Quality improvement lessons learned from National Implementation of the "Patient Safety Events in Community Care: Reporting, Investigation, and Improvement Guidebook".

OBJECTIVE: To evaluate nationwide implementation of a Guidebook designed to standardize safety practices across VA-delivered and VA-purchased care (i.e., Community Care) and identify lessons learned and strategies to improve them. DATA SOURCES AND STUDY SETTING: Qualitative data collected from key informants at 18 geographically diverse VA facilities across 17 Veterans Integrated Services Networks (VISNs). STUDY DESIGN: We conducted semi-structured interviews from 2019 to 2022 with VISN Patient Safety Officers (PSOs) and VA facility patient safety and quality managers (PSMs and QMs) and VA Facility Community Care (CC) staff to assess lessons learned by examining organizational contextual factors affecting Guidebook implementation based on the Consolidated Framework for Implementation Research (CFIR). DATA COLLECTION/EXTRACTION METHODS: Interviews were conducted virtually with 45 facility staff and 10 VISN PSOs. Using directed content analysis, we identified CFIR factors affecting implementation. These factors were mapped to the Expert Recommendations for Implementing Change (ERIC) strategy compilation to identify lessons learned that could be useful to our operational partners in improving implementation processes. We met frequently with our partners to discuss findings and plan next steps. PRINCIPAL FINDINGS: Six CFIR constructs were identified as both facilitators and barriers to Guidebook implementation: (1) planning for implementation; (2) engaging key knowledge holders; (3) available resources; (4) networks and communications; (5) culture; and (6) external policies. The two CFIR constructs that were only barriers included: (1) cosmopolitanism and (2) executing implementation. CONCLUSIONS: Our findings suggest several important lessons: (1) engage all collaborators involved in implementation; (2) ensure end-users have opportunities to provide feedback; (3) describe collaborators' purpose and roles/responsibilities clearly at the start; (4) communicate information widely and repeatedly; and (5) identify how multiple high priorities can be synergistic. This evaluation will help our partners and key VA leadership to determine next steps and future strategies for improving Guidebook implementation through collaboration with VA staff.

Measuring Patient-Reported Use and Outcomes From Complementary and Integrative Health Therapies: Development of the Complementary and Integrative Health Therapy Patient Experience Survey.

Background: Assessing the use and effectiveness of complementary and integrative health (CIH) therapies via survey can be complicated given CIH therapies are used in various locations and formats, the dosing required to have an effect is unclear, the potential health and well-being outcomes are many, and describing CIH therapies can be challenging. Few surveys assessing CIH therapy use and effectiveness exist, and none sufficiently reflect these complexities. Objective: In a large-scale Veterans Health Administration (VA) quality improvement effort, we developed the "Complementary and Integrative Health Therapy Patient Experience Survey", a longitudinal, electronic patient self-administered survey to comprehensively assess CIH therapy use and outcomes. Methods: We obtained guidance from the literature, subject matter experts, and Veteran patients who used CIH therapies in designing the survey. As a validity check, we completed cognitive testing and interviews with those patients. We conducted the survey (March 2021-April 2023), inviting 15,608 Veterans with chronic musculoskeletal pain with a recent CIH appointment or referral identified in VA electronic medical records (EMR) to participate. As a second validity check, we compared VA EMR data and patient self-reports of CIH therapy utilization a month after survey initiation and again at survey conclusion. Results: The 64-item, electronic survey assesses CIH dosing (amount and timing), delivery format and location, provider location, and payor. It also assesses 7 patient-reported outcomes (pain, global mental health, global physical health, depression, quality of life, stress, and meaning/purpose in life), and 3 potential mediators (perceived health competency, healthcare engagement, and self-efficacy for managing diseases). The survey took 17 minutes on average to complete and had a baseline response rate of 45.3%. We found high degrees of concordance between self-reported and EMR data for all therapies except meditation. Conclusions: Validly assessing patient-reported CIH therapy use and outcomes is complex, but possible.

