Abstract
Background:
This literature review sets out to increase the knowledge on patient safety within the telehealth modality of care, to inform the relevant local health service departments on the key considerations to minimize patient harm.
Methods:
A systematic search in Medline and Cumulative Index to Nursing and Allied Health Literature (CINAHL), Google Scholar, and the University of New England (UNE) Library Search was conducted. A combination of key terms “Telehealth” OR “Telecare” OR “Telemedicine” AND “patient safety” AND “rural” was used. Based on the screening and eligibility criteria, 21 peer-reviewed articles published in English between 2015 and 2020 were included in the review.
Results and Discussion:
On evaluating the included studies, three main themes and various corresponding subthemes emerged. The main themes were that of telehealth experience (TE), telehealth outcomes (TO), and telehealth risks (TR), with the corresponding subthemes of telehealth experience from a patient perspective (TE-PT), telehealth experience from a carer perspective (TE-CR), telehealth experience from a clinician perspective (TE-CN), positive telehealth (TO-P), and negative telehealth outcomes (TO-N), and patient (TR-PT) and clinician telehealth risks (TR-CN).
Conclusions:
The results suggest that patients generally have positive experiences and are accepting telehealth as a modality of care. Furthermore, patient outcomes appear to be comparable with in-person care, with additional benefits of lower costs to both the service and patients.
Introduction
This literature review encompasses the two broad areas of telehealth and patient safety, in the context of a recent surge in telehealth activity within the Australian public health care system, and the potential for a rise in associated patient safety risks and issues. This recent surge in telehealth activity, and accompanying transition toward telehealth models of care, has occurred as a mitigating strategy in response to the COVID-19 pandemic. 1 Telehealth allows for the continuation of health care within this environment, which has required social distancing, reduced travel, and necessary quarantine measures, all of which have seen an unprecedented and accelerated move toward this outpatient model of care. 1 –3 With this significant move away from in-person health care, it is crucial to note that patient safety risks are considerably higher in the outpatient setting, with an estimated 40% of patients experiencing harm, as compared with a lower 10% of inpatients. 4 However, at first glance there appears to be very little guidance at both a state and national level on key patient safety measures relating to telehealth. 5 –7
The main difference between traditional in-person consultations and telehealth services is the absence of a physical interaction between patient and health care professional. 8 Telehealth encompasses all activities that provide care without this direct contact, and include communication between multiple clinicians, as well as between the patient and clinician. 9 In addition, the term telecare can be used interchangeably with telehealth; however, it also includes the use of remote monitoring technologies. 10 Various telehealth benefits have been described in the past for patients, clinicians, and the heath service, with these including greater access to services for patients, greater focus on patient-centered care, reduced service costs, reduced travel time, and a lower burden on some aspects of the health system. 11 There has been an effort to embed telehealth within the New South Wales (NSW) health care system before COVID-19 with the NSW Health Strategic review, however, commencing from the 2020/2021 financial year, this is now an expectation with an inclusion within the NSW Health performance framework to monitor and evaluate the use of audiovisual modalities of care at local health district (LHD) level. 11,12
Patient safety is the avoidance and prevention of error and adverse outcomes stemming from the health care process, and is summed up by the right care provided at the right time and place. 13 In general, some of the common patient safety issues include diagnostic errors, medication errors, and clinical deterioration from untreated sepsis. 4 Much of the research and discourse on patient safety has been within the hospital setting where the higher proportion of health care services are delivered, despite some of the higher risks seen in the outpatient setting. 4,10 With respect to telehealth, safety issues seem to revolve around areas such as potential for inaccurate clinical assessments and diagnosis, overtreatment, and technological challenges, which could lead to harm. 8,14 In addition, a need has been identified to better address patient safety risks and mitigation strategies to avoid and minimize potential harm resulting from this modality of care. 15
The aim of this literature review is to increase knowledge on patient safety within the telehealth modality of care, and in doing so, inform the LHD telehealth and patient safety departments, and subsequent LHD telehealth governance committee, on the main patient safety considerations relevant to telehealth. The nature of the research question is that of an outward exploration perspective, with the purpose to determine and articulate what is currently known on the subject. Once these relevant patient safety risks are identified and understood, then key measures and practical solutions can be developed and implemented.
