Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Trauma exposure correlates among patients receiving care in federally qualified health centers.

Over 80% of adults in the general population experience trauma. Rates of patients with posttraumatic stress disorder (PTSD) are high in primary care settings and are likely to be even higher in federally qualified health centers (FQHCs). Trauma exposure has been linked to psychiatric symptoms and physical health comorbidities, though little research has focused on FQHC patients. This study addresses this by examining clinical and sociodemographic correlates of specific trauma types among FQHC patients. We analyzed secondary data from patients who screened positive for PTSD and were receiving health care in FQHCs in a clinical trial (N = 978). Individuals who did versus did not experience a specific trauma type were compared using between-group tests. In the sample, 91.3% of participants were exposed to a DSM-5 Criterion A traumatic event, with 79.6% experiencing two or more trauma types. Witnessing a life-threatening event (57.3%) and physical assault (55.7%) were the most common traumatic experiences. Physical health comorbidities and worse physical health functioning were associated with a higher likelihood of exposure to all trauma types, with effect sizes larger than PTSD, ds = 0.78-1.35. Depressive and anxiety symptoms were also associated with a higher likelihood of experiencing nearly all trauma types to a lesser magnitude. People of color, OR = 2.45, and individuals experiencing financial inequities, OR = 1.73, had higher odds of experiencing serious accidents as well as other trauma types. The findings highlight the need for trauma-informed care, including routine trauma and PTSD screening, for FQHC patients.

Minimal important difference metrics and test-retest reliability of the PTSD Checklist for DSM-5 with a primary care sample.

The PTSD Checklist for DSM-5 (PCL-5) is a measure of posttraumatic stress disorder (PTSD) symptom severity that is widely used for clinical and research purposes. Although previous work has examined metrics of minimal important difference (MID) of the PCL-5 in veteran samples, no work has identified PCL-5 MID metrics among adults in primary care in the United States. In this secondary analysis, data were evaluated from primary care patients (N = 971) who screened positive for PTSD and participated in a large clinical trial in federally qualified health centers in three U.S. states. Participants primarily self-identified as women (70.2%) and White (70.3%). We calculated test-retest reliability using clinic registry data and multiple distribution- and anchor-based metrics of MID using baseline and follow-up survey data. Test-retest reliability (Pearson's r, Spearman's ρ, intraclass correlation coefficient) ranged from adequate to excellent (.79-.94), with the shortest time lag demonstrating the highest reliability estimate. The MID for the PCL-5 was estimated using multiple approaches. Distribution-based approaches indicated an MID range of 8.5-12.5, and anchor-based approaches indicated an MID range of 9.8-11.7. Taken together, the MID metrics indicate that PCL-5 change scores of 9-12 likely reflect real change in PTSD symptoms and indicate at least an MID for patients, whereas PCL-5 change scores of 5 or less likely are not reliable. These findings can help inform clinicians using the PCL-5 in similar populations to track patient responses to treatment and help researchers interpret PCL-5 score changes in clinical trials.

A mixed-methods evaluation of why an implementation trial failed to engage veterans with posttraumatic stress disorder in trauma-focused psychotherapy.

An effectiveness trial found that telemedicine collaborative care for posttraumatic stress disorder (PTSD) significantly increased engagement in trauma-focused psychotherapy (TFP) and improved PTSD symptoms. However, in a subsequent implementation trial, very few veterans enrolled in collaborative care initiated TFP. We conducted a mixed-methods evaluation to determine why veterans did not initiate TFP in the implementation trial. After conducting chart reviews of 1,071 veterans with PTSD enrolled in collaborative care, patients were categorized into four mutually exclusive TFP groups: TFP not discussed; TFP discussed, declined; TFP discussed, did not decline; and TFP initiated. We conducted semistructured interviews with 43 unique patients and 58 unique providers (i.e., care managers and mental health specialists). Almost half (48.6%) of the veterans had no documentation of discussing TFP with their care manager; another 28.9% discussed it but declined. Most veterans (77.1%) had an encounter with a mental health specialist, 36.8% of whom never discussed TFP, and 35.7% of whom discussed it but declined. Providers reported that many veterans were not able, willing, or ready to engage in TFP and that non-trauma-focused therapies were better aligned with their treatment goals. Veterans gave numerous reasons for not initiating TFP, including having bad prior experiences with TFP and wanting to avoid thinking about past traumatic experiences. Commonly cited reasons for noninitiation were providers never discussing TFP with veterans and veterans declining TFP after discussing it with their provider. Interventions, such as shared decision-making tools, may be needed to engage providers and patients in informed discussions about TFP.

