Quantitative Analysis of Nonvisit Care Activities Performed by Ambulatory Care. Kimberly A. Kosloski Tarpenning, Pharm.D. 1

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-- Quantitative Analysis of Nonvisit Care Activities Performed by Ambulatory Care Pharmacists in the Outpatient Primary Care Clinic Setting Running title: Ambulatory Pharmacist Nonvisit Care Kimberly A. Kosloski Tarpenning, Pharm.D. 1 Sarah A. McGill, Pharm.D. 2 Jessica A. Peterson, Pharm.D. 3 Kaitlin J. Yost, Pharm.D. 4 Marc D. Tumerman, M.D. 5 Author Affiliations: 1 Pharmacy Services, Mayo Clinic Health System in Owatonna, Owatonna, Minnesota; 2 Pharmacy Services, Mayo Clinic Health System-Franciscan Healthcare in Sparta, Sparta, Wisconsin; 3 Pharmacy Services, Mayo Clinic, Jacksonville, Florida; 4 Pharmacy Services, Mayo Clinic Health System in Eau Claire, Eau Claire, Wisconsin, and Mayo Clinic Health System Chippewa Valley in Chippewa Falls, Chippewa Falls, Wisconsin; 5 Department of Family Medicine, Mayo Clinic Health System-Franciscan Healthcare in Sparta, Sparta, Wisconsin. Corresponding Author: Marc D. Tumerman, M.D., Department of Family Medicine, Mayo Clinic Health System-Franciscan Healthcare in Sparta, 310 W Main St, Sparta, WI 54656; e-mail: tumerman.marc@mayo.edu. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/jac5.1094

Acknowledgment: We thank Gabrielle Thompson for her contribution to data compilation, as well as Jordan Haag, Pharm.D. and Audrey Umbreit, Pharm.D. for their assistance in project design, technical editing, and language editing and for comments that greatly improved the manuscript. Conflict of interest: The authors have no conflicts of interest to declare.

Abstract Introduction: The value of pharmacists as direct patient care providers in integrated ambulatory care teams has been demonstrated. As the reimbursement landscape changes, patient care outside of office visits is increasing through nonvisit care. Objective: We aimed to quantify the time spent by ambulatory care pharmacists on nonvisit care activities in the outpatient primary care clinic setting. Methods: Data were collected from four outpatient ambulatory care practices in our institution over 12 weeks. The primary objective was to quantify the time spent performing nonvisit care activities. Secondary objectives were to quantify the number of patients affected, the number of nonvisit care activities, the types of medication therapy problems (MTPs) encountered during nonvisit care activities, and the resulting medication therapy interventions. Results: A total of 1311 patients were affected during the study, and pharmacists spent a daily average of 1.6 hours performing nonvisit patient care. Among 1548 nonvisit care activities, staff face-to-face curbside consult was the most frequent (41%). Among 1866 MTPs identified (1.4 MTP per patient), the most common problems identified were need for education (31%), adverse medication events (21%), need for an additional medication (20%), and nonadherence (12%). The most common interventions were health care team education (28%), recommendation to switch medication (18%), patient education (17%), and start a new medication (14%). Conclusion: Ambulatory care pharmacists spent considerable time performing nonvisit care, with multiple MTPs identified during these encounters. Health care teams

frequently used pharmacists for nonvisit patient care. Further research is needed to determine the best utilization of pharmacist resources allocated to nonvisit care in an integrated ambulatory care practice. Keywords: ambulatory care; pharmacy; population health; practice management