16
Importantly, this literature review aims to research relevant current studies to answer the following question:
Within a regional Australian healthcare setting, what are the key considerations in ensuring a safe telehealth model of care?
Methods
SEARCH STRATEGY
The overall process was influenced by the systematic quantitative literature review principles from Pickering and Byrne. 17 The two electronic databases of Medline and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were used for the main literature search, which were selected based on both the relevance to the research question and being the principle databases for the disciplines of medicine, nursing, and allied health. 18 Furthermore, Google Scholar and the University of New England (UNE) Library Search were used during the search, with the search strategy including reference and citation checks of relevant recent articles. 19
A combination of the following key words was used while searching in each of the aforementioned databases: Telehealth OR Telecare OR Telemedicine AND patient safety AND rural. The initial search was limited to the presence of these key words in the title or abstract.
ELIGIBILITY CRITERIA
Subsequent to the initial identification process, studies that met the following inclusion criteria were included: – Peer reviewed – Published between 2015 and 2020 – Published in English – Empirical research
An exclusion criterion was applied for studies whose focus was primarily on telemonitoring, and where there was no supportive telehealth.
SEARCH OUTCOMES
The initial search, which included rural in the search terms, only yielded a small number of articles from Medline, CINAHL, and UNE Library Search (n = 33). Google Scholar returned a larger number (n = 5,060); however, screening the title and abstract from the first five result pages indicated that there was little affinity for the search terms. The search was then expanded by dropping “rural” as a search term. The yield from this expanded search was far greater (n = 16,455), with the results further narrowed following initial screening of peer-reviewed and published in English between 2015 and 2020 (n = 6,605). Duplicates were then removed, and the eligibility criteria of being empirical research relevant to the research question, excluding telemonitoring as the primary focus, were applied by reviewing the abstracts (n = 241), and then full texts, resulting in the final number of studies included in the review (n = 21). See Figure 1 for a summary of the search and screening process, displayed using an adapted Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. 20

Summary of the search and screening process.
DATA EXTRACTION AND QUALITY ASSESSMENT
A database was developed with relevant categories and subcategories to summarize the included literature. 17 Quality assessment of the studies was guided using a generic critical appraisal tool by Woolliams et al., as cited in Aveyard, 21 and the relevant Critical Appraisal Skills Programme (CASP) checklists. 22 Table 1 provides a summary of the 21 included studies and contains study aim, sample size, main findings, and main limitations.
Study Aim, Sample Size, Main Findings, and Limitations from Studies Included in the Literature Review
AT, Assistive Telecare; CKD, chronic kidney disease; HCP, health care professional; HR, heart rate; TMS, telemedicine support.
Results
CHARACTERISTICS OF STUDIES
The main characteristics of the 21 included studies are provided in Table 2. The majority of studies (81%) had been published between 2017 and 2020. Over half of the studies were conducted in North America, either in the United States (n = 10) or in Canada (n = 1). Six studies were undertaken in either Australia (n = 3) or the United Kingdom (n = 3), with the remaining five studies based in Europe (Norway n = 2, Denmark n = 1, Spain n = 1). A quantitative methods approach was the most prominent, having been used in 48% of the studies, with a further 33% of studies using a qualitative approach and 19% using a mixed-methods approach. The most common data collection method was interview, which was used in 48% of the relevant studies, with unobtrusive (29%) and experimental (24%) being the next commonly used. In terms of result outcome, most studies (67%) had a positive outcome relative to the study aim.
The Country, Methods, Data Collection, Result Outcomes and Themes from Studies Included in the Literature Review
TE-CN, telehealth experience from a carer perspective; TE-CR, telehealth experience from a carer perspective; TE-PT, telehealth experience from a patient perspective; TO-N, negative telehealth outcomes; TO-P, positive telehealth outcomes; TR-CN, clinician telehealth risks; TR-PT, patient telehealth risks.
On evaluating the included studies, three main themes and various corresponding subthemes emerged. The main themes were that of telehealth experience (TE), telehealth outcomes (TO), and telehealth risks (TR), with the corresponding subthemes of telehealth experience from a patient perspective (TE-PT), telehealth experience from a carer perspective (TE-CR), telehealth experience from a clinician perspective (TE-CN), positive telehealth (TO-P) and negative telehealth outcomes (TO-N), and patient (TR-PT) and clinician telehealth risks (TR-CN).
