key: cord-0758249-2mrkbgrg authors: Kierkegaard, P.; Hicks, T.; Yang, Y.; Lee, J.; Hayward, G.; Turner, P. J.; Allen, A. J.; Nicholson, B. D. title: Primary care and point-of-care testing during a pandemic: Clinician's perspectives on integrating rapid testing for COVID-19 into the primary care pathway date: 2021-04-19 journal: nan DOI: 10.1101/2021.04.13.21255347 sha: 466195236905f144c1d06a9b5020db95af74f256 doc_id: 758249 cord_uid: 2mrkbgrg Background: Real-world evidence to support the adoption of SARS-CoV-2 point-of-care (POC) tests in primary care is limited. As the first point of contact of the health system for most patients, POC testing can potentially support general practitioners (GPs) quickly identify infectious and non-infectious individuals to rapidly inform patient triaging, clinical management, and safely restore more in-person services. Objectives: To explore the potential role of SARS-CoV-2 point-of-care testing in primary care services. Design: A qualitative study using an inductive thematic analysis. Setting: 21 general practices located across three regions in England. Results: Three major themes were identified related to POC test implementation in primary care: (1) Insights into SARS-CoV-2 POC tests; (2) System and organisational factors; and (3) Practice-level service delivery strategies. Thematic subcategories included involvement in rapid testing, knowledge and perception of the current POC testing landscape, capacity for testing, economic concerns, resource necessities, perception of personal risk and safety, responsibility for administering the test, and targeted testing strategies. Conclusion: GPs knowledge of POC tests influences their degree of trust, uncertainty, and their perception of risk of POC test use. Concerns around funding, occupational exposure, and workload play a crucial role in GPs hesitation to provide POC testing services. These concerns could potentially be addressed with government funding, the use of targeted testing, and improved triaging strategies to limit testing to essential patient cohorts. With support from three NIHR Local Clinical Research Networks (LCRN), GPs were invited by a standardised email outlining the purpose of the study. Eligible participants were English speaking, practicing GPs, providing care during the pandemic. GPs who worked at practices that were closed, or not providing care services throughout the pandemic, were not eligible. Reasons for nonparticipation were not elicited. A participant information sheet, visual pathway diagram triaging SARS-COV-2 testing, and consent form were sent to GPs who expressed an interest. We did not reimburse participants. The authors had no prior contact or relationships with the majority of research participants. We obtained written, informed consent from all study participants. Interviewees were asked for permission to record interviews, and to publish excerpts from interviews. Apart from one participant, all interviewees granted the team permission to record the interview and to publish deidentified excerpts from the interview. The project approved and registered as a service evaluation by the Newcastle Joint Research Office and We used an interview guide to prompt study participants to share their perspectives. The interview guide was informed by prior research conducted by members of the study team [16] [17] [18] , informal discussions with primary and secondary care physicians, and prior studies on the role of primary care during past epidemics [19] [20] [21] . We iteratively refined it after review by a general practitioner (BDN) and two pilot interviews. A pathway diagram representing patient triage into national SARS-CoV-2 testing centres was also included to stimulate discussion, based on information extracted from NHS and NICE guidelines (Supplemental file 1). Semi-structured interviews were conducted via videoconference between September and November 2020 by an experienced male qualitative researcher (PK) and three researchers (one male, two females) with training in qualitative methods (TH, YY, JA). All interviews lasted between 30-60 minutes. We documented observations about each interview (e.g., field notes) immediately after each interview. We continued to recruit and interview study participants until no new themes emerged from the interviews (saturation) [22] . Data management and analysis took place from October to December 2020. All interviews were transcribed verbatim using the Otter.ai software and both interview transcripts and notes were checked, anonymised, and corrected against the audio files. Transcripts were not returned to participants for review. Anonymized interview transcripts were securely stored on an encrypted server. During data collection, the study team met regularly to review content and themes. We used NVivo 1.3 software (QSR International) for inductive thematic analysis [13] . Four researchers coded the transcripts: a health services researcher (PK), diagnostics evaluation methodologist (JA), biomedical engineer (TH), and health economist (YY). Transcripts were read and re-read to identify recurring themes [23] . PK coded transcripts and drafted the codebook using open coding followed by closed thematic coding to allow the iterative expansion and reduction of themes and subthemes [13] . The codebook was discussed amongst the research team in weekly meetings. Newly identified themes (intercoder agreement) relating to the original transcripts were aligned where necessary. Disagreements were resolved by consensus. Interviews continued until data saturation, determined when the study team judged that no new themes were identified [24] [25] [26] . All four researchers (PK, TH, YY, JA) then reread the results to ensure they reflected the original interview data. We recruited twenty-two GPs (10 women and 12 men) from twenty-one general practices across five regions in the UK (Table 1) . All the participants were actively involved in providing remote and in-person care services to patients during the pandemic. