Legal Services for Veterans (LSV): Protocol for evaluating the grant-based LSV initiative supporting community organizations' delivery of legal services to veterans.

BACKGROUND: 1.8 million Veterans are estimated to need legal services, such as for housing eviction prevention, discharge upgrades, and state and federal Veterans benefits. While having one's legal needs met is known to improve one's health and its social determinants, many Veterans' legal needs remain unmet. Public Law 116-315 enacted in 2021 authorizes VA to fund legal services for Veterans (LSV) by awarding grants to legal service providers including nonprofit organizations and law schools' legal assistance programs. This congressionally mandated LSV initiative will award grants to about 75 competitively selected entities providing legal services. This paper describes the protocol for evaluating the initiative. The evaluation will fulfill congressional reporting requirements, and inform continued implementation and sustainment of LSV over time. METHODS: Our protocol calls for a prospective, mixed-methods observational study with a repeated measures design, aligning to the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) and Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) frameworks. In 2023, competitively selected legal services-providing organizations will be awarded grants to implement LSV. The primary outcome will be the number of Veterans served by LSV in the 12 months after the awarding of the grant. The evaluation has three Aims. Aim 1 will focus on measuring primary and secondary LSV implementation outcomes aligned to RE-AIM. Aim 2 will apply the mixed quantitative-qualitative Matrixed Multiple Case Study method to identify patterns in implementation barriers, enablers, and other i-PARIHS-aligned factors that relate to observed outcomes. Aim 3 involves a mixed-methods economic evaluation to understand the costs and benefits of LSV implementation. DISCUSSION: The LSV initiative is a new program that VA is implementing to help Veterans who need legal assistance. To optimize ongoing and future implementation of this program, it is important to rigorously evaluate LSV's outcomes, barriers and enablers, and costs and benefits. We have outlined the protocol for such an evaluation, which will lead to recommending strategies and resource allocation for VA's LSV implementation.

Developing and testing a COVID-19 vaccination acceptance intervention: A pragmatic trial comparing vaccine acceptance intervention vs usual care - Rationale, methods, and implementation.

BACKGROUND: COVID-19 has resulted in significant disability and loss of life. COVID-19 vaccines effectively prevent severe illness, hospitalization, and death. Nevertheless, many people remain hesitant to accept vaccination. Veterans perceive healthcare providers (HCP) and staff as trusted vaccine information sources and thereby are well suited to initiate vaccine discussions. The overall objective of this study is to implement and test a virtual COVID-19 Vaccine Acceptance Intervention (VAI) training that is informed by motivational interviewing (MI) techniques. METHODS: The VAI training is being delivered to VA HCPs and staff within a Hybrid Type 2 pragmatic implementation-effectiveness trial using Implementation Facilitation as the implementation strategy. The implementation team includes external facilitators paired with VA Healthcare System (VAHCS)-level internal facilitators. The trial has three aims: 1) Examine the effectiveness of the VAI versus usual care on unvaccinated veterans' vaccination rates in a one-year cluster randomized controlled trial, with randomization at the level of VAHCS. 2) Determine factors associated with veterans' decisions to accept or decline primary COVID-19 vaccination, and better understand how these factors influence vaccination decisions, through survey and qualitative data; and 3) Use qualitative interviews with HCPs and staff from clinics with high and low vaccination rates to learn what was helpful and not helpful about the VAI and implementation strategies. CONCLUSION: This is the first multisite randomized controlled trial to test an MI-informed vaccine acceptance intervention to improve COVID-19 vaccine acceptance. Information gained can be used to inform healthcare systems' approaches to improve future vaccination and other public health campaigns. CLINICALTRIALS: gov Identifier: NCT05027464.

Exploring the acceptability of behavioral interventions for veterans with persistent "medically unexplained" physical symptoms.

