Framework for Canadian telehealth guidelines

EDUCATION AND PRACTICE

Overview

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" Framework for Canadian telehealth guidelines: summary of the environmental scan John C Hogenbirk, Pam D Brockwayw, John Finleyz, Penny Jennetty, Maryann Yeoy, Dianne Parker-Taillon, Raymond W Pong, Claudine C Szpilfogelz, Dan Reidz, Sandra MacDonald-Renczww and Trevor Cradduckzz Centre for Rural and Northern Health Research, Laurentian University, Sudbury, Ontario; wAlberta Research Council, Alberta; z Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia; yHealth Telematics Unit, Faculty of Medicine, University of Calgary, Alberta; National Initiative for Telehealth (NIFTE) Secretariat, Ottawa; wwHealth Canada, Office of Nursing Policy, Ottawa, Ontario; zzThe Keston Group, Nanaimo, British Columbia, Canada

Summary A Canadian project (the National Initiative for Telehealth Guidelines) was established to develop telehealth guidelines that would be used by health professionals, by telehealth providers as benchmarks for standards of service and by accrediting agencies for accreditation criteria. An environmental scan was conducted, which focused on organizational, human resource, clinical and technological issues. A literature review, a stakeholder survey (245 mail-outs, 84 complete responses) and 48 key informant interviews were conducted. A framework of guidelines was developed and published as a preliminary step towards pan-Canadian policies. Interim recommendations were that organizations and jurisdictions might consider formal agreements to specify: (1) organizational interoperability; (2) technical interoperability; (3) personnel requirements; (4) quality and continuity-of-care responsibilities; (5) telehealth services; (6) remuneration; and (7) quality assurance processes. An additional recommendation was that flexible mechanisms were needed to ensure that accreditation criteria will be realistic and achievable in the context of rapid changes in technology, service integration and delivery, as well as in the context of operating telehealth services in remote or underserved areas.

Introduction

....................................................................... There is continuing interest in telemedicine and telehealth in Canada, despite problems such as policy and regulatory barriers.1–4 The development of telehealth-specific policies, procedures, guidelines and standards for use in Canada and internationally may be useful.5,6 The National Initiative for Telehealth Guidelines (NIFTE) was set up to establish a consensus on guidelines. These guidelines could be used by health professionals to help develop their specific standards, Accepted 13 July 2005 Correspondence: John C Hogenbirk, Centre for Rural and Northern Health Research, Laurentian University, 935 Ramsey Lake Road, Sudbury, Ontario P3E 2C6, Canada (Fax: þ1 705 675 4855; Email: [email protected])

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by telehealth provider organizations as service benchmarks and by accrediting agencies to develop accreditation standards. To achieve the goals of the initiative, six activities were undertaken: (1) development of a network of stakeholders to assist the development of telehealth in Canada; (2) development of a database of telehealth stakeholders, programmes, providers and technology developers; (3) an environmental scan of the current status of telehealth in Canada with respect to standards, guidelines, policies or procedures; (4) development of guidelines for telehealth which can be used by health-care organizations in developing discipline- or programme-specific standards;

J C Hogenbirk et al. Framework for Canadian telehealth guidelines

(5)

(6)

provision of telehealth information to the Canadian Council for Health Service Accreditation to facilitate the development of standards for telehealth accreditation; dissemination of information about the initiative.

The present paper reports on the third of these activities, the environmental scan.

Methods

....................................................................... The environmental scan comprised a literature review, a stakeholder survey and key informant interviews. It was conducted by four research teams, which investigated: (1) (2) (3) (4)

clinical standards and outcomes; human resources; organizational context; technology and equipment.

The four components were selected through a preliminary literature review augmented by the experience of the research team and others, as expressed at conferences and workshops.

Literature review The purpose of the literature review was to examine the scope of information available and identify knowledge gaps associated with telehealth-related organizational, technical, clinical and human resource issues. The literature search involved searching online databases for potentially relevant publications, screening of abstracts to identify studies for further review, plus examination of the references sections of publications to identify other potentially useful studies.

