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.

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review.

CONTEXT: There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood. OBJECTIVE: To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. METHODS: Review was limited to peer-reviewed studies published in English from 1970 to 2011: (1) in adults with SCI, (2) evaluating training protocols consisting of repeated sessions over at least 4 weeks to maintain or improve cardiovascular health, (3) including volitional exercise modalities and functional electrical stimulation (FES)-enhanced exercise modalities, and (4) including a specific statement about AEs. Trained reviewers initially identified a total of 145 studies. After further screening, 38 studies were included in the review. Quality of evidence was evaluated using established procedures. RESULTS: There were no serious AEs reported. There were no common AEs reported across most types of interventions, except for musculoskeletal AEs related to FES walking. There were few AEs in volitional exercise studies. CONCLUSION: There is no evidence to suggest that cardiovascular exercise done according to guidelines and established safety precautions is harmful. To improve the strength of these conclusions, future publications should include definition of AEs, information about pre-intervention screening, and statements of the nature and extent of AEs.

Improving the Usability of Written Exposure Therapy for Therapists in the Department of Veterans Affairs Telemental Health: Formative Study Using Qualitative and User-Centered Design Methods.

BACKGROUND: User modifications are common in evidence-based psychosocial interventions (EBPIs) for mental health disorders. Often, EBPIs fit poorly into clinical workflows, require extensive resources, or pose considerable burden to patients and therapists. Implementation science is increasingly researching ways to improve the usability of EBPIs before implementation. A user-centered design can be used to support implementation methods to prioritize user needs and solutions to improve EBPI usability. OBJECTIVE: Trauma-focused EBPIs are a first-line treatment for patients with posttraumatic stress disorder (PTSD) in the Department of Veterans Affairs. Written exposure therapy (WET) is a brief, trauma-focused EBPI wherein patients handwrite about trauma associated with their PTSD. Initially developed for in-person delivery, WET is increasingly being delivered remotely, and outcomes appear to be equivalent to in-person delivery. However, there are logistical issues in delivering WET via video. In this evaluation, we explored usability issues related to WET telehealth delivery via videoconferencing software and designed a solution for therapist-facing challenges to systematize WET telehealth delivery. METHODS: The Discover, Design and Build, and Test framework guided this formative evaluation and served to inform a larger Virtual Care Quality Enhancement Research Initiative. We used qualitative descriptive methods in the Discover phase to understand the experiences and needs of 2 groups of users providing care within the Department of Veterans Affairs: in-person therapists delivering WET via video because of the COVID-19 pandemic and telehealth therapists who regularly deliver PTSD therapies. We then used user-centered design methods in the Design and Build phase to brainstorm, develop, and iteratively refine potential workflows to address identified usability issues. All procedures were conducted remotely. RESULTS: In the Discover phase, both groups had challenges delivering WET and other PTSD therapies via telehealth because of technology issues with videoconferencing software, environmental distractions, and workflow disruptions. Narrative transfer (ie, patients sending handwritten trauma accounts to therapists) was the first target for design solution development as it was deemed most critical to WET delivery. In the Design and Build phase, we identified design constraints and brainstormed solution ideas. This led to the development of 3 solution workflows that were presented to a subgroup of therapist users through cognitive walkthroughs. Meetings with this subgroup allowed workflow refinement to improve narrative transfers. Finally, to facilitate using these workflows, we developed PDF manuals that are being refined in subsequent phases of the implementation project (not mentioned in this paper). CONCLUSIONS: The Discover, Design and Build, and Test framework can be a useful tool for understanding user needs in complex EBPI interventions and designing solutions to user-identified usability issues. Building on this work, an iterative evaluation of the 3 solution workflows and accompanying manuals with therapists and patients is underway as part of a nationwide WET implementation in telehealth settings.

A comparison of patient-reported mental health outcomes for the Department of Veterans Affairs' regional telehealth and Community Care Programs.

