Utility and Impact of the Implementation of Same-Day, Self-administered Electronic Patient-Reported Outcomes Assessments in Routine HIV Care in two North American Clinics.

The PROgress study assessed the value and feasibility of implementing web-based patient-reported outcomes assessments (PROs) within routine HIV care at two North American outpatient clinics. People with HIV (PWH) completed PROs on a tablet computer in clinic before their routine care visit. Data collection included PROs from 1632 unique PWH, 596 chart reviews, 200 patient questionnaires, and 16 provider/staff questionnaires. During an initial setup phase involving 200 patients, PRO results were not delivered to providers; for all subsequent patients, providers received PRO results before the consultation. Chart review demonstrated that delivery of PRO results to providers improved patient-provider communication and increased the number of complex health and behavioral issues identified, recorded, and acted on, including suicidal ideation (88% with vs 38% without PRO feedback) and anxiety (54% with vs 24% without PRO feedback). In post-visit questionnaires, PWH (82%) and providers (82%) indicated that the PRO added value to the visit.

Capturing Relevant Patient Data in Clinical Encounters Through Integration of an Electronic Patient-Reported Outcome System Into Routine Primary Care in a Boston Community Health Center: Development and Implementation Study.

BACKGROUND: Electronic patient-reported outcome (ePRO) systems can improve health outcomes by detecting health issues or risk behaviors that may be missed when relying on provider elicitation. OBJECTIVE: This study aimed to implement an ePRO system that administers key health questionnaires in an urban community health center in Boston, Massachusetts. METHODS: An ePRO system that administers key health questionnaires was implemented in an urban community health center in Boston, Massachusetts. The system was integrated with the electronic health record so that medical providers could review and adjudicate patient responses in real-time during the course of the patient visit. This implementation project was accomplished through careful examination of clinical workflows and a graduated rollout process that was mindful of patient and clinical staff time and burden. Patients responded to questionnaires using a tablet at the beginning of their visit. RESULTS: Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model in terms of applying technological innovation to streamline clinical processes and improve patient care. CONCLUSIONS: Our program demonstrates that implementation of an ePRO system in a primary care setting is feasible, allowing for facilitation of patient-provider communication and care. Other community health centers can learn from our model for application of technological innovation to streamline clinical processes and improve patient care.

HIV Provider Documentation and Actions Following Patient Reports of At-risk Behaviors and Conditions When Identified by a Web-Based Point-of-Care Assessment.

We compared same-day provider medical record documentation and interventions addressing depression and risk behaviors before and after delivering point-of-care patient-reported outcomes (PROs) feedback for patients who self-reported clinically relevant levels of depression or risk behaviors. During the study period (1 January 2006-15 October 2010), 2289 PRO assessments were completed by HIV-infected patients. Comparing the 8 months before versus after feedback implementation, providers were more likely to document depression (74% before vs. 87% after feedback, p = 0.02) in patients with moderate-to-severe depression (n = 317 assessments), at-risk alcohol use (41 vs. 64%, p = 0.04, n = 155) and substance use (60 vs. 80%, p = 0.004, n = 212). Providers were less likely to incorrectly document good adherence among patients with inadequate adherence after feedback (42 vs. 24%, p = 0.02, n = 205). While PRO feedback of depression and adherence were followed by increased provider intervention, other domains were not. Further investigation of factors associated with the gap between awareness and intervention are needed in order to bridge this divide.

Usability Testing the "Personal Patient Profile-Prostate" in a Sample of African American and Hispanic Men.

Shared treatment decision making in a cancer setting requires a patient's understanding of the potential benefits and risks of each treatment option. Graphical display of risk information is one approach to improving understanding. Little is known about how patients engage with infographics in the context of health education materials and whether interactions vary with health literacy levels. We conducted an observational study, using an eye tracker device, of how men with newly diagnosed localized prostate cancer visually engaged with an on-screen infographic depicting risk information in the Personal Patient Profile-Prostate. Health literacy was measured with the Short Assessment of Health Literacy-English. Gaze patterns on an exemplar screens containing infographics about survival were analyzed and explored with respect to sociodemographic and health literacy data. Acceptability of Personal Patient Profile-Prostate was measured with the Acceptability E-scale. Twenty-six English-speaking men participated, and eye tracking data were collected for 12 men on the exemplar page of risk information that we analyzed. We found preliminary evidence of visual scanning and of participants with lower literacy focusing sooner on infographics versus text. Acceptability for Personal Patient Profile-Prostate was high. These findings suggest that infographics may be of higher relative value to participants with low health literacy. Eye trackers may provide valuable information on how people visually engage with infographics and may inform development of health education materials, although care must be taken to minimize data loss.

Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress.

