A Pilot Randomized Trial of an Interactive Web-based Tool to Support Surrogate Decision Makers in the Intensive Care Unit.

Rationale: Breakdowns in clinician-family communication in intensive care units (ICUs) are common, yet there are no easily scaled interventions to prevent this problem.Objectives: To assess the feasibility, usability, acceptability, and perceived effectiveness of a communication intervention that pairs proactive family meetings with an interactive, web-based tool to help surrogates prepare for clinician-family meetings.Methods: We conducted a two-arm, single-blind, patient-level randomized trial comparing the Family Support Tool with enhanced usual care in two ICUs in a tertiary-care hospital. Eligible participants included surrogates of incapacitated patients judged by their physicians to have ≥40% risk of death or severe long-term functional impairment. The intervention group received unlimited tool access, with prompts to complete specific content upon enrollment and before two scheduled family meetings. Before family meetings, research staff shared with clinicians a one-page summary of surrogates' main questions, prognostic expectations, beliefs about the patient's values, and attitudes about goals of care. The comparator group received usual care enhanced with scheduled family meetings. Feasibility outcomes included the proportion of participants who accessed the tool before the first family meeting, mean number of logins, and average tool engagement time. We assessed tool usability with the System Usability Scale, assessed tool acceptability and perceived effectiveness with internally developed questionnaires, and assessed quality of communication and shared decision-making using the Quality of Communication questionnaire.Results: Of 182 screened patients, 77 were eligible. We enrolled 52 (67.5%) patients and their primary surrogate. Ninety-six percent of intervention surrogates (24/25) accessed the tool before the first family meeting (mean engagement time, 62 min ± 27.7) and logged in 4.2 times (±2.1) on average throughout the hospitalization. Surrogates reported that the tool was highly usable (mean, 82.4/100), acceptable (mean, 4.5/5 ± 0.9), and effective (mean, 4.4/5 ± 0.2). Compared with the control group, surrogates who used the tool reported higher overall quality of communication (mean, 8.9/10 ± 1.6 vs. 8.0/10 ± 2.4) and higher quality in shared decision-making (mean, 8.7/10 ± 1.5 vs. 8.0/10 ± 2.4), but the difference did not reach statistical significance.Conclusions: It is feasible to deploy an interactive web-based tool to support communication and shared decision-making for surrogates in ICUs. Surrogates and clinicians rated the tool as highly usable, acceptable, and effective.

Developing the family support tool: An interactive, web-based tool to help families navigate the complexities of surrogate decision making in ICUs.

INTRODUCTION: Although family members of incapacitated, critically ill patients often struggle in the role of surrogate decision maker, there are no low-cost, easily-scaled interventions to address this problem. AIM OF THE STUDY: To develop and pilot-test the Family Support Tool, an interactive, web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs. MATERIAL AND METHODS: We used a mixed methods, user-centered process to create the Family Support Tool, including: 1) creation of a preliminary design by an expert panel; 2) engagement of a key stakeholder panel to iteratively refine the preliminary design; 3) user testing of a low-fidelity prototype of the tool by 6 former ICU surrogates; 4) creation of a web-based prototype; and 5) user testing of the web-based prototype with 14 surrogates and ICU physicians, including semi-structured interviews and quantitative measurement of usability, acceptability, and perceived effectiveness. RESULTS: The initial design contained a collection of videos and exercises designed to help individuals understand the surrogate's role and think through the patient's values and preferences. Based on family stakeholders' feedback about the emotional overwhelm they experience early in an ICU stay, we redesigned the tool to be viewed in sections, with the first section focused on decreasing surrogates' emotional distress, and later sections focused on helping surrogates prepare for family meetings. Surrogates actively making decisions in the ICU judged the final tool to be highly usable (mean summary score 83.5, correlating to 95th percentile when normalized to devices of its type), acceptable (mean 4.2 +/- 0.5 out of 5), and effective (mean 4.3 +/- 0.6 out of 5). All surrogates reported the tool helped them consider goals of care and all indicated they would recommend the tool to a friend. CONCLUSIONS: We successfully developed a web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs that has high potential for scalability. Surrogates judged the tool to be usable, acceptable, and effective. These data support proceeding to test the tool in a pilot randomized clinical trial.

Effect of a Virtual Pharmacy Review Program: A Population Health Case Study.