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 The degree in which GPs are involved providing POC testing for SARS-CoV-2. "We don't currently have a rapid test. I'd say there isn't current provision or not through our practice or NHS." (GP 06) Knowledge and perception of the current POC test landscape GPs understanding of POC tests currently in-development or approved for market use. "I don't know anything about them. I knew that they're very early on this point of care testing for antibodies but that seems to have gone away." (GP 01) The perceived value of POC testing to help in the clinical management of patients. "Patients, especially with respiratory symptoms, would benefit from a rapid testing, because then we can actually see them, or the patients who have weak symptoms who we don't know if they have got COVID or not. So, I think it will fit in. It will be immensely helpful." (GP 10) System and organisational factors related to service implementation The anticipated impact of implementing POC tests and fears of overwhelming primary care services. "Because primary care doesn't have capacity to test as a general rule." (GP 05) Economic concerns Factors related to costs and incentives and their relationship to workload capacity. "We've still got to carry on trying to earn our QOF points and so there's not been any leeway there at all." (GP 19) Practice-level implementation and service delivery strategies Viewpoints concerning the affect POC tests would have on service delivery considering the potential for occupational exposure and assurance. "As an individual practice, I think it's sort of the anxiety to have POC [tests] and be the contact. How would you practically administer those tests and what sort of PPE would we need to see these patients?" (GP 01) Responsibility for administering the test Preferences in terms of which staff member should be assigned to perform the testing. "That's not something that my surgery will be keen to provide a GP for, because you've spent all day taking a sample. And it is something that personally, I feel that an HCA or, you know, someone of a less extensive qualification would be able to be trained to deliver" (GP 14) Targeted testing strategies Discussions where GPs preferred to use a selection criterion strategy to determine who should be tested. "You would prioritise that resource to the symptomatic unwell patients …. The asymptomatic testing really would only be when you've got plenty of resource to do that because, you know, suddenly your tests are going to go through the roof." (GP 09) Testing location The locational set-up of where and how general practices would triage and test patients. "I think if it's just a quick point of care test, I think more practices potentially might take it up and arrange a thing where they see the patient in the car park and do a very quick test." (GP 07) Our analysis revealed three major themes, and several subthemes (Table 2) . Quotes are anonymized to 127 protect participant confidentiality. The following sections describe each of these themes and summarize 128 the key findings with illustrative quotes. 129 Theme 1: Awareness of SARS-CoV-2 testing 130 GPs reported limited exposure, experience, and access to SARS-CoV-2 POC tests. All respondents said 132 they did not have access to POC tests. 133 "There was no direct testing available in the COVID Clinic because there was no testing within 134 primary care nationwide, as far as we're aware, and so anybody that needed a test would be 135 directed to the gov.uk website or 119 to get their test done." (GP 08) 136 GPs said they often received inquiries from patients under the impression that they could access SARS-137 CoV-2 tests. 138 "We have several people a day asking for tests and we have several people asking why we can't 139 do the tests, and we give them the same answer every time that we don't have access to the 140 tests." (GP 16) 141 GPs general level of understanding of POC tests varied across practices. In most cases, their knowledge 143 of SARS-CoV-2 POC tests was based on the news or social media leading several of them to express 144 concerns around the limited evidence-base. 145 "Not a great deal because we don't really have much information. I know that there's a swab 146 related [test] , what we would call a pregnancy test, or a lateral flow test. But that's basically all 147 what we know." (GP 14) 148 Although GPs familiarity with these tests varied, there was a broad consensus that the evidence-base for 149 POC tests and their accuracy needs to be improved to raise their confidence in using the tests. 150 "I know that the technology is out there, I don't know how accurate it is, and how easy it is to 151 use. By that I mean, it doesn't sound like very reliable sources. But that is the most, I think that's 152 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101/2021.04.13.21255347 doi: medRxiv preprint the quickest way you can get information and you have to be very careful about how you assess 153 whether the data is credible or not." (GP 01) 154 GPs expressed that POC tests could potentially add value to the management of patient care, especially 156 in terms of supporting them in distinguishing between COVID-19 and other respiratory illnesses to 157 inform effective triaging, and treatment decisions. 