Whole System Demonstrator Research Articles

The Effect of Telehealth on Quality of Life and Psychological Outcomes Over a 12-Month Period in a Diabetes Cohort Within the Whole Systems Demonstrator Cluster Randomized Trial.

BackgroundMuch is written about the promise of telehealth and there is great enthusiasm about its potential. However, many studies of telehealth do not meet orthodox quality standards and there are few studies examining quality of life in diabetes as an outcome.Objective To assess the impact of home-based telehealth (remote monitoring of physiological, symptom and self-care behavior data for long-term conditions) on generic and disease-specific health-related quality of life, anxiety, and depressive symptoms over 12 months in patients with diabetes. Remote monitoring provides the potential to improve quality of life, through the reassurance it provides patients.MethodsThe study focused on participant-reported outcomes of patients with diabetes within the Whole Systems Demonstrator (WSD) Telehealth Questionnaire Study, nested within a pragmatic cluster-randomized trial of telehealth (the WSD Telehealth Trial), held across 3 regions of England. Telehealth was compared with usual-care, with general practice as the unit of randomization. Participant-reported outcome measures (Short-Form 12, EuroQual-5D, Diabetes Health Profile scales, Brief State-Trait Anxiety Inventory, and Centre for Epidemiological Studies Depression Scale) were collected at baseline, short-term (4 months) and long-term (12months) follow-ups. Intention-to-treat analyses testing treatment effectiveness, were conducted using multilevel models controlling for practice clustering and a range of covariates. Analyses assumed participants received their allocated treatment and were conducted for participants who completed the baseline plus at least one follow-up assessment (n=317). Results Primary analyses showed differences between telehealth and usual care were small and only reached significance for 1 scale (diabetes health profile-disinhibited eating, P=.006). The magnitude of differences between trial arms did not reach the trial-defined minimal clinically important difference of 0.3 standard deviations for most outcomes. Effect sizes (Hedge's g) ranged from 0.015 to 0.143 for Generic quality of life (QoL) measures and 0.018 to 0.394 for disease specific measures.ConclusionsSecond generation home-based telehealth as implemented in the WSD evaluation was not effective in the subsample of people with diabetes. Overall, telehealth did not improve or have a deleterious effect quality of life or psychological outcomes for patients with diabetes over a 12-month period.

Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire

Introduction Telehealth (TH) is a potential solution to the increased incidence of chronic illness in an ageing population. The extent to which older people and users with chronic conditions accept and adhere to using assistive technologies is a potential barrier to mainstreaming the service. This study reports the development and validation of the Whole Systems Demonstrator (WSD) Service User Technology Acceptability Questionnaire (SUTAQ). Methods Questionnaires measuring the acceptability of TH, quality of life, well-being and psychological processes were completed by 478 users of TH. The 22 acceptability items were subject to principal components analysis (PCA) to determine sub-scales. Scale scores, relationships between scales and other patient-reported outcome measures (PROMs), and group differences on scales were utilised to check the reliability and validity of the measure. Results PCAs of SUTAQ items produced six TH acceptability scales: enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, kit as substitution and satisfaction. Significant correlations within these beliefs and between these scales and additional PROMs were coherent, and the SUTAQ sub-scales were able to predict those more likely to refuse TH. Discussion The SUTAQ is an instrument that can be used to measure user beliefs about the acceptability of TH, and has the ability to discriminate between groups and predict individual differences in beliefs and behaviour. Measuring acceptability beliefs of TH users can provide valuable information to direct and target provision of services to increase uptake and maintain use of TH.

An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions.

