Shirley Large

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

BackgroundAs 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/DesignThis 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.DiscussionThis 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 registrationCurrent Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731.

TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation

Objective To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression. Design The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients’ and health professionals’ experience of telehealth; a quantitative survey of patients’ interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention (‘Healthlines’) was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations. Setting Primary care. Results The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care. Conclusions A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg), mean diastolic −2.8 (−4.0 to −1.6 mm Hg); weight −1.0 kg (−1.8 to −0.3 kg), and body mass index −0.4 ( −0.6 to −0.1) but not cholesterol −0.1 (−0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (−0.4, −1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure. Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care. Trial registration Current Controlled Trials ISRCTN 27508731.

A U.K. case study of who uses NHS Direct: investigating the impact of age, gender, and deprivation on the utilization of NHS Direct

OBJECTIVES National Health Service (NHS) Direct provides a 24/7 telephone-based healthcare advice and information service to the public in England. Locally based studies have suggested variation in the uptake of this service among the United Kingdoms diverse population. This study seeks to examine this issue at a national level. SUBJECTS AND METHODS One months period of national data was collected (July 2010) from the NHS Direct Clinical Assessment System for all 0845 4647 calls in England. Calls were matched to place of residence and were analyzed for age, gender, and deprivation using negative binominal regression. RESULTS Within the context of NHS Direct the pattern of calls was highest for children 5 years old and under, with lowest call rates found for males and older people (65+ years old). Furthermore, call rates were lowest in the most deprived areas for children (0-15 years old). Gender differences were noted, whereby male call rates were higher in the most deprived areas for all age groups. Furthermore, call rates for or on behalf of older females (60+ years old) were lower in areas of extreme deprivation. CONCLUSIONS The findings suggest there is variation in usage of NHS Direct. Such usage appears to be influenced by age, gender, and deprivation. Further research is required to examine the underlying factors that contribute to variation in uptake of these services. This will enable the development of future promotional campaigns that can target particular sections of the population to encourage use of telephone-based health services.

Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial

Objectives To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. Design A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least 1 modifiable risk factor. Intervention A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication and improve adherence. Participants in the control arm received usual care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework. Results 641 participants were randomised—325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient National Health Service (NHS) costs of £138 (95% CI 66 to 211) and an incremental QALY gain of 0.012 (95% CI −0.001 to 0.026). The incremental cost-effectiveness ratio was £10 859. Net monetary benefit at a cost-effectiveness threshold of £20 000 per QALY was £116 (95% CI −58 to 291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete case analysis. Conclusions There is evidence to suggest that the Healthlines telehealth intervention was likely to be cost-effective at a threshold of £20 000 per QALY. Trial registration number ISRCTN27508731; Results. Prospectively registered 05 July 2012.

Young people's use of NHS Direct: a national study of symptoms and outcome of calls for children aged 0-15

Objectives National Health Service (NHS) Direct provides 24/7 expert telephone-based healthcare information and advice to the public in England. However, limited research has explored the reasons to why calls are made on behalf of young people, as such this study aimed to examine call rate (CR) patterns in younger people to enable a better understanding of the needs of this population in England. Setting NHS Direct, England, UK. Participants and methods CRs (expressed as calls/100 persons/annum) were calculated for all calls (N=358 503) made to NHS Direct by, or on behalf of, children aged 0–15 during the combined four ‘1-month’ periods within a year (July 2010, October 2010, January 2011 and April 2011). χ² Analysis was used to determine the differences between symptom, outcome and date/time of call. Results For infants aged <1, highest CRs were found for ‘crying’ for male (n=14, 440, CR=13.61) and female (n=13 654, CR=13.46) babies, which is used as a universal assessment applied to all babies. High CRs were also found for symptoms relating to ‘skin/hair/nails’ and ‘colds/flu/sickness’ for all age groups, whereby NHS Direct was able to support patients to self-manage and provide health information for these symptoms for 59.7% and 51.4% of all cases, respectively. Variations in CRs were found for time and age, with highest peaks found for children aged 4–15 in the 15:00–23:00 period and in children aged <1 in the 7:00–15:00 period. Conclusions This is the first study to examine the symptoms and outcome of calls made to NHS Direct for and on behalf of young children. The findings revealed how NHS Direct has supported a range of symptoms through the provision of health information and self-care support which provides important information about service planning and support for similar telephone-based services.

A study of urgent and emergency referrals from NHS Direct within England

Objectives The presented study aimed to explore referral patterns of National Health Service (NHS) Direct to determine how patients engage with telephone-based healthcare and how telephone-based healthcare can manage urgent and emergency care. Setting NHS Direct, England, UK Participants NHS Direct anonymised call data (N=1 415 472) were extracted over a representative 1-year period, during the combined month periods of July 2010, October 2010, January 2011 and April 2011. Urgent and emergency calls (N=269 558; 19.0%) were analysed by call factors and patient characteristics alongside symptom classification. Categorical data were analysed using the χ2 test of independence with cross-tabulations used to test within-group differences. Primary and secondary outcome measures Urgent and emergency referrals to 999; accident and emergency or to see a general practitioner urgently, which are expressed as call rate per 100 persons per annum. Outcomes related to symptom variations by patient characteristics (age, gender, ethnicity and deprivation) alongside differences by patient characteristics of call factors (date and time of day). Results Urgent and emergency referrals varied by a range of factors relating to call, patient and symptom characteristics. For young children (0–4), symptoms related to ‘crying’ and ‘colds and flu’ and ‘body temperature change’ represented the significantly highest referrals to ‘urgent and emergency’ health services symptoms relating to ‘mental health’ alongside ‘pain’ and ‘sensation disorders’ represented the highest referrals to urgent and emergency health services for adults aged 40+ years. Conclusions This study has highlighted characteristics of ‘higher likelihood’ referrals to urgent and emergency care through the delivery of a national nurse-led telephone healthcare service. This research can help facilitate an understanding of how patients engage with both in and out of hours care and the role of telephone-based healthcare within the care pathway.