OBJECTIVE: This study evaluated the factors that led to enrollment in, and satisfaction with, behavioral interventions for Veterans living with Gulf War Illness (GWI). METHODS: One-on-one interviews were conducted pre- and post-intervention with participants randomized to receive either telephone delivered problem-solving treatment (n = 51) or health education (N = 49). A total of 99 Veterans were interviewed pre-intervention and 60 post-intervention. Qualitative data were thematically coded and similarities in themes across the two interventions were examined. RESULTS: Before the study began, participants reported desiring to learn new information about their GWI, learn symptom-management strategies, and support improvements to care for other patients with GWI. After the intervention, Veterans felt positively about both interventions because they built strong therapeutic relationships with providers, their experiences were validated by providers, and they were provided GWI information and symptom-management strategies. Results also suggested that interventions do not have to be designed to meet all of the needs held by patients to be acceptable. A minority of participants described that they did not benefit from the interventions. CONCLUSION: The results suggest that satisfaction with behavioral interventions for GWI is driven by a strong therapeutic relationship, validating patient's experiences with GWI, and the intervention meeting some of the patient's needs, particularly increasing knowledge of GWI and improving symptom management.

Staff and Veteran Perspectives on Residential Treatment Programs' Responses to COVID-19: A Qualitative Study Guided by the WHO's After Action Review Framework.

Healthcare must rapidly and systematically learn from earlier COVID-19 responses to prepare for future crises. This is critical for VA's Mental Health Residential Rehabilitation and Treatment Programs (RRTPs), offering 24/7 care to Veterans for behavioral health and/or homelessness. We adapted the World Health Organization's After Action Review (AAR) to conduct semi-structured small-group discussions with staff from two RRTPs and Veterans who received RRTP care during COVID-19, to examine COVID-19's impact on these programs. Six thematic categories emerged through qualitative analysis (participant-checked and contextualized with additional input from program leadership), representing participants' recommendations including: Keep RRTPs open (especially when alternative programs are inaccessible), convey reasons for COVID-19 precautions and programming changes to Veterans, separate recovery-oriented programming from COVID-19-related information-sharing, ensure Wi-Fi availability for telehealth and communication, provide technology training during orientation, and establish safe procedures for off-site appointments. AAR is easily applicable for organizations to debrief and learn from past experiences.

Veteran Acceptance of Sleep Health Information Technology: a Mixed-Method Study.

Sleep disturbances, including chronic insomnia and sleep apnea, are major concerns for US veterans, with rising rates and detrimental effects on physical, mental, and social well-being. Sleep disturbances in veterans are also underdiagnosed and undertreated for reasons that include limited sleep clinician availability, long wait times, and the time commitment for treatment. Greater use of sleep health information technologies could improve access to assessment and treatment of sleep disturbances. However, the assessment of acceptance of these technologies among veterans is still ongoing. This mixed-method study combines data from two separate but similar randomized controlled trials to assess acceptance of sleep health information technologies for veterans with chronic insomnia. Sleep health information technologies included in these trials were the following: (1) a WatchPAT sleep monitor for home-based sleep assessment, including detection of sleep apnea, and (2) the VA mobile app Cognitive Behavioral Therapy for Insomnia (CBT-i Coach), which supports self-management of insomnia. The combined sample of 37 veterans receiving care within one New England VA medical center completed a six-week trial using both health information technology tools. Participants completed a survey and interview at the end of the 6 weeks. Overall, participants found the tools acceptable, easy to use, and useful and reported they would use them in the future. Thus, these sleep health information technologies appear to provide an acceptable remote option for assessing and managing sleep issues for veterans. ClinicalTrials.gov NCT02392000; http://clinicaltrials.gov/ct2/show/NCT02392000 and ClinicalTrials.gov NCT03305354; https://clinicaltrials.gov/ct2/show/NCT03305354.

Effect of Problem-solving Treatment on Self-reported Disability Among Veterans With Gulf War Illness: A Randomized Clinical Trial.