TELEHEALTH EXPERIENCE
The theme of telehealth experience was described in nine of the studies, and included the various perspectives of patients, carers, and clinicians. Patient and carer experiences are important aspects in the provision of safe and reliable care, as patients who report a good health care experience are more likely to have better outcomes; and in exploring patient experience, health care services have an opportunity to improve the provision of care. 13 Furthermore, clinician experience can affect the efficiency and performance of the health system. 23 Within NSW Health, there is a growing emphasis on the importance of both patient and clinician experiences, in the respective receiving and provision of care. 24 This is aptly illustrated by the NSW Health Quadruple Aims of, “improving experiences for people, families and carers; improving experiences for service providers and clinicians; improving health outcomes for the population; and improving cost efficiency of the health system.” 24
There were five studies with a focus on telehealth experience from either a patient or carer perspective. Purandare and Hickish set out to evaluate the acceptability of using telemedicine in patients undergoing chemotherapy, finding all involved patients were satisfied with the remote assessments. 25 This study was limited by a small participant sample and a convenience sampling method. Soegaard-Ballester et al. aimed at assessing both the patient satisfaction and clinical outcomes within a postoperative telehealth model, using a mixed methodology with unobtrusive and interview data collection methods. 26 They found that most patients were satisfied with, and preferred, a telehealth follow-up to that of an in-person follow-up, citing reduced travel time and convenience as main motivating factors. Similarly, Kyanko et al. conducted a mixed-methods study using survey and focus group collection methods, aimed at characterizing patient and physician telehealth acceptability. 27 Within the patient survey, they found that 84% of patients were satisfied by the telehealth modality; however, 50% preferred in-person appointments; with the authors unable to account for this contradiction, and postulating that while telehealth is able to meet immediate patient needs, it is not a substitute for the rapport and relationship building possible through in-person visits. Of note, there was only a 31% completion rate, and the study was limited by its exclusive cohort of culturally and linguistically diverse participants.
Cook et al.'s study was the only study to explore telecare from a family-carer perspective, by conducting semistructured interviews with 14 family-carers of patients who were using an assistive telehealth and telecare service. 28 Their study found that family-carers who perceived assistive telehealth and telecare services to be functional and useful were more likely to support a patient's decision and engagement with the service. Only one family-carer per patient was interviewed, with the authors acknowledging that other family-carers' perspectives may have been excluded. Mullen-Fortino et al. conducted a retrospective review of 7,803 patient encounters and surveyed 246 patients, to determine the efficiency and effectiveness of presurgical telehealth assessment. 29 Within the survey section of their study, there was a 68% response rate, with most patients stating that telehealth was “easy and efficient,” and any dissatisfaction was related to technology such as connectivity and audio issues.
There were five studies with a focus on telehealth experience from a clinician perspective. One of the key studies was that of Shulver et al., which was based in Australia and included a regional emphasis. 30 In this study, focus groups with a total of 44 health care workers were conducted to determine their perspectives on telehealth, and the impact clinical experience and rural/urban setting have on implementation. Four themes emerged from their results, which described clinician attitudes that could impact telehealth services. These themes were provided as follows: the workability of telehealth, which refers to the possibilities of expanding and enhancing services; acceptable level of patient risk, referring to the acknowledgment that patient safety risks exist within this modality; shifting responsibilities, denoting the presence of a support person with the patient during telehealth; and change of architecture, which encompasses the recognition that current organizational structures would need to be redesigned to fully support a telehealth shift. The study found that both clinician experiences and services based in regional locations were more enthusiastic about the potential for telehealth to enhance patient access.
Using semistructured interviews with 36 primary care clinicians, Kayyali et al. evaluated experiences and awareness of telehealth as an impediment to its adoption. 31 Like Shulver et al., key themes relating to telehealth emerged, such as awareness and understanding, experiences and benefits, barriers and facilitators, and misconceptions. 30 There was a mixed response regarding awareness and a lack of experience, with barriers flagged such as a need for clinician and patient training packages and resources. Generalization of the results was limited by convenience sampling and urban representation, despite achieving theme saturation. As mentioned previously, the mixed study by Kyanko et al. also assessed physician telehealth acceptability using both survey and focus group methods. 27 They found that physicians were satisfied with telehealth, viewing it as a patient-centered and safe way to communicate; however, it is particularly suitable for selecting patient groups such as those requiring lifestyle counseling, acute nonemergency care, chronic disease management, and test result discussions. Results were limited due to the recruitment strategy, which favored the inclusion of physicians who were already advocates of telehealth.
