JOURNAL OF THE INTERNATIONAL SOCIETY FOR TELEMEDICINE AND EHEALTH

FRAMEWORK FOR PERSON-CENTRED TELEHEALTH RESEARCH

Claudia C. Bartz PhD, RN, FAAN

International Council of Nurses

Abstract Introduction This paper describes a framework for the integration of person-centeredness with telehealth The concept of person-centredness is here described as research methodologies. The evidence base for an interaction in which the health care provider and telehealth is improving but research with human recipient are in a collaborative partnership, preferably subjects continues to be necessary for confidence in before, during and after direct care episodes.1-3 the telehealth-related technologies and applications “Provider” here means any health care person available now and in the future. To identify aspects qualified to render care at a certain level and of person-centred research, an exploratory review “recipient” could mean an individual, group or of telehealth research was followed by two phases community. Person-centredness has been distinguished of systematic qualitative analysis. All of the from person-centred medicine, personalized medicine telehealth research reports considered had, as and patient-centred care.1-6 participants, people with diabetes (adolescents and The exploratory analysis and phase one study adults). This diagnostic group was chosen to underlying this paper have been described in previous narrow the scope of the analysis to a manageable publications.1,2 Both samples were drawn from size. Diabetes is a worldwide disease and predicted research involving people with diabetes, first, in order to increase in morbidity and mortality in the next to narrow the number of research reports and, second, decades. A framework for the assessment of person- because diabetes is a worldwide non-communicable centred research was devised, based on three disease estimated to affect more than 340 million ethical concepts: respect, benefit and justice in the people by year 2030.7 sense of fairness. The concepts are described with Briefly, the exploratory analysis used a random their related actions. With the application of these sample of 12 papers that met the criteria of telehealth concepts and actions during the conceptualisation, research involving people with diabetes and published design, sample accrual, interventions and data in 2012. The analysis looked for commonalities across collection segments of telehealth research, the the methods sections of the papers. For example, participants who are necessary to advancing sampling processes and researchers’ activities with telehealth research may have a better experience intervention and control groups were compared.1 with the research process. Rather than researchers The phase one study then used a convenience making assumptions about what people need, the sample of 14 reports published 2011-2013 (excluding participants themselves can contribute to the the papers in the exploratory analysis) to further the research design and data interventions. The study commonality analysis and to identify patterns in the data resulting from the addition of person-centred methods. 2 The papers were assessed, first, for research applications may be more reliable (consistent) and purpose, participant recruitment and demographics, valid (accurate), with participants having a sense of interventions, data collection methods, and, second, making an important contribution. Participants for textual descriptions considered to represent may also be more willing to continue to serve in evidence of respect, benefit and justice or fairness for future research. the participants. For example, if self-management planning or health-related goal setting were parts of Keywords: person-centredness; telehealth; research the intervention, we looked for evidence of active methods; human subjects; diabetes. participant involvement with these activities. Or, we