Overcoming barriers to implementation: mapping implementation strategies in four hospital in home programs within the Veterans Health Administration.

The Hospital at Home model, called Hospital-in-Home (HIH) in the Department of Veterans Affairs, delivers coordinated, high-value care aligned with older adult and caregiver preferences. Documenting implementation barriers and corresponding strategies to overcome them can address challenges to widespread adoption. To evaluate HIH implementation barriers and identify strategies to address them, we conducted interviews with 8 HIH staff at 4 hospitals between 2010 and 2013. We utilized qualitative directed content analysis guided by the Consolidated Framework for Implementation Research (CFIR) and mapped identified barriers to possible strategies using the CFIR-Expert Recommendations for Implementing Change (ERIC) Matching Tool. We identified 11 barriers spanning 5 CFIR domains. Three implementation strategies - identifying and preparing champions, conducting educational meetings, and capturing and sharing local knowledge - achieved high expert endorsement for each barrier. A mix of strategies targeting resources, organizational readiness and fit, and leadership engagement should be considered to support the sustainability and spread of HIH.

A Novel Informatics Tool to Detect Periprocedural Antibiotic Allergy Adverse Events for Near Real-time Surveillance to Support Audit and Feedback.

Importance: Standardized processes for identifying when allergic-type reactions occur and linking reactions to drug exposures are limited. Objective: To develop an informatics tool to improve detection of antibiotic allergic-type events. Design, Setting, and Participants: This retrospective cohort study was conducted from October 1, 2015, to September 30, 2019, with data analyzed between July 1, 2021, and January 31, 2022. The study was conducted across Veteran Affairs hospitals among patients who underwent cardiovascular implantable electronic device (CIED) procedures and received periprocedural antibiotic prophylaxis. The cohort was split into training and test cohorts, and cases were manually reviewed to determine presence of allergic-type reaction and its severity. Variables potentially indicative of allergic-type reactions were selected a priori and included allergies entered in the Veteran Affair's Allergy Reaction Tracking (ART) system (either historical [reported] or observed), allergy diagnosis codes, medications administered to treat allergic reactions, and text searches of clinical notes for keywords and phrases indicative of a potential allergic-type reaction. A model to detect allergic-type reaction events was iteratively developed on the training cohort and then applied to the test cohort. Algorithm test characteristics were assessed. Exposure: Preprocedural and postprocedural prophylactic antibiotic administration. Main Outcomes and Measures: Antibiotic allergic-type reactions. Results: The cohort of 36 344 patients included 34 703 CIED procedures with antibiotic exposures (mean [SD] age, 72 [10] years; 34 008 [98%] male patients); median duration of postprocedural prophylaxis was 4 days (IQR, 2-7 days; maximum, 45 days). The final algorithm included 7 variables: entries in the Veteran Affair's hospitals ART, either historic (odds ratio [OR], 42.37; 95% CI, 11.33-158.43) or observed (OR, 175.10; 95% CI, 44.84-683.76); PheCodes for "symptoms affecting skin" (OR, 8.49; 95% CI, 1.90-37.82), "urticaria" (OR, 7.01; 95% CI, 1.76-27.89), and "allergy or adverse event to an antibiotic" (OR, 11.84, 95% CI, 2.88-48.69); keyword detection in clinical notes (OR, 3.21; 95% CI, 1.27-8.08); and antihistamine administration alone or in combination (OR, 6.51; 95% CI, 1.90-22.30). In the final model, antibiotic allergic-type reactions were identified with an estimated probability of 30% or more; positive predictive value was 61% (95% CI, 45%-76%); and sensitivity was 87% (95% CI, 70%-96%). Conclusions and Relevance: In this retrospective cohort study of patients receiving periprocedural antibiotic prophylaxis, an algorithm with a high sensitivity to detect incident antibiotic allergic-type reactions that can be used to provide clinician feedback about antibiotic harms from unnecessarily prolonged antibiotic exposures was developed.

