A randomized prospective trial of an ostomy telehealth intervention for cancer survivors.

BACKGROUND: Cancer survivors with ostomies face complex challenges. This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC). METHODS: Three academic centers randomized participants. OSMT group sessions were led by ostomy nurses and peer ostomates (three for ostomates-only, one for support persons, and one review session for both). Surveys at baseline, OSMT completion, and 6 months were primary outcome patient activation (PAM), self-efficacy (SE), City of Hope quality of life-Ostomy (COH-O), and Hospital Anxiety and Depression Scale (HADS). Surveys were scored per guidelines for those completing at least two surveys. Linear mixed effects models were used to select potential covariates for the final model and to test the impact of OSMT within each timeframe. RESULTS: A total of 90 OSMT and 101 UC fulfilled analysis criteria. Arms were well-matched but types of tumors were unevenly distributed (p = .023). The OSMT arm had a nonsignificant improvement in PAM (confidence interval [CI], -3.65 to 5.3]; 4.0 vs. 2.9) at 6 months. There were no significant differences in other surveys. There was a significant OSMT benefit for urinary tumors (four SE domains). Higher OSMT session attendance was associated with post-session improvements in five SE domains (p < .05), two COH-O domains (p < .05), and HADS anxiety (p = .01). At 6 months, there remained improvements in one SE domain (p < .05), one COH-O domain (p < .05), and HADS anxiety (p < .01). CONCLUSIONS: No clear benefit was seen for the OSMT intervention, although there may be an advantage based on type of tumor. Benefit with greater session attendance was also encouraging. PLAIN LANGUAGE SUMMARY: Cancer patients with ostomies have many challenges. We tested a telehealth curriculum compared to usual care. There are indications of benefit for the program for those that attend more sessions and those with urostomies.

Intimacy and survivors of cancer with ostomies: findings from the Ostomy Self-management Training trial.

BACKGROUND: Many people with abdominal or pelvic cancers require an ostomy during surgical treatment, which can cause significant issues with physical and emotional intimacy in relationships. AIM: To evaluate the effect of a telehealth-based education program on intimacy over time for survivors of cancer with ostomies. METHODS: We performed a secondary analysis of our multicenter randomized controlled trial to determine intimacy outcomes and to compare the effects of the Ostomy Self-management Training (OSMT) program vs usual care. Partnered patients were included who provided answers to the City of Hope Quality of Life-Ostomy survey for at least 2 time points during the study. We evaluated the effect of baseline information, such as gender on intimacy. OUTCOMES: The primary outcome was intimacy, estimated by a composite score created from questions within the City of Hope Quality of Life-Ostomy survey. RESULTS: Of 216 enrolled volunteers, 131 had a partner: 68 in the OSMT arm and 63 in the usual care arm. Of these, 48 were women and 83 were men. The tumor types represented in this study were colorectal (n = 69), urinary (n = 45), gynecologic (n = 10), and other (n = 7; eg, melanoma, liposarcoma). From the cohort, 87 answered the 5 composite intimacy score questions at 2 time points, including baseline. There was significant improvement over time in composite intimacy scores for participants in the OSMT arm vs the usual care arm. CLINICAL IMPLICATIONS: Our OSMT intervention had a positive effect on factors that contribute to intimacy for survivors of cancer with ostomies, suggesting that a survivorship curriculum can improve their experiences after ostomy surgery. STRENGTHS AND LIMITATIONS: OSMT allowed for discussion of intimacy and other sensitive topics, which can be challenging. These discussions demonstrate benefit to participants and can serve as frameworks for cancer treatment providers. The focus of this work on partnered participants provides insight into the interpersonal challenges of a life with an ostomy, but it may overlook the important perspectives of nonpartnered participants and the partners themselves. Furthermore, limited power prevented us from conducting subgroup analyses exploring the effects of factors such as gender and tumor type on intimacy. CONCLUSION: At 6-month follow-up, the novel intimacy composite score indicated improvement for participants completing the OSMT intervention. Future research studies with higher power will validate this intimacy measurement and identify intimacy differences in similar populations based on tumor type.

Clinical and Demographic Differences Among Cancer Survivors With Ostomies With and Without Informal Caregivers.

