Alexis Foster

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.

Being Human: A Qualitative Interview Study Exploring Why a Telehealth Intervention for Management of Chronic Conditions Had a Modest Effect

Background Evidence of benefit for telehealth for chronic conditions is mixed. Two linked randomized controlled trials tested the Healthlines Service for 2 chronic conditions: depression and high risk of cardiovascular disease (CVD). This new telehealth service consisted of regular telephone calls from nonclinical, trained health advisers who followed standardized scripts generated by interactive software. Advisors facilitated self-management by supporting participants to use Web-based resources and helped to optimize medication, improve treatment adherence, and encourage healthier lifestyles. Participants were recruited from primary care. The trials identified moderate (for depression) or partial (for CVD risk) effectiveness of the Healthlines Service. Objective An embedded qualitative study was undertaken to help explain the results of the 2 trials by exploring mechanisms of action, context, and implementation of the intervention. Methods Qualitative interview study of 21 staff providing usual health care or involved in the intervention and 24 patients receiving the intervention. Results Interviewees described improved outcomes in some patients, which they attributed to the intervention, describing how components of the model on which the intervention was based helped to achieve benefits. Implementation of the intervention occurred largely as planned. However, contextual issues in patients’ lives and some problems with implementation may have reduced the size of effect of the intervention. For depression, patients’ lives and preferences affected engagement with the intervention: these largely working-age patients had busy and complex lives, which affected their ability to engage, and some patients preferred a therapist-based approach to the cognitive behavioral therapy on offer. For CVD risk, patients’ motivations adversely affected the intervention whereby some patients joined the trial for general health improvement or from altruism, rather than motivation to make lifestyle changes to address their specific risk factors. Implementation was not optimal in the early part of the CVD risk trial owing to technical difficulties and the need to adapt the intervention for use in practice. For both conditions, enthusiastic and motivated staff offering continuity of intervention delivery tailored to individual patients’ needs were identified as important for patient engagement with telehealth; this was not delivered consistently, particularly in the early stages of the trials. Finally, there was a lack of active engagement from primary care. Conclusions The conceptual model was supported and could be used to develop further telehealth interventions for chronic conditions. It may be possible to increase the effectiveness of this, and similar interventions, by attending to the human as well as the technical aspects of telehealth: offering it to patients actively wanting the intervention, ensuring continuity of delivery by enthusiastic and motivated staff, and encouraging active engagement from primary care staff.

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.

The Contribution of Therapist Effects to Patient Dropout and Deterioration in the Psychological Therapies.

BACKGROUND In the psychological therapies, patient outcomes are not always positive. Some patients leave therapy prematurely (dropout), while others experience deterioration in their psychological well-being. METHODS The sample for dropout comprised patients (n = 10 521) seen by 85 therapists, who attended at least the initial session of one-to-one therapy and completed a Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at pre-treatment. The subsample for patient deterioration comprised patients (n = 6405) seen by the same 85 therapists but who attended two or more sessions, completed therapy and returned a CORE-OM at pre-treatment and post-treatment. Multilevel modelling was used to estimate the extent of therapist effects for both outcomes after controlling for patient characteristics. RESULTS Therapist effects accounted for 12.6% of dropout variance and 10.1% of deterioration variance. Dropout rates for therapists ranged from 1.2% to 73.2%, while rates of deterioration ranged from 0% to 15.4%. There was no significant correlation between therapist dropout rate and deterioration rate (Spearmans rho = 0.07, p = 0.52). CONCLUSIONS The methods provide a reliable means for identifying therapists who return consistently poorer rates of patient dropout and deterioration compared with their peers. The variability between therapists and the identification of patient risk factors as significant predictors has implications for the delivery of safe psychological therapy services. Copyright

Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial

Objectives To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. Design A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. Intervention A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. Results The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. Conclusions The intervention was likely to be cost-effective under a lifetime perspective. Trial registration number ISRCTN27508731; Results.

Advance telephone notification of follow-up in the healthlines study: a nested study of patients with depression

Methods Participants in one of the three study centres were alternately allocated to either be telephoned 2-7 days before sending an 8-month follow-up questionnaire by post or email, or to be sent the questionnaire without pre-calling. All participants received up to five questionnaire completion reminders. The primary outcome was completion of the PHQ-9 outcome. Secondary outcomes were number of reminders and time to questionnaire completion.