Pharmacists roles within the health care team have expanded from medication dispensing to include new roles as patient care providers. In our institution, as well as many other organizations, pharmacists serve as advanced practice providers delivering comprehensive medication management (CMM) in the outpatient primary care setting. According to the American College of Clinical Pharmacy, CMM is defined as the standard of care that ensures each patient s medications (ie, prescription, nonprescription, alternative, traditional, vitamins, or nutritional supplements) are individually assessed to determine that each medication is appropriate for the patient, effective for the medical condition, safe given the patient s comorbidities and other medications being taken, and able to be taken by the patient as intended. 1 CMM is a formal, collaborative approach in which clinical pharmacists work together with members of the health care team to optimize therapeutic outcomes for patients. 1 Through CMM, clinical pharmacists actively manage medication therapies; identify, prevent, and resolve medication therapy problems (MTPs); and formulate follow-up and monitoring plans to assess patients progress toward therapeutic goals. 2,3 With this innovative pharmacist role, several studies have established that pharmacist-provided CMM services can improve patient outcomes while simultaneously decreasing overall health care spending. 4,5 Specifically, pharmacist-provided CMM has led to significant clinical improvements in diabetes mellitus and hypertension management. 6 Other studies have shown that pharmacist-provided CMM services have had a positive return on investment, with $1.29 to $12 savings in overall health care costs

for every $1 spent on CMM services. 5,7 CMM services provided by pharmacists integrated within the health system have been shown to produce high rates of patient satisfaction. In one study of patient surveys completed over 10 years, 95.3% of respondents agreed or strongly agreed that their overall health and well-being had improved because of CMM, and 98.1% agreed or strongly agreed that they would recommend this service to family and friends. 5 The value of pharmacists in the interdisciplinary patient care team has been recognized and in the primary care setting, more pharmacists are serving as advanced practice providers focusing not only on CMM but also on other direct patient care activities including comprehensive disease state management, disease prevention, care coordination, and follow-up care. 3,8 Previous studies have focused on the clinical, financial, and humanistic impact of pharmacist integration relating to direct patient care, but there are few data on the effects of integrated pharmacists on indirect patient care. Pharmacists embedded in a primary care practice frequently perform a combination of indirect and direct patient care duties in addition to administrative functions and provision of formalized staff education. Indirect care, hereafter termed nonvisit care, includes individualized patient care activities outside of scheduled face-to-face or telehealth appointments. Examples of nonvisit care include informal curbside consults with other health care providers regarding a patient-specific medication question, electronic communication with health care staff providing education about a patient s new medication, or a patient telephone call to discuss adverse effect management.

With the changing reimbursement landscape, from a fee-for-service to a value-based payment model, our organization and others have recognized the importance of effectively managing nonvisit care activities by using the knowledge and expertise of advanced practice pharmacists. Despite these additional responsibilities being assumed by integrated pharmacists, data specifically quantifying the amount of time they spend on nonvisit care activities are lacking. Quantifying pharmacist time spent and describing the types of nonvisit care activities is an initial step toward evaluating the role and effects of integrated pharmacists on nonvisit care. Several organizations have published minimum standards of care for CMM pharmacists. 9-11 These expectations encompass patient assessment and collaboration with the health care team, but another key component of CMM services is the identification and resolution of MTPs (also known as drug therapy problems). In past studies, 4,5,7 MTPs have been used to classify types of pharmacist interventions regarding direct patient care but could also be used for analyzing the influence of pharmacists on nonvisit care. Typically, MTPs are classified into several categories and subcategories: indication (unnecessary medication, need for additional medication), effectiveness (ineffective medication, dosage too low), safety (dosage too high, adverse medication event), and convenience/compliance (nonadherence). 5,12,13 In one study from a large, multicenter integrated health system with data from 10 years of pharmacist-provided CMM services, the MTPs most commonly identified were needs additional therapy (indication), dosage too low (effectiveness), and nonadherence (convenience/compliance). 5 In

addition to identifying and resolving MTPs, CMM pharmacists often provide nonvisit care in the form of medication education for patients and providers. 9,10 As the primary care environment continues to transition from volume-based to value-based care, the optimized utilization of advanced practice pharmacists may substantially affect health care outcomes and costs. One critical factor in optimizing utilization of advanced practice pharmacists is discovering the proper balance between the time spent on direct patient care versus nonvisit care. Because of the lack of research regarding how pharmacists nonvisit care activities affect the health care team and their patients, we aimed to describe and quantify nonvisit care activities provided by four advance practice pharmacists, or ambulatory care pharmacists, at four different outpatient primary care practices at our institution. The primary objective was to quantify the time outpatient ambulatory care pharmacists spent completing nonvisit care activities over a 12-week period in primary care clinics. Secondary objectives were to quantify the number of patients affected, determine the types of nonvisit care activities completed, and classify the types of MTPs and medication therapy interventions most frequently addressed during nonvisit care activities. Methods Project Design, Setting, and Participants This quantitative evaluation study included information gathered between February and September 2017 at four ambulatory care practices within Mayo Clinic Enterprise. The collection window was established to ensure that data were collected