INTRODUCTION: The growing emphasis on value-based health care has created a need for innovative population health management strategies. Pharmacists are underused resources for implementation of meaningful population health models that ensure appropriate medication use through optimization of electronic medical record (EMR) technology and pharmacist knowledge. The objective of our program was to improve the health outcomes of a patient population with diabetes while also reducing costs. PROGRAM DESCRIPTION: A virtual pharmacy review (ViPRx) program was used to remotely provide previsit comprehensive medication reviews for patients in the defined population. The pharmacist used the EMR to review medications and relevant histories and to intervene when needed to ensure appropriate medication use. Pharmacist recommendations and supporting statements were delivered to the provider's EMR in-box 1-2 days before a scheduled visit. The information technology resources and virtual model allow the pharmacist to manage patient care and collaborate with providers electronically across multiple clinic locations. OBSERVATIONS: The pharmacist managed a panel of over 700 patients in this virtual model. The program has yielded improvements in key diabetes metrics. Most notable is a 6% increase in the percentage of patients with a hemoglobin A1c (HbA1c) value of 9% or less and a 7% improvement in the controlled low-density lipoprotein (LDL) measure. Monitoring parameters (nephropathy screening, HbA1c, and LDL) increased by 8%-12% from baseline. Additional positive outcomes include improved medication adherence in the defined population as seen by a 1.5% improvement in medication possession ratio for diabetes medications. Reductions in per member per month (PMPM) prescription costs are estimated at $11 per month through discontinuation of unnecessary and duplicate medications. IMPLICATIONS: The results of this case study on the effect of a virtual pharmacy review program demonstrate an opportunity for pharmacists to engage in a population health management model that improves patient outcomes and may reduce the rate at which PMPM prescription drug costs increase. DISCLOSURES: No outside funding supported this work. The authors have no conflicts of interest to disclose. This work was presented at the 2017 Vizient Connections Summit; April 6, 2017; Las Vegas, NV, and the 2018 Cerner Health Conference; October 10, 2018; Kansas City, MO.

Evaluating the Usability and Acceptability of Communication Tools Among Older Adults.

Acutely ill patients may have trouble communicating their symptoms and needs verbally. The current study evaluated the usability and acceptability of six commercially available communication tools with older adults in a non-clinical, controlled setting. Participants evaluated various communication boards and communication applications (apps) by using the tools to communicate needs and symptoms in various scenarios. Participants completed a modified technology acceptance questionnaire and selected the tool they perceived as most useful and easy to use. Bivariate analysis was used to compare communication boards and apps. Performance on most tasks was significantly better using communication boards compared to communication apps. However, participants reported that given more time and training, the apps could be used effectively. A feasibility study is needed to determine whether acutely ill older adults can use these communication tools to successfully convey their symptoms and needs in a hospital setting [Journal of Gerontological Nursing, 44(9), 30-39.].

Key stakeholders' perceptions of the acceptability and usefulness of a tablet-based tool to improve communication and shared decision making in ICUs.

PURPOSE: Although barriers to shared decision making in intensive care units are well documented, there are currently no easily scaled interventions to overcome these problems. We sought to assess stakeholders' perceptions of the acceptability, usefulness, and design suggestions for a tablet-based tool to support communication and shared decision making in ICUs. METHODS: We conducted in-depth semi-structured interviews with 58 key stakeholders (30 surrogates and 28 ICU care providers). Interviews explored stakeholders' perceptions about the acceptability of a tablet-based tool to support communication and shared decision making, including the usefulness of modules focused on orienting families to the ICU, educating them about the surrogate's role, completing a question prompt list, eliciting patient values, educating about treatment options, eliciting perceptions about prognosis, and providing psychosocial support resources. The interviewer also elicited stakeholders' design suggestions for such a tool. We used constant comparative methods to identify key themes that arose during the interviews. RESULTS: Overall, 95% (55/58) of participants perceived the proposed tool to be acceptable, with 98% (57/58) of interviewees finding six or more of the seven content domains acceptable. Stakeholders identified several potential benefits of the tool including that it would help families prepare for the surrogate role and for family meetings as well as give surrogates time and a framework to think about the patient's values and treatment options. Key design suggestions included: conceptualize the tool as a supplement to rather than a substitute for surrogate-clinician communication; make the tool flexible with respect to how, where, and when surrogates can access the tool; incorporate interactive exercises; use video and narration to minimize the cognitive load of the intervention; and build an extremely simple user interface to maximize usefulness for individuals with low computer literacy. CONCLUSION: There is broad support among stakeholders for the use of a tablet-based tool to improve communication and shared decision making in ICUs. Eliciting the perspectives of key stakeholders early in the design process yielded important insights to create a tool tailored to the needs of surrogates and care providers in ICUs.

Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.

