Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trialBMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2647 (Published 01 June 2016) Cite this as: BMJ 2016;353:i2647
- Chris Salisbury, professor of primary care1,
- Alicia O’Cathain, professor of health services research2,
- Clare Thomas, programme manager1,
- Louisa Edwards, trial manager1,
- Daisy Gaunt, research associate in medical statistics3,
- Padraig Dixon, senior research associate in health economics1,
- Sandra Hollinghurst, senior lecturer in health economics1,
- Jon Nicholl, dean2,
- Shirley Large, screening and immunisation coordinator4,
- Lucy Yardley, professor of health psychology5,
- Tom Fahey, professor of general practice6,
- Alexis Foster, study manager2,
- Katy Garner, research associate1,
- Kimberley Horspool, study manager and research associate2,
- Mei-See Man, trial manager1,
- Anne Rogers, professor of health systems implementation7,
- Catherine Pope, professor of medical sociology7,
- Alan A Montgomery, professor of medical statistics and clinical trials8
- 1Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol BS8 2PS, UK
- 2School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
- 3Bristol Randomised Trials Collaboration, School of Social and Community Medicine, University of Bristol, Bristol, UK
- 4NHS England South (Wessex), Southampton, UK
- 5Department of Psychology, University of Southampton, Southampton, UK
- 6Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Republic of Ireland
- 7Faculty of Health Sciences, University of Southampton, Southampton, UK
- 8Nottingham Clinical Trials Unit, Nottingham Health Science Partners, Queen’s Medical Centre, Nottingham, UK
- Correspondence to: C Salisbury
- Accepted 2 May 2016
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.
We thank the patients, healthcare professionals, health information advisors, and other NHS Direct staff who contributed time and effort to make this trial possible; Sarah Williams at Solent NHS Trust who took over responsibility for hosting the intervention when NHS Direct closed; Steve Bellerby who managed implementation of the Healthlines software at both trusts; members of the trial steering and data monitoring committees, particularly Michelle McPhail and Anne Jacob who were patient and public representatives; Hayden Bosworth for permission to adapt his behavioural intervention, and both he and Felicia McCann for their help with adaptation; Roberta Ara for input into the design and implementation of the lifetime cost effectiveness cohort simulation model; Glyn Lewis and Simon Brownsell who were applicants on the research programme grant but not directly involved in this trial; the Primary Care Research Network (now, NIHR Clinical Research Network) for assisting us with recruitment of general practitioners; and Frederika Collihole, Richard Campbell, Ben Davies, Lorna Duncan, Diane Beck, and Janet Cooke who supported participant recruitment, data entry, and trial administration. This study was designed and delivered in collaboration with Bristol Randomised Trials Collaboration (BRTC), a UKCRC Registered Clinical Trials Unit in receipt of National Institute for Health Research CTU support funding.
Contributors: CS, AO’C, SH, JN, SL, LY, TF, AR, CP, and AAM developed the protocol for the study, obtained funding, provided methodological advice, and supervised the conduct of the trial. CS led protocol development and the funding application, acted as chief investigator with overall responsibility for the conduct of the trial, and led the drafting of the article. AO’C supervised the conduct of the trial in Sheffield. CT, MSM, and LE acted as trial managers, coordinating the conduct of the trial across the centres. LE, AF, KG, and KH undertook participant recruitment and follow-up, data collection, and data entry. DG developed the statistical analysis plan and undertook the statistical analysis. PD undertook the economic analysis. SL coordinated development and delivery of the intervention with NHS Direct. AAM supervised the statistical analysis. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. All authors approved the final version of this manuscript. CS is guarantor.
Funding: This report summarises independent research funded by the National Institute for Health Research (NIHR) under its programme grant for applied research (grant reference No RP-PG-0108-10011). CS’s time is supported by the NIHR Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West) at University Hospitals Bristol NHS Foundation Trust. The views and opinions expressed in this report are those of the authors and do not necessarily reflect those of the NIHR the NHS, or the Department of Health. The funder had no role in the conduct of the study, the writing of the manuscript, or the decision to submit it for publication. The corresponding author (CS) had full access to all the data in the study and had final responsibility for the decision to submit for publication. CS, AOC, and JN act as members of boards for NIHR but were not on the board which commissioned this project.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from NIHR in grant funding but no other support for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; their spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and no non-financial interests that may be relevant to the submitted work. The Healthlines patient portal is the intellectual property of Solent NHS Trust. The telephone algorithms were adapted with permission from a patient assessment system, which is the intellectual property of Duke University. Interested readers should refer to the website www.bristol.ac.uk/healthlines/ and contact the author for further information.
Ethical approval: This study was approved by the National Research Ethics Service Committee South West–Frenchay (reference 12/SW/0009). All participants provided informed consent to take part in the trial.
Data sharing: The research team will consider reasonable requests for sharing of patient level data. Requests should be made to CS. Consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.
Transparency: The lead author (manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.
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