OBJECTIVES: To compare patient-reported outcomes for veterans with limited access to Department of Veterans Affairs (VA) mental health services referred to the Veterans Community Care Program (VCCP) or regional telehealth Clinical Resource Hubs-Mental Health (CRH-MH). DATA SOURCES: This national evaluation used secondary data from the VA Corporate Data Warehouse, chart review, and primary data collected by baseline survey between October 8, 2019 and May 27, 2020 and a 4-month follow-up survey. STUDY DESIGN: A quasi-experimental longitudinal study design was used to sample 545 veterans with VCCP or CRH-MH referrals for new treatment episodes. Patient-reported outcomes included symptom severity, perceived access, utilization, and patient-centeredness. DATA COLLECTION: During the baseline and follow-up surveys, all veterans were administered the Patient Health Questionnaire-8 (PHQ-8) to assess depression severity, and veterans with a provisional diagnosis of posttraumatic stress disorder (PTSD) were also administered the PTSD Checklist for DSM-5 (PCL-5) to assess PTSD symptom severity. The 4-month follow-up survey also asked about perceived access using the Perceived Access Inventory, the number of encounters, and patient-centeredness of care using the Patient-Centered Care portion of the Veterans Satisfaction Survey. PRINCIPAL FINDINGS: Results indicated that compared to VCCP consults, veterans with CRH-MH consults reported 0.65 (CI95  = 0.51-0.83, p < 0.01) times the number of barriers to care, but a non-significant lower number of encounters (-0.792, CI95 -2.221, 0.636, p = 0.28). There was no significant (p = 0.24) difference in satisfaction with patient-centeredness, with both groups "agreeing" on average to positively worded questions. Veterans in both groups experienced little improvement in depression or PTSD symptom severity, and there were no clinically meaningful differences between groups. CONCLUSIONS: Overall findings indicate that the CRH-MH and VCCP generate similar patient-reported outcomes. Future research should compare the quality and cost of care delivered by the VCCP and CRH-MH programs.

Economic costs of implementing evidence-based telemedicine outreach for posttraumatic stress disorder in VA.

Background: Telemedicine outreach for posttraumatic stress disorder (TOP) is a virtual evidence-based practice (EBP) involving telephone care management and telepsychology that engages rural patients in trauma-focused psychotherapy. This evaluation examined implementation and intervention costs attributable to deploying TOP from a health system perspective. Methods: Costs were ascertained as part of a stepped wedge cluster randomized trial at five sites within the Veterans Affairs (VA) Healthcare System. All sites initially received a standard implementation strategy, which included internal facilitation, dissemination of an internal facilitators operational guide, funded care manager, care managing training, and technical support. A subset of clinics that failed to meet performance metrics were subsequently randomized to enhanced implementation, which added external facilitation that focused on incorporating TOP clinical processes into existing clinic workflow. We measured site-level implementation activities using project records and structured activity logs tracking personnel-level time devoted to all implementation activities. We monetized time devoted to implementation activities by applying an opportunity cost approach. Intervention costs were measured as accounting-based costs for telepsychiatry/telepsychology and care manager visits, ascertained using VA administrative data. We conducted descriptive analyses of strategy-specific implementation costs across five sites. Descriptive analyses were conducted instead of population-level cost-effectiveness analysis because previous research found enhanced implementation was not more successful than the standard implementation in improving uptake of TOP. Results: Over the 40-month study period, four of five sites received enhanced implementation. Mean site-level implementation cost per month was $919 (SD = $238) during standard implementation and increased to $1,651 (SD = $460) during enhanced implementation. Mean site-level intervention cost per patient-month was $46 (SD = $28) during standard implementation and $31 (SD = $21) during enhanced implementation. Conclusions: Project findings inform the expected cost of implementing TOP, which represents one factor health systems should consider in the decision to broadly adopt this EBP. Plain Language Summary: What is already known about the topic: Trauma-focused psychotherapy delivered through telemedicine has been demonstrated as an effective approach for the treatment of post-traumatic stress disorder (PTSD). However, uptake of this evidence-based approach by integrated health systems such as the Veterans Affairs (VA) Health Care System is low. What does this paper add: This paper presents new findings on the costs of two implementation approaches designed to increase adoption telemedicine outreach for PTSD from a health system perspective. What are the implications for practice, research, and policy: Cost estimates from this paper can be used by health systems to inform the relative value of candidate implementation strategies to increase adoption of evidence-based treatments for PTSD or other mental health conditions.