BACKGROUND: Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. PURPOSE: Our purpose is to describe the protocol to evaluate Pocket PATH (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial (RCT) to evaluate health IT intended for patient use. METHODS: An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies are described to maintain equipoise, to monitor data safety and intervention fidelity, and to keep pace with changing technology during such trials. LESSONS LEARNED: The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care, and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. CONCLUSIONS: Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting RCTs and include strategies to address the unique issues associated with the evaluation of health IT for patient use.

Data safety and monitoring for research involving remote health monitoring.

Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study. However, practical guidance for establishing and implementing appropriate DSM plans for such studies are lacking. In this article, we provide a review of the DSM considerations associated with monitoring health remotely and describe the Pocket Personal Assistant for Tracking Health project as an exemplar for how to develop effective DSM plans for research that captures clinical data using remote health-monitoring devices. Protecting the safety and welfare of participants is one of the most important mandates for research involving human subjects. Investigators have an ethical and scientific responsibility to monitor the safety of research participants. Investigators typically fulfill this responsibility by monitoring and reporting adverse events.

Evaluation of a hand-held, computer-based intervention to promote early self-care behaviors after lung transplant.

BACKGROUND: Lung transplant recipients are expected to perform self-care behaviors to maximize transplant-related health outcomes. Despite high non-adherence rates in performing these self-care behaviors, and the dire clinical consequences of such non-adherence, interventions are lacking. Pocket Personal Assistant for Tracking Health (Pocket PATH) is a hand-held device developed for patients to record health data, review data trends, and report condition changes to the transplant team. METHODS: A pilot trial was conducted to compare self-care agency, self-care behaviors, and health-related quality of life (HRQOL) between recipients randomized to use Pocket PATH (n = 15) vs. standard care (n = 15) for the first two months following hospital discharge after lung transplantation. RESULTS: Baseline characteristics were equivalent across groups. Patients in the Pocket PATH group showed significantly higher ratings of self-care agency, performed self-care behaviors at significantly higher rates, and reported significantly better HRQOL than standard care controls. CONCLUSION: Pocket PATH is more efficacious than standard care in promoting early self-care agency, self-care behaviors, and HRQOL in lung recipients. A large-scale randomized controlled trial is needed to test the impact of Pocket PATH on long-term self-care behaviors.

User-centered design and interactive health technologies for patients.

Despite recommendations that patients be involved in the design and testing of health technologies, few reports describe how to involve patients in systematic and meaningful ways to ensure that applications are customized to meet their needs. User-centered design is an approach that involves end users throughout the development process so that technologies support tasks, are easy to operate, and are of value to users. In this article, we provide an overview of user-centered design and use the development of Pocket Personal Assistant for Tracking Health (Pocket PATH) to illustrate how these principles and techniques were applied to involve patients in the development of this interactive health technology. Involving patient-users in the design and testing ensured functionality and usability, therefore increasing the likelihood of promoting the intended health outcomes.

Enabling devices, empowering people: the design and evaluation of Trackball EdgeWrite.

PURPOSE: To describe the research and development that led to Trackball EdgeWrite, a gestural text entry method that improves desktop input for some people with motor impairments. To compare the character-level version of this technique with a new word-level version. Further, to compare the technique with competitor techniques that use on-screen keyboards. METHOD: A rapid and iterative design-and-test approach was used to generate working prototypes and elicit quantitative and qualitative feedback from a veteran trackball user. In addition, theoretical modelling based on the Steering law was used to compare competing designs. RESULTS: One result is a refined software artifact, Trackball EdgeWrite, which represents the outcome of this investigation. A theoretical result shows the speed benefit of word-level stroking compared to character-level stroking, which resulted in a 45.0% improvement. Empirical results of a trackball user with a spinal cord injury indicate a peak performance of 8.25 wpm with the character-level version of Trackball EdgeWrite and 12.09 wpm with the word-level version, a 46.5% improvement. Log file analysis of extended real-world text entry shows stroke savings of 43.9% with the word-level version. Both versions of Trackball EdgeWrite were better than on-screen keyboards, particularly regarding user preferences. Follow-up correspondence shows that the veteran trackball user with a spinal cord injury still uses Trackball EdgeWrite on a daily basis 2 years after his initial exposure to the software. CONCLUSIONS: Trackball EdgeWrite is a successful new method for desktop text entry and may have further implications for able-bodied users of mobile technologies. Theoretical modelling is useful in combination with empirical testing to explore design alternatives. Single-user lab and field studies can be useful for driving a rapid iterative cycle of innovation and development.