Academic Journals

Abstract
Background
Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated.

Objective
The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents.

Methods
Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities co-ordinator, and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences.

Results
Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space.

Conclusions
A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.

Authors
Susie Donnelly, Brenda Reginatto, Oisin Kearns, Marie Mc Carthy, Bill Byrom, Willie Muehlhausen, Brian Caulfield

Reference
Donnelly S., Reginatto B., Kearns O., Mc Carthy M., Byrom B., Muehlhausen W., Caulfield B., The Burden of a Remote Trial in a Nursing Home Setting: Qualitative Study J Med Internet Res 2018;20(6):e220
doi:10.2196/jmir.9638

Abstract

Aims
We undertook a mixed-methods evaluation of a Web-based conferencing service (virtual consult) between general practitioners (GPs) and cardiologists in managing patients with heart failure in the community to determine its effect on use of specialist heart failure services and acceptability to GPs.

Methods and results
All cases from June 2015 to October 2016 were recorded using a standardized recording template, which recorded patient demographics, medical history, medications, and outcome of the virtual consult for each case. Quantitative surveys and qualitative interviewing of 17 participating GPs were also undertaken. During this time, 142 cases were discussed—68 relating to a new diagnosis of heart failure, 53 relating to emerging deterioration in a known heart failure patient, and 21 relating to therapeutic issues. Only 17% required review in outpatient department following the virtual consultation. GPs reported increased confidence in heart failure management, a broadening of their knowledge base, and a perception of overall better patient outcomes.

Conclusions
These data from an initial experience with Heart Failure Virtual Consultation present a very positive impact of this strategy on the provision of heart failure care in the community and acceptability to users. Further research on the implementation and expansion of this strategy is warranted.

Authors
Joseph Gallagher, Stephanie James, Ciara Keane, Annie Fitzgerald, Bronagh Travers, Etain Quigley (ARCH), Christina Hecht, Shuaiwei Zhou, Chris Watson, Mark Ledwidge, Kenneth McDonald

Reference
Gallagher, J., James, S., Keane, C., Fitzgerald, A., Travers, B., Quigley, E., Hecht, C., Zhou, S., Watson, C., Ledwidge, M., and McDonald, K. (2017) Heart Failure Virtual Consultation: bridging the gap of heart failure care in the community – A mixed-methods evaluation. ESC Heart Failure, doi: 10.1002/ehf2.12163.

Abstract
In recent years, there has been significant growth in software companies targeting the healthcare sector by developing new technologies to improve healthcare delivery and services. This has given rise to the emergence of Smart and Connected Health (SCH) – a new socio-technical model for healthcare management. This article explains how SCH software innovation promotes smart health that ultimately contributes towards the coverage and quality of healthcare services, improved health outcomes, reduced costs and improved quality of life. In addition, it highlights the growing reliance and trust we place on software to support healthcare decisions. This article provides an overview of the key success factors (KSF) for SCH software solutions.

Authors
Dr Noel Carroll (ARCH/UL)

Reference
Carroll, N. (2016). Key Success Factors for Smart and Connected Health Software Solutions, Computer 49 (11), 32-38.

Abstract
Purpose
Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting of Connected Health innovation. Many of these regulatory developments fall under ‘medical devices’ giving rise to Software-as-a-Medical Device (SaaMD).

Design/methodology/approach
Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explores the key regulatory developments in the context of Connected Health in order to provide a practical guide to understanding how regulation can potentially shape healthcare innovation.

Findings
Several key issues are identified and we present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. We also identify the key challenges in Connected Health and identify areas for future research.

Originality/value
A key outcome of this research is a clearer understanding on the opportunities and challenges regulation and standards presents in Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

Journal of Systems and Information Technology

Authors
Dr Noel Carroll (ARCH/UL) and Prof Ita Richardson (ARCH/UL)

Reference
Noel Carroll , Ita Richardson , (2016) “Software-as-a-Medical Device: Demystifying Connected Health Regulations”, Journal of Systems and Information Technology, Vol. 18 Iss: 2

Link
More information available here.

Abstract
Gerontechnology can be briefly defined as the study of technology and aging for ensuring an optimal technological environment for people up to a high age. Two developments in society have led to its emergence. Older people are emancipating as their demographic numbers increase, and their importance in society is growing. Technology is innovating and spreading, presently in particular with new materials and information and communication technology (ICT), leading to rapid change in society. Unfortunately, the two processes tend to develop unconnected. Gerontechnology aims at directing technology towards the ambitions of aging persons such as good health, independent living, and full social participation.

Authors
Dr Noel Carroll (ARCH/UL), Prof Ita Richardson (ARCH/UL), and Prof Catriona Kennedy (UL)

Journal
Gerontechnology Journal

Reference
Carroll, N., Kennedy, C., & Richardson, I. (2016). Challenges towards a Connected Community Healthcare Ecosystem (CCHE) for managing long-term conditions. Gerontechnology, 14(2), 64-77

Link
More information available here.

Abstract
As a society we have to reimagine our health and social care models to meet the challenge of an ageing population with greater levels of chronic disease. The digital revolution offers us the potential to leverage technological innovations to develop proactive ‘connected’ health and social care models that are built around the patient’s needs to facilitate efficient management of wellness and health throughout their lifespan. However, efforts to utilise technological innovations for this purpose have not been universally successful to date, indicating that technology itself is only part of the solution. To achieve a truly connected, technology enabled, health and social care model we need to overcome some key challenges; Firstly we need to optimise the process of sensing data from end users in the home and community such that monitoring protocols are built around the person and designed with respect to their needs to provide for accurate and reliable harvesting of target data. We then need to gather and mine large datasets from the home and community in order to analyse the complex relationships between home and community acquired data and health status. Only then can we begin to design, implement and evaluate new models of care that leverage technology platforms. In meeting this challenge we can leverage technology to transform the way in which we promote and manage wellness and health throughout the lifespan.

Authors
Brian M Caulfield & Seamas C Donnelly

Link
Full Publication Available here.

Case Studies

Publication Type
Ivey Publishing – Case Study

Overview
After the Irish pharmacy industry’s deregulation, large competitors entered the market, upsetting small private players like single shop outlets and independent chains. While some of the new competitors implemented sophisticated technologies, others announced price cuts of up to 31 per cent on drugs. Not only did market shares for small players shrink, but the recession, changes in payment structures, government spending cuts and decreased consumer loyalty further reduced pharmacies’ profit margins. Many private pharmacists had observed that other pharmacies in Ireland and in the United States had successfully adopted connected health technologies (CHTs) to improve their performance. In order to compete against powerful multinational retail pharmacies, private pharmacists needed to analyze their business models and make any necessary alterations as soon as possible. Should they reinforce their current business models or try to innovate? Did they have the capabilities to develop CHTs and would these investments prove worthwhile?

Authors
Dr Nicole Gross, Dr Niall Connolly, Dr Peter McNamara

Link
This Case Study can be purchased here.