Stakeholder survey The objective of the telehealth stakeholder survey was to determine the presence or absence of policies, procedures, guidelines or standards related to the provision or receipt of telehealth services. A mailing list of individuals and organizations was compiled. All potential stakeholders were asked for their consent before their names were added to the list. The survey was conducted using a six-part questionnaire (demographics, general, organizational, technical, clinical and human resources) that was mailed to the individuals. Face and content validity were established by a pilot test of the questionnaire with a sample of nine stakeholders, selected to be representative of the four content areas. The respondents’ open-ended Journal of Telemedicine and Telecare Volume 12 Number 2

survey responses were transcribed and the content was analysed by each research team. A total of 245 questionnaires were mailed out to the stakeholders and 156 were returned (64% response rate). There were 84 completed questionnaires, comprising 65 from responders who had completed all four main sections (organizational, human resources, clinical and technical) and another 19 where up to three of the four main sections had been completed in addition to the demographics and general sections. The effective response rate was therefore 34%. The six-part questionnaire was designed so that it could be answered by the person who was the most knowledgeable for any given section. For instance, clinical personnel could complete the clinical outcomes section, while administrative personnel could complete the organizational section. Of the 84 completed questionnaires, 92% were completed by one person, with the remainder completed by up to six people: an average of 1.2 people helped to complete each questionnaire. Some of the larger telehealth organizations with multiple sites had multiple responses (i.e. more than one completed questionnaire per organization). We identified 50 more or less distinct organizations in the 84 completed questionnaires in which at least one of the four major sections had been completed: roughly 1.6 respondents per organization. Therefore, responses to questions about the organizations themselves were not necessarily independent – our methods maximized the diversity of opinion within and among organizations.

Interviews The objective of the key informant interviews was to interview Canadians who were knowledgeable about telehealth issues. Many of those interviewed were directly involved in the provision or receipt of telehealth services. We selected individuals from different backgrounds (e.g. clinical, administrative, technical), different organizations (e.g. with different numbers of employees, types of telehealth service, private/public ownership) and different regions of Canada. The research teams contacted only those individuals who had agreed to be interviewed. Interview questions were pilot-tested in October 2002. The interviews were conducted in October–December 2002. Each team conducted 11–13 interviews, which lasted 30–90 min.

Results

....................................................................... Survey respondents (n ¼ 84 completed questionnaires) and key informants (n ¼ 48) were predominantly clinicians by profession (e.g. nurses, physicians, allied 2006

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health professionals) and most were currently employed as telehealth directors or telehealth coordinators. Survey respondents were affiliated mostly with hospitals, other health-care centres, regulatory bodies or professional associations. Key informants were affiliated typically with provincial health regions, universities/colleges, hospitals and other health-care centres. Over 60% of the survey respondents and 90% of the key informants thought that telehealth should be accredited. There was some diversity of opinion as to whether telehealth should be accredited as one of the several service modalities within a health-care organization or, if the programme was sufficiently large and distinct, as a separate programme. Five main issues were identified in all four components of the environmental scan: (1)

(2)

(3)

(4)

(5)

Virtual organization. Standards, guidelines, policies and procedures at all levels need to reflect the reality of a ‘virtual organization’ in areas such as the standardization of system utilization measures, scheduling and referrals, as well as technical and network interoperability throughout the health-care system. Integration of telehealth policies. Existing standards need to be reviewed to determine if telehealth is covered and, if not, they should be rewritten to state explicitly how they apply to telehealth. Telehealth-specific policy issues. Telehealth-specific documents need to be developed only in those areas unique to telehealth, such as: remuneration/ reimbursement; cross-border licensure and liability issues; documentation and storage of telehealth records; and the roles and responsibilities of non-clinical staff during confidential telehealth activities. Flexibility and sensitivity to innovation. Due to rapid changes in telehealth technology and the evolving nature of standards, there is a need to review and revise telehealth standards more frequently than in other service areas.7 Multiple types of telehealth clinical applications and technologies. Different documents are needed within different telehealth applications (e.g. radiology, cardiology, home care). Different documents are also needed for the introduction of new applications and for the diffusion or regular use of telehealth.

Clinical standards and outcomes

....................................................................... Telehealth systems were recognized as a means of improving access to and quality of health-care services, particularly for rural or underserved populations.

