Who does not participate in telehealth trials and why? A cross-sectional survey.

BACKGROUND: Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients decline to participate in telehealth trials and their reasons for doing so. METHODS: Two linked randomised controlled trials were undertaken, one for patients with depression and one for patients with raised cardiovascular disease risk (the Healthlines Study). The trials compared usual care with additional support delivered by the telephone and internet. Patients were recruited via their general practice and could return a form about why they were not participating. RESULTS: Of the patients invited, 82.9% (20,021/24,152) did not accept the study invite, either by returning a decline form (n = 7134) or by not responding (n = 12,887). In both trials patients registered at deprived general practices were less likely to accept the study invite. Decline forms were received from 29.5% (7134/24,152) of patients invited. There were four frequently reported types of reasons for declining. The most common was telehealth-related: 54.7% (3889/,7115) of decliners said they did not have access or the skills to use the internet and/or computers. This was more prevalent amongst older patients and patients registered at deprived general practices. The second was health need-related: 40.1% (n = 2852) of decliners reported that they did not need additional support for their health condition. The third was related to life circumstances: 27.2% (n = 1932) of decliners reported being too busy. The fourth was research-related: 15.3% (n = 1092) of decliners were not interested in the research. CONCLUSIONS: A large proportion of patients declining participation in these telehealth trials did so because they were unable to engage with telehealth or did not perceive a need for it. This has implications for engagement with telehealth in routine practice, as well as for trials, with a need to offer technological support to increase patients' engagement with telehealth. More generally, triallists should assess why people decline to participate in their studies. TRIAL REGISTRATION: The Healthlines Study has the following trial registrations: depression trial: ISRCTN14172341 (registered 26 June 2012) and CVD risk trial: ISRCTN27508731 (registered 05 July 2012).

Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials.

BACKGROUND: As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring. METHODS/DESIGN: This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ≥5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals' and patients' views of the intervention. DISCUSSION: This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention. TRIAL REGISTRATION: Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731.

Clinical outcomes of Queensland children with cystic fibrosis: a comparison between tertiary centre and outreach services.

OBJECTIVE: To evaluate and compare the clinical outcomes of children with cystic fibrosis (CF) managed primarily at a tertiary cystic fibrosis centre (CFC) with those treated at regional centres by local health care professionals and the cystic fibrosis outreach service (CFOS). DESIGN, SETTING AND PATIENTS: Retrospective study of 273 children with CF born between 19 October 1982 and 19 February 2002 and with clinical data available between 1 January 2000 and 31 December 2002. Patients were grouped into CFC (n = 131) or CFOS (n = 142), with CFOS then further categorised into three groups depending on the level of care they received. MAIN OUTCOME MEASURES: Pulmonary function, Pseudomonas aeruginosa status, height and weight z scores, and hospital admission rates. RESULTS: There were no significant differences in pulmonary function, P. aeruginosa status, or height and weight z scores between children managed by CFC or by CFOS. Children receiving more care at the CFC (level of care [LOC] 1 and 2) were more likely to have multiple hospital admissions than children receiving more care in regional areas (LOC 3 and 4) (P < 0.001). CONCLUSION: The CFOS model provides effective delivery of specialised multidisciplinary care to children and adolescents living in rural and regional Queensland.