Informal caregivers have an essential role for cancer survivors (CS). There may be important clinical and demographic differences between CS with ostomies based on caregiver status. Our aim was to identify items that may lead to future recommendations and interventions for CS with ostomies. This is a secondary analysis of 216 CS with ostomies that were enrolled in a clinical trial. Baseline data collected included demographics, clinical characteristics, and surveys (patient activation, self-efficacy, City of Hope Quality of Life - Ostomy). These factors were compared based on caregiver status using chi-squared analysis and t-tests. Logistic regression was used to examine the factors that affect the likelihood of having a caregiver. Most participants had an identified caregiver (57%; 124/216). There was no difference in age based on caregiver status (mean 64.4 and 62.0 for those with and without a caregiver, respectively). Of those with a caregiver, 66.9% were males, 79.0% were partnered, and 87.1% were white. Those with caregivers had a higher prevalence of diabetes (p < 0.001), heart disease (p = 0.002), and mobility issues (p = 0.002). Survivors with caregivers had both higher incomes (p = 0.012) and levels of education (p = 0.049). The only difference in survey measures was those with a caregiver were more successful at getting help when needed (p = .045). Differences in gender and comorbidities of CS with caregivers demand further investigation. Interventions such as encouraging CS without caregivers to utilize available sources of social support, including other survivors with ostomies, may improve their care and quality of life.

Stakeholder engagement and participation in the design, delivery, and dissemination of the ostomy self-management telehealth (OSMT) program.

PURPOSE: Stakeholder engagement is increasingly integrated into clinical research processes. We conducted a mixed methods analysis to describe stakeholders' (peer ostomates, ostomy nurses, telehealth engineers) perceptions of their engagement and participation in a multisite, randomized trial of a telehealth-delivered curriculum for cancer survivors with ostomies. METHODS: Stakeholder notes were analyzed using narrative analysis. We constructed a 15-item survey that assessed the following areas: adherence to stakeholder engagement principles, engagement/influence throughout the study process, impact on perceived well-being, and satisfaction. Stakeholders were invited to complete the survey anonymously. Quantitative survey data were tabulated through summary statistics. RESULTS: Across intervention sessions, an average of 7.7 ± 1.4 stakeholders attended and 2.6 ± 1.4 submitted a note per session. The survey response rate was 73% (11/15). Stakeholders reported high agreement that the study adhered to engagement principles (91% reciprocal relationships, 100% co-learning, partnership, and transparency/honesty/trust). They felt highly engaged (18% moderate, 73% great deal) and that they had influence on study initiation (27% moderate, 55% great deal), intervention delivery (9% moderate, 82% great deal), fidelity assessment (18% moderate, 73% great deal), analysis and interpretation (55% moderate, 27% great deal), and dissemination (45% moderate, 45% great deal). They reported high overall satisfaction with roles (91% great deal), believed the program was helpful for participants (91%), and that serving on study team benefited their own well-being (100%). CONCLUSIONS: Our strategy of stakeholder inclusion led to high engagement, input, satisfaction, and belief in success of program, which could be mirrored in other trials.

Cancer survivors' greatest challenges of living with an ostomy: findings from the Ostomy Self-Management Telehealth (OSMT) randomized trial.

OBJECTIVES: An ostomy results in lifelong quality of life changes for a cancer survivor. We describe the greatest challenges reported from a randomized trial of cancer survivors with stomas (ostomies). METHODS: Cancer survivors with ostomies participating in a multi-site randomized prospective trial of an Ostomy Self-Management Telehealth (OSMT) program versus usual care (UC) were surveyed at six months post accrual. An open-ended question requested greatest challenges after ostomy surgery. Quantitative descriptive and qualitative analyses were used to examine greatest challenges reported. RESULTS: A total of 118 trial participants identified greatest challenges with 55 in the OSMT and 63 in the UC. Six conceptual domains were used to code comments-physical, psychological, social, and spiritual quality of life; ostomy-specific issues, and healthcare issues. The OSMT contributed 187 comments, and UC contributed 235 comments. Ostomy specific issues and social well-being had the most comments overall with UC contributing more comments in all domains except physical well-being. Word Clouds revealed post-operative and treatment-related issues and going out in public as the most common challenges in both groups. Word Clouds compared types of ostomies revealing bowel function challenges (colostomy group), difficulties going out in public (ileostomy group), and positive support (urostomy group). CONCLUSIONS: Fewer challenges submitted by the OSMT group provide the beginning evidence of the OSMT program impact. Dominant challenges across both groups were social well-being and ostomy care. Challenges varied by type of ostomy. Findings support long-term care and support for all cancer survivors with ostomies. TRIAL REGISTRATION: NCT02974634.

Programmatic Costs of the Telehealth Ostomy Self-Management Training: An Application of Time-Driven Activity-Based Costing.