Deploying a telemedicine collaborative care intervention for posttraumatic stress disorder in the U.S. Department of Veterans Affairs: A stepped wedge evaluation of an adaptive implementation strategy.

OBJECTIVE: To address barriers to trauma-focused psychotherapy for veterans with posttraumatic stress disorder (PTSD), we compared two implementation strategies to promote the deployment of telemedicine collaborative care. METHOD: We conducted a Hybrid Type III Effectiveness Implementation trial at six VA medical centers and their 12 affiliated Community Based Outpatient Clinics. The trial used a stepped wedge design and an adaptive implementation strategy that started with standard implementation, followed by enhanced implementation for VA medical centers that did not achieve the performance benchmark. Implementation outcomes for the 544 veterans sampled from the larger population targeted by the intervention were assessed from chart review (care management enrollment and receipt of trauma-focused psychotherapy) and telephone survey (perceived access and PTSD symptoms) after each implementation phase. The primary outcome was enrollment in care management. RESULTS: There was no significant difference between standard implementation and enhanced implementation on any of the implementation outcomes. 41.6% of sampled veterans had a care manager encounter, but only 6.0% engaged in trauma-focused psychotherapy. CONCLUSIONS: While telemedicine collaborative care was shown to be effective at engaging veterans in trauma-focused psychotherapy in a randomized controlled trial, neither standard nor enhanced implementation strategies were sufficient to support successful deployment into routine care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02737098.

Clinical assessment and management of obesity in individuals with spinal cord injury: a review.

BACKGROUND: Diagnosing and managing obesity in individuals with spinal cord injury (SCI) remain challenging. METHODS: Literature on the epidemiology, impact, and management of obesity in individuals with SCI was reviewed. FINDINGS: Although nearly 66% of individuals with SCI are either overweight or obese, little guidance is available to measure and monitor obesity in the clinical setting. The use of anthropometric indices and specific cut points available for able-bodied persons is limited by the body composition changes that follow SCI. Indices of upper body obesity warrant examination in SCI because they provide an index of central obesity, which is more closely linked to some obesity-related conditions than is overall obesity. Investigations into the sequelae of excess body fat and its distribution are also needed in SCI because past research in this area has been inconclusive. Although limited, evidence regarding obesity interventions in SCI may be promising. CONCLUSIONS: The best anthropometric tool to define obesity in the clinical setting remains unknown. SCI-specific assessment tools and a better understanding of the sequelae of excess body weight will lead to better targeting of prevention and treatment efforts. More research is needed on the individual components of a weight management program unique to SCI. Until then, providers are urged to use a team approach and draw on existing resources and applicable research in able-bodied individuals to facilitate weight management in individuals with SCI.

Diabetes mellitus in individuals with spinal cord injury or disorder.