Knowledge about Treatment (KaT) in Mental Health Services.

This study developed and psychometrically evaluated a brief measure of mental health treatment knowledge (N = 726). Scores from Knowledge about Treatment (KaT) demonstrated a unidimensional measure with good model fit, internal consistency reliability, convergent and predictive validity, test-retest reliability, and measurement invariance across gender, ethnicity, education, and poverty status.

How Did Veterans' Reliance on Veterans Health Administration Outpatient Care Change After Expansion of the Veterans Community Care Program?

BACKGROUND: The Veterans Community Care Program (VCCP) aims to address access constraints in the Veterans Health Administration (VA) by reimbursing care from non-VA community providers. Little existing research explores how veterans' choice of VA versus VCCP providers has evolved as a significant VCCP expansion in 2014 as part of the Veterans Access, Choice, and Accountability Act. OBJECTIVES: We examined changes in reliance on VA for primary care (PC), mental health (MH), and specialty care (SC) among VCCP-eligible veterans. RESEARCH DESIGN: We linked VA administrative data with VCCP claims to retrospectively examine utilization during calendar years 2016-2018. SUBJECTS: 1.78 million veterans enrolled in VA before 2013 and VCCP-eligible in 2016 due to limited VA capacity or travel hardship. MEASURES: We measured reliance as the proportion of total annual outpatient (VA+VCCP) visits occurring in VA for PC, MH, and SC. RESULTS: Of the 26.1 million total outpatient visits identified, 45.6% were for MH, 29.9% for PC, and 24.4% for SC. Over the 3 years, 83.2% of veterans used any VA services, 23.8% used any VCCP services, and 20.0% were dual VA-VCCP users. Modest but statistically significant declines in reliance were observed from 2016-2018 for PC (94.5%-92.2%), and MH (97.8%-96.9%), and a more significant decline was observed for SC (88.5%-79.8%). CONCLUSIONS: Veterans who have the option of selecting between VA or VCCP providers continued using VA for most of their outpatient care in the initial years after the 2014 VCCP expansion.

The Patient Mania Questionnaire (PMQ-9): a Brief Scale for Assessing and Monitoring Manic Symptoms.

BACKGROUND: Measurement-based care is an effective clinical strategy underutilized for bipolar disorder partly due to lacking a widely adopted patient-reported manic symptom measure. OBJECTIVE: To report development and psychometric properties of a brief patient-reported manic symptom measure. DESIGN: Secondary analysis of data collected in a randomized effectiveness trial comparing two treatments for 1004 primary care patients screening positive for bipolar disorder and/or PTSD. PARTICIPANTS: Two analytic samples included 114 participants with varied diagnoses and test-retest data, and 179 participants with psychiatrist-diagnosed bipolar disorder who had two or more assessments with the nine-item Patient Mania Questionnaire-9 [PMQ-9]). MAIN MEASURES: Internal and test-retest reliability, concurrent validity, and sensitivity to change were assessed. Minimally important difference (MID) was estimated by standard error of measurement (SEM) and by standard deviation (SD) effect sizes. KEY RESULTS: The PMQ-9 had high internal reliability (Cronbach's alpha = 0.88) and test-retest reliability (0.85). Concurrent validity correlation with manic symptom measures was high for the Internal State Scale-Activation Subscale (0.70; p<0.0001), and lower for the Altman Mania Rating Scale (0.26; p=0.007). Longitudinally, PMQ-9 was completed at 1511 clinical encounters in 179 patients with bipolar disorder. Mean PMQ-9 score at first and last encounters was 14.5 (SD 6.5) and 10.1 (SD 7.0), a 27% decrease in mean score during treatment, suggesting sensitivity to change. A point estimate of the MID was approximately 3 points (range of 2-4). CONCLUSIONS: The PMQ-9 demonstrated excellent test-retest reliability, concurrent validity, internal consistency, and sensitivity to change and was widely used and acceptable to patients and clinicians in a pragmatic clinical trial. Combined with the Patient Health Questionnaire-9 (PHQ-9) measure of depressive symptoms this brief measure could inform measurement-based care for individuals with bipolar disorder in primary care and mental health care settings given its ease of administration and familiar self-report response format.