In the final 2 studies, which provided a clinician perspective on telehealth, Johannessen et al. using an exploratory qualitative design conducted focus group interviews with 10 homecare professionals, 10 and Madden et al. conducted a mixed-methods design with survey and semistructured interviews. 1 Johannessen et al. were exploring perceptions of safety, 10 whereas Madden et al. were aiming to determine the level of transition to telehealth and provider experience, during the COVID-19 pandemic. 1 Johannessen et al. found that participants perceived the use of telecare as potentially enhancing patient safety and protection against injury; however, some of the technological limitations and limited user understanding could result in harm. 10 Madden et al. found rapid telehealth implementation within a prenatal setting, with positive attitudes from clinician's toward telehealth. 1
TELEHEALTH OUTCOMES
Telehealth outcome was a theme found in 11 of the included studies, with 9 studies reporting positive outcomes and 2 studies finding mixed or negative outcomes. For telehealth to be a viable modality of care, patient and service outcomes need to be comparable with in-person care. There is a consensus that telehealth can enhance service capacity and improve patient access; however, the effectiveness of telehealth needs to be considered in terms of: system effectiveness, as the ability for telehealth to assist in care coordination and information sharing between providers; clinical effectiveness, as the impact on health outcomes and other quality process measures; operational effectiveness, as the level of telehealth integration within hospital and other care settings; and technical effectiveness, which refers to the ability for seamless transmission and exchange of accurate information between providers and with patients. 32 As was expected from this theme, which intuitively sits within a positivist position when primarily comparing variables and measures, 82% of the studies employed a quantitative approach, with the remaining 18% using a mixed-methods approach.
Using a prospective audit with 41 spinal disorder patients, Beard et al. set out to determine the appropriateness and access to a telehealth clinic in a rural setting. 33 Their study demonstrated that a telehealth model of care was an efficient method for this nonurgent patient cohort to access surgical consultation, with benefits of low costs and no reported adverse outcomes. However, the study was limited by a nonprobability convenience sampling. Using a randomized control trial with 402 patients, Müller et al. evaluated the long-term efficacy and safety of telemedicine consultations for nonacute headaches. 34 They found no significant differences between the groups, demonstrating that telemedicine was as efficient and safe as an in-person consultation. Important to note was the absence of a placebo group and blinding. Vesterby et al. in another randomized control trial studied 72 patients undergoing a total hip replacement by assigning either a regular postoperative follow-up group or a telemedicine support (TMS) group, with the aim to determine whether TMS would affect self-assessed quality of life, readmission rates, or postoperative complications. 35 Length of stay was lower in the TMS group, with no statistical difference between groups indicating no adverse clinical parameters with telemedicine. Though, the eligibility criteria for the TMS group likely favored patients with higher levels of self-efficacy.
In a quasi-experimental prospective study, Valdivieso et al. assessed the effect of telehealth support on quality of life, health care access, and mortality in an elderly chronic condition cohort, and found the telehealth group experienced a significant improvement in self-assessed quality of life at 12 months, with no differences in mortality or health care access. 36 Randomization of the study was compromised due to a breach of the study protocol. Mullen-Fortino et al., mentioned in the telehealth experience section, also assessed telehealth outcomes within their study. 29 The focus was on efficiency and effectiveness, as measured by comparing the duration of both in-person and telehealth surgical preadmission appointments and surgical cancellations. The study found that telehealth appointments were more efficient as they were on average 24 min shorter than in-person appointments (95% confidence interval [CI]) and did not result in any more operative cancellations (95% CI). Nandra et al. performed a retrospective descriptive study of 655 audiovisual telehealth service encounters, finding low levels of readmissions in a subgroup of 152 postoperative patents. 37 The study design lacked a matched cohort to compare the outcome against. In a matched cohort study, Rademacher et al. compared the efficiency and patient safety of in-person screening and telescreening for 3,430 patients presenting to an emergency department (ED). 38 Efficiency was measured by number of patients medically assessed and safety by the number of patients leaving ED without being seen, with results showing comparable levels of efficiency and a 20% decrease (95% CI) in patients leaving without being seen between 1am and 3am.