before workflow changes occurred in the department. Data were obtained during a 12- week period to account for the variability in practice changes across the different sites during data collection. Because of the differences in practices and schedules, each investigative pharmacist chose a predetermined 12-week period within the collection window to gather data for the study. The ambulatory care practices, located in three states (Minnesota, Wisconsin, and Florida), support clinics that consist of primary care providers in family medicine, internal medicine, or both services, along with a varying number of specialty providers. The number of paneled patients in the clinics ranged from 7300 to more than 37,000 (Table 1). Each ambulatory care practice schedule had 2 hours of each 8-hour clinic day set aside for responsibilities outside of patient appointments, including administrative work, nonvisit care activities, patient appointment preparation, and documentation. Nonvisit care activities in this study were defined as patient-specific clinical problems or questions that occur outside of formal health care team education and patient care appointments conducted either in the clinic, electronically, or by telephone. These nonvisit care activities are communications initiated by either the patient or a member of the health care team to the ambulatory care pharmacist for the purpose of patient care. This study was reviewed by our institutional review board and considered exempt from further review, with categorization as a quality assurance project. Data Collection Data were collected through two different methods: an internally developed software program, PhARMS (Pharmacist Ambulatory Resource Management System),

and a spreadsheet created to collect data. PhARMS is a software program used by pharmacists to manually record daily activities as part of a departmental data collection workflow. Investigative pharmacists, all of whom are authors, each collected data during a predetermined 12-week period completed between February and September 2017. Primary outcome data were manually recorded and collected using PhARMS through normal workflow, which allowed for classification of nonvisit care activities into specific subcategories to determine type of nonvisit care activities used (Table 2). In this study, information entered in the PhARMS nonvisit care activities work category during the study period was obtained through generated reports for each ambulatory care practice. Each report contained the following information for each entry: unique patient identifier, nonvisit care activity subcategory, time spent, and date of service. Secondary outcome data were collected using a spreadsheet generated for this study to capture data not gathered by PhARMS, such as MTP and medication therapy intervention for each nonvisit care activity, in addition to a unique patient identifier for each entry. Each investigator used a separate identical spreadsheet to collect appropriate data for nonvisit care activities completed at their respective practice. To comprehensively study the resources pharmacists dedicate to nonvisit care, it is imperative to find a way to capture this educational role that pharmacists provide when a traditional MTP may not be an appropriate choice. For this purpose, we elected to include education as an additional MTP category, which allowed us to capture all pharmacist interventions while continuing to use the traditional MTP identification classification.

Pharmacists from each ambulatory care practice reviewed multiple different scenarios for each nonvisit care activity type before data collection to establish consistent categorization. Quality assurance discussions occurred consistently throughout the data collection periods to maintain nonvisit care activity categorization. Descriptive Statistics Raw data were analyzed using means and ranges. Before beginning data collection, an internal statistician was consulted about the study to ensure that proper statistics were used. Results Primary Outcome: Time Spent This study was conducted by four ambulatory care pharmacists with a total of 3.6 full-time equivalents, spread out between four ambulatory care practices in one health system. During the 12-week period, 346 total hours were spent on nonvisit care activities, out of 1728 total clinic hours scheduled, on the basis of pharmacist full-time equivalents. The mean time spent per day on nonvisit care activities was 1.6 hours per practice (range, 0.6-2.7 hours). The time spent per activity varied by activity type. Patient telephone call and patient portal message took the most time per activity, both averaging 17 minutes per activity. Staff inbox message averaged 15 minutes per activity, and staff telephone call averaged 14 minutes per activity. Staff face-to-face curbside consult was the least timeconsuming, averaging 10 minutes per activity.