Caregiver Experiences and Roles in Care Seeking During COPD Exacerbations: A Qualitative Study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a progressive, debilitating illness characterized by exacerbations that require timely intervention. COPD patients often rely on informal caregivers-relatives or friends-for assistance with functioning and support. Caregivers perform roles that may be particularly important during acute exacerbations in monitoring symptoms and seeking medical intervention. However, little is known about caregivers' roles and experiences as they support their patients during exacerbations. PURPOSE: To explore the experiences, roles in care seeking, and needs of caregivers during COPD exacerbations. METHODS: Semi-structured interviews were conducted with 24 caregivers of Veterans with COPD who experienced a recent exacerbation. Interviews were recorded, transcribed, and analyzed using inductive content analysis. RESULTS: Five themes arose: (a) caregivers reported continuously monitoring changes in patients symptom severity to identify exacerbations; (b) caregivers described emotional reactions evoked by exacerbations and constant vigilance; (c) caregivers described disagreements with their patient in interpreting symptoms and determining the need for care seeking; (d) caregivers noted uncertainty regarding their roles and responsibilities in pursuing care and their approaches to promote care varied; and (e) expressed their need for additional information and support. Caregivers of patients with COPD often influence whether and when patients seek care during exacerbations. Discrepancies in symptom evaluations between patients and caregivers paired with the lack of information and support available to caregivers are related to delays in care seeking. Clinical practice should foster self-management support to patient-caregiver dyads to increase caregiver confidence and patient openness to their input during exacerbations.

Voluntary, temporary out-of-home firearm storage: A survey of firearm retailers and ranges in two states.

Out-of-home storage of personal firearms is one recommended option for individuals at risk of suicide, and statewide online maps of storage locations have been created in multiple states, including Colorado and Washington. We sought to examine both the extent to which firearm retailers and ranges offer temporary, voluntary firearm storage and the perceived barriers to providing this service. We invited all firearm retailers and ranges in Colorado and Washington to complete an online or mailed survey; eligible sites had to have a physical location where they could provide storage. Between June-July 2021, 137 retailers/ranges completed the survey (response rate = 25.1%). Nearly half (44.5%) of responding firearm retailers/ranges in Colorado and Washington State indicated they had ever provided firearm storage. Among those who had ever offered storage, 80.3% currently offered storage while 19.7% no longer did. The majority (68.6%) of participants had not heard of the Colorado/Washington gun storage maps and 82.5% did not believe they were currently listed on the maps. Respondents indicated liability waivers would most influence their decision about whether to start or continue providing temporary, voluntary storage of firearms. Understanding current practices, barriers, and concerns about providing out-of-home storage by retailers and ranges may support development of more feasible approaches for out-of-home firearm storage during times of suicide risk.

Differences in functional and structural social support among female and male veterans and civilians.

PURPOSE: Social support is an important correlate of health behaviors and outcomes. Studies suggest that veterans have lower social support than civilians, but interpretation is hindered by methodological limitations. Furthermore, little is known about how sex influences veteran-civilian differences. Therefore, we examined veteran-civilian differences in several dimensions of social support and whether differences varied by sex. METHODS: We performed a cross-sectional analysis of the 2012-2013 National Epidemiologic Survey of Alcohol and Related Conditions-III, a nationally representative sample of 34,331 respondents (male veterans = 2569; female veterans = 356). We examined veteran-civilian differences in functional and structural social support using linear regression and variation by sex with interactions. We adjusted for socio-demographics, childhood experiences, and physical and mental health. RESULTS: Compared to civilians, veterans had lower social network diversity scores (difference [diff] = - 0.13, 95% confidence interval [CI] - 0.23, - 0.03). Among women but not men, veterans had smaller social network size (diff = - 2.27, 95% CI - 3.81, - 0.73) than civilians, attributable to differences in religious groups, volunteers, and coworkers. Among men, veterans had lower social network diversity scores than civilians (diff = - 0.13, 95% CI - 0.23, - 0.03); while among women, the difference was similar but did not reach statistical significance (diff = - 0.13, 95% CI - 0.23, 0.09). There was limited evidence of functional social support differences. CONCLUSION: After accounting for factors that influence military entry and social support, veterans reported significantly lower structural social support, which may be attributable to reintegration challenges and geographic mobility. Findings suggest that veterans could benefit from programs to enhance structural social support and improve health outcomes, with female veterans potentially in greatest need.