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JOURNAL OF THE INTERNATIONAL SOCIETY FOR TELEMEDICINE AND EHEALTH assessed what, if any, non-coercive benefits, such as for review. The literature search resulted in 46 papers diabetic education materials, were received by of telehealth research that involved people with participants in both the control and intervention groups diabetes. of the study. Of the 46 papers, 23 were de-selected for not fitting The framework’s organising concepts of respect, the study criteria. Reasons for de-selection were chart benefit and fairness were drawn from a review of review (1), letter to editor (1), cost-benefit study (1), documents addressing the ethics of research, most assessed primary care providers (1), methods only specifically the UNESCO Universal Declaration on with no results (3), technical assessments (5), research Bioethics and Human Rights,8 the Helsinki participants had multiple non-communicable diseases Declaration,9 and The Belmont Report.10 The outcome (8), and used in previous papers for this longitudinal of the two studies described above was a proposed 17- study (3). item framework for person-centred research, with The remaining 23 papers, one from 2012 and the seven actions reflecting respect, five actions reflecting rest from 2013, were then subject to content analysis benefit and five actions reflecting fairness.2 guided by the findings of the exploratory analysis1 and We then determined that it was necessary to convenience sample analysis.2 Both of these studies proceed to a phase two study using a more thorough had resulted in the proposed 17-item framework for literature search to assess the feasibility of the person-centredness in research. proposed actions before recommending the application of the framework actions in actual telehealth research Results protocols. The significance of this work is that it may improve Ten countries were represented in the study sample: the experience and value for people participating in Australia,11,12 Belgium,13,14 Denmark,15 Italy,16 Japan,17 telehealth research. Integrating exemplars of the triad Kenya,18,19 Sweden,20 Taiwan,21 Turkey22 and USA.23- of respect, benefit and fairness with telehealth research 33 Research designs of the 23 papers were: randomised conceptualisation and methods could improve (9), quasi-experimental (2), and descriptive (12). participants’ experience. If participants have a sense of Ethics or institutional review was reported for 16 commitment to their role, the consistency and studies; in 2 studies ethics reviews were not noted. In 5 accuracy of research findings may be substantially studies the authors noted that the protocol had been strengthened. described in previous publications and neither ethics review nor participant consent were noted in the This paper more completely describes the second papers examined for this study. Participant consent phase of the multi-part study of telehealth research in was noted in 14 papers, not noted in 3, and, in one people with diabetes.3 The qualitative study looked for study, the nurses, but not the patient participants, were evidence of person-centredness, using the framework consented. In 6 reports, theories or conceptual of respect, benefit and justice in the sense of fairness. frameworks were noted, to include the Trans- A final framework for telehealth researchers is theoretical Model of Behaviour Change, Self-Care described. Theory, Self-Efficacy Theory, Social Cognitive Theory, Chronic Care Model, and Community-based Methods Participatory Research. Power analyses for determination of optimal sample size were noted in 8 A formal literature search was completed using of the 23 studies. databases PubMed, CINAHL, PsycINFO, EMBASE, The 17-item proposed framework served well to Global Health, HealthStar, ISI Web of Science, and guide the content analysis in the phase two study. also Google. Inclusion criteria were 2012 to 1 August (Table 1) 2013, in English, and adolescents or older. The search Using content analysis, sub-categories were string was diabetes OR diabetic AND telemedicine OR supported, revised, merged or deleted. The impact of telehealth OR telenursing OR telerehabilitation. After the derived actions depended on what was written in the initial search, several more papers fitting the search the papers. For example, the use of diabetic self- criteria were identified by the librarian and provided management or goal-setting could have been inferred

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JOURNAL OF THE INTERNATIONAL SOCIETY FOR TELEMEDICINE AND EHEALTH from many of the studies but only those that web-based materials used for interventions (second mentioned the processes specifically were labelled as and third items) were similar enough to merge and such. Realising that adding some or all the simplify to: ‘include participants in design’. recommendations for person-centredness to research Six studies elicited participants’ goals or supported methods that are already complex and challenging, self-management plans. The items about setting goals every effort was made to concentrate the items into a or designing their own self-management plans were set that could be reasonably used during the research considered similar enough to merge (fourth and fifth process. items) and simplify to: ‘have participants set own goals.’ The involvement of participants in goal-setting Table 1. 17-item Proposed Framework. and development of their management plans was part of the study methodology. RESPECT For item 6, ‘include two-way email Use ‘participants’ rather than ‘subjects’ or communications,’ many two-way communication ‘patients’ methods were used to good effect in the study sample. Include participants in design of interventions Participants appreciated feedback and social Include participants in design of web-based interaction. Therefore this item was kept as ‘use active materials, eg, messaging two-way communication.’ Item 7, ‘use gentle Have participants set own goals communications’ was not found in any phase two Have participants design own self-management study and so was deleted. plans The phase two study had five papers that Include 2-way email communications emphasised cultural and linguistically appropriate Use ‘gentle’ communications materials and interventions. This was seen as BENEFIT important enough to add as an action in the Respect set Consider assessing QOL and designing of actions as: ‘match cultural and linguistic needs.’ interventions to improve QOL Benefit Assess and, if needed, decrease participants’ fears The actions for Benefit were reduced from five to four. Include families in discussions with participants Quality of life (QOL) or satisfaction or both were Give participants feedback during and after study assessed or elicited in nine studies. This supported Include communications intended to motivate continued use of this action: ‘assess QOL and participants satisfaction.’ The second item, ‘assess and, if needed, FAIRNESS decrease participants’ fears’ was not repeated in any Offer participation to whole population, eg, phase two study and so was deleted. community The third item, ‘include families in discussions Have interested persons make the initial contact with participants,’ was supported in the phase two with the researcher studies. Discussions and feedback including Avoid implying that participants are remainders or motivation were blended in ten studies; some second choice group researchers went into participants’ homes. The final Educate all participant groups (if any receive item, ‘include families,’ would need to be weighed by education) the researcher for its applicability to a particular study. Avoid having a ‘usual care’ group The privacy rights of the research participant would, of course, have to be respected, as would his or her Respect willingness to involve family members in the research The actions for Respect were reduced from seven to methods. five. ‘Participant’ was used in ten of 23 studies some The fourth item, ‘give participants feedback during or all of the time. It implies a somewhat higher degree and after study,’ was also supported by the finding of of respect than does ‘subject.’ Five studies asked discussions and feedback including motivation. We participants or persons similar to the participants to aid considered it important to include the ideas of with development of materials. The items about motivation and feedback. The fifth item ‘include including people in the design of interventions and communications intended to motivate participants’