Background. Policy makers require estimates of comparative effectiveness that apply to the population of interest, but there has been little research on quantitative approaches to assess and extend the generalizability of randomized controlled trial (RCT)–based evaluations. We illustrate an approach using observational data. Methods. Our example is the Whole Systems Demonstrator (WSD) trial, in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care. First, we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of nonparticipants who received usual care. We matched on 65 baseline variables obtained from the electronic medical record. Second, we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether “usual care” is defined by the RCT control group or nonparticipants. Thus, we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched nonparticipants. Results. For some endpoints, such as the number of outpatient attendances, the placebo tests passed, and the effectiveness estimates were robust to the choice of comparison group. However, for other endpoints, such as emergency admissions, the placebo tests failed and the estimates of treatment effect differed markedly according to whether telehealth patients were compared with RCT controls or matched nonparticipants. Conclusions. The proposed placebo tests indicate those cases when estimates from RCTs do not generalize to routine clinical practice and motivate complementary estimates of comparative effectiveness that use observational data. Future RCTs are recommended to incorporate these placebo tests and the accompanying sensitivity analyses to enhance their relevance to policy making.

The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial

home-based telecare (TC) is utilised to manage risks of independent living and provide prompt emergency responses. This study examined the effect of TC on health-related quality of life (HRQoL), anxiety and depressive symptoms over 12 months in patients receiving social care. a study of participant-reported outcomes [the Whole Systems Demonstrator (WSD) Telecare Questionnaire Study; baseline n = 1,189] was nested in a pragmatic cluster-randomised trial of TC (the WSD Telecare trial), held across three English Local Authorities. General practice (GP) was the unit of randomisation and TC was compared with usual care (UC). participant-reported outcome measures were collected at baseline, short-term (4 months) and long-term (12 months) follow-up, assessing generic HRQoL, anxiety and depressive symptoms. Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment (n = 873). analyses found significant differences between TC and UC on Short Form-12 mental component scores (P < 0.05), with parameter estimates indicating being a member of the TC trial-arm increases mental component scores (UC-adjusted mean = 40.52; TC-adjusted mean = 43.69). Additional significant analyses revealed, time effects on EQ5D (decreasing over time) and depressive symptoms (increasing over time). TC potentially contributes to the amelioration in the decline in users' mental HRQoL over a 12-month period. TC may not transform the lives of its users, but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC. International Standard Randomised Controlled Trial Number Register: ISRCTN 43002091.

What influences withdrawal because of rejection of telehealth – the whole systems demonstrator evaluation

Purpose – The widespread deployment of telehealth (TH) has been conducted in the absence of any clear understanding of how acceptable these devices are to patients. One potential limitation of the widespread deployment of TH is that patients may refuse. Moreover an understanding of the reasons for refusing to use TH devices will provide an understanding of the barriers. Design/methodology/approach – This investigation from the Whole Systems Demonstrator (WSD) programme, a pragmatic cluster randomised controlled trial into the effectiveness of TH, examined reasons for patients in the intervention cohort of the trial refusing TH, and the potential barriers to its deployment. Findings – Active rejection of the TH intervention was the most frequent reason for withdrawal. After examination of trial-related, health, socio-demographic, cognitive, emotional and behavioural factors, patients diagnosed with diabetes, as opposed to heart failure or chronic obstructive pulmonary disease, and patients’ beliefs about the acceptability of the intervention predicted whether or not they withdrew from the trial because of the intervention. Originality/value – Beliefs that the TH intervention resulted in increased accessibility to care, satisfaction with equipment and fewer concerns about the privacy, safety and discomfort associated with using TH equipment predicted continued participation in the WSD trial. Findings suggest that potentially modifiable beliefs about TH predict those more likely to reject the intervention. These findings have important implications for understanding individual differences in the acceptance of TH and subsequent success in mainstreaming TH in healthcare services.

Stimulating whole system redesign: Lessons from an organizational analysis of the Whole System Demonstrator programme.

Whole system integration of health and social care has been positioned as key to improving care, increasing efficiency and controlling costs. However, evidence for the benefits of whole system integration is scarce. Drawing on organizational theory, this study uses the implementation of remote care services, viewed as an enabler for whole system working, to explore the reality of achieving this policy objective. Qualitative, longitudinal data were collected across nine UK sites adopting remote care over three years. Three sites formed the Department of Health's Whole Systems Demonstrator (WSD) programme for remote care. In addition, the implementation of remote care was explored in six other sites unconstrained by the randomized control trial procedures of the WSD programme. The methods were ethnographic (including 235 hours of observations and 184 interviews). Participants were health and social care staff and Government policy makers. Remote care did not lead to system redesign; however, local 'ownership' of new services did lead to more collaborative practices across the care system. Lack of integration was an enduring and endemic challenge across all sites, relating to differences in statutory responsibilities, absence of shared budgets and hybrid organizational roles, differences in work practices and organizational philosophies, and ambiguity around what 'whole system working' actually entailed. Policy initiatives like the WSD programme provide opportunities to phase in collaborative practices and create an awareness of the need for joint working. However, the progress observed suggests that the concept of whole system redesign around remote care is currently unrealistic.