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Duty of care (NIFTE guideline CSO-1).8 Only 20% of the 70 survey respondents indicated that their organization had specific criteria for ‘duty of care’ to the patient in a telehealth encounter for situations when the health-care provider saw (79%) or examined (58%) the patient via telehealth or face to face, or viewed the patient’s record (53%). The survey respondents and the key informants (total n=11) consistently indicated that the distance that might exist between a telehealth practitioner and patient did not alter whether there was an established practitioner–patient relationship. Communication with patients (CSO-2–5). Approximately 78% of the survey respondents said that their organization evaluated the quality of communication between the health-care provider and patient, for written (66%) and/or verbal feedback (56%) by the patient. Both the survey and interviews indicated that the quality of communication in the telehealth setting was largely dependent on the comfort of the telehealth practitioner with the technical environment, the general communication ability of the health-care professional and the appropriateness of the clinical application to the telehealth setting. Among the survey respondents and key informants there was little agreement about the need for a training programme that specifically addressed communicative behaviours in the telehealth setting. Standards and quality of clinical care (CSO-6–10). The key informants indicated that the ‘appropriate’ or ‘reasonable’ standard of care (with respect to context, location and timing) delivered via telehealth should be at least equivalent to the standard expected in traditional health-care delivery, where such a comparator exists. If the ‘reasonable’ standard of care cannot be met, then the telehealth professional needs to address what is the alternative for care and decide if it is acceptable to proceed. The survey revealed a divergence of opinion as to whether there should be clinical practice guidelines specific to telehealth: 24 of the 50 respondents said that their organizations had guidelines specific to telehealth and 26 reported none. The key informants indicated that existing guidelines from the various professional bodies were sufficient, with modifications if necessary. In nursing triage by telemedicine, both the survey respondents and key informants consistently indicated a need for specific practice guidelines. For example, 58% of the 33 respondents said that their organizations had or were developing protocolbased decision-making tools for tele-triage. Clinical outcomes (CSO-11). There was little comprehensive evaluation of telehealth applications, particularly in the area of clinical outcomes and costeffectiveness: only 32 of the 70 respondents indicated that their organization either collected clinical and

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cost-analysis data or were in the development stages. Typical clinical outcome indicators reported by the 32 respondents included: eliminating the need for patient or clinician travel (94%); timeliness of health-care intervention (66%); appropriate health-care intervention received (63%); and appropriate sharing of information (63%). Correct diagnosis (41%), patient satisfaction (22%) and cost analysis (25%) were also noted. For telephone triage, 45% of 29 respondents stated that their organization did not have a protocol to evaluate the appropriateness of the triage decision and 62% of 26 respondents said that their organization did not have a protocol to evaluate the clinical outcome. Informed consent (CSO-12–17). There were diverse opinions about the need for expressed consent with routine video-consultations. Of the 69 respondents, 46% indicated the need for expressed consent in all circumstances, 25% indicated that expressed consent was required under ‘certain conditions’, while 25% indicated that consent was implied in the telehealth setting. Of the 50 respondents who felt that formal consent was required in all, or for certain conditions, a written format rather than verbal was considered most appropriate.

Human resources

....................................................................... Human resource (HR) policies and procedures address the issue of having sufficient numbers of suitably qualified people who are ready and willing to provide health services via telecommunications technology. Plans and policies (HR-1–2). Approximately 40% of the 75 survey respondents said that their organization had telehealth-specific HR plans. It was inferred from the comments of several informants (total n=12) that the development of a comprehensive HR plan for telehealth might be time consuming and expensive, and so HR policies related directly to telehealth patient safety and competency of personnel should be updated first, and new policies should be created only when absolutely necessary. Roles and responsibilities (HR-3–6). Personnel were often reassigned and telehealth duties were added onto existing duties.9–11 In all, 58% of the informants said that as the number of telehealth functions increased, so did the need for a full-time person to coordinate activities. The need for role or position descriptions was partly based on the need to identify and allocate scarce human resources.12,13 A few key informants suggested that without formal recognition, the real needs of telehealth programmes might not be fully appreciated by senior administrators. Another view, espoused in the Journal of Telemedicine and Telecare Volume 12 Number 2

literature,14 and by over 80% of the key informants, was that telehealth-specific position descriptions were also needed to define roles and responsibilities so as to prevent unnecessary duplication of services without the loss of safeguards needed to ensure quality of service. Licensure (HR-7–8). Cross-border licensure becomes an issue when health professionals licensed in one jurisdiction seek to practise in other jurisdictions: 58% of the key informants called for full licensure in the professional’s jurisdiction only, provided both patient and professional were in Canada. Another 25% of the informants called for licensure or some form of agreement in both jurisdictions. These arrangements could take different forms, such as a national licence, special licence, mutual recognition, endorsement and telehealth practice under regulation.2,15–19 Several informants suggested that a pan-Canadian mechanism could be based on mutual recognition or a special licence that was accepted and administered by the regulatory bodies in each jurisdiction. A special telehealth permit might help to resolve the cross-border licensure issue and might help to resolve some of the uncertainty with respect to credentialling and privileging.2 It seems likely, however, that if a special telehealth permit was required for crossjurisdictional telehealth, then it would be required for telehealth activities within a jurisdiction. Thus, some key informants argued that it was potentially restrictive for telehealth practice and unnecessary for clinical purposes. Over two-thirds of the key informants said that crossing international jurisdictions required much more in the way of formal agreements in which licensure requirements were stated explicitly. Competence and qualifications (HR-9–11). The organizations of 60% of survey respondents and 92% of key informants did not require any formal competencies, qualifications or education in telehealth. A few key informants thought that a pan-Canadian set of qualifications and competencies specific to telehealth should be developed, starting with telehealth coordinators and then separately for each healthcare profession. Education, orientation and training (HR-12–13). Over 50% of the respondents and informants said that much of the onus on education and training fell on the telehealth service provider and the health-care practitioner. There were some opportunities to list orientation and training initiatives across Canada and to standardize the more common elements for adoption by all provinces or territories.5 Regulatory bodies and professional associations were well placed to review and assist in the development of orientation and training programmes specific to their professions. 2006