Importance: Few evidence-based treatments are available for Gulf War illness (GWI). Behavioral treatments that target factors known to maintain the disability from GWI, such as problem-solving impairment, may be beneficial. Problem-solving treatment (PST) targets problem-solving impairment and is an evidence-based treatment for other conditions. Objective: To examine the efficacy of PST to reduce disability, problem-solving impairment, and physical symptoms in GWI. Design, Setting, and Participants: This multicenter randomized clinical trial conducted in the US Department of Veterans Affairs compared PST with health education in a volunteer sample of 511 Gulf War veterans with GWI and disability (January 1, 2015, to September 1, 2019); outcomes were assessed at 12 weeks and 6 months. Statistical analysis was conducted between January 1, 2019, and December 31, 2020. Interventions: Problem-solving treatment taught skills to improve problem-solving. Health education provided didactic health information. Both were delivered by telephone weekly for 12 weeks. Main Outcomes and Measures: The primary outcome was reduction from baseline to 12 weeks in self-report of disability (World Health Organization Disability Assessment Schedule). Secondary outcomes were reductions in self-report of problem-solving impairment and objective problem-solving. Exploratory outcomes were reductions in pain, pain disability, and fatigue. Results: A total of 268 veterans (mean [SD] age, 52.9 [7.3] years; 88.4% male; 66.8% White) were randomized to PST (n = 135) or health education (n = 133). Most participants completed all 12 sessions of PST (114 of 135 [84.4%]) and health education (120 of 133 [90.2%]). No difference was found between groups in reductions in disability at the end of treatment. Results suggested that PST reduced problem-solving impairment (moderate effect, 0.42; P = .01) and disability at 6 months (moderate effect, 0.39; P = .06) compared with health education. Conclusions and Relevance: In this randomized clinical trial of the efficacy of PST for GWI, no difference was found between groups in reduction in disability at 12 weeks. Problem-solving treatment had high adherence and reduced problem-solving impairment and potentially reduced disability at 6 months compared with health education. These findings should be confirmed in future studies. Trial Registration: ClinicalTrials.gov Identifier: NCT02161133.

Enhancing community integration after incarceration: findings from a prospective study of an intensive peer support intervention for veterans with an historical comparison group.

BACKGROUND: The transition to the community after incarceration presents challenges for returning citizens, including the immediate need to secure housing, employment, and income. Additionally, health care is essential for this population due to high rates of chronic physical health and mental health problems and substance use disorders. There is growing recognition of the need for interventions that support returning citizens as they navigate community reintegration while simultaneously tending to physical and behavioral health needs. We developed and pilot tested a peer support intervention designed to provide social, emotional, and logistic support and promote linkage and engagement in healthcare for returning citizens. We tested the intervention with US military veterans in Massachusetts who were being released from prison and jail. Outcomes related to linkage to and engagement in healthcare were evaluated using an historical comparison group. Engagement in peer support, housing status, and reincarceration rates were monitored for the intervention group. RESULTS: There were 43 veterans in the intervention group, and 36 in the historical comparison group. For linkage to primary care within 90 days of release, there were no statistically significant differences between the intervention and comparison groups (58% versus 67%). Intervention participants were significantly more likely to receive substance use treatment than the comparison group (86% versus 19%, p < .0001) and the mean monthly substance use visits was greater in the intervention group (0.96 versus 0.34, p < .007). Engagement in mental health services was greater for the intervention group than the comparison group (93% versus 64%, p < .003). There were no significant differences between groups for emergency department use and hospitalization. At the end of the study period, the majority of intervention participants who had been released for over a year were living in permanent housing (84%). Recidivism among the was low, with 7% re-arrested during the study period. CONCLUSIONS: Augmenting reentry support through intensive peer support appears to have substantial benefits for veterans in terms of engaging them in health care and contributing to their longer-term stability, including housing and recidivism. Flexible reentry support such as this intervention may be well suited to meet the widely varying needs of returning citizens.

Applying after action review to examine residential treatment programs' responses to COVID-19.

Resurgences of COVID-19 cases are a grave public health concern. Hence, there is an urgent need for health care systems to rapidly and systematically learn from their responses to earlier waves of COVID-19. To meet this need, this article delineates how we adapted the World Health Organization's After Action Review (AAR) framework to use within our health care system of the United States Department of Veterans Affairs. An AAR is a structured, methodical evaluation of actions taken in response to an event (e.g., recent waves of COVID-19). It delivers an actionable report regarding (i) what was expected, (ii) what actually happened, (iii) what went well, and (iv) what could have been done differently, and thus what changes are needed for future situations. We share as an example our examination of Mental Health Residential Rehabilitation and Treatment Programs in Massachusetts (a COVID-19 hotspot). Our work can be further adapted, beyond residential treatment, as a consistent framework for reviewing COVID-19 responses across multiple health care programs. This will identify both standardized and tailored preparations that the programs can make for future waves of the pandemic. Given the expected resurgences of COVID-19 cases, the time to apply AAR is now.

Mobile Intervention to Improve Sleep and Functional Health of Veterans With Insomnia: Randomized Controlled Trial.