BACKGROUND: Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness. OBJECTIVE: The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress. METHODS: Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients' homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ≥2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher's exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample. RESULTS: Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group. CONCLUSIONS: The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use. TRIAL REGISTRATION: Clinicaltrials.gov NCT00852852; http://clinicaltrials.gov/ct2/show/NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7).

Venous Thromboembolism Among People With HIV: Design, Implementation, and Findings of a Centralized Adjudication System in Clinical Care Sites Across the United States.

BACKGROUND: People with HIV (PWH) are at increased risk for venous thromboembolism (VTE). We conducted this study to characterize VTE including provoking factors among PWH in the current treatment era. METHODS: We included PWH with VTE between 2010 and 2020 at 6 sites in the CFAR Network of Integrated Clinical Systems cohort. We ascertained for possible VTE using diagnosis, VTE-related imaging, and VTE-related procedure codes, followed by centralized adjudication of primary data by expert physician reviewers. We evaluated sensitivity and positive predictive value of VTE ascertainment approaches. VTEs were classified by type and anatomic location. Reviewers identified provoking factors such as hospitalizations, infections, and other potential predisposing factors such as smoking. RESULTS: We identified 557 PWH with adjudicated VTE: 239 (43%) had pulmonary embolism with or without deep venous thrombosis, and 318 (57%) had deep venous thrombosis alone. Ascertainment with clinical diagnoses alone missed 6% of VTEs identified with multiple ascertainment approaches. DVTs not associated with intravenous lines were most often in the proximal lower extremities. Among PWH with VTE, common provoking factors included recent hospitalization (n = 134, 42%), infection (n = 133, 42%), and immobilization/bed rest (n = 78, 25%). Only 57 (10%) PWH had no provoking factor identified. Smoking (46%), HIV viremia (27%), and injection drug use (22%) were also common. CONCLUSIONS: We conducted a robust adjudication process that demonstrated the benefits of multiple ascertainment approaches followed by adjudication. Provoked VTEs were more common than unprovoked events. Nontraditional and modifiable potential predisposing factors such as viremia and smoking were common.

Types of Stroke Among People Living With HIV in the United States.

BACKGROUND: Most studies of stroke in people living with HIV (PLWH) do not use verified stroke diagnoses, are small, and/or do not differentiate stroke types and subtypes. SETTING: CNICS, a U.S. multisite clinical cohort of PLWH in care. METHODS: We implemented a centralized adjudication stroke protocol to identify stroke type, subtype, and precipitating conditions identified as direct causes including infection and illicit drug use in a large diverse HIV cohort. RESULTS: Among 26,514 PLWH, there were 401 strokes, 75% of which were ischemic. Precipitating factors such as sepsis or same-day cocaine use were identified in 40% of ischemic strokes. Those with precipitating factors were younger, had more severe HIV disease, and fewer traditional stroke risk factors such as diabetes and hypertension. Ischemic stroke subtypes included cardioembolic (20%), large vessel atherosclerosis (13%), and small vessel (24%) ischemic strokes. Individuals with small vessel strokes were older, were more likely to have a higher current CD4 cell count than those with cardioembolic strokes and had the highest mean blood pressure of the ischemic stroke subtypes. CONCLUSION: Ischemic stroke, particularly small vessel and cardioembolic subtypes, were the most common strokes among PLWH. Traditional and HIV-related risk factors differed by stroke type/subtype. Precipitating factors including infections and drug use were common. These results suggest that there may be different biological phenomena occurring among PLWH and that understanding HIV-related and traditional risk factors and in particular precipitating factors for each type/subtype may be key to understanding, and therefore preventing, strokes among PLWH.

Development and evaluation of the personal patient profile-prostate (P3P), a Web-based decision support system for men newly diagnosed with localized prostate cancer.

BACKGROUND: Given that no other disease with the high incidence of localized prostate cancer (LPC) has so many treatments with so few certainties related to outcomes, many men are faced with assuming some responsibility for the treatment decision along with guidance from clinicians. Men strongly consider their own personal characteristics and other personal factors as important and influential to the decision. Clinical researchers have not developed or comprehensively investigated interventions to facilitate the insight and prioritizing of personal factors along with medical factors that are required of a man in preparation for the treatment decision. OBJECTIVES: The purpose of this pilot study was to develop and evaluate the feasibility and usability of a Web-based decision support technology, the Personal Patient Profile-Prostate (P3P), in men newly diagnosed with LPC. METHODS: Use cases were developed followed by infrastructure and content application. The program was provided on a personal desktop computer with a touch screen monitor. Participant responses to the query component of P3P determined the content of the multimedia educational and coaching intervention. The intervention was tailored to race, age, and personal factors reported as influencing the decision. Prepilot usability testing was conducted using a "think aloud" interview to identify navigation and content challenges. These issues were addressed prior to deployment in the clinic. A clinical pilot was conducted in an academic medical center where men sought consultation and treatment for LPC. Completion time, missing data, and acceptability were measured. RESULTS: Prepilot testing included 4 men with a past diagnosis of LPC who had completed therapy. Technical navigation issues were documented along with confusing content language. A total of 30 additional men with a recent diagnosis of LPC completed the P3P program in clinic prior to consulting with a urologist regarding treatment options. In a mean time of 46 minutes (SD 13 minutes), participants completed the P3P query and intervention components. Of a possible 4560 items for 30 participants, 22 (0.5%) were missing. Acceptability was reported as high overall. The sections of the intervention reported as most useful were the statistics graphs, priority information topics, and annotated external website links. CONCLUSIONS: The P3P intervention is a feasible and usable program to facilitate treatment decision making by men with newly diagnosed LPC. Testing in a multisite randomized trial with a diverse sample is warranted.