A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine.

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

Provider Perspectives on Implementing Shared Decision Making for PTSD Treatment in VA Primary Care.

Shared decision making is an important implementation "pull" strategy for increasing uptake of evidence-based mental health practices. In this qualitative study, we explored provider perspectives on implementing shared decision making at the point of mental health treatment initiation using a publicly available, patient-facing decision support tool for post-traumatic stress disorder (PTSD). We conducted semi-structured interviews with 22 mental health providers (psychiatrists, nurses, psychologists, and social workers) working in one of five VA primary care clinics. Interviewed were analyzed using thematic analysis. Provider were enthusiastic about using decision aids as a source of high quality information that could improve patient experience and confidence in treatment. However, providers had concerns about decision aid accessibility, time constraints to conduct shared decision making in-session, and patient motivation to engage in shared decision making. Providers stated they would prefer to use shared decision making with patients that they felt were most likely to follow through with treatment. While providers believed that shared decision making could improve PTSD treatment planning, they thought it most appropriate for patients with the highest levels of motivation and fewest barriers to care. These beliefs may limit widespread adoption and reflect missed opportunities to reach difficult-to-engage patients.

Military Service and Military Health Care Coverage are Associated with Reduced Racial Disparities in Time to Mental Health Treatment Initiation.

We aimed to evaluate whether military service and access to veteran heath care coverage attenuates racial/ethnic disparities in time to mental health treatment initiation for posttraumatic stress disorder (PTSD), major depressive disorder, and/or alcohol-use disorder. Results are based on 13,528 civilians and 1392 veterans from NESARC-III. Among civilians, racial/ethnic minorities reported longer time to PTSD and depression treatment initiation than non-Hispanic whites. Among veterans, racial/ethnic minorities did not differ from whites in time to PTSD and depression treatment initiation, and showed shorter time to treatment initiation for alcohol-use disorder treatment. Racial/ethnic minorities with past year veteran health care coverage showed the strongest evidence for attenuated disparities.

Bipolar disorder in primary care: a qualitative study of clinician and patient experiences with diagnosis and treatment.

Objective: To understand primary care patients' and clinicians' experiences with diagnosis and treatment of patients with bipolar disorder in primary care. Methods: We conducted a qualitative study using thematic content analysis of individual interviews with nine primary care clinicians and six patients from Federally Qualified Health Centers to understand their experiences with the diagnosis and treatment of bipolar disorder. Results: Themes of bipolar disorder detection, referral to specialty mental health care and medication treatment emerged from individual interviews with primary care patients and clinicians. Clinicians and patients faced challenges deciding to continue with care in primary care that is easier to access, but less intensive, than specialty care that can be harder to access but at times of higher quality. Conclusions: Potential next steps in research include identifying ways to support primary care clinicians in detection of patients with bipolar disorder, and strategies to support treatment of patients in primary care with easier access to specialty care including consultation in primary care or co-management with specialty care.

Spillover Effects of Massachusetts Health Reform on Mental Health Use by VA and Medicare Dual Enrollees.

Older veterans can obtain care from the Veterans Affairs Health System (VA), Medicare or both. We examined whether their use of mental health care was impacted by capacity effects stemming from younger, uninsured veterans' enrolling in VA to satisfy the individual mandate within Massachusetts Health Reform (MHR). Using administrative data, we applied a difference-in-difference approach to compare pre-post changes in mental health use following MHR implementation. Findings indicated MHR was associated with increases in use through Medicare and the probability of dual VA-Medicare use. These results provide support for the possibility that limited capacity led to care seeking outside VA.

Measuring Psychiatric Symptoms Remotely: a Systematic Review of Remote Measurement-Based Care.

