The business case for hospital mobility programs in the veterans health care system: Results from multi-hospital implementation of the STRIDE program.

OBJECTIVE: To conduct a business case analysis for Department of Veterans Affairs (VA) program STRIDE (ASsisTed EaRly MobIlization for hospitalizeD older VEterans), which was designed to address immobility for hospitalized older adults. DATA SOURCES AND STUDY SETTING: This was a secondary analysis of primary data from a VA 8-hospital implementation trial conducted by the Function and Independence Quality Enhancement Research Initiative (QUERI). In partnership with VA operational partners, we estimated resources needed for program delivery in and out of the VA as well as national implementation facilitation in the VA. A scenario analysis using wage data from the Bureau of Labor Statistics informs implementation decisions outside the VA. STUDY DESIGN: This budget impact analysis compared delivery and implementation costs for two implementation strategies (Replicating Effective Programs [REP]+CONNECT and REP-only). To simulate national budget scenarios for implementation, we estimated the number of eligible hospitalizations nationally and varied key parameters (e.g., enrollment rates) to evaluate the impact of uncertainty. DATA COLLECTION: Personnel time and implementation outcomes were collected from hospitals (2017-2019). Hospital average daily census and wage data were estimated as of 2022 to improve relevance to future implementation. PRINCIPAL FINDINGS: Average implementation costs were $9450 for REP+CONNECT and $5622 for REP-only; average program delivery costs were less than $30 per participant in both VA and non-VA hospital settings. Number of walks had the most impact on delivery costs and ranged from 1 to 5 walks per participant. In sensitivity analyses, cost increased to $35 per participant if a physical therapist assistant conducts the walks. Among study hospitals, mean enrollment rates were higher among the REP+CONNECT hospitals (12%) than the REP-only hospitals (4%) and VA implementation costs ranged from $66 to $100 per enrolled. CONCLUSIONS: STRIDE is a low-cost intervention, and program participation has the biggest impact on the resources needed for delivering STRIDE. TRIAL REGISTRATION: ClinicalsTrials.gov NCT03300336. Prospectively registered on 3 October 2017.

Differences in healthcare costs over 10 years following discharge from military service by weight trajectory.

The prevalence of overweight and obesity among military personnel has increased substantially in the past two decades. Following military discharge many personnel can receive integrated health care from the Veterans Health Administration. Prior research related to the economic impacts of obesity has not examined health care costs following the transition into civilian life following military discharge. To address this evidence gap, this study sought to compare longitudinal costs over 10 years across weight categories among VA enrollees recently discharged from the military.

Association Between a National Behavioral Weight Management Program and Veterans Affairs Health Expenditures.

OBJECTIVE: The association between participation in a behavioral weight intervention and health expenditures has not been well characterized. We compared Veterans Affairs (VA) expenditures of individuals participating in MOVE!, a VA behavioral weight loss program, and matched comparators 2 years before and 2 years after MOVE! initiation. METHODS: Retrospective cohort study of Veterans who had one or more MOVE! visits in 2008-2017 who were matched contemporaneously to up to 3 comparators with overweight or obesity through sequential stratification on an array of patient characteristics, including sex. Baseline patient characteristics were compared between the two cohorts through standardized mean differences. VA expenditures in the 2 years before MOVE! initiation and 2 years after initiation were modeled using generalized estimating equations with a log link and distribution with variance proportional to the standard deviation (gamma). RESULTS: MOVE! participants (n=499,696) and comparators (n=1,336,172) were well-matched, with an average age of 56, average body mass index of 35, and similar total VA expenditures in the fiscal year before MOVE! initiation ($9662 for MOVE! participants and $10,072 for comparators, standardized mean difference=-0.019). MOVE! participants had total expenditures that were statistically lower than matched comparators in the 6 months after initiation but modestly higher in the 6 months to 2 years after initiation, though differences were small in magnitude (1.0%-1.6% differences). CONCLUSIONS: The VA's system-wide behavioral weight intervention did not realize meaningful short-term health care cost savings for participants.

Feasibility of a family-involved intervention to increase engagement in evidenced-based psychotherapies for posttraumatic stress disorder: A pilot study.