BACKGROUND: Insomnia is a prevalent and debilitating disorder among veterans. Cognitive behavioral therapy for insomnia (CBTI) can be effective for treating insomnia, although many cannot access this care. Technology-based solutions and lifestyle changes, such as physical activity (PA), offer affordable and accessible self-management alternatives to in-person CBTI. OBJECTIVE: This study aims to extend and replicate prior pilot work to examine whether the use of a mobile app for CBTI (cognitive behavioral therapy for insomnia coach app [CBT-i Coach]) improves subjective and objective sleep outcomes. This study also aims to investigate whether the use of the CBT-i Coach app with adjunctive PA improves sleep outcomes more than CBT-i Coach alone. METHODS: A total of 33 veterans (mean age 37.61 years, SD 9.35 years) reporting chronic insomnia were randomized to use either the CBT-i Coach app alone or the CBT-i Coach app with a PA intervention over 6 weeks, with outcome measures of objective and subjective sleep at pre- and posttreatment. RESULTS: Although the PA manipulation was unsuccessful, both groups of veterans using the CBT-i Coach app showed significant improvement from baseline to postintervention on insomnia (P<.001), sleep quality (P<.001), and functional sleep outcomes (P=.002). Improvements in subjective sleep outcomes were similar in those with and without posttraumatic stress disorder and mild-to-moderate sleep apnea. We also observed a significant but modest increase in objective sleep efficiency (P=.02). CONCLUSIONS: These findings suggest that the use of a mobile app-delivered CBTI is feasible and beneficial for improving sleep outcomes in veterans with insomnia, including those with comorbid conditions such as posttraumatic stress disorder or mild-to-moderate sleep apnea. TRIAL REGISTRATION: ClinicalTrials.gov NCT03305354; https://clinicaltrials.gov/ct2/show/NCT03305354.

Implementing Automated Text Messaging for Patient Self-management in the Veterans Health Administration: Qualitative Study Applying the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability Framework.

BACKGROUND: The Veterans Health Administration (VHA) is deploying an automated texting system (aTS) to support patient self-management. OBJECTIVE: We conducted a qualitative evaluation to examine factors influencing national rollout of the aTS, guided by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework, which is intended to support the evaluation of novel technologies. METHODS: Semistructured interviews were conducted with 33 staff and 38 patients who were early adopters of the aTS. Data were analyzed following deductive and inductive approaches using a priori codes and emergent coding based on the NASSS. RESULTS: We identified themes across NASSS domains: (1) Condition: The aTS was considered relevant for a range of patient needs; however, perceptions of patient suitability were guided by texting experience and clinical complexity rather than potential benefits. (2) Technology: Onboarding of the aTS presented difficulty and the staff had different opinions on incorporating patient-generated data into care planning. (3) Value: Supply-side value relied on the flexibility of the aTS and its impact on staff workload whereas demand-side value was driven by patient perceptions of the psychological and behavioral impacts of the aTS. (4) Adopters: Limited clarity on staff roles and responsibilities presented challenges in incorporating the aTS into clinical processes. (5) Organization: Staff were willing to try the aTS; however, perceptions of leadership support and clinic readiness hindered usage. (6) Wider system: Staff focused on enhancing aTS interoperability with the electronic medical record. (7) Embedding and adaptation over time: The interplay of aTS versatility, patient and staff demands, and broader societal changes in preferences for communicating health information facilitated aTS implementation. CONCLUSIONS: VHA's new aTS has the potential to further engage patients and expand the reach of VHA care; however, patients and staff require additional support to adopt, implement, and sustain the aTS. The NASSS highlighted how the aTS can be better embedded into current practices, which patients might benefit most from its functionality, and which aspects of aTS messages are most relevant to self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT03898349; https://clinicaltrials.gov/ct2/show/NCT03898349.

"Because the country, it seems though, has turned their back on me": Experiences of institutional betrayal among veterans living with Gulf War Illness.