An organisational analysis of the implementation of telecare and telehealth: the whole systems demonstrator.

BackgroundTo investigate organisational factors influencing the implementation challenges of redesigning services for people with long term conditions in three locations in England, using remote care (telehealth and telecare).MethodsCase-studies of three sites forming the UK Department of Health’s Whole Systems Demonstrator (WSD) Programme. Qualitative research techniques were used to obtain data from various sources, including semi-structured interviews, observation of meetings over the course programme and prior to its launch, and document review. Participants were managers and practitioners involved in the implementation of remote care services.ResultsThe implementation of remote care was nested within a large pragmatic cluster randomised controlled trial (RCT), which formed a core element of the WSD programme. To produce robust benefits evidence, many aspect of the trial design could not be easily adapted to local circumstances. While remote care was successfully rolled-out, wider implementation lessons and levels of organisational learning across the sites were hindered by the requirements of the RCT.ConclusionsThe implementation of a complex innovation such as remote care requires it to organically evolve, be responsive and adaptable to the local health and social care system, driven by support from front-line staff and management. This need for evolution was not always aligned with the imperative to gather robust benefits evidence. This tension needs to be resolved if government ambitions for the evidence-based scaling-up of remote care are to be realised.

Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study

BackgroundTelehealth (TH) and telecare (TC) interventions are increasingly valued for supporting self-care in ageing populations; however, evaluation studies often report high rates of non-participation that are not well understood. This paper reports from a qualitative study nested within a large randomised controlled trial in the UK: the Whole System Demonstrator (WSD) project. It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial.MethodsQualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention (n = 19), or who withdrew from the intervention arm (n = 3). Participants were recruited from the four trial groups (with diabetes, chronic obstructive pulmonary disease, heart failure, or social care needs); and all came from the three trial areas (Cornwall, Kent, east London). Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home. Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes.ResultsBarriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes: requirements for technical competence and operation of equipment; threats to identity, independence and self-care; expectations and experiences of disruption to services. Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderstandings. Respondents’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance, and views that interventions could undermine self-care and coping. Finally, participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued.ConclusionsThese findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake. These insights have implications for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction. It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation.

Exploring the impact of telehealth on the work of frontline health professionals within the Whole System Demonstrator study

Introduction: A central aim of the Whole System Demonstrator (WSD) programme is to find out how telehealth can help people manage their own long-term health conditions and to evaluate the potential benefits of this technological intervention within a randomised control trial. However, the adoption of this intervention at local level will entail significant changes in practice of care, in the division of health care work and in traditional professional-patient relationships and so will be contingent on the support of frontline health professionals directly responsible for its delivery. This was the rationale behind this theme 4 sub study within the Whole System Demonstrator evaluation study. Aims and objectives: To examine health professionals’ views and experiences of implementing telehealth and their retrospective judgements of barriers and facilitators to its success. Methods: We undertook a 2-year qualitative longitudinal study. The method of data collection was semi-structured in-depth interviews with a purposive sample of frontline health professionals. The first year comprised baseline qualitative interviews with key health professionals directly involved in the delivery of telehealth in three Whole System Demonstrator sites: the London Borough of Newham, Cornwall and Kent. Interview participants included community matrons, teleheath monitoring nurses and general practitioners who deliver care to patients with long-term conditions. Follow-up interviews were conducted around one year later, prior to the end of the study and all interview data were thematically analysed and managed by NVivo. Results: Currently under embargo by DH. Conclusions: Currently under embargo by DH.

