Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention

Salisbury, Chris; O’Cathain, Alicia; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Lewis, Glyn; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Dixon, Padraig; Montgomery, Alan

doi:10.1016/s2215-0366(16)00083-3

Cited by 79 publications

(85 citation statements)

References 27 publications

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“…In fact, overall, eHealth is becoming an everyday term and is, to various degrees, permeating the lives of many. For instance, in a recent study, Salisbury et al (2016) conducted a trial test of the effectiveness of integrating a (multicomponent) telehealth intervention into general practice for the treatment and management of depression. The need of telemedicine is, however, not confined to mental disease.…”

Section: Discussionmentioning

confidence: 99%

Assessing Cognitive Function in Older Adults Using a Videoconference Approach

et al. 2016

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BackgroundThe use of communication technologies is an emerging trend in healthcare and research. Despite efficient, reliable and accurate neuropsychological batteries to evaluate cognitive performance in-person, more diverse and less expensive and time consuming solutions are needed. Here we conducted a pilot study to determine the applicability of a videoconference (VC, Skype®) approach to assess cognitive function in older adults, using The Telephone Interview for Cognitive Status-Modified – Portuguese version (TICSM-PT).MethodsAfter inclusion and exclusion criteria, 69 individuals (mean age = 74.90 ± 9.46 years), selected from registries of local health centers and assisted-living facilities, were assessed on cognitive performance using videoconference, telephone and in-person approaches.FindingsThe videoconference administration method yielded comparable results to the traditional application. Correlation analyses showed high associations between the testing modalities: TICSM-PT VC and TICSM-PT telephone (r = 0.885), TICSM-PT VC and MMSE face-to-face (r = 0.801). Using the previously validated threshold for cognitive impairment on the TICSM-PT telephone, TICSM-PT VC administration presented a sensitivity of 87.8% and a specificity of 84.6%.InterpretationFindings indicate for the range of settings where videoconference approaches can be used, and for their applicability and acceptability, providing an alternative to current cognitive assessment methods. Continued validation studies and adaptation of neuropsychological instruments is warranted.

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Section: Discussionmentioning

confidence: 99%

Assessing Cognitive Function in Older Adults Using a Videoconference Approach

et al. 2016

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“…Improving the effectiveness of the intervention is likely to require better targeting of the intervention to those interested in using it, efforts to improve patient engagement and more effective optimisation of anti-depressant medication when patients fail to respond to treatment. 14 In conclusion, the Healthlines service was found to be acceptable to patients as a means of condition management, 18 and response to treatment after 4 months was higher for participants randomised to the intervention. 14 However, the intervention was associated with a small incremental QALY gain at 12 months and was not likely to be cost-effective at a threshold value of £20 000.…”

Section: Limitationsmentioning

confidence: 83%

“…14 Analysis of secondary trial outcomes indicated greater improvements in anxiety, and greater satisfaction with support, among those randomised to the intervention. 14 The second consideration is that analysis of correlation (using Spearman's rho) indicates that high PHQ-9 scores (indicating greater severity of depression) and low EQ-5D scores (indicating lower quality of life) are correlated at baseline and all followup time points. The null of independence was rejected in each case (P<0.001), and the absolute value of the correlations were largest with the anxiety/depression domain of the EQ-5D instrument.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial

et al. 2016

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BackgroundDepression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression.AimsTo investigate the cost-effectiveness of a telehealth intervention (‘Healthlines') for patients with depression.MethodA prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was 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). Cost–consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome.ResultsA total of 609 participants were randomised – 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI −0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a cost-effectiveness threshold of £20 000 was −£143 (95% CI −£164 to −£122) and the probability of the intervention being cost-effective at this threshold value was 0.30. Productivity costs were higher in the intervention arm, but out-of-pocket expenses were lower.ConclusionsThe Healthlines service was acceptable to patients as a means of condition management, and response to treatment after 4 months was higher for participants randomised to the intervention. However, the positive average intervention effect size was modest, and incremental costs were high relative to a small incremental QALY gain at 12 months. The intervention is not likely to be cost-effective in its current form.Declaration of interestNone.Copyright and usage© The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

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“…When implemented effectively, these technologies can be used to increase access to timely, quality, or specialty care [2][3][4][5][6][7] ; monitor disease progression 2,6 ; improve adherence to treatment regimens 8,9 ; and even improve patient outcomes. 2,6,[10][11][12][13] Despite gains in routine health care, adoption of PT as a mainstream tool remains limited in interventional clinical research and the pharmaceutical industry. 14 In 2016, a survey of pharmaceutical trial sponsors, eConsent vendors, and contract research organizations (CROs) reported only 28 pharmaceutical trials in 12 countries that had successfully used eConsent to consent patients.…”

Section: Introductionmentioning

confidence: 99%

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

Polhemus¹,

Kadhim

Barnes

et al. 2019

Ther Innov Regul Sci

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Background: Patient-facing digital technologies (also called "Patient Technology" [PT]) have the potential to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized. Methods: In order to understand the factors affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts, including pharmaceutical company representatives, clinical trial investigators at a number of trial sites worldwide, and clinical trial participants. All interview and survey responses were blinded and aggregated by a third-party consultant and themes were extracted. Results: There was general consensus around the potential value of patient-facing technology as a clinical research tool, though a variety of challenges faced by each stakeholder were discussed. Detailed accounts of opportunities (improved patient experience, compliance, and engagement; clinical trial efficiencies; improved data quality and insights) and barriers (organizational and corporate cultural challenges, business-related challenges, user willingness and burden, and regulatory challenges) are reported. Conclusions: While the barriers to PT adoption explored here were numerous, they were also generally consistent. A number of proposals for establishing more holistic, collaborative, and strategic approaches to PT implementation in clinical trials are discussed. Such approaches could facilitate more effective, widespread adoption of PT, and thereby a more patient-centric clinical trial paradigm.

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Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention

Abstract: National Institute for Health Research (NIHR).

Cited by 79 publications

References 27 publications

Assessing Cognitive Function in Older Adults Using a Videoconference Approach

Assessing Cognitive Function in Older Adults Using a Videoconference Approach

Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

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