PURPOSE OF REVIEW: This article systematically reviews studies examining remote measurement-based care (RMBC), defined as using technology to measure patients' psychiatric symptoms outside the context of a clinical encounter. RECENT FINDINGS: Thirty-six studies were identified that measured patients' psychiatric symptoms remotely and provided feedback to treatment providers. The majority were single group designs. There was evidence supporting the short-term feasibility and acceptability of RMBC, although long-term sustainability was less clear. Thirteen randomized controlled trials were identified. RMBC was typically implemented as part of a multicomponent intervention (e.g., internet-based cognitive behavioral therapy with feedback to provider). Three studies experimentally isolated the clinical effects of RMBC, with two reporting no statistically significant differences between the RMBC and control conditions and one reporting greater symptom improvement associated with RMBC. RMBC appears feasible and acceptable and may be a promising intervention for improving mental health care, but additional experimental studies are needed.

Do trauma type, stressful life events, and social support explain women veterans' high prevalence of PTSD?

OBJECTIVES: To examine factors that account for women veterans' higher prevalence of past-year DSM-5 posttraumatic stress disorder (PTSD) compared to women civilians and men veterans. METHODS: Cross-sectional analyses of the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III). Face-to-face interviews with 379 women veterans, 20,007 women civilians, and 2740 men veterans were conducted. Trauma type (child abuse, interpersonal violence, combat or war zone, and other), number of trauma types, past-year stressful life events, current social support, and DSM-5 PTSD were assessed using the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Generalized linear models were used that accounted for the complex survey design. RESULTS: Women veterans had a higher unadjusted prevalence of past-year PTSD (11.40%) compared to their civilian (5.96%) and male (5.19%) counterparts. Individual predictor models indicated that the difference between women veterans' and civilians' prevalence of PTSD was attenuated when adjusting for number of trauma types, whereas the difference between men and women veterans was attenuated when adjusting for child abuse, interpersonal violence, and stressful life events. Nonetheless, while full adjustment in a multiple predictor model accounted for the difference in PTSD between women veterans and civilians, gender differences between men and women veterans remained. CONCLUSIONS: Number of trauma types, type of trauma, and social factors may together help explain women veterans' higher PTSD prevalence compared to women civilians, but do not fully account for differences between men and women veterans. Results highlight a need to explore additional explanatory factors and evaluate associations with longitudinal data.

Applying the Principles for Digital Development: Case Study of a Smartphone App to Support Collaborative Care for Rural Patients With Posttraumatic Stress Disorder or Bipolar Disorder.

BACKGROUND: Despite a proliferation of patient-facing mobile apps for mental disorders, there is little literature guiding efforts to incorporate mobile tools into clinical care delivery and integrate patient-generated data into care processes for patients with complex psychiatric disorders. OBJECTIVE: The aim of this study was to seek to gain an understanding of how to incorporate a patient-provider mobile health (mHealth) platform to support the delivery of integrated primary care-based mental health services (Collaborative Care) to rural patients with posttraumatic stress disorder and/or bipolar disorder. METHODS: Using the Principles for Digital Development as a framework, we describe our experience designing, developing, and deploying a mobile system to support Collaborative Care. The system consists of a patient-facing smartphone app that integrates with a Web-based clinical patient registry used by behavioral health care managers and consulting psychiatrists. Throughout development, we engaged representatives from the system's two user types: (1) providers, who use the Web-based registry and (2) patients, who directly use the mobile app. We extracted mobile metadata to describe the early adoption and use of the system by care managers and patients and report preliminary results from an in-app patient feedback survey that includes a System Usability Scale (SUS). RESULTS: Each of the nine Principles for Digital Development is illustrated with examples. The first 10 patients to use the smartphone app have completed symptom measures on average every 14 days over an average period of 20 weeks. The mean SUS score at week 8 among four patients who completed this measure was 91.9 (range 72.5-100). We present lessons learned about the technical and training requirements for integration into practice that can inform future efforts to incorporate health technologies to improve care for patients with psychiatric conditions. CONCLUSIONS: Adhering to the Principles for Digital Development, we created and deployed an mHealth system to support Collaborative Care for patients with complex psychiatric conditions in rural health centers. Preliminary data among the initial users support high system usability and show promise for sustained use. On the basis of our experience, we propose five additional principles to extend this framework and inform future efforts to incorporate health technologies to improve care for patients with psychiatric conditions: design for public health impact, add value for all users, test the product and the process, acknowledge disruption, and anticipate variability.