Der-Martirosian et al. conducted a mixed-methods study to identify the capability and types of telehealth services used by Veteran Affairs after the Hurricane Sandy natural disaster, by analyzing 47,107 clinical files during the 12 months prior and 12 months postevent and conducting 31 semistructured interviews. 39 The following three themes emerged from the interviews: patient outreach, provision of telecare, and patient safety. However, there was little discussion around the implication of these themes. Their quantitative findings showed an increase in the use of telehealth services post a natural disaster, with telehealth offering the potential to improve access and continuity of care, and the study then proposing a likely decrease in adverse health outcomes as a result. As previously mentioned, part of the study from Soegaard-Ballester et al. focused on clinical outcomes within a postoperative telehealth model, by assessing clinical records during the 30-day postoperative period for any adverse clinical events, and finding no instances of major morbidity or mortality for this cohort. 26 These results were limited by a low sample number, which prevented statistical analysis.
Regarding studies with a mixed or negative telehealth outcome theme, Ishani et al. conducted a randomized control trial with 601 chronic kidney disease patients to investigate if telehealth was a feasible care method, and whether this approach would affect health outcomes. 40 They found that telehealth could be effectively implemented by an interprofessional team for both rural and urban patients; however, they reported no statistically significant evidence that this model reduced the risk of death or hospitalization compared with normal care. However, they did find that rural patients did benefit with a reduction in trend for both these measures. The study was limited by a potential bias from the intervention group, given that they were queried more often regarding hospitalization events, which may have increased their recall bias. Finally, Chan et al. set out to evaluate the usability and reliability of a remote pulse oximeter for a telehealth rehabilitation program with 15 patients with chronic lung disease (CLD) and equivalent size control group, using a questionnaire and direct observation. 41 Usability assessed by the questionnaire showed that the oximeter was acceptable to both groups; however, heart rate and oxygen levels were not measured accurately in the CLD group. The focus of this study and negative outcome was less relevant to the telehealth modality, and this literature review's research question.
TELEHEALTH RISKS
The broad theme of telehealth risk was present in four of the included studies, with three studies including findings on patient risks and one study focusing on the risks to clinicians. The process of risk management, which includes identifying and appropriately managing risks, should be an integral part within health care organizations, as risks can contribute to failures in strategic, operational, financial, and safety systems. 42 Furthermore, from a patient safety perspective, requirements of risk assessment and management form part of the NSQHS Standards. 43
Warren et al. conducted a qualitative study whereby after-hour patient-initiated calls received at two radiation oncology departments were retrospectively reviewed to identify opportunities to reduce patient safety risks and improve quality of care. 44 A total of 454 calls were received from 369 patients. Actionable improvements were identified in both safety and quality, and included identifying that only 50% of the calls had been documented by the on-call providers, and the need for improved communication with the primary oncology team during business hours to address common treatment adverse effect concerns and medication management. The previously mentioned study by Shulver et al. also included clinicians' perspectives on patient risks, specifically the acceptable level of risk with telehealth. 30 The participating clinicians recognized that there was a level of risk with this modality, such as a patient falling during the appointment; however, there was a notable difference between clinicians depending on the level of experience they had with telehealth, with experienced clinicians more accepting the need to plan and manage the risks as part of the service. There was also a sense that risk could be mitigated by having a carer or family member with the patient during the session. Cole et al. evaluated the quality and safety impact of clinical pharmacist involvement in a telehealth transitional care management program for high medication risk patients. 45 There were 88 patients involved in this prospective pilot study, with 76 in the intervention group and 12 in the nonintervention group, and medication errors and unplanned hospital readmission rates used as key measures. Statistical significance was not achieved; however, 80 medication-related problems were identified and resolved in the intervention group, with this group also having a lower readmission rate.
