New strategies to improve both effectiveness and access to care
Authors: Martha L Bruce
Journal: The Lancet Psychiatry (2016)

In The Lancet Psychiatry, Chris Salisbury and colleagues present their findings from a large, pragmatic trial testing the effectiveness of integrating a multicomponent telehealth intervention into general practice for the treatment and management of depression.1Salisbury C O'Cathain A Edwards L et al.Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.Lancet Psychiatry. 2016; (published online April 27, 2016.)http://dx.doi.org/10.1016/S2215-0366(16)00083-3Google Scholar Depression was chosen as an exemplar of chronic disease: an episodic disorder that, although responsive to active treatments (medication or psychotherapy), often requires time to establish the most effective regimen, ongoing management to maximise the likelihood of remission, and long-term maintenance treatment to minimise recurrence.2Bockting CL Hollon SD Jarrett RB Kuyken W Dobson K A lifetime approach to major depressive disorder: The contributions of psychological interventions in preventing relapse and recurrence.Clin Psychol Rev. 2015; 41: 16-26Crossref PubMed Scopus (177) Google Scholar Despite this complexity, most depression is treated by general practitioners (GPs) who commonly prescribe antidepressants, but might not have the time, workforce, or resources to provide optimum ongoing treatment and management.3Trivedi MH Lin EH Katon WJ Consensus recommendations for improving adherence, self-management, and outcomes in patients with depression.CNS Spectr. 2007; 12: 1-27PubMed Google Scholar Thus, despite a large evidence base for depression treatment and management, many individuals with depression lack access to effective care.4Pence BW O'Donnell JK Gaynes BN The depression treatment cascade in primary care: a public health perspective.Curr Psychiatry Rep. 2012; 14: 328-335Crossref PubMed Scopus (81) Google Scholar, 5Duhoux A Fournier L Gauvin L Roberge P Quality of care for major depression and its determinants: a multilevel analysis.BMC Psychiatry. 2012; 12: 142Crossref PubMed Scopus (46) Google Scholar The study findings show the promise of technology to improve the reach and effectiveness of chronic disease management while potentially reducing the burden on GPs. The intervention is unique by both combining several evidence-based telehealth strategies for depression treatment (eg, online cognitive behavioural therapy) and management (eg, telephone-based motivational interviewing) into a single package and by integrating the intervention into routine general practice. The programme is tailored to each participant's needs and preferences. Thus telehealth offers more patients more access to more options than have previously been available. Implementation of this complex intervention for participants recruited from 43 general practices is a remarkable accomplishment. Indeed, implementation of even simple interventions into routine practice in a single setting is challenging. This challenge is compounded by the need for a research methodology to demonstrate effectiveness. The investigators used the practices' shared electronic medical records (EMRs) to identify potentially eligible patients and draw a random sample, thereby increasing the study's potential generalisability. The study recruited and randomly assigned an impressively large sample of 609 participants who reported clinically significant symptoms and met diagnostic criteria and 85% of participants were retained during 1 year. The results showed that patients randomly assigned to the telehealth intervention had more rapid improvement in depression severity than did patients receiving usual care. After 4 months, 68 (27%) of 255 participants who received the telehealth intervention responded to treatment, compared with 50 (19%) of 270 participants in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1–2·5, p=0·019). Does it matter who these participants were? The research team initially contacted 16 570 patients who met the EMR eligibility criteria and were approved by their GP. However, only 2375 patients (14%) expressed interest in participating. Most efficacy trials, especially medication treatment studies, focus on outcomes with an expectation that the results will be broadly generalisable. However, the recruitment methodology (eg, advertisements or clinician referral) is almost guaranteed to accrue a sample that differs from the population at large.6Kennedy-Martin T Curtis S Faries D Robinson S Johnston J A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.Trials. 2015; 16: 495Crossref PubMed Scopus (432) Google Scholar If interventions are to be developed that are both effective across the general population and improve access to care, then understanding of the extent to which participants represent the wider target population is important. And if participants are not representative, it is useful to know whether the factors that affect study non-participation are also relevant to effectiveness and access to care. For example, did these individuals think their depressive symptoms were unimportant? Or that their current treatment was sufficient? Or were they reluctant to enrol in research? Or were they reluctant to participate in telehealth? Such reluctance might not be a problem if the goal of telehealth is to serve only a small subset of patients. However, if the goal is to improve access to care and reduce burden on general practices, then the intervention should be acceptable and feasible to as many eligible patients as possible. Thus information about how patients (including those who decline to participate) perceive telehealth is important. At the same time, telehealth might still be novel enough to expect only early adopters to participate. Most people who currently use once-innovative practices (such as smartphones or Facebook or online dating) only did so after the first wave of adopters had confirmed their value. From that perspective, information about patients' reluctance to participate in telehealth would be useful—not as an indicator of the intervention's future reach, but as a barometer of the work needed to increase the acceptability of telehealth once effectiveness has been demonstrated. Because participants were randomly assigned to treatment, factors affecting non-participation might not bias the effectiveness data, but they could restrict generalisability. For studies testing new strategies for the implementation of evidence-based practices aiming to optimise both effectiveness and access, minimisation of selection bias takes on a greater importance. Alternative study designs might better fit these goals. For example, trials that compare evidence-based interventions or test new implementation strategies might benefit from designs in which the unit of randomisation is a cluster (eg, clinician or practice) and the intervention becomes the standard of care for general practice.7Donner A Klar N Pitfalls of and controversies in cluster randomization trials.Am J Public Health. 2004; 94: 416-422Crossref PubMed Scopus (306) Google Scholar, 8Eldridge S Ashby D Bennett C Wakelin M Feder G Internal and external validity of cluster randomised trials: systematic review of recent trials.BMJ. 2008; 336: 876-880Crossref PubMed Scopus (149) Google Scholar Such designs could make it possible to separate research participation from intervention participation and to inform the reasons that patients do or do not participate in each. And effectiveness can be assessed in both research patients (using research measures) and the patient populations as a whole (using de-identified medical records). These and other designs might help to optimise research on interventions designed to improve access to evidence-based care. I report no competing interests. Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex interventionThis telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision. Full-Text PDF Open Access