Drive‐up INR testing and phone‐based consultations service during COVID‐19 pandemic in a pharmacist‐lead anticoagulation clinic in Qatar: Monitoring, clinical, resource utilization, and patient‐ oriented outcomes

Abstract Background Coronavirus disease 2019 (COVID‐19) pandemic has resulted in unprecedented pressure on healthcare systems and led to widespread utilization of telemedicine or telehealth services. Combined with teleclinics, using drive‐up fingerstick International normalized ratio (INR) testing was recommended to decrease exposure risk of anticoagulation patients. Objective To evaluate the impact of transitioning from clinic‐based anticoagulation management services to drive‐up and phone‐based services during COVID‐19 pandemic in Qatar. Methods The study comprised of two components: a retrospective cohort study of all eligible patients who attended anticoagulation clinic over 1‐year period (6 months before and 6 months after service transition) and a cross‐sectional survey of eligible patients who agreed to provide data about their satisfaction with the new service. Monitoring parameters, clinical outcomes, and resource utilization related to warfarin therapy were compared before and after service transition. Patients' experience was explored through a structured survey. Results There was no statistically significant difference between clinic‐based and phone‐based anticoagulation services in mean time and number of visits within therapeutic range (P = .67; P = .06 respectively); mean number of extreme subtherapeutic and supratherapeutic INR values (P = .32 and P = .34, respectively); incidence of thromboembolic complications and warfarin related hospitalization. There was one reported bleeding and one emergency visit (0.9%) in the phone‐based group vs none in the clinic‐based group. Frequency of INR testing and compliance to attending clinics appointments declined significantly (P = .002; P = .001, respectively). Overall, patients were highly satisfied with the new service. The majority of patients found it better (51.6%) or just as good as the traditional service (44.5%). Patients who preferred the new service were significantly younger than their counterparts (P = .005). Conclusion The service of drive‐up INR testing and phone‐based consultations was shown to be comparable to traditional anticoagulation service, a finding that supports maintaining such services as part of the new normal after the pandemic is over.

Patients who preferred the new service were significantly younger than their counterparts (P = .005).
Conclusion: The service of drive-up INR testing and phone-based consultations was shown to be comparable to traditional anticoagulation service, a finding that supports maintaining such services as part of the new normal after the pandemic is over. resulted in unprecedented pressure on economics and healthcare systems and created the biggest healthcare crisis in the century. 1 With more than 2 million reported deaths, 2 the crisis necessitated public health strategies to reduce the risk of COVID-19 transmission, preserve personal protective equipment, and accommodate patient surges on facilities while maintaining access to essential health services. Thus, the practice of telemedicine was globally advocated and adopted. 3,4 Advanced age and concurrent comorbid conditions are wellrecognized predictors of poor COVID-19 outcomes. 5,6 A recent study of anticoagulation clinics in Qatar demonstrated that 63% of patients were hypertensive, 59% had diabetes, and 11% had chronic heart failure. 7 Alongside the necessity for close follow-up and International Normalized Ratio (INR) monitoring, such patients are at particularly higher risk of COVID-19 exposure and complications.
Strategies recommended to decrease the risk of COVID-19 exposure in this population include switching to direct oral anticoagulants (DOAC), transitioning to patient self-testing, extending INR monitoring intervals, and using drive-up fingerstick INR testing, which eliminates the need to enter the clinic or facility. 8 Some of these strategies were adapted by anticoagulation services in Qatar. 9,10 The practice of phone-based anticoagulation management service (AMS) was described since the 1990s, particularly for homebound and rural populations. 11 Multidisciplinary, phone-based AMS was associated with higher patients' knowledge about warfarin and better satisfaction with care when compared with traditional physician-based practice. 12 Moreover, anticoagulation management delivered via telehealth (phone or web-based consultations) yielded similar clinical and surrogate outcomes in most comparisons to specialized face-to-face anticoagulation clinics 13,14,15 and better outcomes than usual care management. 14,16 Al-Wakra hospital's anticoagulation clinic was the first to adapt the service of drive-up (drive-through) anticoagulation testing, combined with telehealth consultations, in the Middle East and North Africa (MENA) region. 9 The aim of this study is to evaluate the impact of transitioning from clinic-based anticoagulation management services to drive-up and phone-based services during COVID-19 pandemic in Qatar.

| Study design and ethics
The study was consisted of two components.
Phase 1: A retrospective cohort study of all eligible patients who attended the anticoagulation clinic at AWH over 1-year period (6 months before and 6 months after service transition).
Phase 2: A cross-sectional survey of eligible patients who agreed to provide data about their satisfaction with the new service.
The study was deemed as "service evaluation project,", thus Institutional Review Board (IRB) review and approval was waived.