People living with medically unexplained symptoms (MUS) often have poor quality of life and health outcomes. Many struggle to engage with and trust in healthcare systems. This qualitative study examined how experiences with institutions influence perceptions of medical care for MUS by applying the theoretical framework of institutional betrayal to narratives of U.S. military Veterans living with Gulf War Illness (GWI). Institutional betrayal refers to situations in which the institutions people depend upon for safety and well-being cause them harm. Experiences of institutional betrayal both during active military service and when first seeking treatment appeared to shape perceptions of healthcare in this sample. Veterans expressed the belief that the military failed to protect them from environmental exposures. Veterans' concerns regarding subsequent quality of healthcare were intrinsically linked to a belief that, despite official documentation to the contrary, the predominant paradigm of both the U.S. Department of Defense and the U.S. Department of Veterans Affairs (VA) is that GWI does not exist. Veterans reported that providers are not adequately trained on treatment of GWI and do not believe Veterans' descriptions of their illness. Veterans reported taking up self-advocacy, doing their own research on their condition, and resigning themselves to decrease engagement with VA healthcare or seek non-VA care. The study's findings suggest institutional level factors have a profound impact on perceptions of care and the patient-provider relationship. Future research and policy aimed at improving healthcare for people living with MUS should consider the concept of institutional betrayal.

The CORE (Consensus on Relevant Elements) Approach to Determining Initial Core Components of an Innovation.

Identifying an intervention's core components is indispensable to gauging whether an intervention is implemented with fidelity and/or is modified; it is often a multi-stage process, starting with the first stage of identifying an initial set of core components that are gradually refined. This first stage of identifying initial core components has not been thoroughly examined. Without a clear set of steps to follow, interventions may vary in the rigor and thought applied to identifying their initial core components. We devised the CORE (Consensus on Relevant Elements) approach to synthesize opinions of intervention developers/implementers to identify an intervention's initial core components, particularly applicable to innovative interventions. We applied CORE to a peer-based intervention that aids military veterans with post-incarceration community reintegration. Our CORE application involved four intervention developers/implementers and two moderators to facilitate the seven CORE steps. Our CORE application had two iterations, moving through Steps 1 (individual core component suggestions) through 7 (group discussion for consensus), then repeating Steps 4 (consolidation of component definitions) through 7. This resulted in 18 consensus-reached initial core components of the peer-based intervention, down from the 60 that the developers/implementers individually suggested at Step 1. Removed components were deemed to not threaten the intervention's effectiveness even if absent. CORE contributes to filling a critical gap regarding identifying an intervention's initial core components (so that the identified components can be subsequently refined), by providing concrete steps for synthesizing the knowledge of an intervention's developers/implementers. Future research should examine CORE's utility across various interventions and implementation settings.

Coordinating across correctional, community, and VA systems: applying the Collaborative Chronic Care Model to post-incarceration healthcare and reentry support for veterans with mental health and substance use disorders.

BACKGROUND: Between 12,000 and 16,000 veterans leave incarceration annually. As is known to be the case for justice-involved populations in general, mental health disorders (MHDs) and substance use disorders (SUDs) are highly prevalent among incarcerated veterans, and individuals with MHDs and SUDs reentering the community are at increased risk of deteriorating health and recidivism. We sought to identify opportunities to better coordinate care/services across correctional, community, and VA systems for reentry veterans with MHDs and SUDs. METHODS: We interviewed 16 veterans post-incarceration and 22 stakeholders from reentry-involved federal/state/community organizations. We performed a grounded thematic analysis, and recognizing consistencies between the emergent themes and the evidence-based Collaborative Chronic Care Model (CCM), we mapped findings to the CCM's elements - work role redesign (WRR), patient self-management support (PSS), provider decision support (PDS), clinical information systems (CIS), linkages to community resources (LCR), and organizational/leadership support (OLS). RESULTS: Emergent themes included (i) WRR - coordination challenges among organizations involved in veterans' reentry; (ii) PSS - veterans' fear of reentering society; (iii) PDS - uneven knowledge by reentry support providers regarding available services when deciding which services to connect a reentry veteran to and whether he/she is ready and/or willing to receive services; (iv) CIS - lapses in MHD/SUD medications between release and a first scheduled health care appointment, as well as challenges in transfer of medical records; (v) LCR - inconsistent awareness of existing services and resources available across a disparate reentry system; and (vi) OLS - reentry plans designed to address only immediate transitional needs upon release, which do not always prioritize MHD/SUD needs. CONCLUSIONS: Applying the CCM to coordinating cross-system health care and reentry support may contribute to reductions in mental health crises and overdoses in the precarious first weeks of the reentry period.

Automated Text Messaging With Patients in Department of Veterans Affairs Specialty Clinics: Cluster Randomized Trial.