Poor insight and future thinking in early dementia limit patient projections of potential utility of technological innovations and advanced care planning.

Introduction: Cognitive psychology posits that thinking about the future relies on memory such that those with memory impairment may have trouble imaging their future technology and other needs. Methods: We conducted a content analysis of qualitative data from interviews with six patients with MCI or early dementia regarding potential adaptations to a mobile telepresence robot. Using a matrix analysis approach, we explored perceptions of (1) what technology could help with day-to-day functioning in the present and future and (2) what technology may help people with memory problems or dementia stay home alone safely. Results: Very few participants could identify any technology to assist themselves or other people with memory problems and could not provide suggestions on what technology may help them stay home alone safely. Most perceived that they would never need robotic assistance. Discussion: These findings suggest individuals with MCI or early dementia have limited perspectives on their own functional abilities now and in the future. Consideration of the individuals' diminished understanding of their own future illness trajectory is crucial when engaging in research or considering novel technological management solutions and may have implications for other aspects of advanced care planning.

A Citation Review of 83 Dissemination and Implementation Theories, Models, or Frameworks Utilized in U.S.-Based Aging Research.

BACKGROUND AND OBJECTIVES: Dissemination-implementation.org outlines 110 theories, models, and frameworks (TMFs): we conducted a citation analysis on 83 TMFs, searching Web of Science and PubMed databases. RESEARCH DESIGN AND METHODS: Search terms were broad and included "aging," "older," "elderly," and "geriatric." We extracted each TMF in identified articles from inception through January 28, 2022. Included articles must have used a TMF in research or quality improvement work directly linked to older adults within the United States. RESULTS: We reviewed 2,681 articles of which 295 articles cited at least one of 56 TMFs. Five TMFs represented 50% of the citations: Reach, Effectiveness, Adoption, Implementation, and Maintenance 1.0, Consolidated Framework for Implementation Research, Greenhalgh Diffusion of Innovation in Service Organizations, Quality Enhancement Research Initiative, Community-Based Participatory Research, and Promoting Action on Research Implementation in Health Services. TMF application varied and there was a steady increase in TMF citations over time, with a 2- to 3-fold increase in citations in 2020-2021. We identified that only 41% of TMF use was meaningful. DISCUSSION AND IMPLICATIONS: Our results suggest TMF utilization is increasing in aging research, but there is a need to more meaningful utilize TMFs. As the population of older adults continues to grow, there will be increasing demand for effective evidence-based practices and models of care to be quickly and effectively translated into routine care. Use of TMFs is critical to building such evidence and to identifying and evaluating methods to support this translation.

Identification of Implementation Strategies Using the CFIR-ERIC Matching Tool to Mitigate Barriers in a Primary Care Model for Older Veterans.

BACKGROUND AND OBJECTIVES: As the proportion of the U.S. population over 65 and living with complex chronic conditions grows, understanding how to strengthen the implementation of age-sensitive primary care models for older adults, such as the Veterans Health Administration's Geriatric Patient-Aligned Care Teams (GeriPACT), is critical. However, little is known about which implementation strategies can best help to mitigate barriers to adopting these models. We aimed to identify barriers to GeriPACT implementation and strategies to address these barriers using the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change (CFIR-ERIC) Matching Tool. RESEARCH DESIGN AND METHODS: We conducted a content analysis of qualitative responses obtained from a web-based survey sent to GeriPACT members. Using a matrix approach, we grouped similar responses into key barrier categories. After mapping barriers to CFIR, we used the Tool to identify recommended strategies. RESULTS: Across 53 Veterans Health Administration hospitals, 32% of team members (n = 197) responded to our open-ended question about barriers to GeriPACT care. Barriers identified include Available Resources, Networks & Communication, Design Quality & Packaging, Knowledge & Beliefs, Leadership Engagement, and Relative Priority. The Tool recommended 12 Level 1 (e.g., conduct educational meetings) and 24 Level 2 ERIC strategies (e.g., facilitation). Several strategies (e.g., conduct local consensus discussions) cut across multiple barriers. DISCUSSION AND IMPLICATIONS: Strategies identified by the Tool can inform on-going development of the GeriPACT model's effective implementation and sustainment. Incorporating cross-cutting implementation strategies that mitigate multiple barriers at once may further support these next steps.