OBJECTIVE: To assess the feasibility of a family-involved intervention, family support in mental health recovery (FAMILIAR), for veterans with posttraumatic stress disorder (PTSD) seeking psychotherapy at a single Veterans Administration Health System. METHOD: This mixed-methods study reports qualitative and quantitative findings from a single-group pilot of 24 veterans and their support partners (SPs) about experiences with the intervention and interviews with eight VA mental health clinicians and leaders and the study interventionist to explore intervention feasibility. Findings across data sources were merged within domains of Bowen and colleagues' pilot study feasibility framework. RESULTS: Out of 24 dyads, 16 veterans and 15 associated SPs completed the intervention. Participants viewed the intervention to be valuable and feasible. Veterans and SPs reported that they enrolled in the study to develop a shared understanding of PTSD and treatment. While participants identified few logistical barriers, finding a time for conjoint sessions could be a challenge. Veterans, SPs, and providers discussed benefits of the intervention, including that it facilitated conversation between the veteran and SP about PTSD and mental health care and helped to prepare the dyad for treatment. Providers noted potential challenges integrating family-involved interventions into clinical workflow in VA and suggested the need for additional training and standardized procedures for family-centered care. CONCLUSIONS: Our study identified potential implementation facilitators (e.g., standard operating procedures about session documentation, confidentiality, and family ethics) and challenges (e.g., clinical workflow integration) that require further study to bring FAMILIAR into routine clinical care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial.

BACKGROUND: STRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran's Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes. METHODS: Replicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with "full dose" of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption. DISCUSSION: Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies. TRIAL REGISTRATION: This study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656 ).

Real World Use of Anti-Obesity Medications and Weight Change in Veterans.

BACKGROUND: Anti-obesity medications (AOMs) can be initiated in conjunction with participation in the VA national behavioral weight management program, MOVE!, to help achieve clinically meaningful weight loss. OBJECTIVE: To compare weight change between Veterans who used AOM + MOVE! versus MOVE! alone and examine AOM use, duration, and characteristics associated with longer duration of use. DESIGN: Retrospective cohort study using VA electronic health records. PARTICIPANTS: Veterans with overweight or obesity who participated in MOVE! from 2008-2017. MAIN MEASURES: Weight change from baseline was estimated using marginal structural models up to 24 months after MOVE! initiation. The probability of longer duration of AOM use (≥ 180 days) was estimated via a generalized linear mixed model. RESULTS: Among MOVE! participants, 8,517 (1.6%) used an AOM within 24 months after MOVE! initiation with a median of 90 days of cumulative supply. AOM + MOVE! users achieved greater weight loss than MOVE! alone users at 6 (3.2% vs. 1.6%, p < 0.001), 12 (3.4% vs. 1.4%, p < 0.001), and 24 months (2.7% vs. 1.5%, p < 0.001), and had a greater probability of achieving ≥ 5% weight loss at 6 (38.8% vs. 26.0%, p < 0.001), 12 (43.1% vs. 28.4%, p < 0.001), and 24 months (40.4% vs. 33.3%, p < 0.001). Veterans were more likely to have ≥ 180 days of supply if they were older, exempt from medication copays, used other medications with significant weight-gain, significant weight-loss, or modest weight-loss side effects, or resided in the West North Central or Pacific regions. Veterans were less likely to have ≥ 180 days of AOM supply if they had diabetes or initiated MOVE! later in the study period. CONCLUSIONS: AOM use following MOVE! initiation was uncommon, and exposure was time-limited. AOM + MOVE! was associated with a higher probability of achieving clinically significant weight loss than MOVE! alone.

Effects of Implementation of a Supervised Walking Program in Veterans Affairs Hospitals : A Stepped-Wedge, Cluster Randomized Trial.