A cost-minimisation study of 1,001 NHS Direct users.

BackgroundTo determine financial and quality of life impact of patients calling the ‘0845’ NHS Direct (NHS Direct) telephone helpline from the perspective of NHS service providers.MethodsCost-minimisation of repeated cohort measures from a National Survey of NHS Direct’s telephone service using telephone survey results. 1,001 people contacting NHS Direct’s 0845 telephone service in 2009 who agreed to a 4-6 week follow-up. A cost comparison between NHS Direct recommendation and patient-stated first alternative had NHS Direct not been available. Analysis also considers impact on quality of life of NHS Direct recommendations using the Visual Analogue Scale of the EQ-5D.ResultsSignificant referral pattern differences were observed between NHS Direct recommendation and patient-stated first alternatives (p < 0.001). Per patient cost savings resulted from NHS Direct’s recommendation to attend A&E (£36.54); GP Practice (£19.41); Walk-In Centre (£49.85); Pharmacist (£25.80); Dentist (£2.35) and do nothing/treat at home (£19.77), while it was marginally more costly for 999 calls (£3.33). Overall an average per patient saving of £19.55 was found (a 36% saving compared with patient-stated first alternatives). For 5 million NHS Direct telephone calls per year, this represents an annual cost saving of £97,756,013. Significant quality of life differences were observed at baseline and follow-up between those who believed their problem was ‘urgent’ (p = 0.001) and those who said it was ‘non-urgent’ (p = 0.045). Whilst both groups improved, self-classified ‘urgent’ cases made greater health gains than those who said they were ‘non-urgent’ (urgent by 21.5 points; non-urgent by 16.1 points).ConclusionsThe ‘0845’ service of NHS Direct produced substantial cost savings in terms of referrals to the other parts of the NHS when compared with patients’ own stated first alternative. Health-related quality of life also improved for users of this service demonstrating that these savings can be produced without perceived harm to patients.

Barriers and facilitators to using NHS Direct: a qualitative study of `users’ and `non-users’

BackgroundNHS Direct, introduced in 1998, has provided 24/7 telephone-based healthcare advice and information to the public in England and Wales. National studies have suggested variation in the uptake of this service amongst the UK’s diverse population. This study provides the first exploration of the barriers and facilitators that impact upon the uptake of this service from the perspectives of both `users’ and `non- users’.MethodsFocus groups were held with NHS Direct `users’ (N = 2) from Bedfordshire alongside `non-users’ from Manchester (N = 3) and Mendip, Somerset (N = 4). Each focus group had between five to eight participants. A total of eighty one people aged between 21 and 94 years old (M: 58.90, SD: 22.70) took part in this research. Each focus group discussion lasted approximately 90 minutes and was audiotape-recorded with participants’ permission. The recordings were transcribed verbatim. A framework approach was used to analyse the transcripts.ResultsThe findings from this research uncovered a range of barriers and facilitators that impact upon the uptake of NHS Direct. `Non-users’ were unaware of the range of services that NHS Direct provided. Furthermore, `non-users’ highlighted a preference for face-to face communication, identifying a lack of confidence in discussing healthcare over the telephone. This was particularly evident among older people with cognitive difficulties. The cost to telephone a `0845’ number from a mobile was also viewed to be a barrier to access NHS Direct, expressed more often by `non-users’ from deprived communities. NHS Direct `users’ identified that awareness, ease of use and convenience were facilitators which influenced their decision to use the service.ConclusionsAn understanding of the barriers and facilitators which impact on the access and uptake of telephone-based healthcare is essential to move patients towards the self-care model. This research has highlighted the need for telephone-based healthcare services to increase public awareness; through the delivery of more targeted advertising to promote the service provision available.

Who uses NHS Direct? Investigating the impact of ethnicity on the uptake of telephone based healthcare

IntroductionNHS Direct, a leading telephone healthcare provider worldwide, provided 24/7 health care advice and information to the public in England and Wales (1998-2014). The fundamental aim of this service was to increase accessibility, however, research has suggested a disparity in the utilisation of this service related to ethnicity. This research presents the first national study to determine how the diverse population in England have engaged with this service.MethodsNHS Direct call data from the combined months of July, 2010 October, 2010, January 2011 and April, 2011 was analysed (N = 1,342, 245) for all 0845 4647 NHS Direct core service calls in England. Expected usage of NHS Direct was determined for each ethnic group of the population by age and gender and compared by actual usage using Chi-square analysis. A one-way analysis of variance (ANOVA) was used to determine variations of uptake by ethnic group and Index for Multiple Deprivation (IMD) 2010 rank.ResultsResults confirmed that all mixed ethnic groups (White and Black Caribbean, White and Black African, White and Asian) had a higher than expected uptake of NHS Direct which held consistent across all age groups. Lower than expected uptake was found for Black (African/Caribbean) and Asian (Bangladeshi/Indian/Chinese) ethnic group which held consistent by age and gender. For the Pakistani ethnic group usage was higher than expected in adults aged 40 years and older although was lower than expected in younger age groups (0-39).ConclusionFindings support previous research suggesting a variation in usage of NHS Direct influenced by ethnicity, which is evidenced on a national level. Further research is now required to examine the underlying barriers that contribute to the ethnic variation in uptake of this service.