| Study setting
The study was conducted in Al-Wakra anticoagulation clinic, one of three specialized anticoagulation clinics in Qatar. The clinic operates 5 days/week and is staffed by one full-time equivalent (FTE) clinical pharmacy specialist and one FTE nurse. Pharmacists providing anticoagulation services in Qatar must hold a post-graduate degree in clinical pharmacy, have a minimum 3-year experience, and complete specialized education and training in anticoagulation management. In April 2020, the time when COVID-19 cases started to rise in Qatar, the anticoagulation service was shifted from in-person clinic visits where point-of-care (POC) INR was checked and consultations provided to drive-up INR testing and phone-based consultations. 9 Patients were requested to drive-up a designated lane to the testing spot where the anticoagulation nurse confirmed patients' identity and performed the standard POC INR testing. Results were wirelessly transferred to the patients' electronic medical record (Cerner) and verified by the clinic's pharmacist who subsequently called the patients and conducted a teleconsultation. The consultations were structured similar to those in the clinic where the pharmacist gathered relevant information, decided on dosing regimen and next follow-up appointment, and reinforced patient education. Patients with INR values above five were instructed to repeat the test via venipuncture in the hematology lab, which is located inside the building before proceeding with the consultation. The service was provided by the same pharmacist and nurse, using the same POC INR testing device throughout the study period.
In contrast to the low-priced consultation fees that nonexempted patients pay for face-to-face visits, the service was provided free of charge for all patients.

| Study population and timeline
For the cohort study (phase 1), retrospective electronic chart review of all consecutive adult patients (≥18-years old) who received warfarin therapy and visited AWH anticoagulation clinic for a minimum of 6 months before and 6 months after service transition was conducted.
Exclusion criteria included pregnancy, hospitalization during the study period, warfarin therapy interruption for >1 week, and less than three retrievable INR measurements in each 6 month-period before and after service transition.
The patient satisfaction survey (phase II) included all service recipients who visited the clinic before and after transition and agreed to complete the survey between the dates of October 20 and November 20, 2020. were classified into major bleeding and/or clinically relevant nonmajor bleeding, according to internationally recognized criteria. 18,19 Patient satisfaction data were collected by staff nurses through interviews using a structured patient survey. The survey was developed based on a thorough literature review of existing patient satisfaction surveys, particularly in the field of telemedicine. 12,[20][21][22][23][24] It was then assessed for face validity by two experts in the field and pilottested for content validity and clarity by three pharmacists and two nurses with feedback incorporated into the final survey.

| Data collection
The survey consisted of four domains. Domain 1: demographic information, including age, gender, occupation, and educational level. Domain 2: aspects of care, which consisted of 10 questions addressing the three main aspects of care: quality of care (5 questions), access issues (3 questions), and interpersonal issues (1 question), followed by an overall satisfaction assessment (1 question). Respondents rated their agreement on relevant statements on a 5-element Likert scale where 5 indicated "strongly agree" and 1 indicated "strongly disagree." Domain 3: Compared the new service to the conventional service. Patients were requested to rate their current experience compared with traditional clinic visits on a four-point-scale as: better than a traditional visit; just as good as; worse; or not sure. Additionally, patients were requested to indicate how likely they were to continue using the new service after the COVID-19 pandemic ends and how likely would they recommend it to someone else on a five-point scale as: definitely will; probably will; probably will not; definitely will not; not sure. If the answer to the first question was probably will not; definitely will not; not sure, the respondent was asked an openended question to identify the main reason for preferring the traditional service. Domain 4: included two open-ended questions.
"What do you like best about the new service?" and "What can we do to improve?" To avoid potential bias, neither the clinic's pharmacist nor the nurse was involved in conducting patients' interviews. All survey responses were kept anonymous.

| Study outcomes
The objective of the study was to compare the quality of anticoagulation management among patients attending anticoagulation clinic before and after the transition from clinic-based INR testing and consultations to drive-up testing and teleconsultations, through