Prevalence of One-Year Mortality after Implantable Cardioverter Defibrillator Placement: An Opportunity for Palliative Care?

Background: Current guidelines recommend against placement of implantable cardioverter defibrillators in patients with a life expectancy less than one year. These patients may benefit from early palliative care services; however, identifying this population is challenging. Objective: Determine whether a validated prognostic tool, based on patient factors and health care utilization from electronic medical records, accurately predicts one-year mortality at the time of implantable cardioverter defibrillator placement. Design: We used the United States (U.S.) Veterans Administration's "Care Assessment Needs" one-Year Mortality Score to identify patients at high risk of mortality (score ≥95) before their procedure. Data were extracted from the Corporate Data Warehouse. Logistic regression was used to assess the odds of mortality at different score levels. Setting/Subjects: Patients undergoing a new implantable cardioverter defibrillator procedure between October 1, 2015 and September 30, 2017 in the U.S. Veterans Administration. Results: Of 3194 patients with a new implantable cardioverter defibrillator placed, 657 (21.8%) had a score ≥95. The mortality rate among these patients was 151/657 (22.9%) compared with 281/3194 (8.8%) for all patients undergoing a new implantable cardioverter defibrillator procedure. Patients with a score ≥95 had 14.0 (95% confidence interval 8.0-24.4) higher odds of death within one year of the procedure compared with those with a score ≤60. Conclusions: The "Care Assessment Needs" Score is a valid predictor of one-year mortality following implantable cardioverter defibrillator procedures. Integrating its use into the management of Veterans Administration (VA) patients considering implantable cardioverter defibrillators may improve shared decision making and engagement with palliative care.

Achieving transformation to lean management systems in health care.

OBJECTIVE: To understand what factors and organizational dynamics enable Lean transformation of health care organizations. DATA SOURCES: Primary data were collected through two waves of interviews in 2016-2017 with leaders and staff at seven veterans affairs medical centers participating in Lean enterprise transformation. STUDY DESIGN: Using an observational study design, for each site we coded and rated seven potential enablers of transformation. The outcome measure was the extent of Lean transformation, constructed by coding and rating 11 markers of depth and spread of transformation. Using multivalue coincidence analysis (CNA), we identified enablers that distinguished among sites having different levels of transformation. We identified representative quotes for the enablers. DATA COLLECTION METHODS: We interviewed 121 executive leaders, middle managers, expert consultants, systems redesign staff, frontline supervisors, and staff. PRINCIPAL FINDINGS: Two sites achieved high Lean transformation, three medium, and two low. Together leadership support and capability development were sufficient for the three-level Lean transformation outcomes with 100% consistency and 100% coverage. High scores on both corresponded to high Lean transformation; medium on either one corresponded to medium transformation; and low on both corresponded to low transformation. Additionally, low scores in communication and availability of data and very low scores in alignment characterized low-transformation sites. Sites with high leadership support also had a high veteran engagement. CONCLUSIONS: This multisite study develops a novel measure of the extent of organization-wide Lean transformation and uses CNA to identify enablers linked to transformation. It provides insights into why and how some organizations are more successful at transformation than others. Findings support the applicability of the organization transformation model that guided the study and highlight the roles of executive leadership and capability development in the dynamics of transformation.

Hospital In Home: Evaluating Need and Readiness for Implementation (HENRI) in the Department of Veterans Affairs: protocol for a mixed-methods evaluation and participatory implementation planning study.