BACKGROUND: In trials, hospital walking programs have been shown to improve functional ability after discharge, but little evidence exists about their effectiveness under routine practice conditions. OBJECTIVE: To evaluate the effect of implementation of a supervised walking program known as STRIDE (AssiSTed EaRly MobIlity for HospitalizeD VEterans) on discharge to a skilled-nursing facility (SNF), length of stay (LOS), and inpatient falls. DESIGN: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT03300336). SETTING: 8 Veterans Affairs hospitals from 20 August 2017 to 19 August 2019. PATIENTS: Analyses included hospitalizations involving patients aged 60 years or older who were community dwelling and admitted for 2 or more days to a participating medicine ward. INTERVENTION: Hospitals were randomly assigned in 2 stratified blocks to a launch date for STRIDE. All hospitals received implementation support according to the Replicating Effective Programs framework. MEASUREMENTS: The prespecified primary outcomes were discharge to a SNF and hospital LOS, and having 1 or more inpatient falls was exploratory. Generalized linear mixed models were fit to account for clustering of patients within hospitals and included patient-level covariates. RESULTS: Patients in pre-STRIDE time periods (n = 6722) were similar to post-STRIDE time periods (n = 6141). The proportion of patients with any documented walk during a potentially eligible hospitalization ranged from 0.6% to 22.7% per hospital. The estimated rates of discharge to a SNF were 13% pre-STRIDE and 8% post-STRIDE. In adjusted models, odds of discharge to a SNF were lower among eligible patients hospitalized in post-STRIDE time periods (odds ratio [OR], 0.6 [95% CI, 0.5 to 0.8]) compared with pre-STRIDE. Findings were robust to sensitivity analyses. There were no differences in LOS (rate ratio, 1.0 [CI, 0.9 to 1.1]) or having an inpatient fall (OR, 0.8 [CI, 0.5 to 1.1]). LIMITATION: Direct program reach was low. CONCLUSION: Although the reach was limited and variable, hospitalizations occurring during the STRIDE hospital walking program implementation period had lower odds of discharge to a SNF, with no change in hospital LOS or inpatient falls. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Quality Enhancement Research Initiative (Optimizing Function and Independence QUERI).

Informing a home time measure reflective of quality of life: A data driven investigation of time frames and settings of health care utilization.

OBJECTIVE: To evaluate short- and long-term measures of health care utilization-days in the emergency department (ED), inpatient (IP) care, and rehabilitation in a post-acute care (PAC) facility-to understand how home time (i.e., days alive and not in an acute or PAC setting) corresponds to quality of life (QoL). DATA SOURCES: Survey data on community-residing veterans combined with multipayer administrative data on health care utilization. STUDY DESIGN: VA or Medicare health care utilization, quantified as days of care received in the ED, IP, and PAC in the 6 and 18 months preceding survey completion, were used to predict seven QoL-related measures collected during the survey. Elastic net machine learning was used to construct models, with resulting regression coefficients used to develop a weighted utilization variable. This was then compared with an unweighted count of days with any utilization. PRINCIPAL FINDINGS: In the short term (6 months), PAC utilization emerged as the most salient predictor of decreased QoL, whereas no setting predominated in the long term (18 months). Results varied by outcome and time frame, with some protective effects observed. In the 6-month time frame, each weighted day of utilization was associated with a greater likelihood of activity of daily living deficits (0.5%, 95% CI: 0.1%-0.9%), as was the case with each unweighted day of utilization (0.6%, 95% CI: 0.3%-1.0%). The same was true in the 18-month time frame (for both weighted and unweighted, 0.1%, 95% CI: 0.0%-0.3%). Days of utilization were also significantly associated with greater rates of instrumental ADL deficits and fair/poor health, albeit not consistently across all models. Neither measure outperformed the other in direct comparisons. CONCLUSIONS: These results can provide guidance on how to measure home time using multipayer administrative data. While no setting predominated in the long term, all settings were significant predictors of QoL measures.

Exploring the importance of predisposing, enabling, and need factors for promoting Veteran engagement in mental health therapy for post-traumatic stress: a multiple methods study.

PURPOSE: This study explored Veteran and family member perspectives on factors that drive post-traumatic stress disorder (PTSD) therapy engagement within constructs of the Andersen model of behavioral health service utilization. Despite efforts by the Department of Veterans Affairs (VA) to increase mental health care access, the proportion of Veterans with PTSD who engage in PTSD therapy remains low. Support for therapy from family members and friends could improve Veteran therapy use. METHODS: We applied a multiple methods approach using data from VA administrative data and semi-structured individual interviews with Veterans and their support partners who applied to the VA Caregiver Support Program. We integrated findings from a machine learning analysis of quantitative data with findings from a qualitative analysis of the semi-structured interviews. RESULTS: In quantitative models, Veteran medical need for health care use most influenced treatment initiation and retention. However, qualitative data suggested mental health symptoms combined with positive Veteran and support partner treatment attitudes motivated treatment engagement. Veterans indicated their motivation to seek treatment increased when family members perceived treatment to be of high value. Veterans who experienced poor continuity of VA care, group, and virtual treatment modalities expressed less care satisfaction. Prior marital therapy use emerged as a potentially new facilitator of PTSD treatment engagement that warrants more exploration. CONCLUSIONS: Our multiple methods findings represent Veteran and support partner perspectives and show that amid Veteran and organizational barriers to care, attitudes and support of family members and friends still matter. Family-oriented services and intervention could be a gateway to increase Veteran PTSD therapy engagement.

