scholarly journals Strategies to Integrate Genomic Medicine into Clinical Care: Evidence from the IGNITE Network

2021 ◽  
Vol 11 (7) ◽  
pp. 647
Author(s):  
Nina R. Sperber ◽  
Olivia M. Dong ◽  
Megan C. Roberts ◽  
Paul Dexter ◽  
Amanda R. Elsey ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Program Implementation ◽  
Clinical Care ◽  
Genomic Medicine ◽  
Implementation Strategies ◽  
Clinical Decision ◽  
Implementing Change ◽  
Implementation Outcomes ◽  
Planning Framework

The complexity of genomic medicine can be streamlined by implementing some form of clinical decision support (CDS) to guide clinicians in how to use and interpret personalized data; however, it is not yet clear which strategies are best suited for this purpose. In this study, we used implementation science to identify common strategies for applying provider-based CDS interventions across six genomic medicine clinical research projects funded by an NIH consortium. Each project’s strategies were elicited via a structured survey derived from a typology of implementation strategies, the Expert Recommendations for Implementing Change (ERIC), and follow-up interviews guided by both implementation strategy reporting criteria and a planning framework, RE-AIM, to obtain more detail about implementation strategies and desired outcomes. We found that, on average, the three pharmacogenomics implementation projects used more strategies than the disease-focused projects. Overall, projects had four implementation strategies in common; however, operationalization of each differed in accordance with each study’s implementation outcomes. These four common strategies may be important for precision medicine program implementation, and pharmacogenomics may require more integration into clinical care. Understanding how and why these strategies were successfully employed could be useful for others implementing genomic or precision medicine programs in different contexts.

Impact of precision medicine on clinical care: A single institution retrospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14601-e14601
Author(s):  
Rajvi Patel ◽  
Ryann Quinn ◽  
Xinhua Zhu
Keyword(s):  
Retrospective Study ◽  
Precision Medicine ◽  
Clinical Care ◽  
Objective Response ◽  
Molecular Characteristics ◽  
Genomic Testing ◽  
Tumor Type ◽  
Lost To Follow Up ◽  
Line Chemotherapy

e14601 Background: In Oncology, precision medicine (PM) looks at molecular characteristics of tumors instead of traditional histology to determine treatment strategies. Examples are EGFR, ALK, BRAF, ROS1 and PD-L1 in non-small cell lung cancer, HER2 in breast and gastric cancer, K-RAS, N-RAS in colon cancer, and MMR/MSI in all solid tumors. Genomic testing is commonly done for patients with advanced cancer resistant to standard treatment. FoundationOne-CDx (F1CDx) is expensive but only FDA approved test for somatic genomic profiling of tumors. It is necessary to review an expensive test and its impact on clinical care. At our institution, we have patients who have had F1CDx testing. Our aim was to determine proportion of tumors that have actionable mutation (AM) for which there are currently FDA or non-FDA approved targeted treatment(s) (TT) available, proportion of pts who received TT, and barriers to receiving TT. Methods: Retrospective study of 1000 patients treated at our institution who had F1CDx testing done between September 2012 and July 2018. Variables collected included primary tumor type, F1CDx results, treatments received, and any barriers. Descriptive statistics including frequencies and proportions were utilized. Results: Of 1000 pts, 652 had tumors harboring AM. Of the 652 pts: 42 went on a clinical trial, 165 received standard next line chemotherapy, 135 received TT (38 pts received currently non-FDA approved TT), 144 either went on hospice or died prior to receiving treatment, 142 were lost to follow up, 21 were treated with surgery only, and 3 had issues with insurance approval of TT. Conclusions: Of the 65% of pts with tumors harboring AM, only 20% received TT. 25% of pts received standard next line chemotherapy. Going on hospice and being lost to follow up largely accounted for patients not receiving TT. Therefore, treating physicians should strongly consider pts’ performance status and co-morbidities prior to sending expensive genomic testing as it may have limited impact on clinical outcome. Our next steps to further investigate will be to look at objective response rate, progression free survival, and overall survival in pts who received non-FDA approved TT.

scholarly journals A Review of Genome-Based Precision Medicine Efforts Within the Department of Defense