Secondary Outcomes Patients Affected A total of 1311 patients were affected by nonvisit care activities during the study, with a mean (range) of 327 patients (190-509 patients) per pharmacist. The mean number of patients affected each day by an ambulatory care pharmacist was 6. Number and Type of Nonvisit Care Activities A total of 1548 nonvisit care activities were completed during the study period, with a mean of 7.2 activities per day. The most frequent type of nonvisit care activity was staff face-to-face curbside consult, which accounted for 41% (638 activities). Staff inbox message accounted for 30% (466 activities), and patient telephone call accounted for 19% (297 activities). The remaining activity types, patient portal message and staff telephone call/page, accounted for 6% (86 activities) and 4% (61 activities), respectively. The most commonly used nonvisit care activity types were similar across each ambulatory care practice (Figure 1). MTPs and Medication Therapy Interventions Of 1866 total MTPs identified during the study (mean, 1.4 MTPs per patient), the most common type was education required (31%, n=572). Adverse medication events (21%, n=390) and need for additional medication (20%, n=380) were also frequently identified (Figure 2). Nonadherence represented 12% (n=217) of MTPs, and the remaining 16% (n=307) comprised a combination of ineffective medication, dosage too low, dosage too high, and unnecessary medication. Each ambulatory care practice identified a different primary MTP, but the top four MTPs education required,

nonadherence, adverse medication event, and need for additional medication were consistent between all of the practices. The most frequent medication therapy intervention was health care team education, which accounted for 28% (n=520) (Figure 3). Eighteen percent (n=327) of the medication therapy interventions were attributed to switch/change medication, and 17% (n=324) to patient education. Start new medication or dosage recommendation was the recommended medication therapy intervention for 14% (n=266) and 11% (n=213), respectively. The remaining 12% of medication therapy interventions consisted of medication discontinuation, patient self-monitoring, laboratory monitoring, or other (referrals to providers or triage). Discussion For each 8-hour day, ambulatory care pharmacists dedicated, on average, 20% of their time (96 minutes) to nonvisit care activities. Not only is this a substantial component of an ambulatory care pharmacist s time, this assistance with nonvisit care activities may increase the capacity of other health care team members. Using the ambulatory care pharmacist for medication-related nonvisit care activities leverages the distinctive knowledge of the pharmacist as the medication expert. Time spent on nonvisit care activities varied considerably among pharmacists, with several contributing factors considered. Each ambulatory care practice varied substantially in provider composition, availability of specialty services, responsibilities associated with inpatient services, and pharmacist full-time equivalent

support (Table 1). The tenure of each pharmacist in each practice and the ambulatory services offered were different between sites and may have affected staff familiarity with pharmacist services and their subsequent utilization for nonvisit care activities. Furthermore, some ambulatory care practices were involved in preparation for and implementation of electronic health record vendor change during data collection, which most likely affected practice through all disciplines. These practice-specific factors, in addition to pharmacist-specific factors, may help explain the noticeable variability in total time spent on nonvisit care (range, 0.6-2.7 hours per day) among individual pharmacists. Although staff face-to-face curbside consults were the most frequent type of nonvisit care activity, they also required the least time per activity (mean, 10 minutes per activity). Other nonvisit care types took substantially longer, averaging 14 to 17 minutes per activity. This could provide some further direction with regard to the most efficient use of ambulatory care pharmacist time for nonvisit care activities. This finding also indicates that ambulatory care pharmacists are often used for nonvisit care activities conducted in person, which may imply that pharmacist visibility and availability encourage staff engagement for a brief consult or question. Individual ambulatory care pharmacists responded to between 5 and 10 nonvisit care activities on average daily, with more nonvisit care activities correlating to more time spent per day on nonvisit care. Variability is expected because of unique ambulatory care practice and team factors including, but not limited to, patient population and number and type of providers. Also, a temporal increase in education-based nonvisit care activities seemed to occur when practices added new providers, particularly those