BACKGROUND/OBJECTIVE: To examine diabetes prevalence, care, complications, and characteristics of veterans with a spinal cord injury or disorder (SCI/D). METHODS: A national survey of veterans with an SCI/D was conducted using Behavioral Risk Factor Surveillance System (BRFSS) survey questions. Data were compared with national Centers for Disease Control and Prevention BRFSS data for veteran and nonveteran general populations. RESULTS: Overall prevalence of diabetes in individuals with an SCI/D was 20% (3 times higher than in the general population). Veterans with an SCI/D and veterans, in general, had a higher prevalence of diabetes across all age groups; however, those with an SCI/D who were 45 to 59 years of age had a higher prevalence than other veterans. One fourth of the persons with an SCI/D and diabetes reported that diabetes affected their eyes or that they had retinopathy (25%), and 41% had foot sores that took more than 4 weeks to heal. More veterans, both with (63%) and without an SCI/D (60%), took a class on how to manage their diabetes than the general population (50%). Veterans with an SCI/D and diabetes were more likely to report other chronic conditions and poorer quality of life than those without diabetes. CONCLUSIONS: Diabetes prevalence is greater among veterans with an SCI/D compared with the civilian population, but is similar to that of other veterans, although it may occur at a younger age in those with an SCI/D. Veterans with an SCI/D and diabetes reported more comorbidities, more slow-healing foot sores, and poorer quality of life than those without diabetes. Efforts to prevent diabetes and to provide early intervention in persons with SCI/D are needed.

Screening for cobalamin deficiency in geriatric outpatients: prevalence and influence of synthetic cobalamin intake.

OBJECTIVES: To describe the prevalence of cobalamin (Cbl) deficiency in older adult outpatients and to determine whether regular intake of a synthetic source of cobalamin confers protection against Cbl deficiency. DESIGN: Cross-sectional study. SETTING: Two university-affiliated geriatric medicine outpatient clinics. PARTICIPANTS: Three hundred fifteen older adults (age range 65-100) without a history of previously diagnosed or treated Cbl deficiency, severe anemia, or a life-threatening illness. MEASUREMENTS: Detailed information on total synthetic Cbl intake (from vitamins, fortified cereal, and supplemental nutritional formula sources) and laboratory measures of serum Cbl, metabolite panel (serum methylmalonic acid, homocysteine, cystathionine, and 2-methylcitric acid), complete blood count, and serum creatinine levels. RESULTS: Cbl deficiency (serum Cbl < or =300 pg/mL and methylmalonic acid (MMA)>271 nmol/L) was found in 13% of screened patients. Forty-six percent of screened patients reported regularly taking a source of synthetic Cbl. Serum Cbl correlated with synthetic Cbl intake, and patients regularly taking synthetic Cbl were significantly less likely to be Cbl deficient than persons not taking supplemental Cbl (8% vs 17%, P =.02). CONCLUSION: Regular use of a multivitamin/synthetic Cbl source confers some degree of protection against Cbl deficiency in older adults. The relatively high prevalence rates and benefit of synthetic Cbl intake in this study reinforce recommendations that older adults should be screened for Cbl deficiency and should incorporate synthetic sources of Cbl as part of a balanced diet. Appropriate screening intervals and the optimal dose of supplemental Cbl to prevent Cbl deficiency remains to be determined.

Leptin levels are appropriate for body mass index in older men who experience involuntary weight loss.

OBJECTIVES: To determine the relationship between leptin and unintentional weight loss in older adults. DESIGN: Prospective cohort study over 2 years. SETTING: University-affiliated Veterans Affairs Medical Center. PARTICIPANTS: The subjects were 105 community-dwelling male veterans aged 65 and older who had participated in a prospective cohort study on nutrition and health conducted at the Veterans Affairs Puget Sound Health Care System from 1986 to 1989. MEASUREMENTS: Anthropometric data and fasting blood specimens were collected at baseline and annually for the subsequent 2 years. Stored blood specimens were analyzed for leptin, insulin, glucose, C-reactive protein, sex hormone binding globulin, and testosterone levels. RESULTS: Over 2 years, 75 men were weight stable (weight loss <4% of baseline) and 30 men had unintentional weight loss (weight loss>4% of baseline). The baseline body mass index (BMI) and leptin levels for the two groups were not statistically different. Positive correlations existed between leptin level and BMI at each time point for weight-stable and weight-loss subjects. Furthermore, a significant relationship existed between changes in leptin and changes in BMI over 1 year in multiple regression analysis (r =.436, P <.001 after the first year; and r =.630, P =.027 after the second year). CONCLUSIONS: Like in younger adults, plasma leptin levels remained proportional to BMI, and changes in BMI were accurately reflected by changes in leptin levels in older individuals. Fasting leptin levels did not predict involuntary weight loss over 2 years of follow-up.