OBJECTIVES: Programmatic cost assessment of novel clinical interventions can inform their widespread dissemination and implementation. This study aimed to determine the programmatic costs of a telehealth Ostomy Self-Management Training (OSMT) intervention for cancer survivors using Time-Driven Activity-Based Costing (TDABC) methodology. METHODS: We demonstrated a step-by-step application of TDABC based on a process map with core OSMT intervention activities and associated procedures and determined resource use and costs, per unit procedure. We also assessed per-patient costs from a payer perspective and provided estimates of total hours and costs by personnel, activity, and procedure. RESULTS: The per-patient cost of the OSMT was $1758. Personnel time accounted for 91% of the total cost. Site supervisor and information technology technician time were the most expensive personnel resources. Telehealth technical and communication equipment accounted for 8% of the total cost. Intervention coordination and monitoring efforts represented most of the total time cost (62%), followed by the intervention delivery (35%). The procedures with the highest cost were communication via phone or virtual meetings (24%), email exchanges (18%), and telehealth session delivery (18%). CONCLUSIONS: Future efforts to replicate, disseminate, and implement the OSMT intervention should anticipate funding for nonclinical components of the intervention, including coordination and monitoring, and consider how these activities can be performed most efficiently. For institutions without established telemedicine programs, selection of videoconferencing platforms and adequate staffing for participant technical support should be considered. Our step-by-step application of TDABC serves as a case study demonstrating how interventionists can gather data on resource use and costs of intervention activities concurrently with their collection of trial data.

An Ostomy Self-management Telehealth Intervention for Cancer Survivors: Technology-Related Findings From a Randomized Controlled Trial.

BACKGROUND: An Ostomy Self-management Telehealth (OSMT) intervention by nurse educators and peer ostomates can equip new ostomates with critical knowledge regarding ostomy care. A telehealth technology assessment aim was to measure telehealth engineer support requirements for telehealth technology-related (TTR) incidents encountered during OSMT intervention sessions held via a secure cloud-based videoconferencing service, Zoom for Healthcare. OBJECTIVE: This paper examines technology-related challenges, issues, and opportunities encountered in the use of telehealth in a randomized controlled trial intervention for cancer survivors living with a permanent ostomy. METHODS: The Arizona Telemedicine Program provided telehealth engineering support for 105 OSMT sessions, scheduled for 90 to 120 minutes each, over a 2-year period. The OSMT groups included up to 15 participants, comprising 4-6 ostomates, 4-6 peer ostomates, 2 nurse educators, and 1 telehealth engineer. OSMT-session TTR incidents were recorded contemporaneously in detailed notes by the research staff. TTR incidents were categorized and tallied. RESULTS: A total of 97.1% (102/105) OSMT sessions were completed as scheduled. In total, 3 OSMT sessions were not held owing to non-technology-related reasons. Of the 93 ostomates who participated in OSMT sessions, 80 (86%) completed their OSMT curriculum. TTR incidents occurred in 36.3% (37/102) of the completed sessions with varying disruptive impacts. No sessions were canceled or rescheduled because of TTR incidents. Disruptions from TTR incidents were minimized by following the TTR incident prevention and incident response plans. CONCLUSIONS: Telehealth videoconferencing technology can enable ostomates to participate in ostomy self-management education by incorporating dedicated telehealth engineering support. Potentially, OSMT greatly expands the availability of ostomy self-management education for new ostomates. TRIAL REGISTRATION: ClinicalTrials.gov NCT02974634; https://clinicaltrials.gov/ct2/show/NCT02974634.

Reading List: Select Healthcare Transformation Library 2.0.

Reading List: Select Healthcare Transformation Library 2.0 represents a broad-based, annotated, general reading list for students of health care innovation. The books were drawn from the 5,000-book private home library of Ronald S. Weinstein, MD, President Emeritus of the American Telemedicine Association. Weinstein is a lifelong book collector with special interests in the history of medical innovation and poetry. A Massachusetts General Hospital-trained pathologist and inductee into the US Distance Learning Association's Hall of Fame, he is known as a pioneer in telemedicine and the "father of telepathology" for his invention, patenting, and commercialization of telepathology, a subspecialty of telemedicine that is a billion-dollar worldwide industry today. This Reading List: Select Healthcare Transformation Library 2.0 consists of 41 books divided into 10 sections: (1) Human Intelligence, Behavior, and Creativity; (2) Societal Revolutions; (3) Innovation; (4) Healthcare System Transformations; (5) Education; (6) Transformational Technologies-Part 1 (AI, Automation, and Robotics); (7) Transformational Technologies-Part 2 (Telemedicine and Telehealth); (8) Digital Medicine; (9) Healthcare Transformation Implementation; and (10) COVID-19 Pandemic as an Innovation Accelerator.

Invention and Early History of Telepathology (1985-2000).