early in their practice career. In ambulatory care practices where the pharmacist was a highly visible physical presence in the health care team, overall utilization may have been higher. This may have affected the nonvisit care activity type, thus further contributing to variability in overall time spent on nonvisit care activities between practices. Ambulatory care pharmacists with a heavier direct patient care volume and administrative workload would most likely be less visible to clinic staff, which may have deterred providers from engaging the pharmacist in nonvisit care activities. Education, adverse medication event, need for additional medication, and nonadherence were the four most frequent MTPs identified in the study and were similar in all ambulatory care practices. This correlated to a previous study of pharmacistprovided direct patient care, which identified the top three MTPs of needing additional medication, dose change, and nonadherence. 5 Although pharmacist-provided education to patients and the health care team is not a traditional MTP category, it was included in this study in an attempt to fully capture how ambulatory care pharmacist time was spent on nonvisit care activities. 5,12,13 Education accounted for approximately 30% of total MTPs, with health care team education occurring at nearly twice the frequency of patient education. This extent of pharmacologic education to patients and staff further illustrates the need to use ambulatory care pharmacists unique knowledge base and skill set in the primary care setting. Applicability of billing for nonvisit care activities, such as chronic care management billing, would most likely be limited in the sense that nonvisit care activities, such as those captured in this study, seem to occur at unique time points for

patients with limited follow-up. Because pharmacists spent substantial time each day on nonvisit care activities, reviewing the billing opportunities available could be considered a priority in the ambulatory care practice. This study focused exclusively on nonvisit care activities that directly affected individual patient care. Pharmacists are also involved in population-based activities, such as provider in-service education, quality assurance programs, or other clinic-based initiatives. Because these activities have limited effects on individual patient care, they were excluded from this study. Further research should evaluate the effects of pharmacist involvement with population-based activities in a clinic setting. Limitations This description of outpatient ambulatory care pharmacist involvement in nonvisit care is limited in scope and by the lack of comparative published literature for external validation of findings. Also, because of the unique structure of outpatient ambulatory care pharmacist utilization in our institution, the applicability of this study to other practices may be limited. One way to further describe practices and evaluate consistency between sites would be to capture nonvisit care activities in conjunction with scheduled pharmacist appointment volume and time spent. The 12-week time frame was believed to be adequate for both collecting data and minimizing variability in day-to-day practice. Although this time frame was limited it provides a basis for further research opportunities in the future to support these findings. Classification of education required as an MTP has not previously been included by other known studies. Arguably, this may not represent an MTP itself but may

be considered as a separate classification of nonvisit care activity. This decision to include education required as an MTP influences the overall description and quantification of nonvisit care activities, and further consideration may be needed to determine how to best capture this pharmacist-provided service. Another limitation of the study are the major variabilities between the ambulatory care practices included. In addition to number and type of primary care providers, availability of specialty services, and populations served, pharmacist-specific factors including use of collaborative practice agreements and length of time in an established role contributed to variation in study sites. Although this variability helps diversify the study, the heterogeneity may have skewed the data. Conclusion This study demonstrated that an ambulatory care pharmacist embedded in a primary care team offers additional resources that health care organizations can leverage to assist with nonvisit care activities. Although consistencies were identified in the type of nonvisit care activities performed by each ambulatory care pharmacist, practicespecific factors most likely affected the extent of individual pharmacist utilization. The study results were similar to those of previous work in direct patient care in the type of MTPs identified, with an additional category of pharmacist-provided education captured to more fully quantify ambulatory care pharmacist contributions through nonvisit care. Providers have voiced that, in a busy practice, it is often difficult to do timely research on the best treatment options for complex medical conditions while ensuring safe prescribing. Having an ambulatory care pharmacist readily available for curbside

consults to assist in these decisions enhances provider satisfaction through better efficiency and increases quality and safety of patient care. Team-based care is emphasized to the patient when they are part of shared decision-making that occurs in real time with multiple medical disciplines. In the midst of health care practices so highly dependent on electronic data processing, curbside consults with an ambulatory care pharmacist also facilitate a richness of professional interaction among members of the health care team that enhances provider satisfaction and thus favors reduced burnout. The findings of this study and providers viewpoints should lead future research to quantify the decrease in workload burden for consulting providers and care team members, determine the best utilization strategy for ambulatory care pharmacists for nonvisit care activities, determine billing opportunities for nonvisit care activities, and evaluate patient and provider satisfaction with pharmacist involvement.