BACKGROUND AND OBJECTIVES: The Department of Veterans Affairs (VA) Hospital-In-Home (HIH) program delivers patient-centered, acute-level hospital care at home. Compared to inpatient care, HIH has demonstrated improved patient safety, effectiveness, and patient and caregiver satisfaction. The VA Office of Geriatrics & Extended Care (GEC) has supported the development of 12 HIH program sites nationally, yet adoption in VA remains modest, and questions remain regarding optimal implementation practices to extend reach and adaptability of this innovation. Guided by theoretical and procedural implementation science frameworks, this study aims to systematically gather evidence from the 12 HIH programs and to develop a participatory approach to engage stakeholders, assess readiness, and develop/adapt implementation strategies and evaluation metrics. RESEARCH DESIGN AND METHODS: We propose a multi-phase concurrent triangulation design comprising of (1) qualitative interviews with key informants and document review, (2) quantitative evaluation of effectiveness outcomes, and (3) mixed-methods synthesis and adaptation of a Reach Effectiveness Adoption Implementation Maintenance (RE-AIM)-guided conceptual framework. RESULTS: The prospective phase will involve a participatory process of identifying stakeholders (leadership, HIH staff, veterans, and caregivers), engaging in planning meetings informed by implementation mapping, and developing implementation logic models and blueprints. The process will be assessed using a mixed-methods approach through participant observation and document review. DISCUSSION AND IMPLICATION: This study will support the continued spread of HIH programs, generate a catalog of HIH implementation evidence, and create implementation tools and infrastructure for future HIH development. The multi-phase nature of informing prospective planning with retrospective analysis is consistent with the Learning Health System framework.

Improving a Mobile Telepresence Robot for People With Alzheimer Disease and Related Dementias: Semistructured Interviews With Stakeholders.

BACKGROUND: By 2050, nearly 13 million Americans will have Alzheimer disease and related dementias (ADRD), with most of those with ADRD or mild cognitive impairment (MCI) receiving home care. Mobile telepresence robots may allow persons with MCI or ADRD to remain living independently at home and ease the burden of caregiving. The goal of this study was to identify how an existing mobile telepresence robot can be enhanced to support at-home care of people with MCI or ADRD through key stakeholder input. OBJECTIVE: The specific aims were to assess what applications should be integrated into the robot to further support the independence of individuals with MCI or ADRD and understand stakeholders' overall opinions about the robot. METHODS: We conducted in-person interviews with 21 stakeholders, including 6 people aged >50 years with MCI or ADRD living in the community, 9 family caregivers of people with MCI or ADRD, and 6 clinicians who work with the ADRD population. Interview questions about the robot focused on technology use, design and functionality, future applications to incorporate, and overall opinions. We conducted a thematic analysis of the data obtained and assessed the patterns within and across stakeholder groups using a matrix analysis technique. RESULTS: Overall, most stakeholders across groups felt positively about the robot's ability to support individuals with MCI or ADRD and decrease caregiver burden. Most ADRD stakeholders felt that the greatest benefits would be receiving help in emergency cases and having fewer in-person visits to the doctor's office. Caregivers and clinicians also noted that remote video communication with their family members using the robot was valuable. Adding voice commands and 1-touch lifesaving or help buttons to the robot were the top suggestions offered by the stakeholders. The 4 types of applications that were suggested included health-related alerts; reminders; smart-home-related applications; and social, entertainment, or well-being applications. Stakeholders across groups liked the robot's mobility, size, interactive connection, and communication abilities. However, stakeholders raised concerns about their physical stability and size for individuals living in smaller, cluttered spaces; screen quality for those with visual impairments; and privacy or data security. CONCLUSIONS: Although stakeholders generally expressed positive opinions about the robot, additional adaptations were suggested to strengthen functionality. Adding applications and making improvements to the design may help mitigate concerns and better support individuals with ADRD to live independently in the community. As the number of individuals living with ADRD in the United States increases, mobile telepresence robots are a promising way to support them and their caregivers. Engaging all 3 stakeholder groups in the development of these robots is a critical first step in ensuring that the technology matches their needs. Integrating the feedback obtained from our stakeholders and evaluating their effectiveness will be important next steps in adapting telepresence robots.