Hodgkin Lymphoma Survivor Wellness: Development of a Web-Based Intervention.

BACKGROUND: Informational and supportive care resources are needed for Hodgkin lymphoma (HL) survivors. OBJECTIVES: The aim of this article is to adapt and evaluate a previously developed survivorship care website for HL survivors. METHODS: A mixed-methods, user-centered design, including one-time focus groups, was followed by iterative web design and user testing. Transcripts were content analyzed, and survey responses were summarized. FINDINGS: HL survivors need survivorship care education and support. Tailored web-based resources may be an effective adjunct to clinical care. The Survivor Wellness website is a usable web-based resource for HL survivors that may facilitate survivorship care.

Evaluating Clinical Implementation Approaches for Prostate Cancer Decision Support.

INTRODUCTION: Shared decision making is widely promoted for counseling men with localized prostate cancer. Results of randomized trials suggest decision aid efficacy. However, few practices or institutions have implemented decision support as standard practice. In this study we evaluated various implementation strategies for the decision aid P3P (Personal Patient Profile-Prostate) and analyzed feedback from clinical site staff and providers. METHODS: A hybrid type 1 effectiveness-implementation trial was conducted. Primary data were collected in 6 urology clinics of 3 geographically distinct health networks. During the implementation phase site specific strategies were codesigned with site leaders. Referral and access metrics for men with localized prostate cancer were monitored for up to 7 months. Clinical staff reports of barriers and facilitators of implementation were evaluated in professionally facilitated focus groups. RESULTS: Of 495 men with localized prostate cancer seen in the clinics 252 (51%, 95% CI 46-55) were informed of the program and of those men 107 (43%, 95% CI 36-49) accessed it. The highest access rates were observed with patient care coordinator e-mail and telephone contact (82%) or verbal physician instruction followed by e-mail and telephone invitations (87%). During focus groups physicians appraised the summaries as useful. Staff identified barriers included creating new workflows within heavy workloads and staff misunderstanding of context and resources. Promoters of successful implementation included an identified clinical lead and physician engagement. CONCLUSIONS: Implementation success was realized when physicians engaged and staff provided followup contact. New practice changes to implement interventions require multimodal strategies for early success.

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. PERSPECTIVE: We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment.

Types of Myocardial Infarction Among Human Immunodeficiency Virus-Infected Individuals in the United States.

Importance: The Second Universal Definition of Myocardial Infarction (MI) divides MIs into different types. Type 1 MIs result spontaneously from instability of atherosclerotic plaque, whereas type 2 MIs occur in the setting of a mismatch between oxygen demand and supply, as with severe hypotension. Type 2 MIs are uncommon in the general population, but their frequency in human immunodeficiency virus (HIV)-infected individuals is unknown. Objectives: To characterize MIs, including type; identify causes of type 2 MIs; and compare demographic and clinical characteristics among HIV-infected individuals with type 1 vs type 2 MIs. Design, Setting, and Participants: This longitudinal study identified potential MIs among patients with HIV receiving clinical care at 6 US sites from January 1, 1996, to March 1, 2014, using diagnoses and cardiac biomarkers recorded in the centralized data repository. Sites assembled deidentified packets, including physician notes and electrocardiograms, procedures, and clinical laboratory tests. Two physician experts adjudicated each event, categorizing each definite or probable MI as type 1 or type 2 and identifying the causes of type 2 MI. Main Outcomes and Measures: The number and proportion of type 1 vs type 2 MIs, demographic and clinical characteristics among those with type 1 vs type 2 MIs, and the causes of type 2 MIs. Results: Among 571 patients (median age, 49 years [interquartile range, 43-55 years]; 430 men and 141 women) with definite or probable MIs, 288 MIs (50.4%) were type 2 and 283 (49.6%) were type 1. In analyses of type 1 MIs, 79 patients who underwent cardiac interventions, such as coronary artery bypass graft surgery, were also included, totaling 362 patients. Sepsis or bacteremia (100 [34.7%]) and recent use of cocaine or other illicit drugs (39 [13.5%]) were the most common causes of type 2 MIs. A higher proportion of patients with type 2 MIs were younger than 40 years (47 of 288 [16.3%] vs 32 of 362 [8.8%]) and had lower current CD4 cell counts (median, 230 vs 383 cells/µL), lipid levels (mean [SD] total cholesterol level, 167 [63] vs 190 [54] mg/dL, and mean (SD) Framingham risk scores (8% [7%] vs 10% [8%]) than those with type 1 MIs or who underwent cardiac interventions. Conclusions and Relevance: Approximately half of all MIs among HIV-infected individuals were type 2 MIs caused by heterogeneous clinical conditions, including sepsis or bacteremia and recent use of cocaine or other illicit drugs. Demographic characteristics and cardiovascular risk factors among those with type 1 and type 2 MIs differed, suggesting the need to specifically consider type among HIV-infected individuals to further understand MI outcomes and to guide prevention and treatment.

