Best-worst scaling methodology to evaluate constructs of the Consolidated Framework for Implementation Research: application to the implementation of pharmacogenetic testing for antidepressant therapy.

BACKGROUND: Despite the increased demand for pharmacogenetic (PGx) testing to guide antidepressant use, little is known about how to implement testing in clinical practice. Best-worst scaling (BWS) is a stated preferences technique for determining the relative importance of alternative scenarios and is increasingly being used as a healthcare assessment tool, with potential applications in implementation research. We conducted a BWS experiment to evaluate the relative importance of implementation factors for PGx testing to guide antidepressant use. METHODS: We surveyed 17 healthcare organizations that either had implemented or were in the process of implementing PGx testing for antidepressants. The survey included a BWS experiment to evaluate the relative importance of Consolidated Framework for Implementation Research (CFIR) constructs from the perspective of implementing sites. RESULTS: Participating sites varied on their PGx testing platform and methods for returning recommendations to providers and patients, but they were consistent in ranking several CFIR constructs as most important for implementation: patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and identification of champions. CONCLUSIONS: This study demonstrates the feasibility of using choice experiments to systematically evaluate the relative importance of implementation determinants from the perspective of implementing organizations. BWS findings can inform other organizations interested in implementing PGx testing for mental health. Further, this study demonstrates the application of BWS to PGx, the findings of which may be used by other organizations to inform implementation of PGx testing for mental health disorders.

Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy.

There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.

Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System.

Pharmacogenomics (PGx) studies how a person's genes affect the response to medications and is quickly becoming a significant part of precision medicine. The clinical application of PGx principles has consistently been cited as a major opportunity for improving therapeutic outcomes. Several recent studies have demonstrated that most individuals (> 90%) harbor PGx variants that would be clinically actionable if prescribed a medication relevant to that gene. In multiple well-conducted studies, the results of PGx testing have been shown to guide therapy choice and dosing modifications which improve treatment efficacy and reduce the incidence of adverse drug reactions (ADRs). Although the value of PGx testing is evident, its successful implementation in a clinical setting presents a number of challenges to molecular diagnostic laboratories, healthcare systems, providers and patients. Different molecular methods can be applied to identify PGx variants and the design of the assay is therefore extremely important. Once the genotyping results are available the biggest technical challenge lies in turning this complex genetic information into phenotypes and actionable recommendations that a busy clinician can effectively utilize to provide better medical care, in a cost-effective, efficient and reliable manner. In this paper we describe a successful and highly collaborative implementation of the PGx testing program at the University of Minnesota and MHealth Fairview Molecular Diagnostic Laboratory and selected Pharmacies and Clinics. We offer detailed descriptions of the necessary components of the pharmacogenomic testing implementation, the development and technical validation of the in-house SNP based multiplex PCR based assay targeting 20 genes and 48 SNPs as well as a separate CYP2D6 copy number assay along with the process of PGx report design, results of the provider and pharmacists usability studies, and the development of the software tool for genotype-phenotype translation and gene-phenotype-drug CPIC-based recommendations. Finally, we outline the process of developing the clinical workflow that connects the providers with the PGx experts within the Molecular Diagnostic Laboratory and the Pharmacy.

Pharmacogenomics education, research and clinical implementation in the state of Minnesota.

Several healthcare organizations across Minnesota have developed formal pharmacogenomic (PGx) clinical programs to increase drug safety and effectiveness. Healthcare professional and student education is strong and there are multiple opportunities in the state for learners to gain workforce skills and develop advanced competency in PGx. Implementation planning is occurring at several organizations and others have incorporated structured utilization of PGx into routine workflows. Laboratory-based and translational PGx research in Minnesota has driven important discoveries in several therapeutic areas. This article reviews the state of PGx activities in Minnesota including educational programs, research, national consortia involvement, technology, clinical implementation and utilization and reimbursement, and outlines the challenges and opportunities in equitable implementation of these advances.