2021 ◽  
Vol 187 (Supplement_1) ◽  
pp. 25-31
Author(s):  
Lucas Poon ◽  
Elaine D Por ◽  
Hyun Joon Cho ◽  
Thomas G Oliver
Keyword(s):  
Patient Care ◽  
Precision Medicine ◽  
Department Of Defense ◽  
National Guard ◽  
Clinical Care ◽  
Genomic Medicine ◽  
Care Plan ◽  
Patient Specific ◽  
Pubmed Database ◽  
Genotype Information

ABSTRACT Introduction Providing patient-specific clinical care is an expanding focus for medical professionals and researchers, more commonly referred to as personalized or precision medicine. The goal of using a patient-centric approach is to provide safer care while also increasing the probability of therapeutic success through careful consideration of the influence of certain extrinsic and intrinsic human factors in developing the patient care plan. Of increasing influence on patient care is the phenotype and genotype information gathered from employing various next-generation sequencing methods. Guided by and partnered with our civilian colleagues, clinical components within the DoD are embracing and advancing genomic medicine in many facets—from the bench to the bedside—and in many therapeutic areas, from Psychiatry to Oncology. In this PubMed-based review, we describe published clinical research and interventions within the DoD using genome-informed data and emphasize precision medicine efforts in earlier stages of development with the potential to revolutionize the approach to therapeutics. Materials and Methods The new PubMed database was searched for articles published between 2015 and 2020 with the following key search terms: precision medicine, genomic, pharmacogenetic, pharmacogenomic, US military, and Department of Defense. Results Eighty-one articles were retrieved in our initial search. After screening the abstracts for studies that only involved direct testing of (or clinical interaction with) active duty, Reserve, National Guard, or civilian personnel working within the DoD and excluding any epidemiological or microbial isolation studies, seven were included in this review. Conclusion There are several programs and studies within the DoD, which investigate or use gene-based biomarkers or gene variants to deliver more precise clinical assessment and treatment. These genome-based precision medicine efforts aim to optimize the clinical care of DoD beneficiaries, particularly service members in the operational environment.

scholarly journals Using Implementation Science Strategy Mapping on the Age-Friendly Health System's 4Ms Journey

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 365-365
Author(s):  
Mary Dolansky ◽  
Anne Pohnert ◽  
Sherry Greenberg
Keyword(s):  
Implementation Science ◽  
Scale Up ◽  
Implementation Strategies ◽  
Mapping Method ◽  
Evidence Based ◽  
Systematic Process ◽  
Implementing Change ◽  
Implementation Outcomes ◽  
Adoption And Implementation ◽  
And Performance

Abstract Background Implementation science is the study of methods to promote the adoption and integration of evidence-based practices into routine health care to improve the quality of care. The purpose of this study was to use Implementation Mapping to guide the implementation of The John A. Hartford evidence-based Age-Friendly Health Systems (AFHS) 4Ms Framework: What Matters, Medications, Mentation, and Mobility. Methods Implementation Mapping, a systematic process for planning implementation strategies, guided the 9-month integration of the 4Ms Framework in the 1,100 MinuteClinics across the US. Implementation Mapping includes five tasks: (1) conduct an implementation needs assessment and identify program adopters and implementers; (2) state adoption and implementation outcomes and performance objectives, identify determinants, and create matrices of change objectives; (3) choose theoretical methods (mechanisms of change) and select or design implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes. Results The implementation plan, developed by the implementation mapping method, was carried out over 9-months. Seven implementation strategies were identified from the Expert Recommendations for Implementing Change (ERIC) project including the provision of education, electronic health record integration, internal champion facilitation, cues to action, and a dashboard to monitor progress. To date, the implementation mapping has resulted in the adoption of the 4Ms by 1145 providers (37%). Monitoring of the adoption of the 4Ms Framework and consideration of future implementation strategies is ongoing. Conclusions Implementation Mapping provided a systematic process to develop strategies to improve the adoption, implementation, sustainment, and scale-up of the evidence-based 4Ms Framework.

scholarly journals Tracking Adaptation and Fidelity When Embedding COPE, Evidence-Based Dementia Care, in PACE Sites

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 176-176
Author(s):  
Laura Gitlin ◽  
Nancy Hodgson
Keyword(s):  
Program Implementation ◽  
Implementation Strategies ◽  
Care Program ◽  
Dementia Care ◽  
Theory Of Change ◽  
Evidence Based ◽  
Delivery Methods ◽  
Implementing Change ◽  
Essential Question ◽  
Core Components