Ascertainment and verification of end-stage renal disease and end-stage liver disease in the north american AIDS cohort collaboration on research and design.

The burden of HIV disease has shifted from traditional AIDS-defining illnesses to serious non-AIDS-defining comorbid conditions. Research aimed at improving HIV-related comorbid disease outcomes requires well-defined, verified clinical endpoints. We developed methods to ascertain and verify end-stage renal disease (ESRD) and end-stage liver disease (ESLD) and validated screening algorithms within the largest HIV cohort collaboration in North America (NA-ACCORD). Individuals who screened positive among all participants in twelve cohorts enrolled between January 1996 and December 2009 underwent medical record review to verify incident ESRD or ESLD using standardized protocols. We randomly sampled 6% of contributing cohorts to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ESLD and ESRD screening algorithms in a validation subcohort. Among 43,433 patients screened for ESRD, 822 screened positive of which 620 met clinical criteria for ESRD. The algorithm had 100% sensitivity, 99% specificity, 82% PPV, and 100% NPV for ESRD. Among 41,463 patients screened for ESLD, 2,024 screened positive of which 645 met diagnostic criteria for ESLD. The algorithm had 100% sensitivity, 95% specificity, 27% PPV, and 100% NPV for ESLD. Our methods proved robust for ascertainment of ESRD and ESLD in persons infected with HIV.

Technical Description of the Distribute Project: A Community-based Syndromic Surveillance System Implementation.

This paper describes the design of a syndromic surveillance system implemented for community-based monitoring of influenza-like illness. The system began as collaboration between colleagues from state and large metropolitan area health jurisdictions, academic institutions, and the non-profit, International Society for Disease Surveillance. Over the six influenza seasons from 2006 to 2012, the system was automated and enhanced, with new features and infrastructure, and the resulting, reliable, enterprise grade system supported peer comparisons between 44 state and local public health jurisdictions who voluntarily contributed summarized data on influenza-like illness and gastrointestinal syndromes. The system was unusual in that it addressed the needs of a widely distributed, voluntary, community engaged in real-time data integration to support operational public health.

Piloting electronic self report symptom assessment - Cancer (ESRA-C) in Hong Kong: a mixed method approach.

PURPOSE: The benefits of utilizing computerized assessment in clinical settings have been reported in studies over the last three decades and more recently in the oncology settings. This study aimed to assess the feasibility and acceptability of using an electronic self report symptom assessment tool among Chinese oncology patients. METHODS AND SAMPLE: The tool, developed by The University of Washington, Distributed Health Assessment and Intervention Research (DHAIR) group was translated into Chinese. The adapted web-based survey platform, the Electronic Self Report Assessment - Cancer (ESRA-C), was tested in a local cancer resource center in Hong Kong. Participants' perceptions of the acceptability and feasibility of the symptom assessment process were assessed using the Acceptability E-scale as well as observation and qualitative interview data. Demographic data were also collected through the touch screen computer system. A convenience sample of 30 (11 male and 19 female) oncology patients was recruited to use the touch-screen computer to assess participants' symptoms using ESRA-C. RESULTS: The acceptability scale indicated moderately high acceptability in each subscale (mean score of 3.32-4.71). On average, participants took 17.5 min (SD: 8.9) to complete the ESRA-C. The qualitative interview data revealed that the majority (25 participants) asserted that the ESRA-C was useful and effective in reporting personal health conditions. CONCLUSIONS: The study suggested that electronic assessment can offer a feasible, attractive, and viable means of implementing regular and comprehensive symptom assessment, which can lead to better symptom management in cancer patients.