BACKGROUND: Acceptability of mobile phone text messaging as a means of asynchronous communication between health care systems and patients is growing. The US Department of Veterans Affairs (VA) has adopted an automated texting system (aTS) for national rollout. The aTS allows providers to develop clinical texting protocols to promote patient self-management and allows clinical teams to monitor patient progress between in-person visits. Texting-supported hepatitis C virus (HCV) treatment has not been previously tested. OBJECTIVE: Guided by the Practical, Robust Implementation and Sustainability Model (PRISM), we developed an aTS HCV protocol and conducted a mixed methods, hybrid type 2 effectiveness implementation study comparing two programs supporting implementation of the aTS HCV protocol for medication adherence in patients with HCV. METHODS: Seven VA HCV specialty clinics were randomized to usual aTS implementation versus an augmented implementation facilitation program. Implementation process measures included facilitation metrics, usability, and usefulness. Implementation outcomes included provider and patient use of the aTS HCV protocol, and effectiveness outcomes included medication adherence, health perceptions and behaviors, and sustained virologic response (SVR). RESULTS: Across the seven randomized clinics, there were 293 facilitation events using a core set of nine implementation strategies (157 events in augmented implementation facilitation, 136 events in usual implementation). Providers found the aTS appropriate with high potential for scale-up but not without difficulties in startup, patient selection and recruitment, and clinic workflow integration. Patients largely found the aTS easy to use and helpful; however, low perceived need for self-management support contributed to high declination. Reach and use was modest with 197 patients approached, 71 (36%) enrolled, 50 (25%) authenticated, and 32 (16%) using the aTS. In augmented implementation facilitation clinics, more patients actively used the aTS HCV protocol compared with usual clinic patients (20% vs 12%). Patients who texted reported lower distress about failing HCV treatment (13/15, 87%, vs 8/15, 53%; P=.05) and better adherence to HCV medication (11/15, 73%, reporting excellent adherence vs 6/15, 40%; P=.06), although SVR did not differ by group. CONCLUSIONS: The aTS is a promising intervention for improving patient self-management; however, augmented approaches to implementation may be needed to support clinician buy-in and patient engagement. Considering the behavioral, social, organizational, and technical scale-up challenges that we documented, successful and sustained implementation of the aTS may require implementation strategies that operate at the clinic, provider, and patient levels. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov NCT03898349; https://clinicaltrials.gov/ct2/show/NCT03898349.

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans.

BACKGROUND: Sleep disturbance is a major health concern among US veterans who have served since 2001 in a combat theater in Iraq or Afghanistan. We report subjective and objective sleep results from a pilot trial assessing self-management-guided use of a mobile app (CBT-i Coach, which is based on cognitive behavioral therapy for insomnia) as an intervention for insomnia in military veterans. OBJECTIVE: The primary aim of this study was to evaluate changes in subjective and objective sleep outcomes from pre to postintervention. METHODS: Subjective outcomes included the Insomnia Severity Index, the Pittsburgh Sleep Quality Inventory, and sleep-related functional status. A wearable sleep monitor (WatchPAT) measured objective sleep outcomes, including sleep efficiency, percent rapid eye movement (REM) during sleep, sleep time, and sleep apnea. A total of 38 participants were enrolled in the study, with 18 participants being withdrawn per the protocol because of moderate or severe sleep apnea and 9 others who dropped out or withdrew. Thus, 11 participants completed the full 6-week CBT-i Coach self-management intervention (ie, completers). RESULTS: Completer results indicated significant changes in subjective sleep measures, including reduced reports of insomnia (Z=-2.68, P=.007) from pre (mean 16.63, SD 5.55) to postintervention (mean 12.82, SD 3.74), improved sleep quality (Z=-2.37, P=.02) from pre (mean 12.82, SD 4.60) to postintervention (mean 10.73, SD 3.32), and sleep-related functioning (Z=2.675, P=.007) from pre (mean 13.86, SD 3.69) to postintervention (mean 15.379, SD 2.94). Among the objective measures, unexpectedly, objective sleep time significantly decreased from pre to postintervention (χ22=7.8, P=.02). There were no significant changes in percent REM sleep or sleep efficiency. CONCLUSIONS: These findings suggest that the CBT-i Coach app can improve subjective sleep and that incorporating objective sleep measures into future, larger clinical trials or clinical practice may yield important information, particularly by detecting previously undetected sleep apnea. TRIAL REGISTRATION: ClinicalTrials.gov NCT02392000; http://clinicaltrials.gov/ct2/show/NCT02392000.