A Dentist, Pilot, and Pastry Chef Walk into a Bar Why Teaching PPCP is Not Enough.

For both education and practice, the dissemination of the Joint Commission of Pharmacy Practitioner's Patient Care Process for Pharmacists has heightened attention to the need for a defined care process for pharmacists. Yet, when one compares this framework with those described in other disciplines, what makes it specific to pharmacy? Graduates must establish their unique role in patient care management among the health care team. Therefore, it is essential that pharmacy educators prepare students to contribute uniquely and communicate articulately about those contributions. This involves intentionally teaching an explicit clinical assessment process and a recognized taxonomy for communicating medication-related needs. In addition, educators must: ensure integration of patient care frameworks unique to pharmacists in curricula, commit to critical evaluation of care process instruction, and partner with external stakeholders to establish the distinct contributions of pharmacists to team-based care.

This is how I think: Evaluation of a preceptor development webinar on incorporating the Pharmacists' Patient Care Process into experiential teaching.

INTRODUCTION: There is a critical need to establish and teach a uniform pharmacists' patient care process (PPCP) to create consistency in the profession. Little is known about preceptor incorporation of the PPCP into experiential teaching. METHODS: Using a pre-/post-program survey, this study aimed to characterize preceptors' perception of PPCP incorporation in teaching, confidence in PPCP articulation to team members and students, and ability to identify precepting strategies before and after completing a continuing education (CE) webinar. RESULTS: 103 of the 158 preceptors enrolled in the CE program completed pre-/post-program surveys. Preceptors' perception of PPCP incorporation with introductory pharmacy practice experience (IPPE) students did not change significantly after the program (1.98 vs. 1.88, p = 0.317). However, advanced pharmacy practice experience (APPE) preceptors were less likely to strongly agree to PPCP incorporation after completing the program (1.91 vs. 1.72, p = 0.016). Preceptors felt increased confidence in their ability to articulate the PPCP to both team members (2.07 vs. 1.60, p = 0.000) and students (2.01 vs. 1.63, p = 0.000). Preceptors strongly agreed they had new strategies to use in precepting. CONCLUSION: In order to prepare student pharmacists, preceptors must be prepared to explicitly incorporate the PPCP into their teaching. A webinar with case examples and a preceptor tool can help equip preceptors to articulate the PPCP to colleagues and students, and to identify strategies to incorporate the PPCP into their precepting.

Improving Comprehensive Medication Management (CMM) Completed Visit Rates in Newly Referred and No-Show Patient Cohorts.

BACKGROUND: Missed appointments are a common problem in health care. No-show rates and incomplete appointments for referred patients affect patient outcomes and clinician's productivity, including comprehensive medication management (CMM) visits that pharmacists provide. This study aims to compare CMM completion rates between various intervention types in communicating with the patient. METHODS: This was a prospective, multi-clinic study to examine newly implemented intervention effects on CMM completion rates. The primary outcomes were CMM completion rates among newly referred patients and CMM completion rates in any no-show patients, including both newly referred and returning patients. In the newly referred patient cohort, three intervention types (blocking time on the pharmacist's schedule to speak to the patient, sending an electronic medical record or EMR-linked message, and sending a letter) were compared to a control group with no interventions. In the no-show cohort, a pharmacist call intervention was compared to a control group consisting of sending a letter. RESULTS: Completed CMM appointment rate was six times likely with a pharmacist's in-person reminder (odds ratio [OR] 6.0; 95% confidence interval [CI] 1.58-22.77) and with an EMR-linked message (OR 6.0; 95% CI 1.76 to 20.52) when compared to sending a letter. In no-show patients, completed CMM appointment rate was 2.36 times likely with a pharmacist's call intervention versus sending a letter. CONCLUSION: Pharmacist's direct reminder to the patient when in clinic and EMR-linked message improved CMM completion rate when compared to mailing a reminder letter. Pharmacist's call to no-show patients for their CMM appointment was effective for the patients to reschedule and complete their CMM appointment compared to mailing a reminder letter.