Patient experiences of a care transition intervention for Veterans to reduce emergency department visits.

OBJECTIVES: Care transition interventions (CTIs) are used to improve outcomes after an emergency department (ED) visit. A recent randomized controlled trial of a Veterans Health Administration (VHA) CTI titled Discharge Information and Support for Patients receiving Outpatient care in the ED (DISPO ED) demonstrated no difference in repeat ED visits. However, changes in health care utilization are not the only measures of a CTI worth evaluation, and there is interest in using patient-centered outcomes to assess CTIs as well. To inform future CTI design and outcome measure selection, the study aims were to understand how patients experienced the CTI and what elements they valued. METHODS: This was a qualitative study of participants randomized to the intervention arm of the DISPO ED trial using semistructured interviews. The interview guide included questions about clinical health and other issues addressed by the study nurse, the most and least helpful aspects of the intervention, and impacts of the intervention on their perceptions of self-management. Interviews were analyzed using directed content analysis. RESULTS: Our sample comprised 24 participants, with average age of 61 years, 58% male, and 50% Black or African American. We identified six major themes related to (1) experiences during the intervention and (2) elements they valued. Patients reported clinical health coaching recommendations covering a wide range of topics as well as care coordination actions such as appointment scheduling. Valuable elements of the intervention highlighted personal characteristics of the study nurse that promoted a sense of interpersonal connection and empathy in their interactions. CONCLUSIONS: Intervention users described assistance with care coordination as well as clinical concerns. We identified aspects that were highly valued by the participants, such as interpersonal support and empathy from the interventionist. These findings suggest the need for more comprehensive nonutilization outcome measures for CTIs to capture the patient's perspective.

BMI Trends for Veterans Up to 10 Years After VA Enrollment Following Military Discharge.

BACKGROUND: Obesity (body mass index [BMI]≥30kg/m2) among US adults has tripled over the past 45 years, but it is unclear how this population-level weight change has occurred. OBJECTIVE: We sought to identify distinct long-term BMI trajectories and examined associations with demographic and clinical characteristics. DESIGN: The design was latent trajectory modeling over 10 years of a retrospective cohort. Subgroups were identified via latent class growth mixture models, separately by sex. Weighted multinomial logistic regressions identified factors associated with subgroup membership. PARTICIPANTS: Participants were a retrospective cohort of 292,331 males and 62,898 females enrolled in VA. MAIN MEASURES: The main outcome measure was 6-month average VA-measured BMI over the course of 10 years. Additional electronic health record measures on demographic, clinical, and services utilization characteristics were also used to characterize latent trajectories. KEY RESULTS: Four trajectories were identified for men and for women, corresponding to standard BMI categories "normal weight" (BMI <25), "overweight" (BMI 25-29.99), and "with obesity" (BMI ≥30): "normal weight" and increasing (males: 28.4%; females: 22.8%), "overweight" and increasing (36.4%; 35.6%), "with obesity" and increasing (33.6%; 40.0%), and "with obesity" and stable (males: 1.6%) or decreasing (females: 1.6%). Race, ethnicity, comorbidities, mental health diagnoses, and mental health service utilization discriminated among classes. CONCLUSIONS: BMI in the 10 years following VA enrollment increased modestly. VA should continue prioritizing weight management interventions to the large number of veterans with obesity upon VA enrollment, because the majority remain with obesity.

Informal Caregiver Support Policies Change Use of Vocational Assistance Services for Individuals With Disabilities.