Qualitative study of patient experiences of responsibility in warfarin therapy.

PURPOSE: Results of a study to characterize the experiences of warfarin-treated patients, including their experiences in taking medication, communicating with clinical pharmacists, and International Normalized Ratio (INR) monitoring, are reported. METHODS: A qualitative analysis of data obtained during interviews with 40 patients at a Veterans Affairs medical center warfarin clinic was conducted. In semistructured interviews, the patients were asked to describe the process whereby their INR values were monitored by pharmacists and their understanding of self-management responsibilities, including medication adherence and implementation of lifestyle modifications that might influence the effectiveness of anticoagulation therapy. RESULTS: Analysis of interview results indicated that patients' experience in the event of variation in INR levels is characterized by misperceptions of the instructions regarding appropriate dietary and lifestyle behaviors, misattribution of responsibility for abnormal readings, and provider uncertainty in ascertaining causation for out-of-range INR values. Patients frequently reported that they interpret pharmacist questions to imply that they are responsible for variable INR values. This perception may indirectly lead to adverse consequences such as withholding of information from anticoagulation care providers and skipping clinic appointments, which could in turn result in suboptimal clinical outcomes. CONCLUSION: Analysis of results of qualitative interviews of patients receiving warfarin indicated that patients may interpret routine questioning about INR variation as implying that they are to blame for poor anticoagulation control.

Forming and activating an internal facilitation group for successful implementation: A qualitative study.

BACKGROUND: This study focuses on an implementation facilitation strategy to improve the delivery of anticoagulation care within pharmacy-run clinics across 8 Veterans Health Administration (VA) medical centers. Other studies have explored various models of implementation facilitation, including external facilitation (EF), internal facilitation (IF), and blended facilitation (BF) combining both approaches. This study focuses on the use of an internal facilitation team of anticoagulation coordinators representing 8 VA anticoagulation clinics to enhance the implementation process. This study examines how the team became instrumental in the successful implementation of evidence-based practice change. METHODS: Semi-structured interviews were conducted annually over 4 years with representatives from each site, the internal facilitators (site champions), at 8 VA hospitals (47 interviews). Additionally, five external facilitators, experts in quality improvement and anticoagulation care who guided the implementation, were interviewed. Analysis drew on a deductive approach based on the Promoting Action on Research Implementation in Health Services (PARIHS) model and emergent thematic analysis to identify factors related to effectiveness of the internal facilitation team. RESULTS: Key findings are that the following factors enhanced successful uptake of the anticoagulation initiative: 1) Regular participation by the site champion in the internal facilitation team; 2) Champion strongly committed to being an agent of change; and 3) Champion received greater support from their supervisors. The first and second factors are interrelated, as internal facilitators who actively and regularly participated in the internal facilitation team often became truly committed to the improvement project. Both factors relate to the third, as supervisor support not only facilitated changes in practice, but also facilitated regular team attendance and stronger participation. CONCLUSIONS: Our study adds to implementation science by detailing how internal facilitators learn their skills over time, and how a group of internal facilitators can help each other succeed. These findings can guide those who wish to incorporate internal facilitation teams as an implementation strategy, and demonstrate how sites can build capacity for implementation efforts. SYNOPSIS: This study focuses on an implementation facilitation strategy to improve the delivery of anticoagulation care within pharmacy-run clinics across 8 Veterans Health Administration medical centers. Internal facilitators (IFs) guided by and supported by an external facilitators (EF), successfully implemented the clinical innovation. This study examines how the IF group became instrumental in the successful implementation of evidence-based practice change.

An analysis of patient-provider secure messaging at two Veterans Health Administration medical centers: message content and resolution through secure messaging.