Supporting Veterans with dementia to remain in the community: strategies used in 12 Veterans Health Administration programs.

The Veterans Health Administration (VA) provides services to growing numbers of Veterans with dementIa, individuals at heightened risk for hospitalizations and nursing home placement. Beginning in 2010, the VA funded 12 innovative pilot programs to improve dementia care and help Veterans remain at home. We conducted a retrospective qualitative analysis of program materials and interviews with physicians, nurses, social workers, and other personnel (n = 33) to understand the strategies these programs adopted. Interviews were conducted every 6 months between 2010-2013 (4-5 interviews per program) and focused on factors affecting program design and implementation, challenges, and strategies to reduce hospitalizations and nursing home placements. Programs varied considerably yet shared three overarching strategies to improve dementia care: involving and supporting family caregivers; engaging interdisciplinary teams; and improving coordination with other healthcare providers. Our results highlight the importance of adapting common dementia care strategies based on the local context and needs of individuals served.

Factors affecting primary care implementation for older veterans with multimorbidity in Veterans Health Administration (VA).

OBJECTIVE: To identify factors affecting implementation of Geriatric Patient-Aligned Care Teams (GeriPACTs), a patient-centered medical home model for older adults with complex care needs including multiple chronic conditions (MCC), designed to provide them with comprehensive, managed, and coordinated primary care. DATA SOURCES: Qualitative data were collected from key informants at eight Veterans Health Administration Medical Centers geographically spread across the United States. STUDY DESIGN: Guided by the Consolidated Framework for Implementation Research (CFIR), we collected prospective primary data through semi-structured interviews with GeriPACT team members (e.g., physicians, nurses, social workers, pharmacists), leaders (e.g., executive leaders, middle managers), and other staff referring to the program. DATA COLLECTION: We conducted in-person, semi-structured interviews with 134 key informants. Interviews were recorded with permission and professionally transcribed. Transcripts were coded in Nvivo 11. We used directed content analysis to identify key factors affecting GeriPACT implementation across sites. PRINCIPAL FINDINGS: Five key factors affected GeriPACT implementation-five CFIR constructs within two CFIR domains. Within the intervention characteristics domain, two constructs emerged, namely, (1) the structure of the GeriPACT model and (2) design, quality, and packaging. Within the inner setting domain, we identified three constructs, namely, (1) available resources (e.g., staffing and space, and infrastructure and information technology), (2) leadership support and engagement, and (3) networks and communications including teamwork, communication, and coordination. CONCLUSIONS: Older veterans with MCC have complex primary care needs requiring high levels of care management and coordination. Knowing what key factors affect GeriPACT implementation is critical. Study findings also contribute to the growing implementation science literature on applying CFIR to evaluate factors that affect program implementation, especially to aging research. Further studies on MCC-focused specialty primary care will help facilitate patient-centered care provision for older adults' complex health needs while also leveraging synergistic work across factors affecting implementation.

Veterans' perspectives on military sexual trauma-related communication with VHA providers.

Given the number of veterans who have experienced military sexual trauma (MST) and the impact of these experiences on veteran health, Veterans Health Administration (VHA) providers frequently communicate with patients about these experiences, either as part of the VHA's universal MST screening program or more comprehensive clinical care. The purpose of this study was to understand veterans' perceptions of communication related to MST disclosures with VHA providers. We conducted qualitative interviews, including a numeric rating question, with 55 veterans whose medical records indicated recent MST-related interactions with VHA providers. The sample included men and women, with and without histories of MST. We analyzed interview transcripts using matrices and identified themes related to satisfaction with communication. Veterans from all groups reported generally high satisfaction with MST-related communication, although men, as a group, reported a much larger range of satisfaction ratings than women. Key provider-related indicators of satisfaction included providers' communication mechanics and nonspecific patient-centered skills and characteristics. One patient-related indicator of lower satisfaction-inherent discomfort discussing MST experiences-was particularly represented among men with MST histories. These data from veteran patients will be reassuring to providers whose concerns about patient reactions to these conversations may inhibit them from raising this important issue. Understanding variables that promote patient satisfaction with MST disclosure communication is critical for promoting sensitive patient-provider interactions about MST. This ultimately can have important downstream effects on veteran health, allowing veterans to forge satisfying relationships with providers and ultimately facilitate recovery from traumatic experiences. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Social Connection and Psychosocial Adjustment among Older Male Veterans Who Return to the Community from VA Nursing Homes.