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In Canada, the responsibility for education and regulation of health professionals resides with the provinces and territories. Remuneration (HR-14–15). The literature review and 36% of the survey responses revealed that there was at least partial fee-for-service reimbursement of telehealth or telemedicine in most jurisdictions in Canada. Coverage was neither complete nor consistent across Canada.1,3 From a HR perspective, lack of fee-for-service reimbursement impedes independent health-care practitioners from participation in telehealth activities.3 Several key informants expressed concern that telehealth duties were added on to existing duties of salaried or waged employees, without a concomitant adjustment in pay. As one key informant asked rhetorically, why would anyone leave a long-term, secure, well defined position for one that is often short-term, poorly defined and laden with extra duties at the same pay level?

Organizational context

....................................................................... Organizational issues focused on administrative policies, standards, guidelines and procedures, but included human and technical aspects (84 surveys, 12 informants). Organizational readiness (OR-1–6). A recommendation was that the implementation of telehealth services should be planned at the organizational and programme levels. Planning for the potential effect of telehealth on the organizational processes and procedures was also required. Planning needs to take into account readiness issues related to organizational structure, technical infrastructure, communication, change management and human resources. It was also noted that health-care system readiness was required for the purposes of network infrastructure, funding, remuneration, as well as support for innovation and diffusion. Overarching organizational leadership issues (OL-1–4). Overarching issues related to virtual organization, integration of policies, telehealth-specific policies, as well as flexibility and sensitivity to innovation were identified as separate issues in the recommended guidelines. Accountability (OL-5–16). Key informants felt that the majority of telehealth accountability issues were very similar to those for face-to-face services. Existing policy documents, guidelines and procedures manuals may require minor modification only. There was a need for organizations to develop a governance framework that focused on telehealth roles and responsibilities, particularly in relation to the position of telehealth within the organization and accountability for telehealth. Quality assurance (OL-17–19). Policies and procedures were needed to define key quality indicators for

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telehealth, to develop an ongoing evaluation plan and to develop some sophistication in telehealth data collection. Five themes were identified: (1) evaluation of human resources; (2) data-collection flexibility and sensitivity to innovation; (3) priority access in rural areas; (4) criteria for system utilization; and (5) the physical environment for telehealth. Standardized performance indicators were needed, related to system utilization, patient and provider satisfaction and technical performance. Quality indicators need to be identified at the programme and organizational level. Continuity (OL-20–22). Administrative interoperability and development of an integrated telehealth delivery model were common themes. Administrative interoperability included: telehealth scheduling procedures; access to information; provision of an integrated system of technologies; and the need for coordination of communication and linkages. An integrated telehealth delivery model would require organizations to look at how they deliver other services and telehealth services and try, as far as possible, to integrate telehealth services into existing routines. The organization of outpatient services was proposed as a model for the coordination of multiple telehealth services.

Technology and equipment

....................................................................... Application-specific standards for security, diagnostic quality, safety, acceptability, interoperability, reliability and scalability requirements were needed for all telehealth applications. There was a lack of initiatives to establish the necessary application-specific guidelines and a lack of clarity regarding who was responsible for setting technology standards and guidelines. Procurement practices (TE-1–2). Over 50% of the 13 key informants thought that procurement practices could be included in the guidelines for standards and accreditation. Based on the rank of 16 criteria in the survey (n=74), ease of use (3.4 of 16), price (4.5 of 16) and conformance to standards (5.5 of 16) were considered the most important. The preferred method for equipment procurement was a ‘request for proposals’ (RFP) (77% of key informants) and it should be developed with user input. Often, an organization that engaged in telehealth for the first time lacked the experience to develop an RFP. A centralized RFP process would reduce organizational burden. To evaluate the equipment during demonstrations, a checklist and weighting system were valuable tools. Safety (TE-3–4). Inclusion of equipment safety was recommended by all of the key informants. Further equipment safety standards need to be developed and