158 "I think it will definitely help because if you get a result quite quickly, at least that way you can 159 reassure yourself and the patient quite quickly that they don't have COVID and don't need to 160 self-isolate. You can tell them "You've got a chest infection, here are your antibiotics". I think 161 that's that would help a lot." (GP 07) 162 Another anticipated that POC testing would enable them to restore in-person care management for 163 other patient cohorts, particularly those with other respiratory illnesses. 164 "Patients, especially with respiratory symptoms, would benefit from a rapid testing, because 165 then we can actually see them, or the patients who have weak symptoms who we don't know if 166 they have got COVID or not." (GP 10) 167 Finally, some GPs said that that tests would be useful for cases of opportunistic testing in the event a 168 patient visits the practice for another condition but exhibits COVID-19 symptoms. 169 "They've come with a skin infection on their leg cellulitis and they come down to the practice 170 and it's quite clear when you're seeing them that their temperature may well be due to cellulitis. 171 But they've also got a cough. They've also lost their taste and smell, and they've just been 172 distracted by the cellulitis. You're sitting in front of a patient in a surgery who might have COVID. 173 Now, it makes no sense at all, for me to send that patient away to go to a regional test site, I 174 want to test that patient there." (GP 21) 175 GPs were concerned that offering POC tests would increase attendance and affect continuity of care by 178 drawing resources away from patients with chronic disease or urgent clinical needs. 179 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101/2021.04.13.21255347 doi: medRxiv preprint "One of the problems is, in terms of all the other stuff, that primary care has to deal with all the 180 other normal cancer and heart disease and stuff. If primary care gets overwhelmed with testing, 181 it's struggling as it is coping with demand, so it adds an extra layer of demand." (GP 12) 182 Most of the respondents emphasised that already busy general practices would struggle to handle the 183 potentially large influx of patients requesting SARS-CoV-2 testing. 184 "I don't think it would be able to work through our system because it would overload it… and we 185 know, we can't just manage doing that." (GP 15) 186 A few GPs considered that testing should be offered based on regional disease prevalence. They were 187 reluctant to provide testing if local prevalence was high but prepared to if local prevalence was low. 188 "If we've got a high prevalence, it's not something we've got the capacity to deal with… But for 189 very low prevalence, speaking like any other standard test I need to complete, I'll be using it 190 with my trained healthcare assistant." (GP 15) 191 The GPs interviewed indicated that POC tests could add pressure onto general practices who already 193 need to meet targets to generate income. GPs expressed that they would need additional resources to 194 hire extra staff in order to minimise the disruption of existing services to meet their reporting 195 requirements. 196 "I think because there's still an expectation for practices to meet all the targets for everything … 197 is there a way to get another healthcare assistant? For example, a nurse or a GP running this 198 separately with which you know at least that way it wouldn't impact on current services that are 199 having to happen." (GP 07) 200 One general practitioner mentioned that general practices would willingly adopt POC tests if financial 201 incentives were introduced to perform the testing. 202 "If you monetize the process, we will look at it…. I think if you monetize this and set up a 203 protocol, a lot of GPs will look at it." (GP 01) 204 There were also concerns about the additional costs relation to procuring infection prevention easures. 205 "You've got extra cleaning fees for the room… glass screens at reception are thousands of 206 pounds." (GP 15) 207 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101/2021.04.13.21255347 doi: medRxiv preprint Theme 3: Practice-level implementation and service delivery strategies 208 Some GPs felt that negative results from POC tests could reassure staff and patients that they are at a 210 reduced risk of exposure during face-to-face consultations. 211 "I think it definitely would make us feel safer again and I think more importantly it would make 212 other patients feel safe because we do still have patients who are very frightened about coming 213 to use our facilities." (GP 19) 214 The use of POC tests in general practice could also give GPs more confidence to invite the patients into 215 the clinic, given they were presently reluctant to offer a face-to-face assessment. 216 "I think it will improve (and) it will make us more confident in face-to-face consultations. So, 217 we've got a huge population with respiratory illness, especially COPD. I think these are the 218 patients who kind of have been missed out on getting seen." (GP 10) 219 However, GPs also explained that there was an increased risk of staff anxiety and absence if there was 220 increased risk of occupational exposure to potentially infectious individuals booking appointments to get 221 tested. 222 "Some people wouldn't come into work, because they would say it's not safe for them to come 223 into work." (GP 17) 224 Health care assistants (HCAs) or nurse practitioners were identified by most interview participants as the 226 most suitable and cost-effective GPs to administer POC tests. 