OBJECTIVES: The goal of this study was to examine psychosocial adjustment following transition from the nursing home (NH) to community and understand the ways in which adjustment intersects with social connection. METHODS: We conducted interviews with community-dwelling older male Veterans after they were discharged from an NH. Interviews focused on Veterans' experience during the transition process. We utilized conventional content analysis to inductively code the interviews. We reviewed evidence in each identified domain for common themes. RESULTS: We interviewed 13 NH residents after recent transitions from the NH back to the community. Four themes were identified: (1) access to and quality of social support network are important for social connection, (2) engagement in meaningful activities with family and friends improves well-being, (3) service providers form link to social connection, and (4) external stressors affect the quality of social connections. CONCLUSIONS: Identified themes aligned with respondents' social connectedness and perceived psychosocial and physical well-being. Our results suggest that social connectedness is one part of the larger milieu of healthy aging including the importance of engagement with social opportunities and having a purpose. CLINICAL IMPLICATIONS: Social connectedness is critical to assess for older adults transitioning between care settings. Developing screening tools and other interventions focused on social isolation are needed.

Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes.

BACKGROUND: The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. DESIGN: Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study's target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? SUMMARY: Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Assessing the Relative Effectiveness of Combining Self-Care with Practitioner-Delivered Complementary and Integrative Health Therapies to Improve Pain in a Pragmatic Trial.

BACKGROUND: Many health care systems are beginning to encourage patients to use complementary and integrative health (CIH) therapies for pain management. Many clinicians have anecdotally reported that patients combining self-care CIH therapies with practitioner-delivered therapies report larger health improvements than do patients using practitioner-delivered or self-care CIH therapies alone. However, we are unaware of any trials in this area. DESIGN: The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the value of veterans participating in practitioner-delivered CIH therapies alone or self-care CIH therapies alone compared with the combination of self-care and practitioner-delivered care. The study is being conducted in 18 Veterans Health Administration sites that received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage, and self-care therapies include tai chi/qi gong, yoga, and meditation. The primary outcome will be improvement on the Brief Pain Inventory 6 months after initiation of CIH as compared with baseline scores. Patients will enter treatment groups on the basis of the care they receive because randomizing patients to specific CIH therapies would require withholding therapies routinely offered at VA. We will address selection bias and confounding by using sites' variations in business practices and other encouragements to receive different types of CIH therapies as a surrogate for direct randomization by using instrumental variable econometrics methods. SUMMARY: Real-world evidence about the value of combining self-care and practitioner-delivered CIH therapies from this pragmatic trial will help guide the VA and other health care systems in offering specific nonpharmacological approaches to manage patients' chronic pain.

Veterans Perceptions of Satisfaction and Convenience with Anticoagulants for Atrial Fibrillation: Warfarin versus Direct Oral Anticoagulants.