This narrative-based paper provides a first-person account of the early history of telepathology (1985-2000) by the field's inventor, Ronald S. Weinstein, M. D. During the 1980s, Dr. Weinstein, a Massachusetts General Hospital-trained pathologist, was director of the Central Pathology Laboratory (CPL) for the National Cancer Institute-funded National Bladder Cancer Project, located at Rush Medical College in Chicago, IL. The CPL did post therapy revalidations of surgical pathology and cytopathology diagnoses before outcomes of the completed clinical trials were published. The CPL reported that interobserver variability was invalidating inclusion of dozens of treated bladder cancer patients in published reports on treatment outcomes. This problem seemed ripe for a technology-assisted solution. In an effort to solve the interobserver variability problem, Dr. Weinstein devised a novel solution, dynamic-robotic telepathology, that would potentially enable CPL uropathologists to consult on distant uropathology cases in real-time before their assignment to urinary bladder cancer, tumor stage, and grade-specific clinical trials. During the same period, universities were ramping up their support for faculty entrepreneurism and creating in-house technology transfer organizations. Dr. Weinstein recognized telepathology as a potential growth industry. He and his sister, Beth Newburger, were a successful brother-sister entrepreneur team. Their PC-based education software business, OWLCAT™, had just been acquired by Digital Research Inc., a leading software company, located in California. With funding from the COMSAT Corporation, a publically traded satellite communications company, the Weinstein-Newburger team brought the earliest dynamic-robotic telepathology systems to market. Dynamic-robotic telepathology became a dominant telepathology technology in the late 1990s. Dr. Weinstein, a serial entrepreneur, continued to innovate and, with a team of optical scientists at The University of Arizona's College of Optical Sciences, developed the first sub-1-min whole-slide imaging system, the DMetrix DX-40 scanner, in the early 2000s.

Second Flexner Century: The Democratization of Medical Knowledge: Repurposing a General Pathology Course Into Multigrade-Level "Gateway" Courses.

Starting in 1910, the "Flexner Revolution" in medical education catalyzed the transformation of the US medical education enterprise from a proprietary medical school dominated system into a university-based medical school system. In the 21st century, what we refer to as the "Second Flexner Century" shifts focus from the education of medical students to the education of the general population in the "4 health literacies." Compared with the remarkable success of the first Flexner Revolution, retrofitting medical science education into the US general population today, starting with K-12 students, is a more daunting task. The stakes are high. The emergence of the patient-centered medical home as a health-care delivery model and the revelation that medical errors are the third leading cause of adult deaths in the United States are drivers of population education reform. In this century, patients will be expected to assume far greater responsibility for their own health care as full members of health-care teams. For us, this process began in the run-up to the "Second Flexner Century" with the creation and testing of a general pathology course, repurposed as a series of "gateway" courses on mechanisms of diseases, suitable for introduction at multiple insertion points in the US education continuum. In this article, we describe nomenclature for these gateway courses and a "top-down" strategy for creating pathology coursework for nonmedical students. Finally, we list opportunities for academic pathology departments to engage in a national "Democratization of Medical Knowledge" initiative.

Flexner 3.0-Democratization of Medical Knowledge for the 21st Century: Teaching Medical Science Using K-12 General Pathology as a Gateway Course.

A medical school general pathology course has been reformatted into a K-12 general pathology course. This new course has been implemented at a series of 7 to 12 grade levels and the student outcomes compared. Typically, topics covered mirrored those in a medical school general pathology course serving as an introduction to the mechanisms of diseases. Assessment of student performance was based on their score on a multiple-choice final examination modeled after an examination given to medical students. Two Tucson area schools, in a charter school network, participated in the study. Statistical analysis of examination performances showed that there were no significant differences as a function of school (F = 0.258, P = .6128), with students at school A having an average test scores of 87.03 (standard deviation = 8.99) and school B 86.00 (standard deviation = 8.18; F = 0.258, P = .6128). Analysis of variance was also conducted on the test scores as a function of gender and class grade. There were no significant differences as a function of gender (F = 0.608, P = .4382), with females having an average score of 87.18 (standard deviation = 7.24) and males 85.61 (standard deviation = 9.85). There were also no significant differences as a function of grade level (F = 0.627, P = .6003), with 7th graders having an average of 85.10 (standard deviation = 8.90), 8th graders 86.00 (standard deviation = 9.95), 9th graders 89.67 (standard deviation = 5.52), and 12th graders 86.90 (standard deviation = 7.52). The results demonstrated that middle and upper school students performed equally well in K-12 general pathology. Student course evaluations showed that the course met the student's expectations. One class voted K-12 general pathology their "elective course-of-the-year."