OBJECTIVE: We sought to understand how patients and primary care teams use secure messaging (SM) to communicate with one another by analyzing secure message threads from 2 Department of Veterans Affairs facilities. METHODS: We coded 1000 threads of SM communication sampled from 40 primary care teams. RESULTS: Most threads (94.5%) were initiated by patients (90.4%) or caregivers (4.1%); only 5.5% were initiated by primary care team members proactively reaching out to patients. Medication renewals and refills (47.2%), scheduling requests (17.6%), medication issues (12.9%), and health issues (12.7%) were the most common patient-initiated requests, followed by referrals (7.0%), administrative issues (6.5%), test results (5.4%), test issues (5.2%), informing messages (4.9%), comments about the patient portal or SM (4.1%), appreciation (3.9%), self-reported data (2.8%), life issues (1.5%), and complaints (1.5%). Very few messages were clinically urgent (0.7%) or contained other potentially challenging content. Message threads were mostly short (2.7 messages), comprising an average of 1.35 discrete content types. A substantial proportion of issues (24.2%) did not show any evidence of being resolved through SM. Time to response and extent of resolution via SM varied by message content. Proactive SM use by teams varied, but was most often for test results (32.7%), medication-related issues (21.8%), medication renewals (16.4%), or scheduling issues (18.2%). CONCLUSIONS: The majority of messages were transactional and initiated by patients or caregivers. Not all content categories were fully addressed over SM. Further education and training for both patients and clinical teams could improve the quality and efficiency of SM communication.

Results of a Regional Effort to Improve Warfarin Management.

BACKGROUND: Improved anticoagulation control with warfarin reduces adverse events and represents a target for quality improvement. No previous study has described an effort to improve anticoagulation control across a health system. OBJECTIVE: To describe the results of an effort to improve anticoagulation control in the New England region of the Veterans Health Administration (VA). METHODS: Our intervention encompassed 8 VA sites managing warfarin for more than 5000 patients in New England (Veterans Integrated Service Network 1 [VISN 1]). We provided sites with a system to measure processes of care, along with targeted audit and feedback. We focused on processes of care associated with site-level anticoagulation control, including prompt follow-up after out-of-range international normalized ratio (INR) values, minimizing loss to follow-up, and use of guideline-concordant INR target ranges. We used a difference-in-differences (DID) model to examine changes in anticoagulation control, measured as percentage time in therapeutic range (TTR), as well as process measures and compared VISN 1 sites with 116 VA sites located outside VISN 1. RESULTS: VISN 1 sites improved on TTR, our main indicator of quality, from 66.4% to 69.2%, whereas sites outside VISN 1 improved from 65.9% to 66.4% (DID 2.3%, P < 0.001). Improvement in TTR correlated strongly with the extent of improvement on process-of-care measures, which varied widely across VISN 1 sites. CONCLUSIONS: A regional quality improvement initiative, using performance measurement with audit and feedback, improved TTR by 2.3% more than control sites, which is a clinically important difference. Improving relevant processes of care can improve outcomes for patients receiving warfarin.

Knowing the patient: A qualitative study on care-taking and the clinical pharmacist-patient relationship.

BACKGROUND: Previous studies have found clinical pharmacists (CPs) and clinical pharmacy specialists (CPSs) in direct patient care have positive effects across various patient outcomes. However, there are also other kinds of care-taking occurring in pharmacy-run clinic appointments that produce value for patients. OBJECTIVE: To identify and characterize how CPs/CPSs in direct care clinics develop and practice care-taking behaviors which advance the pharmacist-patient relationship. METHODS: Semi-structured CP/CPS interviews were conducted once per year for two years (46 year 1, 50 year 2) along with direct observations of clinical pharmacy work as part of an anticoagulation improvement intervention. Participants were from Veterans Health Administration (VHA) medical centers and VHA community-based outpatient clinics in the Northeastern U.S. Interviews were transcribed verbatim and thematically analyzed using NVIVO 10 software. RESULTS: It was found that CPs/CPSs practice "knowing the patient" in ways related to, but distinct from this practice in the nursing literature. For CPs/CPSs, knowing the patient occurred over time, and it produced familiarity and trust between CPs/CPs and patients. A reciprocal relationship developed in which patients came to rely on CP/CPSs for other types of assistance. Patterns of knowing the patient and being known by the patient manifested in three distinct ways: 1) identifying the patient's unmet needs, 2) explaining other medications, and 3) helping the patient navigate the system. CONCLUSION: This research identifies an action, knowing the patient, whereby CPs use their knowledge of the patient to deliver individualized care. This study contributes to the developing literature on pharmacist-patient relationships and pharmacist-patient communication.