The only study to consider clinician risk within telehealth was an Australian study by Clay-Williams et al. who conducted a mixed-methods evaluative study with 15 staff members, to identify possible challenges while transitioning between audio and video telehealth. 46 Three broad categories emerged from this study of social, professional, and technical issues. Within these broad categories, there were subthemes, which included psychological safety concerns from the clinician, such as the risk of being recorded by patients or patients using the medium inappropriately. Despite the small sample, data saturation was reached in this study; however, these results are specific to an anonymous pregnancy and birth helpline, which may not apply to telehealth consultations where the identity of the patient is known to the service.
Discussion
In seeking to find key considerations in the pursuit of a safe telehealth model of care, many of the included studies in the literature review provided strong and relevant evidence, within their respective themes of experience, outcomes, and risk. With regard to the evidence for telehealth experience, the relevant studies suggest that patients are generally satisfied with telehealth assessments, 25,27 and in some cases would prefer this modality of care, given factors such as reduced travel and greater convenience. 26 This is an important consideration, given the regional focus of the research question. Carer experiences are also an important factor and should be considered as their perceptions can impact a patient's decision to engage with this modality. 28 While patients did express satisfaction with telehealth, it is also important to note that there remained an affinity for in-person appointments in some circumstances, which helps build rapport and therapeutic relationships. 27 In addition, where there was patient dissatisfaction with telehealth, this seemed to mainly relate to technological issues. 10,29 The evidence for clinician experience indicates that those with prior telehealth experience, as well as those who are regionally based, were more enthusiastic about the potential for telehealth to improve service access. 30 Moreover, clinician and patient training packages and resources were considered key enablers for telehealth. 31 The type of patient group was also a key consideration for outpatient-based clinician attitudes, with certain groups deemed more appropriate for telehealth, such as lifestyle counseling and chronic disease management. 27
With the evidence relating to patient outcomes, the included studies overwhelmingly supported telehealth as comparable with in-person care regarding clinical outcomes, 26,34 with no difference in adverse events, 33 finding beneficial service outcomes such as lower costs in rural settings 33 and greater efficiencies with shorter appointment times. 29 With respect to the final theme of telehealth risks, the nondocumentation of care episodes was highlighted as a potential issue, 44 as well as the need to consider the psychological safety of clinicians if the service involves an anonymous helpline. 46 Again, the level of clinician experience with the use of telehealth seems to be a key indicator, with greater clinician experience lending itself to the acceptance of new patient risks in the telehealth environment, and of the need to plan and manage the risks as part of the service. 30 Although relatively limited, the prominence of the rural setting, as relevant to this research question, was present in 5 of the 21 included studies. Some of these studies acknowledged the major barriers and challenges in accessing equitable health care, such as higher patient risk factors and lower availability of specialist services. 30,33,39,40 What is more, some of these studies also found relevant evidence of rural telehealth benefits, such as perceived and actual improvements in accessing care, and a greater clinical enthusiasm for the uptake and implementation of this modality. 30,33,46
LIMITATIONS
Due to factors such as a constrained time frame for the completion of the literature review within the designated university trimester, and an acknowledgment that the author does not have expertise in the field of research, an in-depth critique of the research methods and reliability for each of the included studies was not feasible. The difficulty in establishing the reliability, durability, and validity of research papers is a common limitation for students new to a specific research field. 17
Conclusions
This literature review sets out to increase the knowledge on patient safety within the telehealth modality of care, to inform the relevant local health service departments on the key considerations to minimize patient harm. Three main themes emerged from the results of the literature review, which were those of telehealth experience, telehealth outcomes, and telehealth risks. The results suggest that patients generally have positive experiences and are accepting telehealth as a modality of care. Furthermore, patient outcomes appear to be comparable with in-person care, with additional benefits of lower costs to both the service and patients. Training packages for both clinicians and patients are believed to improve experiences and outcomes. However, paramount is the importance of carer experience and input, and the need to continue to offer in-person modality options where appropriate, and to appreciate the technological limitations in some patient groups with respect to literacy and access. These themes, and the evidence from the included studies, formed the basis of eight key recommendations aimed at increasing the safety and effectiveness of telehealth.
Footnotes
Authors' Contributions
All authors contributed to the creation of the article. S.H. designed and conceptualized the review, and wrote the draft article. M.S.I. was involved in designing and implementing the project as a supervisor, and read and approved the final article.
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this review.