BACKGROUND: Atrial fibrillation (AFib) is associated with high morbidity and mortality. Traditionally, AFib was treated with warfarin, yet recent evidence suggests patients may favor direct oral anticoagulants (DOACs). Variation in preferences is common and we explored patients' perceptions of satisfaction and convenience of DOACs versus warfarin within the Veterans Health Administration (VA). PATIENTS AND METHODS: We administered a cross-sectional survey, the Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), to Veterans residing in New England, age ≥65, diagnosed with AFib, and actively taking anticoagulant medication in fiscal year 2018. Survey recipients were randomly selected among patients on warfarin (n=200) or DOACs (n=200). A selection of survey respondents agreed to a follow-up semi-structured interview (n=16) to further investigate perceptions of satisfaction and convenience. RESULTS: Of 400 patients, 187 completed the PACT-Q2 survey (49% on DOACs; 51% on warfarin). DOACs received significantly higher convenience ratings than warfarin (87.6, SD 13.5 vs 81.1, SD 18.8; p=0.007); there was no difference in satisfaction (64.2, SD 20.5 SD, warfarin vs, 67.3, SD 19.4, DOACs). Interview results showed that participants perceived their treatment to be convenient. However, participants expressed challenges related to the convenience of taking warfarin or DOACs, such as warfarin users having to follow dietary recommendations or DOAC users desiring some additional monitoring to answer questions or concerns. Overall, warfarin and DOAC users reported satisfaction with ongoing monitoring methods, although a few DOAC users expressed uncertainties with the frequency of monitoring. For most participants, concerns about side effects did not differ by anticoagulant type nor affect satisfaction. CONCLUSION: Our survey and interview results showed variable patient satisfaction and perceptions of convenience with both DOACs and warfarin. Although DOACs are increasingly prescribed for AFib, some Veterans felt that regular follow-up on warfarin was advantageous. Our findings demonstrate the importance of patient-centered decision-making in AFib treatment in the VA patient population.

Novel Method to Flag Cardiac Implantable Device Infections by Integrating Text Mining With Structured Data in the Veterans Health Administration's Electronic Medical Record.

Importance: Health care-associated infections (HAIs) are preventable, harmful, and costly; however, few resources are dedicated to infection surveillance of nonsurgical procedures, particularly cardiovascular implantable electronic device (CIED) procedures. Objective: To develop a method that includes text mining of electronic clinical notes to reliably and efficiently measure HAIs for CIED procedures. Design, Setting, and Participants: In this multicenter, national cohort study using electronic medical record data for patients undergoing CIED procedures in Veterans Health Administration (VA) facilities for fiscal years (FYs) 2016 and 2017, an algorithm to flag cases with a true CIED-related infection based on structured (eg, microbiology orders, vital signs) and free text diagnostic and therapeutic data (eg, procedure notes, discharge summaries, microbiology results) was developed and validated. Procedure data were divided into development and validation data sets. Criterion validity (ie, positive predictive validity [PPV], sensitivity, and specificity) was assessed via criterion-standard manual medical record review. Exposures: CIED procedure. Main Outcomes and Measures: The concordance between medical record review and the study algorithm with respect to the presence or absence of a CIED infection. CIED infection in the algorithm included 90-day mortality, congestive heart failure and nonmetastatic tumor comorbidities, CIED or surgical site infection International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes, antibiotic treatment of Staphylococci, a microbiology test of a cardiac specimen, and text documentation of infection in specific clinical notes (eg, cardiology, infectious diseases, inpatient discharge summaries). Results: The algorithm sample consisted of 19 212 CIED procedures; 15 077 patients (78.5%) were White individuals, 1487 (15.5%) were African American; 18 766 (97.7%) were men. The mean (SD) age in our sample was 71.8 (10.6) years. The infection detection threshold of predicted probability was set to greater than 0.10 and the algorithm flagged 276 of 9606 (2.9%) cases in the development data set (9606 procedures); PPV in this group was 41.4% (95% CI, 31.6%-51.8%). In the validation set (9606 procedures), at predicted probability 0.10 or more the algorithm PPV was 43.5% (95% CI, 37.1%-50.2%), and overall sensitivity and specificity were 94.4% (95% CI, 88.2%-97.9%) and 48.8% (95% CI, 42.6%-55.1%), respectively. Conclusions and Relevance: The findings of this study suggest that the method of combining structured and text data in VA electronic medical records can be used to expand infection surveillance beyond traditional boundaries to include outpatient and procedural areas.