Abstract One essential question in moving dementia care interventions to practice is, “What is the optimal balance between fidelity to, and adaptation of, a proven program in “real world” settings?" We present a protocol for measuring the adaptation/fidelity and implementation of an evidence-based dementia care program (Care of Persons in their Environment, COPE) in PACE settings. During pre-implementation, science-based elements of COPE were documented including the theory of change, logic model and core components. Possible adaptations to COPE in its delivery were identified and included program structure (sequence of sessions), content (assessments), and delivery methods (online). During implementation, documentation of implementation strategies is captured using an evidence-informed checklist derived from the Expert Recommendations for Implementing Change (ERIC) workgroup. Ongoing documentation of fidelity/adaptation aspects of program implementation is conducted using the FRAME framework. Understanding methods and measures deployed in adaptation and implementation of evidence-based dementia programs can help guide future translation efforts.

scholarly journals Compensatory and Lifestyle-Based Brain Health Program for Subjective Cognitive Decline: Self-Implementation versus Coaching

2021 ◽  
Vol 11 (10) ◽  
pp. 1306
Author(s):  
Harris Liou ◽  
Cynthia M. Stonnington ◽  
Amit A. Shah ◽  
Skye A. Buckner-Petty ◽  
Dona E. C. Locke
Keyword(s):  
Cognitive Decline ◽  
Program Implementation ◽  
Health Program ◽  
Healthy Lifestyle ◽  
Implementation Strategies ◽  
Subjective Cognitive Decline ◽  
Control Group ◽  
Brain Health ◽  
Memory Support

Although recent studies have explored the potential of multidomain brain health programs, there is a dearth of literature on operationalizing this research to create a clinical treatment program specifically for subjective cognitive decline (SCD). Patients seen by geriatricians in primary care and by behavioral neurology services at our institution presenting with SCD were recruited via a patient-appropriate flyer. After all participants had a 1-h brain health consultation with a neuropsychologist and were provided with program materials, they were randomized to attend a 10-week intervention designed to support program implementation (N = 10) or the control group of implementing the program on their own (N = 11). The program included (1) a calendar-based executive and memory support system for compensatory training and (2) training in healthy lifestyle. There were no significant differences between groups for any outcomes. Participants across both groups showed significant improvements with moderate effect sizes in compensatory strategy use, anxiety symptoms, and daily functioning, which were sustained through 6-month follow-up. They also increased physical activity by the end of the intervention period but did not sustain this through 6-month follow-up. Our pilot study demonstrates preliminary feasibility of a cognitive compensatory and lifestyle-based brain health program. Additional research is recommended to further develop two potentially scalable implementation strategies—coaching and self-implementation after brief consultation.

scholarly journals Developing knowledge resources to support precision medicine: principles from the Clinical Pharmacogenetics Implementation Consortium (CPIC)

2016 ◽  
Vol 23 (4) ◽  
pp. 796-801 ◽  
Author(s):  
James M Hoffman ◽  
Henry M Dunnenberger ◽  
J Kevin Hicks ◽  
Kelly E Caudle ◽  
Michelle Whirl Carrillo ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Point Of Care ◽  
Clinical Care ◽  
Clinical Information ◽  
Clinical Decision ◽  
Knowledge Bases ◽  
Knowledge Resources ◽  
Collective Experience ◽  
Implementation Resources ◽  
Machine Readable

Abstract To move beyond a select few genes/drugs, the successful adoption of pharmacogenomics into routine clinical care requires a curated and machine-readable database of pharmacogenomic knowledge suitable for use in an electronic health record (EHR) with clinical decision support (CDS). Recognizing that EHR vendors do not yet provide a standard set of CDS functions for pharmacogenetics, the Clinical Pharmacogenetics Implementation Consortium (CPIC) Informatics Working Group is developing and systematically incorporating a set of EHR-agnostic implementation resources into all CPIC guidelines. These resources illustrate how to integrate pharmacogenomic test results in clinical information systems with CDS to facilitate the use of patient genomic data at the point of care. Based on our collective experience creating existing CPIC resources and implementing pharmacogenomics at our practice sites, we outline principles to define the key features of future knowledge bases and discuss the importance of these knowledge resources for pharmacogenomics and ultimately precision medicine.