227 "It's a skill that needs to be learned, but it's quite a simple one. You need someone who's 228 focused on just that one problem. But it's also time consuming. So, nurse practitioners but they 229 are a lot more expensive. So, you want someone who's not gonna be huge cost and resources." 230 (GP 15) 231 Participants reported that this would also ensure that GPs could devote their limited face-to-face time 232 with patients to provide clinical care as opposed to performing POC tests. 233 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101/2021.04.13.21255347 doi: medRxiv preprint "I'd see it probably more being a nurse or a healthcare assistant if it's just the point-of-care test. 234 It's all about kind of using skills appropriately, isn't it? And obviously trying to free up the doctor 235 time for more doctory things really." (GP 09) 236 Several GPs suggested that testing resources should be reserved for use based on clinical need. They felt 238 that testing should be allocated to unwell patients. 239 "It should be at the discretion of GPs to test when they feel that it is clinically necessary for 240 patient care… For people who don't need any clinical input, I don't want to see 50 patients lined 241 up in the morning to have a COVID-19 test. This should not be an alternative to the drive thru 242 testing or the walking testing. It should be for safe patient care, where they actually need to be 243 seen." (GP 10) 244 There was a consensus amongst participants that testing should only be reserved for patients who are 245 considered high-risk or vulnerable, require in-person consultation, and are unable to travel to a testing 246 centre. 247 "I'd choose the high-risk groups first, but the frail people who can't travel and a lot of anxious 248 people with lung conditions. Probably people who've got mobility problems, difficulties getting 249 to test centres." (GP 15) 250 GPs said that testing should be conducted outside to reduce the risk of infection inside the practice. 252 "If it's a point-of-care test, maybe something even in a car park, where you've got someone 253 driving through and you do a test and they drive off with the result straightaway if possible, or 254 you phone them back if something's longer" (GP 07) 255 A few respondents said that if there was a high volume of testing, POC tests should be offered at a 256 separate mass testing site to reduce the risk of transmission. 257 "I think there should be a separate site rather than the general practice where they can get that 258 rapid test, just to reduce potential risk of cross infection." (GP 09) 259 However, some GPs believed that testing patients in a hub nearby the clinic would be the most 260 appropriate option. 261 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 "We're talking about like a porta cabin or something separate somewhere from the building by 262 you, we can see our own patients, or we open up our red hub again, and we can see our own 263 patients, because we're the only ones that really know them." (GP25) 264 We found multiple challenges to adoption of SARS-CoV-2 POC tests in primary care. GPs had significant 266 reservations based on the limited information available, an overwhelming workload, and the potential 267 for increased occupational exposure to SARS-CoV-2. GPs were more likely to adopt POC tests if 268 conducting testing added value to care management, if additional resources were made available to 269 offset the increased workload, and evidence was available to assure them that POC tests would reduce 270 occupational and patient exposure. 271 Occupational exposure was a concern amongst the GPs we interviewed as increased interaction with 273 patients would entail staff being exposed to more potentially infectious individuals. Increased 274 occupational exposure to patients has been linked with increased stress and anxiety amongst healthcare 275 workers related to being infected and infecting their families [27] [28] [29] [30] [31] [32] . Without establishing and 276 communicating the risks associated with the introduction of POC tests, GPs may not feel reassured by 277 testing, which they fear could result in staff absenteeism during a pandemic [33] [34] [35] [36] [37] [38] [39] . Education and 278 pandemic response training may mitigate fear and absenteeism among clinicians [40, 41] . 279 GPs had limited awareness of the SARS-CoV-2 POC tests. Although GPs were somewhat familiar with 280 some types of POC tests, most of their understanding was sourced from various mass media, and they 281 report concerned with the lack of robust 'real-world' evidence [42] [43] [44] [45] . This suggests that GPs current 282 attitudes and expectations of SARS-CoV-2 POC tests are shaped by a combination of knowledge gaps, 283 perceived risks, and uncertainties. These factors are consequential as they are critical determinants that 284 inform decisions and behaviours [46] [47] [48] [49] . 285 There was a consensus amongst interview participants that HCAs should administer POC tests. Part of 286 this motivation was that HCAs are cost-effective, and are accustomed to taking on responsibilities that 287 remove burdens from GPs and nurses [50, 51] . This reasoning resonates with previous work exploring 288 team-based models in primary care focused on the redistribution of tasks among care team members. 289 Optimising workforce capacity by re-delegating tasks to non-medically qualified staff members can help 290 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 GPs and nurses can prioritise unwell patients requiring treatment [52] [53] [54] [55] [56] [57] . However, we did not seek the 291 views of HCAs. 292 It may be necessary to incentivise POC tests in primary care [58] [59] [60] [61] . GPs argued that increasing capacity 294 to deliver POC tests is dependent on securing additional funding to create the necessary infrastructure. 