Clare Thomas

Are People With Chronic Diseases Interested in Using Telehealth? A Cross-Sectional Postal Survey

Background There is growing interest in telehealth—the use of technology to support the remote delivery of health care and promote self-management—as a potential alternative to face-to-face care for patients with chronic diseases. However, little is known about what precipitates interest in the use of telehealth among these patients. Objective This survey forms part of a research program to develop and evaluate a telehealth intervention for patients with two exemplar chronic diseases: depression and raised cardiovascular disease (CVD) risk. The survey was designed to explore the key factors that influence interest in using telehealth in these patient groups. Methods Thirty-four general practices were recruited from two different regions within England. Practice records were searched for patients with (1) depression (aged 18+ years) or (2) 10-year risk of CVD ≥20% and at least one modifiable risk factor (aged 40-74 years). Within each general practice, 54 patients in each chronic disease group were randomly selected to receive a postal questionnaire. Questions assessed five key constructs: sociodemographics, health needs, difficulties accessing health care, technology-related factors (availability, confidence using technology, perceived benefits and drawbacks of telehealth), and satisfaction with prior use of telehealth. Respondents also rated their interest in using different technologies for telehealth (phone, email and Internet, or social media). Relationships between the key constructs and interest in using the three mediums of telehealth were examined using multivariable regression models. Results Of the 3329 patients who were sent a study questionnaire, 44.40% completed it (872/1740, 50.11% CVD risk; 606/1589, 38.14% depression). Overall, there was moderate interest in using phone-based (854/1423, 60.01%) and email/Internet-based (816/1425, 57.26%) telehealth, but very little interest in social media (243/1430, 16.99%). After adjusting for health needs, access difficulties, technology-related factors, and prior use of telehealth, interest in telehealth had largely no association with sociodemographic variables. For both patient groups and for each of the three technology mediums, the most important constructs related to interest in telehealth were having the confidence to use the associated technology, as well as perceiving greater advantages and fewer disadvantages from using telehealth. To illustrate, greater confidence using phone technologies (b=.16, 95% CI 0.002-0.33), while also perceiving more benefits (b=.31, 95% CI 0.21-0.40) and fewer drawbacks (b=-.23, 95% CI -0.28 to -0.17) to using telehealth were associated with more interest in using phone-based telehealth technologies for patients with depression. Conclusions There is widespread interest in using phone-based and email/Internet-based telehealth among patients with chronic diseases, regardless of their health status, access difficulties, age, or many other sociodemographic factors. This interest could be increased by helping patients gain confidence using technologies and through highlighting benefits and addressing concerns about telehealth. While the same pattern exists for social media telehealth, interest in using these technologies is minimal.

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.

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.

Early prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: a study protocol

Introduction Over 80% of very preterm (<32 weeks) and very low birthweight (<1500 g) infants will have either typical development (TD) or mild developmental delay (MDD) in multiple domains. As differentiation between TD and MDD can be difficult, infants with MDD often miss opportunities for intervention. For many clinicians, the ongoing challenge is early detection of MDD without over servicing the population. This study aims to: (1) identify early clinical biomarkers for use in this population to predict and differentiate between TD and MDD at 24 months corrected age. (2) Determine the extent to which family and caregiver factors will contribute to neurodevelopmental and behavioural outcomes. Methods and analysis Participants will be a prospective cohort of 90 infants (<32 weeks and/or <1500 g). Between 34 weeks gestational age and 16 weeks post-term, infants will have a series of 5 neurological, neuromotor, neurobehavioural and perceptual assessments including General Movement Assessment at preterm, writhing and fidgety age. Primary caregivers will complete questionnaires to identify social risk, maternal depression and family strain. Extensive perinatal data will be collected from the medical record. At 24 months, corrected age (c.a) infants will be assessed using standardised tools including the Bayley Scales of Infant and Toddler Development—Third Edition (Bayley III). Longitudinal trajectories of early assessment findings will be examined to determine any predictive relationship with motor and cognitive outcomes at 24 months c.a. Published data of a cohort of Australian children assessed with the Bayley III at 24 months c.a will provide a reference group of term-born controls. Ethics Ethical approval has been obtained from the Queensland Childrens Health Services Human Research Ethics Committee (HREC/13/QRCH/66), the University of Queensland (2013001019) and the Sunshine Coast Hospital and Health Service, SC-Research Governance (SSA/13/QNB/66). Publication of all study outcomes will be in peer-reviewed journals. Trial registration number ACTRN12614000480684; Pre-results.

Use of primary care electronic records to monitor and improve intervention delivery of a GP practice level intervention