Tobacco cessation practices among primary care physicians in northern Illinois.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23054-e23054
Author(s):  
Cheryl Nocon ◽  
Mihir Bhayani ◽  
Amanda Karcioglu
Keyword(s):  
Primary Care ◽  
Cancer Patients ◽  
Program Implementation ◽  
Primary Care Physicians ◽  
Tobacco Cessation ◽  
Clinical Care ◽  
Electronic Survey ◽  
Clinical Support ◽  
Levels Of Support

e23054 Background: Tobacco cessation is an acknowledged key component of cancer survivorship programs, but significant barriers to program implementation exist. In a 2012 ASCO member survey, 86% of respondents agreed that tobacco cessation should be a routine part of clinical care. However, only 29% reported adequate training. A 2013 survey of physicians at NCI Cancer Centers also showed high levels of support for such programs, but only 1% of oncologists personally engaged themselves. This view is in line with ASCO guidelines that recommend cessation interventions by primary care (PCPs). There is a disconnect between the oncologist’s desire to provide high quality tobacco cessation support for cancer patients and the delegation and delivery of such support. The goal of our study is to evaluate current tobacco cessation practices of PCPs in a large integrated healthcare system. Methods: An electronic survey was sent to all PCPs (n = 165) of the NorthShore Medical Group (Northern Illinois) with questions about their views and practices regarding tobacco cessation. Results: 53 PCPs responded to the survey (response rate of 32%). 94% of respondents believe that PCPs are primarily responsible for addressing tobacco cessation with general patients. 89% believe that PCPs are also responsible for cancer patients, although 34% believe the responsibility should be shared with oncologists. 100% believe that tobacco use affects cancer outcomes in their patients, and 98% report sufficient training in providing cessation support. 90% always ask their patients about tobacco status at the initial visit; this drops to 21% at follow-up visits. For current smokers, 57% of PCPs recommend tobacco cessation all the time and 36% recommend services most of the time. Lack of patient willingness was the most frequently cited barrier to tobacco cessation efforts (74%), followed by lack of time (46%) and lack of resources (42%). Conclusions: PCPs view themselves as primarily responsible for addressing tobacco cessation with their patients but are limited by multiple factors. This primary care-based approach is endorsed by ASCO and other clinical guidelines. More financial and clinical support should be allocated for successful efforts against tobacco dependency.

scholarly journals Updated Diagnostic Criteria for Paraneoplastic Neurologic Syndromes

2021 ◽  
Vol 8 (4) ◽  
pp. e1014
Author(s):  
Francesc Graus ◽  
Alberto Vogrig ◽  
Sergio Muñiz-Castrillo ◽  
Jean-Christophe G. Antoine ◽  
Virginie Desestret ◽  
...  
Keyword(s):  
High Risk ◽  
Diagnostic Criteria ◽  
Clinical Decision Making ◽  
Checkpoint Inhibitors ◽  
Clinical Care ◽  
Clinical Decision ◽  
Intermediate Risk ◽  
Research Initiatives ◽  
Paraneoplastic Neurologic Syndromes

ObjectiveThe contemporary diagnosis of paraneoplastic neurologic syndromes (PNSs) requires an increasing understanding of their clinical, immunologic, and oncologic heterogeneity. The 2004 PNS criteria are partially outdated due to advances in PNS research in the last 16 years leading to the identification of new phenotypes and antibodies that have transformed the diagnostic approach to PNS. Here, we propose updated diagnostic criteria for PNS.MethodsA panel of experts developed by consensus a modified set of diagnostic PNS criteria for clinical decision making and research purposes. The panel reappraised the 2004 criteria alongside new knowledge on PNS obtained from published and unpublished data generated by the different laboratories involved in the project.ResultsThe panel proposed to substitute “classical syndromes” with the term “high-risk phenotypes” for cancer and introduce the concept of “intermediate-risk phenotypes.” The term “onconeural antibody” was replaced by “high risk” (>70% associated with cancer) and “intermediate risk” (30%–70% associated with cancer) antibodies. The panel classified 3 levels of evidence for PNS: definite, probable, and possible. Each level can be reached by using the PNS-Care Score, which combines clinical phenotype, antibody type, the presence or absence of cancer, and time of follow-up. With the exception of opsoclonus-myoclonus, the diagnosis of definite PNS requires the presence of high- or intermediate-risk antibodies. Specific recommendations for similar syndromes triggered by immune checkpoint inhibitors are also provided.ConclusionsThe proposed criteria and recommendations should be used to enhance the clinical care of patients with PNS and to encourage standardization of research initiatives addressing PNS.