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JOURNAL OF THE INTERNATIONAL SOCIETY FOR TELEMEDICINE AND EHEALTH was thus merged into a revised item 4: ‘give given emphasis on the need for randomised trials, and motivation and feedback.’ therefore deleted the item. We found that reimbursement was made for The final list of actions for person-centred participation in two of the phase two studies. telehealth research follows. (Table 2) Reimbursements to research participants, such as a small amount of money or transportation support, must Table 2. Final Concepts and Actions for Person- be managed with care so as not to be, or appear to be, centredness in Telehealth Research. coercive. Modest, culturally appropriate reimbursements are not necessarily prohibited in Respect research. The ethics review committee for each study Use ‘participants’ (not ‘subjects’) must be fully informed about the plan for Include participants in design reimbursement and consider its appropriateness in the Have participants set own goals context of the study. This then was the fourth item in Use active 2-way communication the revised list of actions for Benefit: ‘consider Match cultural and linguistic needs reimbursement for time and travel.’ Benefit Fairness Assess QOL and satisfaction The actions for Fairness were decreased from five to Include families three. The first item, ‘offer participation to whole Give motivation and feedback population, eg, community,’ was kept. The word Consider reimbursement for time and travel ‘population,’ was perhaps the wrong word; as it could Fairness be thought to mean the world population. It could be Offer participation to whole target group substituted with ‘target group.’ The rationale for First contact not by researcher keeping the item was based on finding that some of the Provide useful material to non-intervention group phase two studies reported determining inclusion/exclusion or randomisation of people before Discussion first contact with potential participants was made. This limited the study pool before any participant Following an exploratory study and two content notification could occur. analyses of telehealth research involving diabetics, a The second item, ‘have interested persons make the set of 12 actions was proposed for the integration of initial contact with the researcher,’ was kept but person-centredness with telehealth. The set of concepts reworded to ‘first contact not by researcher.’ This is a and actions is based on human subjects’ research shield against coercion and was supported in five of guiding principles of respect, benefit and justice in the the phase two studies. The third item was: ‘avoid sense of fairness. The five actions for respect, four for implying that participants are remainders or second- benefit and three for fairness would need to be choice group.’ While this had been found in previous considered by the researcher for appropriateness and studies reviewed, it was not found in the phase two applicability to the specific study. studies and so was deleted. This work is intended to bring a wider appreciation The fourth item, ‘educate all participant groups (if of the people who serve as study participants to any receive education),’ was modified to be less telehealth researchers. The qualitative research directive. Six studies in phase two provided materials methods used to derive the set for researchers are the to the non-intervention group. The item was reworded first step in knowledge development. The next step to ‘provide useful material to the non-intervention would be us test the set in telehealth research group.’ This action has to take into consideration what protocols. In this way, the conceptual proposal can be would be useful to people without interfering with the analysed for its practical applicability. specific research interventions and findings. It also Some telehealth research involving people with relates to some extent with the fifth item, ‘avoid diabetes already gives evidence of applying some or having a usual care group.’ We recognised that most of the recommended actions. If the actions were eliminating a usual care group may not be realistic, addressed specifically in the methods, it might be

