EDITORIAL COMMENT

Distance Therapy to Improve Symptoms and Quality of Life: Complementing Office-Based Care With Telehealth Abstract: Two randomized trials exemplify strategies for administering behavioral interventions through distance therapyYthe use of telemedicine or e-health approaches to treating patients outside the conventional in-person office-based visit. In the first trial, telephone-based coping skills training for patients with chronic obstructive pulmonary disease was not more effective than an education control in reducing mortality or rehospitalization. However, it was superior in improving psychological and somatic quality of life. In the second trial, a web-based distress management program was not more effective than usual care in postoperative psychological outcomes in patients receiving an implantable cardioverter defibrillator. However, both of these trials raise important methodological issues in designing and interpreting trials testing telehealth delivery of behavioral interventions. Key issues include: 1) selection of the appropriate control group (e.g., when may a usual care or active comparator be preferable to an attention control?); 2) choice of the appropriate outcome (i.e., one most likely to respond to the specific intervention); 3) enrolling only patients who have at least some threshold level of the symptom or risk level for the outcome being targeted by the intervention; 4) focusing on patients likely to participate in telehealth or other distance-administered treatment programs; and 5) optimal timing for the delivery of behavioral interventions that may occur around the time of major events such as hospitalization or procedures. A policy implication is that once distance therapy interventions are proven effective, reimbursement changes will be necessary to enhance the likelihood of uptake by providers and health care systems.

Encounters, transactions, and other human activities are transitioning from a venue that has historically been up-close and personal to one that is increasingly electronic and remote. We shop and bank online, converse through e-mail or text messages, conduct meetings by conference calls, interact with friends through social media, work at home, give virtual hugs to our grandchildren via Skype, and chat, blog, twitter, tweet, and in general let our fingers do the talking. Just as distance education is rapidly becoming an alternative to the traditional classroom, clinical care provided at a distance is proving to be a viable replacement for some of the office visits that compel patients to sacrifice work, school, family, or personal time as well as travel costs. The telephone, Internet, and other modes of technology are becoming tools of the clinical trade every bit as important as those that once resided in the doctor’s black bag. In this issue of Psychosomatic Medicine, two trials exemplify different approaches to the emerging paradigm of distance therapy (1,2). These two studies targeted psychological and somatic symptoms as well as quality of life (QoL), which are conditions that especially lend themselves to treatment outside the clinic walls (3Y7). Although telehealth, or, more recently, e-health, are supplanting telemedicine as more inclusive terms (8), I intentionally call it ‘‘distance therapy’’ because the rapid evolution of technology and media can make any term a temporary placeholder. In the first trial, Blumenthal et al. (1) randomized 326 patients with chronic obstructive pulmonary disease (COPD) to telephone-based Coping Skills Training (CST) or COPD Education. Strengths of this elegant trial include high patient adherence and low dropout rates; a rich battery of patient-reported outcomes as well as objective measures (e.g., pulmonary function tests and 6-minute walk); and a sophisticated analytic strategy

A podcast discussion of this article is available online with this issue. DOI: 10.1097/PSY.0000000000000111 578

including mediator and moderator analyses. Although CST did not differ from the control group in the primary outcome of time to death or first COPD-related hospitalization, CST did lead to significantly greater improvement in both psychological and somatic QoL. Although the strict conventions of clinical trials might classify this as a ‘‘negative’’ trial because of its failure to separate on the primary outcome, there are three reasons why the interpretation of the study findings may be more sanguine. First, the study was underpowered for the primary outcome. With a 20% primary event rate in the control group, the study was adequately powered only if CST had reduced the event rate to 9%Vwhich is a 55% relative risk reduction. It is not clear why the investigators presumed that CST would have such a large treatment effect on mortality or hospitalization. Indeed, one would expect CST to have a more direct and specific effect on QoL than on mortality or hospitalization. This is reminiscent of depression for which an enormous body of clinical trial evidence showing that integrated care models improve depression outcomes (9) has still not led to widespread adoption because of an insistence by payers and opponents of mental health parity that mortality and/or health care costs also be reduced. Second, the treatment effect size on QoL outcomes in the overall sample was diluted by enrolling a substantial number of patients with only minor impairments in QoL. Additional analyses showed that the subset of patients with poor QoL at baseline had much greater benefits from the intervention. Some of these effects may be attributable to regression to the mean or spontaneous remission, but the findings nonetheless suggest that individuals with a poor QoL may disproportionately benefit from CST. Third, the control group was as much an active comparator as an attention control in that patients in this group received a large number of telephone contacts equivalent to the CST group and including information specific to COPD. This type of control group might have led to an underestimation of the CST treatment effect. Psychosomatic Medicine 76:578Y580 (2014)