295 Alternative time-limited funding arrangements may be needed to increase capacity for POC tests use, 296 such as the Alternative Provider Medical Services (APMS) contract, to cover all associated costs until the 297 pandemic has passed [62] . Workforce optimisation strategies to share resources between general 298 practices across the 'primary care network' (PCN) could offset workload burden for individual practices 299 [63]. However, this may not be a sustainable approach across England given the high variability between 300 PCNs organisational structures and characteristics [64] . GPs suggested that outdoor testing stations 301 would facilitate infection control and reduce the need for patients to travel to distant community testing 302 sites [65], especially frail patients, and or those without vehicles [66] . GPs expressed a strong preference 303 for modular buildings, portable cabins or tents in practice carparks that could be used to triage and 304 dispatch patients and assess contamination risk. This approach is supported by evidence from secondary 305 care from both the . 306 GPs indicated that POC testing could add value to patient management if it served as a discriminator 307 between SARS-CoV-2 and other respiratory viruses. For instance, reliably distinguishing between COVID-308 19 and influenza clinically is impossible because of the overlap of clinical presentations [70] [71] [72] . 309 This suggests that POC testing that can facilitate syndromic testing could provide value in guiding clinical 310 management. Thus, future developments for SARS-CoV-2 POC tests could help meet GPs clinical needs 311 of distinguishing between respiratory illnesses by focusing on multiplex testing. Related studies in 312 secondary care suggests that multiplex testing for influenza and RSV can a positive impact on patient 313 management and is associated with more appropriate clinical decisions, reduced antibiotic use, timelier 314 infection control measures, more appropriate antiviral management, and reduced costs in secondary 315 care settings [73] [74] [75] [76] [77] . 316 POC tests are less efficient and more error-prone when handled by non-laboratory trained individuals 317 [78, 79] . For instance, the accuracy of a lateral flow immune assay for SARS-CoV-2 dropped significantly 318 when used by non-laboratory trained professionals [80] . As GPs identified HCAs as the ideal candidates 319 to administer the POC tests this raises questions about the training required to ensure they are 320 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 administered correctly. We suggest studies developing training protocols and standard operating 321 procedures for individuals without medical or laboratory backgrounds to minimize inaccurate results 322 and test failures [81] . The role of POC tests in home visiting and out-of-hour services warrants further 323 investigation [82] [83] . 324 A strength was the qualitative methods we used. They allowed us to explore the views and experiences 326 of general practice staff in an in-depth and descriptive manner. The topic guide was piloted with two 327 GPs who were not participants in the study, with minimal changes recommended. Although the sample 328 size was small, we achieved information saturation appropriate to a qualitative study design when no 329 new themes were discovered during the interviews [22] . Concurrent thematic analysis ensured that data 330 saturation occurred before data collection was complete. 331 A limitation is that we included general practices from only three regions of England, which may not 332 have captured the variation in clinical practice and might therefore limit the generalisability of findings. 333 The interview participants did not include any nurses and HCAs, who are likely to have play a central 334 part of POC use in primary care. Lastly, the interviews occurred between the 25th of September 2020 335 and the 27th of October when the COVID-19 situation in the UK was changing rapidly, immediately prior 336 to the second national lockdown in November 2020. It is possible participants priorities may have 337 changed subsequently. 338 We explored the perspectives of general practice staff on adopting SARS-CoV-2 POC tests into clinical 340 routine practice. Our findings highlight that GPs awareness of the POC testing landscape varies, as do 341 their perception of risk, and uncertainty regarding the adoption of these tests. Our interviews revealed 342 concerns around the support general practices would need to manage the additional workload, staffing, 343 and risks of occupational exposure. General practices would be willing to provide point-of-care testing 344 services if these concerns could be mitigated through increased government funding, and targeted 345 testing and triaging strategies to limit testing services to essential patient cohorts. Our findings provide 346 important information that can inform policy development concerning planning and implementation of 347 mass testing programmes for COVID-19 and future pandemics. 348 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. Community Healthcare MedTech and In Vitro Diagnostics Co-operative at Oxford Health NHS 377 . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted April 19, 2021. ; https://doi.org/10.1101 https://doi.org/10. /2021 Foundation Trust. 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Home visits for vulnerable older people: journeys 593 to the 'Far End