References 1. American College of Clinical Pharmacy. Comprehensive medication management in team-based care. Available from www.accp.com/docs/positions/misc/cmm%20brief.pdf. Accessed January 24, 2019. 2. American College of Clinical Pharmacy, McBane SE, Dopp AL, et al. Collaborative drug therapy management and comprehensive medication management-2015. Pharmacotherapy 2015;35(4):e39-50. 3. Giberson S, Yoder S, Lee M. Improving patient and health system outcomes through advanced pharmacy practice. A report to the U.S. Surgeon General [2011]. Available from www.pharmacist.com/sites/default/files/files/usphs_report_ussg_1(1).pdf. Accessed January 24, 2019. 4. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc (2003) 2008;48(2):203-11. 5. Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm 2010;16(3):185-95. 6. Brummel AR, Soliman AM, Carlson AM, de Oliveira DR. Optimal diabetes care outcomes following face-to-face medication therapy management services. Popul Health Manag 2013;16(1):28-34.

7. Brummel A, Lustig A, Westrich K, et al. Best practices: improving patient outcomes and costs in an ACO through comprehensive medication therapy management. J Manag Care Spec Pharm 2014;20(12):1152-8. 8. Alkhateeb FM, Clauson KA, McCafferty R, Latif DA. Physician attitudes toward pharmacist provision of medication therapy management services. Pharm World Sci 2009;31(4):487-93. 9. American College of Clinical Pharmacy, Burke JM, Miller WA, et al. Clinical pharmacist competencies. Pharmacotherapy 2008;28(6):806-15. 10. American College of Clinical Pharmacy. Standards of practice for clinical pharmacists. Pharmacotherapy 2014;34(8):794-7. 11. Buxton JA, Babbitt R, Clegg CA, et al. ASHP guidelines: Minimum standard for ambulatory care pharmacy practice. Am J Health Syst Pharm 2015;72(14):1221-36. 12. Kaur S, Roberts JA, Roberts MS. Evaluation of medication-related problems in medication reviews: a comparative perspective. Ann Pharmacother 2012;46(7-8):972-82. 13. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice: the clinician's guide. 2nd ed. New York: McGraw-Hill Medical Pub. Division, 2004.

Table 1. Ambulatory Care Practice Characteristics During Data Collection Characteristic Practice 1 Practice 2 Practice 3 Practice 4 Pharmacist FTE allotment 1.0 1.0 0.8 0.8 Clinic primary care Family Family Family Family practice description Medicine Medicine Medicine Medicine Internal Internal Medicine Medicine No. of paneled patients 7300 37,035 17,523 37,588 No. of primary care 4 17 73 19 physicians No. of primary care 4 15 3 9 advanced practice providers Duration pharmacist was 20 17 12 11 established in practice at time of data collection, months FTE = full-time equivalent. Including residents.

Table 2. Nonvisit Care Subcategory Descriptions Nonvisit Care Subcategory Patient portal message Description Secure electronic communication initiated by a patient to the health care team via electronic health record Staff inbox message Electronic communication initiated by a health care team member to the ambulatory care pharmacist via electronic health record or secure messaging Patient telephone call Communication via telephone initiated by a patient to the ambulatory care pharmacist excluding scheduled appointments Staff telephone call/page Internal communication via telephone initiated by a health care team member to the ambulatory care pharmacist Staff face-to-face curbside consult Face-to-face communication initiated by a health care team member to the ambulatory care pharmacist

Figure Legends Figure 1. Nonvisit care activity types by practice. Figure 2. Medication therapy problems identified. Figure 3. Medication therapy interventions identified.

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