Flexner 2.0-Longitudinal Study of Student Participation in a Campus-Wide General Pathology Course for Graduate Students at The University of Arizona.

Faculty members from the Department of Pathology at The University of Arizona College of Medicine-Tucson have offered a 4-credit course on enhanced general pathology for graduate students since 1996. The course is titled, "Mechanisms of Human Disease." Between 1997 and 2016, 270 graduate students completed Mechanisms of Human Disease. The students came from 21 programs of study. Analysis of Variance, using course grade as the dependent and degree, program, gender, and year (1997-2016) as independent variables, indicated that there was no significant difference in final grade (F = 0.112; P = .8856) as a function of degree (doctorate: mean = 89.60, standard deviation = 5.75; master's: mean = 89.34, standard deviation = 6.00; certificate program: mean = 88.64, standard deviation = 8.25), specific type of degree program (F = 2.066, P = .1316; life sciences: mean = 89.95, standard deviation = 6.40; pharmaceutical sciences: mean = 90.71, standard deviation = 4.57; physical sciences: mean = 87.79, standard deviation = 5.17), or as a function of gender (F = 2.96, P = .0865; males: mean = 88.09, standard deviation = 8.36; females: mean = 89.58, standard deviation = 5.82). Students in the physical and life sciences performed equally well. Mechanisms of Human Disease is a popular course that provides students enrolled in a variety of graduate programs with a medical school-based course on mechanisms of diseases. The addition of 2 new medically oriented Master of Science degree programs has nearly tripled enrollment. This graduate level course also potentially expands the interdisciplinary diversity of participants in our interprofessional education and collaborative practice exercises.

Technologies for interprofessional education: the interprofessional education-distributed "e-Classroom-of-the-Future".

Communications strategies are central to the planning and execution of interprofessional education (IPE) programs. The diversity of telecommunications-based tools and platforms available for IPE is rapidly expanding. Each tool and platform has a potentially important role to play. The selection, testing, and embedding of tools, such as social networking platforms, within education programs can be very challenging. The goal was to create, in Phoenix, a "command-and-control" video conferencing center (the T-Health Amphitheater or Telehealth Amphitheater) in which tele-consultation patients, located physically at one of the affiliated tele-clinics around the state, could be presented electronically to interprofessional teams of faculty members from the University of Arizona Colleges of Medicine, Nursing, Pharmacy, and Public Health, as well as those from the allied health colleges of other universities in Arizona, for interprofessional team training in a virtual classroom setting. The T-Health video conferencing facility was designed and built. Early assessments show that its novel learning environment is student- and faculty-friendly. T-Health Amphitheater's pair of innovative visible social networking platforms (eStacks™ and eSwaps™) may help break down some of the traditional communications barriers encountered in healthcare IPE and medical practices.

Arizona Telemedicine Program Interprofessional Learning Center: facility design and curriculum development.

The Institute for Advanced Telemedicine and Telehealth (i.e., T-Health Institute), a division of the state-wide Arizona Telemedicine Program (ATP), specializes in the creation of innovative health care education programs. This paper describes a first-of-a-kind video amphitheater specifically designed to promote communication within heterogeneous student groups training in the various health care professions. The amphitheater has an audio-video system that facilitates the assembly of ad hoc "in-the-room" electronic interdisciplinary student groups. Off-site faculty members and students can be inserted into groups by video conferencing. When fully implemented, every student will have a personal video camera trained on them, a head phone/microphone, and a personal voice channel. A command and control system will manage the video inputs of the individual participant's head-and-shoulder video images. An audio mixer will manage the separate voice channels of the individual participants and mix them into individual group-specific voice channels for use by the groups' participants. The audio-video system facilitates the easy reconfiguration of the interprofessional electronic groups, viewed on the video wall, without the individual participants in the electronic groups leaving their seats. The amphitheater will serve as a classroom as well as a unique education research laboratory.

The Arizona Telemedicine Program business model.

The Arizona Telemedicine Program (ATP) was established in 1996 when state funding was provided to implement eight telemedicine sites. Since then the ATP has expanded to connect 55 health-care organizations through a membership programme formalized through legal contracts. The ATP's membership model is based on an application service provider (ASP) concept, whereby organizations can share services at lower cost; that is, the ATP acts as a broker for services. The membership fee schedule is flexible, allowing clients to purchase only those services desired. An annual membership fee is paid by every user, based on the services requested. The membership programme income has provided a steady revenue stream for the ATP. The membership-derived revenue represented 30% of the ATP's 2.6 million dollars total income during fiscal year 2003/04.