A pragmatic cluster randomised controlled trial of telehealth on disease specific quality of life in patients’ with chronic obstructive pulmonary disease and their health-related quality of life and psychological distress over 1 year in the Whole System

Introduction: There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with COPD. A systematic review in the area inclusive of all respiratory conditions indicated that there were no UK based studies, or randomised controlled trials (RCTs) evaluating the effectiveness of TH for COPD (Janna et al. 2009). A more recent systematic review found 6 studies, only two of which measured QoL as an outcome (Bolton et al. 2010). One of these studies was a RCT and found improvements in QoL at 3 months (Koff 2009), while the other was a non-controlled before and after study which found no difference in quality of life scores at 6 months (Trappenburg, 2008). Research in this area is plagued by small sample sizes, absence of longer-term follow-ups, insufficient descriptions of the intervention, poor internal validity of whether using the device in the context of a complex healthcare intervention leads to improved outcomes for the patient, and few attempts to measure quality of life in patients with COPD following the introduction of these devices. Aims and objectives: The current investigation is part of the Whole System Demonstrator (WSD) programme that aims to evaluate the effectiveness of telehealth (TH) for patient reported outcomes with Chronic Obstructive Pulmonary Disease (COPD). The primary objective was to evaluate the effectiveness of telehealth for COPD specific QoL and to examine whether there were improvements in HRQoL and psychological distress at short-term and long-term follow-up in this cohort of patients with COPD. Methods: WSD is one of the largest pragmatic cluster randomised controlled trials evaluating TH in the UK. Patients with COPD from three regions in England (Cornwall, Kent and Newham) were recruited from 179 GP practices randomised balancing for region, practice size, deprivation index, non-white proportion and prevalence of COPD. Over 570 patients with COPD completed a comprehensive battery of questionnaires assessing a range of patient reported outcomes. Measures of generic Health-Related Quality of Life (HRQoL) (Short Form-12), disease specific QoL including perceived control over COPD, fatigue caused by the disease and the emotional impact of the disease (Chronic Respiratory Questionnaire). Psychological distress was measured by depression (CESD-10) and anxiety (STAI).

The State of Telehealth and Telecare in the UK: Prospects for Integrated Care

Telehealth and telecare innovations have the potential to improve quality of life, reduce unnecessary hospital and care home admissions, and support care integration by providing care and disease management from multi‐disciplinary care teams linked remotely to users. About 1.7 million people benefit from telecare services in the UK, but telehealth services have only around 5000 users, many of whom receive services through the Department of Health's Whole System Demonstrator (WSD) Pilot Programme. There is an identifiable chasm between early adopters and wider uptake of telehealth and telecare solutions. Key barriers include lack of robust evidence on cost‐effectiveness, of a consumer market and of interoperability of the technology between service sectors, and the implications for professionals and organisations of changing their established methods of practice. Telehealth and telecare could be combined to provide a common platform to integrate care for people requiring both health and social care support, but relatively few people are judged suitable for joint care. This is related both to the nature of the technology and the profile of those people who can use it, and to the different ways in which health and social care systems assess who is most 'at risk', which makes it difficult to assess which individuals might best benefit from an integrated response to their care needs. While there is considerable interest and policy momentum behind the adoption and diffusion of telehealth and telecare in England, more understanding of their benefits is required to convince commissioners and providers of its potential.

Planning and implementing major health and social care technology programmes

Newham Council initiated a pilot project introducing advanced assistive technologies (telecare and telehealth) in 2004. Additional funding in 2006 provided the means to extend a service to over 4000 residents. In 2007, Newham successfully bid to become a Department of Health Whole System Demonstrator (WSD) site. This new project will be integrated with the existing service to target people at risk of hospital admission due to a defined group of long‐term conditions, and people with complex social care needs, with sophisticated technologies, interventions and support in their own homes. This paper describes the project methodology and the particular challenges that are faced. These include the development of a robust evaluation, which will provide statistical evidence of the effects of the technologies across the health and social care spectrum, as well as addressing and overcoming issues associated with information flow, change management and partnership working.