scholarly journals Genomic Information for Clinicians in the Electronic Health Record: Lessons Learned from ClinGen and eMERGE

2019 ◽  
Author(s):  
Marc S Williams ◽  
Casey Overby Taylor ◽  
Nephi A Walton ◽  
Scott R Goehringer ◽  
Samuel Aronson ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Genomic Medicine ◽  
Clinical Decision ◽  
Lessons Learned ◽  
Health Record ◽  
Sustainable Solutions ◽  
Electronic Health ◽  
Credible Information

Genomic knowledge is being translated into clinical care. To fully realize the value, it is critical to place credible information in the hands of clinicians in time to support clinical decision-making. The electronic health record is an essential component of clinician workflow. Utilizing the electronic health record to present information to support the use of genomic medicine in clinical care to improve outcomes represents a tremendous opportunity. However, there are numerous barriers that prevent the effective use of the electronic health record for this purpose. The electronic health record working groups of the electronic MEdical Records and GEnomics network (eMERGE) and the Clinical Genome Resource (ClinGen) project, along with other groups, have been defining these barriers, to allow the development of solutions that can be tested using implementation pilots. In this paper, we present ‘lessons learned’ from these efforts to inform future efforts leading to the development of effective and sustainable solutions that will support the realization of genomic medicine.

scholarly journals Descriptive Evaluation of SBIRT Adoption, Implementation, and Delivery across a Health System

2020 ◽  
Author(s):  
Alyson Keen ◽  
Kelli M Thoele ◽  
Ukamaka Oruche ◽  
Robin Newhouse
Keyword(s):  
Health System ◽  
Implementation Strategies ◽  
Structured Interview ◽  
Evidence Based ◽  
Positive Health ◽  
Sustaining Change ◽  
Implementing Change ◽  
Implementation Studies ◽  
Common Framework

Abstract Background: Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based intervention used to enhance reductions in alcohol and illicit drug use. SBIRT use has resulted in positive health and social outcomes. However, SBIRT implementation remains low. Research on implementation of evidence-based interventions, such as SBIRT, lacks information about challenges and successes related to implementation. The Expert Recommendations for Implementing Change (ERIC) provides a framework that improves the comprehension, clarity, and relevance of strategies available for implementation research. This framework was applied to structure findings from analyses of qualitative interview data gathered from local champions leading SBIRT implementation. The purpose of this study was to understand site coordinators’ (SCs) perceptions of SBIRT implementation and employed strategies. Study aims included (1) describe SCs’ perceptions of barriers, facilitators, and outcomes related to SBIRT implementation, and (2) describe strategies perceived as most effective to implement SBIRT. Methods: This was a descriptive study conducted with 14 SCs, representing 14 medical surgical units within a large healthcare system. A semi-structured interview guide was developed by the study team to capture barriers, facilitators, and outcomes related to SBIRT implementation. A follow-up survey, based on 14 commonly identified ERIC strategies during SC interviews, was administered to determine the SC’s perceptions of the most helpful (i.e. effective) implementation strategies on a scale of 1 (least helpful) to 5 (most helpful).Results: All site coordinators participated in the SBIRT implementation interview, and 11 of 14 (79%) responded to the follow-up survey. Within the categories of barriers, facilitators, and outcomes, 25 subthemes emerged. The most highly rated effective ERIC implementation strategies were purposely reexamining the implementation (M=4.38; n=8), providing ongoing consultation (M=4.13; n=8), auditing and providing feedback (M=4.1; n=10), developing education materials (M=4.1; n=10), identifying and preparing champions (M=4; n=7), and tailoring strategies (M=4; n=7). Conclusion: This study applied a common framework (ERIC) to implementation lessons within a large health system that can be replicated in other implementation studies and quality improvement efforts. Adapting and sustaining change are challenging in healthcare settings. However, understanding and using the most helpful implementations strategies may support healthcare teams to adopt and sustain interventions such as SBIRT.

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