Citation for published version (APA): Rogers, A., Mackenzie, I., Rorie, D., & MacDonald, T. (2017). Successful recruitment to a large online randomised trial: the TIME study. In Trials: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials (Supplement 1 ed., Vol. 18, pp. 222-223). [089] (Trials; Vol. 18, No. Suppl. 1). United Kingdom: BioMed Central. https://doi.org/10.1186/s13063-017-1902-yThe study will address variability in practice, defined in Standard Operating Procedures, that UK Clinical Trials Units (CTU) have in place for: i) defining, ii) classifying, and iii) reporting adverse events in non-CTIMPs. Compared to drug trials, adverse events in non-CTIMPs are not managed well. There is considerable inconsistency in reporting styles between trials of similar design and intervention type. To promote increased consistency, we will conduct a consensus exercise among non-CTIMP experts using a Delphi technique followed by a face-to-face meeting. This method adheres to the recommended sequence outlined by the international network for Enhancing the Quality and Transparency of Health Research (EQUATOR) for developing health research guidelines. A non-CTIMP expert is defined as: a CTU representative, a Chief Investigator or trial manager of non-CTIMPs with >3 trials experience in this role, or a senior member of the Health Research Authority’s Operations team or Ethics Committee. As such, the participants in the consensus exercises will also be the direct beneficiaries from the project maximising its pathway to impact. Following the face-to-face meeting — guidance and explanatory statements will be drafted. The guidance statement will focus on: • how adverse events should be defined in relation to the non-pharmacological intervention, • how CTU standard operating procedures should be designed to reflect the results of the Delphi exercise, • how adverse events should be classified following a judicious causal assessment, and • recommended reporting methods that will promote more effective meta-analyses of non-pharmacological interventions that provide a balanced benefit-harm evaluation. Following study completion, we will work with a selection of UK CTUs to evaluate the implementation of any agreed modifications to current practice.This is the final version of the article. Available from BioMed Central via the DOI in this record.Objective Multi-centre RCT designs provide robust evidence of therapeutic effect of health interventions. However participating centres often differ in how well they conduct the trial and the number of patients successfully recruited. This paper describes barriers different research teams encountered when conducting a complex RCT comparing a surgical procedure with physiotherapy, and the actions taken by the trial management group to overcome obstacles that were hindering recruitment. Methods We conducted 22 interviews with principal investigators and research associates at 14 sites involved in the delivery of a surgical RCT that compared hip arthroscopy and physiotherapy for hip pain. Interview transcripts were analysed thematically and case study approaches were utilised to present results to the trial management group. Results Research teams reported difficulties related to logistics (e.g. Room space); motivation (e.g. PI reluctant to approach patients); and skill (e.g. Lack of knowledge about the treatment arms). Similar Issues were shared by sites that recruited to target and those that did not, however there were differences in the team ’ s response to challenges. Whilst on-target sites found local solutions to issues or support through their research infrastructure or the trial TMG, off-target sites usually did not show proactivity. Site profiles were created and action plans designed based on aspects that were particular to the individual sites. These plans were implemented in collaboration with site teams. Conclusions This qualitative study added to the growing evidence of how aspects of team functioning are important for recruitment to complex RCTs. Trial Management Groups can help research teams identify and ad- dress issues, and therefore contributing to a sense of ownership by the research team. Empowering research teams to find solutions at local level is essential to conduct multi-centre RCTs successfully.

Footprints in Primary Care: Using mixed methods to assess fidelity to a complex intervention for frequently attending patients

Citation for published version (APA): Rogers, A., Mackenzie, I., Rorie, D., & MacDonald, T. (2017). Successful recruitment to a large online randomised trial: the TIME study. In Trials: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials (Supplement 1 ed., Vol. 18, pp. 222-223). [089] (Trials; Vol. 18, No. Suppl. 1). United Kingdom: BioMed Central. https://doi.org/10.1186/s13063-017-1902-yThe study will address variability in practice, defined in Standard Operating Procedures, that UK Clinical Trials Units (CTU) have in place for: i) defining, ii) classifying, and iii) reporting adverse events in non-CTIMPs. Compared to drug trials, adverse events in non-CTIMPs are not managed well. There is considerable inconsistency in reporting styles between trials of similar design and intervention type. To promote increased consistency, we will conduct a consensus exercise among non-CTIMP experts using a Delphi technique followed by a face-to-face meeting. This method adheres to the recommended sequence outlined by the international network for Enhancing the Quality and Transparency of Health Research (EQUATOR) for developing health research guidelines. A non-CTIMP expert is defined as: a CTU representative, a Chief Investigator or trial manager of non-CTIMPs with >3 trials experience in this role, or a senior member of the Health Research Authority’s Operations team or Ethics Committee. As such, the participants in the consensus exercises will also be the direct beneficiaries from the project maximising its pathway to impact. Following the face-to-face meeting — guidance and explanatory statements will be drafted. The guidance statement will focus on: • how adverse events should be defined in relation to the non-pharmacological intervention, • how CTU standard operating procedures should be designed to reflect the results of the Delphi exercise, • how adverse events should be classified following a judicious causal assessment, and • recommended reporting methods that will promote more effective meta-analyses of non-pharmacological interventions that provide a balanced benefit-harm evaluation. Following study completion, we will work with a selection of UK CTUs to evaluate the implementation of any agreed modifications to current practice.This is the final version of the article. Available from BioMed Central via the DOI in this record.Objective Multi-centre RCT designs provide robust evidence of therapeutic effect of health interventions. However participating centres often differ in how well they conduct the trial and the number of patients successfully recruited. This paper describes barriers different research teams encountered when conducting a complex RCT comparing a surgical procedure with physiotherapy, and the actions taken by the trial management group to overcome obstacles that were hindering recruitment. Methods We conducted 22 interviews with principal investigators and research associates at 14 sites involved in the delivery of a surgical RCT that compared hip arthroscopy and physiotherapy for hip pain. Interview transcripts were analysed thematically and case study approaches were utilised to present results to the trial management group. Results Research teams reported difficulties related to logistics (e.g. Room space); motivation (e.g. PI reluctant to approach patients); and skill (e.g. Lack of knowledge about the treatment arms). Similar Issues were shared by sites that recruited to target and those that did not, however there were differences in the team ’ s response to challenges. Whilst on-target sites found local solutions to issues or support through their research infrastructure or the trial TMG, off-target sites usually did not show proactivity. Site profiles were created and action plans designed based on aspects that were particular to the individual sites. These plans were implemented in collaboration with site teams. Conclusions This qualitative study added to the growing evidence of how aspects of team functioning are important for recruitment to complex RCTs. Trial Management Groups can help research teams identify and ad- dress issues, and therefore contributing to a sense of ownership by the research team. Empowering research teams to find solutions at local level is essential to conduct multi-centre RCTs successfully.