROUND: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. OBJECTIVE: Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). METHODS: CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise-death, myocardial infarction, and nonfatal stroke- all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups. RESULTS: Study start-up is underway and usability testing is scheduled to begin in the fall of 2016. CONCLUSIONS: Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS.

Increasing the detection rate of congenital heart disease during routine obstetric screening using cine loop sweeps.

OBJECTIVES: The purpose of this study was to demonstrate an increase in the detection rate of fetal cardiac defects using 2 cine loop sweeps. METHODS: Image reviewers examined a series of 93 cases randomly sorted, including 79 studies with normal findings and 14 studies with abnormal findings. All of the images were assessed by 5 standard criteria. Cases were classified as normal, abnormal, or indeterminate. Reviewers using the conventional approach reviewed 3 still images: the 4-chamber, left ventricular outflow tract, and right ventricular outflow tract views. Reviewers using the cine loop sweeps viewed 2 grayscale sweeps through the fetal heart in real time. The image sequences were reviewed independently by 2 experts, 3 nonexperts, and 2 sonographers blinded to each others' results. RESULTS: The cine loop sweeps had an increased detection rate of 38% for the nonexperts and 36% for the experts compared with the conventional approach. The cine loop sweeps allowed identification of all cardiac defects by at least 2 of the 7 reviewers; the percentage of cases with false-positive findings was 3.9%. With the conventional approach, 2 defects went undetected by all reviewers, and 4 defects were found by only 1 reviewer; the percentage of cases with false-positive findings was 5.4%. CONCLUSIONS: The use of cine loop sweeps has the potential to increase the detection of fetal cardiac defects without increasing the rate of false-positive findings or increasing the interpretation and decision-making times.

Tendon and nerve excursion in the carpal tunnel in healthy and CTD wrists.

BACKGROUND: During hand and finger motions, friction between flexor digitorum superficialis tendon and the median nerve is thought to play a role in the development of cumulative trauma disorders. This study investigated three methods to determine excursions of the flexor digitorum superficialis tendon and median nerve using several motions. METHODS: Twenty-five participants (mean age 37.2 years SD 13.4) were classified as healthy (n=16), self-reported distal upper extremity cumulative trauma disorders (6), or wheelchair users (3). Static carpal tunnel measurements were taken and displacements of the index flexor digitorum superficialis tendon and median nerve were determined via the velocity time integral and post hoc integration of the Doppler ultrasound waveform using a 12-5 MHz linear array transducer, as well as using predictive equations. FINDINGS: Median nerves in symptomatic wrists were larger than healthy wrists by 4.2 mm(2) (left) and 4.1 mm(2) (right) proximally to less than 1.4 mm(2) distally. In healthy wrists, left-right tendon excursion differences ranged from 0.7 mm to 4.3 mm depending on the motion while left to right differences in symptomatic wrists ranged over 22.2 mm. Ultrasound measures of tendon excursion overestimated those determined using predictive equations and were poorly correlated. The ratio of median nerve excursion to tendon excursion was lower in finger only motions compared to wrist motions with or without finger motion. INTERPRETATION: Spectral Doppler ultrasound imaging provided insights into tendon excursion that was not apparent with mathematical modeling. The difference in excursion between finger motions and wrist motions could be beneficial in therapeutic techniques.