Response of elevated methylmalonic acid to three dose levels of oral cobalamin in older adults.

OBJECTIVES: Because the effects of lower-dose oral cobalamin (Cbl) supplements on older people with cobalamin deficiency are not known, we determined whether oral Cbl supplements at three different dose levels would normalize elevated serum methylmalonic acid (MMA) and total homocysteine (tHcy) concentrations. DESIGN: Sequential nonrandomized intervention study of three dose levels. SETTINGS: Two university-based senior care clinics. PARTICIPANTS: Twenty-three older adults (aged >/=65) with serum Cbl levels of 221 pmol/L (300 pg/mL) or lower and serum MMA greater than 271 nmol/L who had been enrolled in a previous screening study for Cbl deficiency (mean age 79 +/- 9; 17 male, 6 female; 17 white, 6 other). INTERVENTION: Sequential daily treatment with 25 microg oral cobalamin, followed by 100 microg and 1,000 microg cobalamin each for a 6-week period. MEASUREMENTS: Serum MMA, tHcy, and other metabolites at baseline and after each 6-week dosing interval. RESULTS: Treatment with 25 microg and 100 microg lowered but did not normalize MMA levels in most subjects. A dose of 1,000 microg/day proved to be the most effective in lowering MMA levels to within normal limits. Serum tHcy was normalized in six of 11 subjects who had elevated tHcy pretreatment with oral Cbl alone and in one subject in combination with a multivitamin. CONCLUSIONS: Most Cbl-deficient older people require more than 100 microg of oral Cbl to normalize serum MMA, which is a larger dose than is available in most standard multivitamins and Cbl supplements.

Association between obesity and diabetes mellitus in veterans with spinal cord injuries and disorders.

OBJECTIVES: To examine the association between body mass index (BMI) and clinically diagnosed diabetes in veterans with spinal cord injuries and disorders. We also sought to determine whether there is evidence to support a 10% reduction in BMI cut points, which would lower the upper limit of normal BMI from 24.99 to 22.49 kg/m, for persons with spinal cord injuries and disorders. DESIGN: Cross-sectional analysis using clinical data on 1938 male veterans. Prevalence ratios (95% confidence intervals) were calculated using a generalized linear model and adjusted for age, race, tobacco use, and paraplegia/tetraplegia status. RESULTS: Compared with the National Heart Lung Blood Institute normal BMI category (18.5-24.99 kg/m), the prevalence of diabetes was 50% higher (adjusted prevalence ratio: 1.50, 95% CI: 1.11-2.01) in the overweight category (25-29.99 kg/m) and approximately 3-fold higher (for obese classes 1-3, adjusted prevalence ratio: 2.74-3.03) in the obese category (BMI >or= 30 kg/m). Compared with the World Health Organization low-normal category (BMI, 18.5-22.99 kg/m), there was no significant difference in the prevalence of diabetes for those in the high normal weight (BMI, 23-24.99 kg/m) or low overweight (BMI, 25-27.49 kg/m) categories. However, the prevalence of diabetes was 2-fold higher among those in the high overweight category (BMI, 27.5-29.99 kg/m; adjusted prevalence ratio: 2.00, 95% CI: 1.33-2.99). CONCLUSIONS: BMI >or=25 kg/m was associated with significantly higher diabetes prevalence in male veterans with spinal cord injuries and disorders, and this risk was especially pronounced at BMI >or=27.5 kg/m. These findings do not support the need to create spinal cord injuries and disorder-specific BMI definitions of overweight for purposes of determining diabetes risk.

Using VA data for research in persons with spinal cord injuries and disorders: lessons from SCI QUERI.