| Statistical analysis
Descriptive statistics were used to analyze baseline demographics.
Depending on their normal distribution, numerical data were presented as mean ± SD or median and interquartile range (IQR).
Continuous variables were tested for normality tests using Kolmogorov-Smirnov. Categorical variables were presented as frequencies and percentages and analyzed using Chi-squared test.
Based on the type of data analyzed, pre and post-service transition outcomes were compared by paired t test and McNemar's Chisquare test.
For the cohort study, a sample size of 100 subjects was found sufficient to detect TTR difference of 10% with SD of ±15 considering alpha error of 5% and 90% power. The sample size calculator by Raosoft Inc. was used for the survey part. 26 Utilizing the margin error of 5%, confidence level of 95%, population size of 150 (estimated number of patients following in the clinic) and response distribution of 50%; and non-response rate of 15%, the minimum required sample size was 125.
Adopted from Polinski and colleagues, patient's preference of the new service compared with the traditional service was based on responses to the question "How did your drive-up and phone visit overall experience compare to a traditional in-person clinic visit?" Responses were categorized into "patient prefers new service" if the response was "better than a traditional visit" and "patient likes new service" if the response was "better than," or "just as good as" a traditional visit. 20 The relationship between patients' demographics and their overall satisfaction and preference of the new service over the traditional one was analyzed by univariate analysis.
A P-value of less than .05 was considered statistically significant.
All statistical tests were carried using the IBM Statistical Package for Social Sciences, SPSS (IBM Corp., Armonk, New York) version 26.

| RESULTS
The cohort study included 108 patients while the satisfaction survey was submitted to 129 subjects among which 128 responded (response rate 99.2%). Demographic data were collected for survey respondents ( Table 1). The majority of patients were males (67.4%) and were of Middle Eastern (67%) origin. Mean age was 51.2 ± 15.2 years and 43% of patients received warfarin for 1 to 5 years.
The most common indication for anticoagulation was atrial fibrillation (31.3%).

| Monitoring parameters
There was no statistically significant difference in mean TTR before

| Clinical outcomes
No difference in the incidence of thromboembolic complications was noted in the two groups. For bleeding outcomes, only one patient in the phone-managed group experienced major bleeding (vaginal bleeding that resulted in >2 g/dL drop in hemoglobin) compared with no patients in the clinic-managed group.

| Resource utilization
The frequency of clinic visits and INR testing was significantly lower in the post-service transition period. Mean number of visits declined from 9.6 ± 5.6 to 8 ± 5.3, P = .002. There was also a significant decline in attendance to scheduled clinic appointments from a mean percent of 88.3 ± 11.5% to 65.8 ± 21.5%, P < .001. Warfarin-related hospitalization was comparable between the two groups (P = 1). One patient in the phone-based group (0.9%) visited ED for a warfarinrelated complication compared with none in the clinic-based group.

| Patient satisfaction
Patients' experience with the new service was remarkably positive. None of the demographic variables evaluated predicted patients' overall satisfaction, preference, or likeness for the service except age.
Patients who preferred the current service over the traditional one were significantly younger than those who found it either as good or worse (47.6 ± 15 vs 55 ± 14.5, P = .005).

| DISCUSSION
The current study explored the clinical efficacy and safety as well as  staffing levels and practitioners providing care were not excluded.
Findings that may have influenced compliance to treatment and clinical outcomes. In contrast, the current service was provided to all patients by the same practitioner over the course of the study.  The study findings revealed a high patient satisfaction with all aspects of the service (access, quality, and interpersonal). Most of the patient's either preferred the service or just found it as good as the conventional one.
Waterman and colleagues, was the first to evaluate satisfaction with phone-based anticoagulation service compared with traditional management by primary-care physicians. Telephonic AMS was associated with significantly higher patients' and physicians' satisfaction with the service's quality and timeliness and resulted in better patients' knowledge about their anticoagulants. 12 In the era of COVID-19, a recent study by Zobeck and colleagues 30  This study has several strengths. Firstly, up to our knowledge, this is the first study that evaluates drive-up testing of INR and phonebased anticoagulation consultations in the MENA region.
Second, concerns about safety, efficacy, resource utilization, and patients' satisfaction were all addressed. Additionally, the service was provided by the same practitioner throughout the course of the study to all patients visiting the clinic which eliminated potential time and selection bias reported in previous literature. 13,27 Moreover, the simplicity of the phone follow-up service without requiring extra resources to operate and maintain such as devices with cameras and internet access made it easier to adapt and sustain.
The study findings, nonetheless, may not be generalizable to healthcare institutions or clinics with different patient populations or healthcare delivery models, or those that switched to virtual visits using video meeting technology instead of telephone only.
In conclusion, the current study confirms that the new drive-up INR testing and anticoagulation teleconsultations provide optimal anticoagulation quality while maintaining acceptable resource utilization and patient satisfaction. A Finding that suggests integrating such service to traditional care delivery even after the pandemic ends.

ACKNOWLEDGMENTS
The study authors would like to acknowledge Ms. Nadia Bentemellist; Ms. Randa Ibrahim; and Ms. Maya Padmanabhan for their valuable efforts in data collection.