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implemented to clarify the grey areas that currently exist within Medical Devices Policy and Canadian Standards Association. Those safety standards that currently exist need to be followed (e.g. C22, ICES 003 and Medical Devices Policy).20–22 There was a lack of awareness of some of the safety standards (approximately 40% of survey respondents were unaware of compliance to ICES 003 and Medical Devices Policy). Security (TE-5). All key informants stated that guidelines for physical and electronic security measures were essential. Security measures for other health-care services should also apply. Diagnostic quality (TE-6–7). All key informants recommended that the application-specific diagnostic quality guidelines or standards should be followed or developed, as needed. Only 18% of 76 survey respondents reported using literature reviews in this regard. A coordinating body should be formed to facilitate development and implementation of such guidelines. Reliability (TE-8–11). Inclusion of equipment reliability was also recommended by all of the key informants. To monitor equipment reliability, logbooks should record: start time, end time, technical problems, user problems and problem resolution. Checklists should be instituted for post-installation testing of equipment and pre-session calibration. Reliability standards and guidelines need to be followed or developed as appropriate. Stable telecommunication networks need to be developed and utilized. Acceptability (TE-12). Inclusion of equipment acceptability was recommended by all key informants. To increase acceptability, user-friendly equipment22–24 should be purchased. The time required to perform a service by telehealth should be no longer than to perform it by conventional methods.22–25 The quality of audio and video22,26–28 and data communications20 must be sufficiently high. Training of users and ongoing evaluation would help to ensure acceptability. Interoperability (TE-13–14). All key informants stated that equipment should be interoperable. Standards for consideration include: data exchange, remote management, audio quality and video streaming. Realtime standards were well developed and work should focus on store-and-forward standards. Standard development should be coordinated nationally, and involve vendors and users. Telehealth information exchange standards must be compatible with health information systems. Separate standards for communication (education and administration) and clinical (diagnosis) purposes should be considered. The development of an information repository on technical interoperability would be helpful. Scalability (TE-15). Inclusion of equipment scalability was recommended by 69% of key informants. To facilitate scalability, the following standards were Journal of Telemedicine and Telecare Volume 12 Number 2

suggested for development: file formats for store and forward, number and type of inputs, interfaces, software and multi-point bridging. Needs assessments and business planning were needed before equipment was purchased. Maintenance (TE-16). All key informants said that equipment maintenance was important. Preventative maintenance was preferred and could include: network checks, equipment checks, software updates, spare parts on hand, interoperability checks, logbook analysis, pre-session tests (with calibration) and the ability to access equipment remotely for maintenance. Equipment maintenance agreements were needed and maintenance services should be available locally. A refresh strategy should detail when to replace or upgrade equipment. Quality assurance and an owner who was held accountable would help ensure proper care of equipment.

Discussion

....................................................................... The primary outcome of the NIFTE work was an extensive framework of national guidelines8 for telehealth designed for use by Canadian health-care professionals, telehealth provider organizations and accreditation bodies. The focus of these guidelines was on telehealth activities that were oriented towards clinical services, specifically in the areas of clinical standards and outcomes, human resources, organizational readiness, organizational leadership, technology and equipment. The NIFTE framework was intended, therefore, to serve as a useful point of reference and to contribute to the overall development of the telehealth field in Canada. There were some limitations to the environmental scan. For instance, literature reviews were restricted to English-language documents published during 1990–2002, although an examination of selected French-language publications and older publications did not suggest any glaring omissions. The survey respondents and key informants were not a random sample, but were broadly representative of people involved in telehealth across Canada. Some respondents and informants belonged to the same organization and thus responses to questions about organizations were not independent. Six informants were interviewed by two teams. One potential limitation of the interviews was that they did not include official representatives from regulatory bodies or professional associations. Key informants were involved with active telehealth programmes and were chosen for their practical expertise and their broad outlook on telehealth. The majority of the informants 2006

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participated in committees that had developed or were developing telehealth policy, guidelines or standards. Notwithstanding the possible limitations, the environmental scan found broad agreement on panCanadian telehealth issues. The majority of the survey respondents and key informants were in favour of accreditation. Many expressed a preference for flexible policies and accreditation processes, associated with the minimum bureaucratic burden. In addition, many respondents thought that telehealth would require specific mention in selected existing policies. Interestingly, several respondents thought that telehealth would prompt new thinking about how health care is delivered, administered and funded. Continued evaluation and research into telehealth accreditation issues seems warranted, given rapid changes to health-care funding and administration, new developments in telecommunications technology and the evolving role of telehealth in the provision of health care. Acknowledgements: We thank the Richard Ivey Foundation for funding and support. We are grateful to the members of the NIFTE Advisory and Steering Committees and to our research colleagues for their counsel and guidance. We thank the survey respondents and key informants for their participation.

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