The Department of Veterans Affairs (VA) provides integrated services to more than 25,000 veterans with spinal cord injuries and disorders (SCI/D). VA data offer great potential for providing insights into healthcare utilization and morbidity, and these capabilities are central to efforts to improve healthcare for veterans with SCI/D. The objective of this article is to introduce researchers to the use of VA data to examine questions related to SCI/D using examples from Spinal Cord Injury (SCI) Quality Enhancement Research Initiative studies. Sources of VA data available to investigators interested in SCI/D-related research include national-level VA administrative and clinical databases and primary data (medical record review, patient surveys). Methods used to identify veterans with SCI/D include the Allocation Resource Center cohort, the Spinal Cord Dysfunction (SCD) Registry, and the VA inpatient SCI flag; only 33% of veterans were included in all three groups (n = 12,306). While neurological level of SCI was unknown for approximately a third of veterans (from SCD Registry data alone), the percent decreased to 13% when augmented with diagnostic codes. Primary data can be used to augment other missing SCI data and to provide more detailed information about complications commonly associated with SCI/D.

Trends in diabetes mellitus indicators in veterans with spinal cord injury.

OBJECTIVE: Persons with spinal cord injury (SCI) are at increased risk for developing diabetes mellitus (DM). However, published data on the care provided to this population are minimal. The purpose of this study was to examine a set of measures of quality of DM care in veterans with SCI. DESIGN: Retrospective analysis of the External Peer Review Program data for veterans with SCI and DM from 2002 to 2004 in the Veterans Healthcare System. Trends in DM measures were examined using generalized estimation equation models. RESULTS: The percentage of veterans who received testing for lipids, retinal, and renal exams significantly increased during this period. This was accompanied by significant improvements in intermediate outcomes, glycemic, lipid, and blood pressure (BP) control. The percentage of veterans with glycosylated hemoglobin (HbA1c) (levels < or = 9%; P < 0.001) and those with poorly controlled levels (HbA1c > 9.5%; P = 0.022) improved. BP (140/90) rates increased from 59% in fiscal year (FY) 2002 to nearly 70% in 2004 (P < 0.001). The percentage of veterans who received renal screening (anatomical tests, physiologic test, and urine microalbumin) increased significantly (P < 0.001). Retinopathy exam rates also increased from 55.1% in FY 2002 to 70.8% in FY 2004 (P < 0.001). CONCLUSIONS: Significant improvements were made in a set of DM measures used to evaluate care provided to veterans with SCI. The positive trends in DM care seen in the general veteran population were also evident in the SCI population.

Prevalence of obesity and high blood pressure in veterans with spinal cord injuries and disorders: a retrospective review.

OBJECTIVE: A frequent cause of mortality in spinal cord injuries and disorders (SCI&D) is cardiovascular disease (CVD). Obesity and high blood pressure (BP) are modifiable risk factors for CVD. DESIGN: Retrospective review of clinical and administrative data for 7959 veterans with SCI&D. Data elements included height, weight, blood pressure, demographics, and level of injury. Analyses included descriptive statistics and generalized logistic regressions. RESULTS: Twenty percent of veterans were obese according to their body mass index (BMI), and 33% were overweight; 22% had high BP (> or = 140/90 mm Hg). Because BMI underestimates obesity in SCI&D, adjusted BMIs for overweight (23-27 kg/m2) and obesity (28+ kg/m2) indicate that those overweight increased to 37%, and 31% were obese. Veterans ages 50-64 or who had paraplegia were more likely to be overweight and obese than others; being white or age 65+ was associated with a higher likelihood of being overweight. Veterans who were overweight or obese, black, older (age 50+), and paraplegic were more likely to have higher blood pressure. CONCLUSIONS: Obesity and high BP rates were lower for veterans with SCI&D than the general population. However, because BMI underestimates body adiposity in SCI&D, obesity is likely a much more prevalent problem in this population and warrants attention.