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EDITORIAL COMMENT Habibovi( et al. (2) randomized 289 patients receiving an implantable cardioverter-defibrillator to a Web-based distress management program or usual care. The intervention consisted of a 12-week online course consisting of 6 sessions that involved homework and online feedback by a coach. This trial was negative with no significant between-group differences in psychological outcomes at 3 months. Although it is certainly possible that the Web-based intervention was too weak to be beneficial, there could be alternative explanations for the study findings. First, only 23% of patients randomized to the Webbased program completed all 6 sessions. This disappointing adherence rate coupled with a similar experience by another group (10) prompted the investigators to suggest that Webbased programs may be best targeted to patients who are interested in the Internet for health care purposes. Second, as in the trial by Blumenthal et al., the study sample was diluted by enrolling a large number of patients without the target condition of interest. Although an earlier study had found the Web-based program helpful in depressed patients, only a minority of the implantable cardioverter-defibrillator patients had depression (13%Y21%) or anxiety (11%Y30%). Subgroup analyses of the anxious-depressed patients still did not show a significant intervention effect; however, the trial would have been underpowered for this distressed subgroup. The investigators justified their study inclusion criteria by claiming that their intent was as much to prevent distress as to treat it. However, the evidence that this Web-based program or, for that matter, most other psychological interventions have preventive benefits is scant compared with the evidence for their ameliorative effects. Third, Habibovi( et al. postulate that the timing of when their intervention was administered may have been suboptimal. Offering the program within the first 2 weeks postimplant might, in the words of the authors, ‘‘have been too soon, as patients are preoccupied with practical issues (e.g., driving restrictions, physical impairments, etc.) and might not be ready to start working on their psychological problems. One way of circumventing premature intervention in patients who do not really need it would be to include a ‘watchful waiting period,’ as has been done in some collaborative care trials in patients with acute coronary syndromes.’’ Also used in trials of poststroke depression (11), a delay in starting psychological interventions may indeed be warranted after medical events and procedures to minimize potential nonadherence that may be related to competing demands during the acute recovery process as well as to allow spontaneous resolution of transient psychological distress. An alternative is to start psychological interventions before scheduled operations or procedures with the aim of reducing psychological distress afterward. Although distress prevention in unselected patients may have weak overall effects, preemptive treatment in the subset of patients at higher risk of experiencing postprocedural distress might have a stronger effect. For example, a CST program that starts before total knee arthroplasty in patients with high pain catastrophizing is currently being evaluated in a multisite randomized clinical trial (12). The results of these two trials have several important implications for behavioral interventions focused on patient-reported

outcomes (e.g., psychological distress, QoL, pain, and other somatic symptoms) in general and telehealth in particular. (1) The conventional wisdom that an attention control group automatically makes a trial more scientifically rigorous is no longer universally accepted (13Y15). First, it may be difficult to achieve an equal amount of attention in both groups, as shown in the trial by Blumenthal et al., where the CST group sessions were on average nearly three times as long as the control group sessions (32.6 versus 10.8 minutes). Second, the credibility of what the attention control group is exposed to may be substantially weakened if the content is entirely nonspecific, prompting investigators to also provide disease-relevant information during the control sessions. This then can overlap to some degree with what the active intervention group receives, which, in turn, may lead to an underestimate of the specific treatment effect. Third, the rationale that an attention control group allows one to test the specific mechanism by which an intervention has a treatment effect can become clouded in the case of complex multicomponent interventions. Fourth, when interventions such as CST have already proven efficacious in previous attention-control trials, their administration in another condition or population may not necessitate yet another attention-controlled trial. (2) Target the subset of patients for which the intervention is expected to be beneficial. Hypertension trials only enroll patients with elevated blood pressure. Similarly, interventions focused on psychological or somatic symptoms should enroll symptomatic patients. Likewise, target patients interested in the intervention which, for distance therapy interventions, should continue to rapidly increase with the Internet and cellular revolution. (3) Symptoms, QoL, and other patient-reported outcomes are sufficient as primary outcomes. The insistence by payers, study sections, or other third parties that ‘‘hard outcomes’’ (e.g., mortality and cost savings) are more important is prejudicial to the symptomatic patient and, moreover, ignores the individual and societal burdens. For example, six of the nine health conditions that account for the greatest number of years lived with disability in the United States are due to predominantly symptom-based disorders, with low back pain, major depression, other musculoskeletal disorders, neck pain, anxiety disorders, and osteoarthritis being the first, second, third, fourth, fifth, and ninth most chronically disabling disorders, respectively (16). (4) Effective distance therapy interventions should be reimbursed, and payment should not be anachronistically linked to office-based care. There will always be an essential and possibly even predominant role of face-to-face encounters in health care, where the provider and patient share the same room. Also, the outpatient office and hospital are obviously necessary for some clinical activities (e.g., physical examination, certain types of diagnostic testing or procedures, surgical operations, and treatments that must be administered in-person). At the same time, we should not allow tradition or outdated reimbursement policies to hinder a more efficient and patient-centered approach that allows office-based and telehealth to complement one another. (5) In addition to saving the patient time and travel costs, distance therapy can allow certain activities (e.g., symptom monitoring and other data collection, self-management, and behavioral therapy homework) to occur asynchronously, that is, on the patient’s own schedule and not requiring simultaneous contact with the health care provider. Distance therapy may also serve as part of a stepped care approach for patients with milder symptoms, reserving office-based visits for individuals who do not respond or who have more serious conditions. Alternatively, distance therapy may augment office-based care, providing more intensive patient education or skills development than is feasible in time-limited clinic encounters as well as reinforcing what the clinician provides in the office. (6) Incorporation of distance therapy into practice should proceed along a middle road (17), resisting the steamroller effect of technology adoption in advance of supporting evidence while, at the same time,

Psychosomatic Medicine 76:578Y580 (2014)

Copyright © 2014 by the American Psychosomatic Society. Unauthorized reproduction of this article is prohibited.

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EDITORIAL COMMENT allaying unreasonable fears of clinicians being replaced by computers. However, once the effectiveness of a particular telehealth intervention has been convincingly demonstrated, patients with the appropriate target condition who embrace distance therapy should not be placed on call waiting.

KURT KROENKE, MD VA HSR&D Center for Health Communication and Information Regenstrief Institute Inc and Indiana University School of Medicine Indianapolis, Indiana Sources of Funding and Conflict of Interest: The author reports no source of funding or potential conflicts of interest.

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Psychosomatic Medicine 76:578Y580 (2014)

Copyright © 2014 by the American Psychosomatic Society. Unauthorized reproduction of this article is prohibited.

Distance therapy to improve symptoms and quality of life: complementing office-based care with telehealth.

Two randomized trials exemplify strategies for administering behavioral interventions through distance therapy-the use of telemedicine or e-health app...
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