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JOURNAL OF THE INTERNATIONAL SOCIETY FOR TELEMEDICINE AND EHEALTH possible for the researcher to compare participant Conflict of Interest. The author declares no conflict involvement and satisfaction with that identified in the of interest. researcher’s previous studies. If a researcher contemplates a first study using telehealth Corresponding author: technologies with participants with diabetes, the Claudia Bartz person-centred actions could be integrated with the 14388 Cedar Lane methods in order to identify the study as person- Suring Wisconsin 54174 USA centred research. [email protected] The generalizability of these actions for person- centredness could be assessed in two ways. A content analysis of telehealth research among participants with References multiple chronic diseases could be undertaken for evidence of person-centredness. Or, telehealth 1. Bartz CC. Telehealth and person-centerd care: researchers who have other than people with diabetes exploring the possibilities. Glob Telemed eHealth for their study could integrate the actions with the Updates Knowl Resour 2013;6:558-562. study methods and assess their relevance or 2. Bartz CC. Evidence for person-centeredness in contribution to the study’s outcomes. telehealth research. J Int Soc Telemed eHealth Study data resulting from the addition of person- 2013;1(3):86-92. centred actions to protocols may be more reliable and 3. Bartz CC. Evidence for person-centeredness in valid. Study participants may, in turn, have a greater telehealth research involving people with sense of making a significant contribution to the body diabetes. Glob Telemed eHealth Updates Knowl of knowledge about telehealth as it applies to diabetes. Resour 2014;7:39-43. Participants may also be more willing to continue to 4. Miles a, Mezzich JE. The care of the patient and serve in future research. the soul of the clinic: person-centered medicine as The major limitation with content analysis of an emergent model of modern clinical practice. published research reports is that only what is printed Int J Pers Cent Med 2011;1(2):207-222. can be evaluated. Researchers may well be using many 5. Miln D, Sheeran L, Dryden T, Mileshkin L, of the proposed actions for person-centredness without Aranda S. Care Requirements of patients with specifying them in the methods or findings. There are advanced cancer within a specialist centre – also differences in methods that are difficult to judge, moving to person-centered approaches. Int J Pers e.g., one study’s self-management plan development Cent Med 2011;1(1):167-176. may be another study’s goal-setting process. Reports 6. What is Personalized Medicine? Available at: that used the same data set for different analyses may http://pcpgm.partners.org/about-us/PM accessed or may not repeat the work leading up to the results 20 December 2015 and findings, e.g., consent process, participant 7. International Diabetes Foundation. Diabetes Facts recruitment plan. and Figures. Available at: http://www.idf.org/worlddiabetesday/toolkit/gp/fa Conclusions cts-figures accessed 6 November 2014. 8. United Nations Educational, Scientific and This paper has described a phase two study that Cultural Organization. (2005). Universal provided a potentially useful and useable set of Declaration on Bioethics and Human Rights. concepts and actions in telehealth research involving Available at: http://portal.unesco.org/en/ev.php- people with diabetes. The concepts and actions may URL_ID=31058&URL_DO=DO_TOPIC&URL_ have greater generalizability in other areas of SECTION=201.html accessed 20 December telehealth or biomedical research. The critical need for 2015. people to participate in research warrants researchers’ 9. World Medical Association. (2013). WMA substantial respect, consideration of participant benefit Declaration of Helsinki Ethical Principles for and fairness to all participants. Medical Research Involving Human Subjects...... Available at:

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