Support policies for caregivers improves care-recipient access to care and effects may generalize to nonhealth services. Using administrative data from the U.S. Department of Veterans Affairs (VA) for veterans <55 years, we assessed the association between enrollment in a VA caregiver support program and veteran use of vocational assistance services: the post-9/11 GI Bill, VA vocational rehabilitation and employment (VR&E), and supported employment. We applied instrumental variables to Cox proportional hazards models. Caregiver enrollment in the program increased veteran supported employment use (hazard ratio = 1.35, 95% confidence interval [1.14, 1.53]), decreased VR&E use (hazard ratio = 0.84, 95% confidence interval [0.76, 0.92]), and had no effect on the post-9/11 GI Bill. Caregiver support policies could increase access to some vocational assistance for individuals with disabilities, particularly supported employment, which is integrated into health care. Limited coordination between health and employment sectors and misaligned incentives may have inhibited effects for the post-9/11 GI Bill and VR&E.

Psychological distress among medically complex veterans with a recent emergency department visit.

Medical complexity and psychological distress are associated with frequent emergency department (ED) use. Despite this known association, our understanding is limited about which patients are at risk for persistent psychological distress and what patterns of distress emerge over time. A secondary data analysis was used to examine self-reported psychological distress (defined as ≥14 unhealthy days due to poor mental health in the past month) at 30 and 180 days following enrollment in a randomized control trial of 513 medically complex Veterans after a nonpsychiatric ED visit. We used a multivariable ordered logistic regression model to examine the association of a priori factors [baseline psychological distress, age, race, income, health literacy, deficits in activities of daily living (ADL), and deficits in instrumental activities of daily living] with three psychological distress classifications (no/low, intermittent, and persistent). Among 513 Veterans, 40% reported at baseline that they had experienced high psychological distress in the previous month. Older age was associated with lower odds of high psychological distress (OR = 0.95; 95% CI: 0.94-0.97). Baseline factors associated with significantly higher odds of persistent psychological distress at 30 and 180 days assessments, included having the inadequate income (OR = 1.61; 95% CI: 1.02-2.55), having low health literacy (OR = 1.63; 95% CI: 1.01-2.62), and reporting at least one ADL deficit (OR = 1.94; 95% CI: 1.13-3.33). Psychological distress at follow-up was common among medically complex Veterans with a recent ED visit. Future research should explore interventions that integrate distress information into treatment plans and/or link to mental health referral services. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Exploring differential response to an emergency department-based care transition intervention.

OBJECTIVE: To identify multivariable subgroups of patients with differential responses to a nurse-delivered care transition intervention after an emergency department (ED) visit in a randomized controlled trial (RCT) using an emerging data-driven method. DESIGN: Secondary analysis of RCT. PARTICIPANTS: 512 individuals enrolled in an RCT of a nurse-delivered care transition intervention after an ED visit. All 512 participants were included in a pre-specified subgroup analysis, and 451 of these had sufficient complete case data to be included in a model-based recursive (MoB) partitioning analysis. METHODS: The primary outcome was having at least one ED visit in 30 days after the index ED visit. Two analytical methods explored heterogeneity of treatment effects: data driven model-based recursive partitioning (MoB) using 37 candidate baseline variables, and a contextual point of comparison with prespecified subgroups defined by ED super-user status (≥ 3 ED visits in previous 6 months or not), sex (male/female), and age, individually examined via treatment arm by subgroup interaction terms in logistic regression models. Internal validation of the MoB analysis via bootstrap resampling with an optimism corrected c-statistic was conducted to provide a bias-corrected estimate. RESULTS: MoB detected treatment effect heterogeneity in a single subgroup, marital status. Unmarried patients randomized to the intervention had a repeat ED use rate of 22% compared to 34% in the usual care group; married patients randomized to the intervention had a 27% ED return rate compared to 12% in the usual care group. Internal validation demonstrated an optimism corrected c-statistic of 0.54. No treatment-by-covariate subgroup interactions were identified among the 3 prespecified subgroups. CONCLUSION: Although exploratory, the results of the MoB analysis suggest that patient factors related to social relationships such as marital status may be important contributors to differential response to a care transition intervention after an ED visit. These were characteristics that the investigators had not anticipated or planned to examine in the individual prespecified subgroup analysis. Data-driven methods can yield unexpected findings and contribute to a more complete understanding of differential treatment effects in subgroup analysis, which can inform further work on development of effective care transition interventions in the ED setting.

Prevalence of insomnia disorder and sleep apnea in a sample of veterans at risk for cardiovascular disease.

STUDY OBJECTIVES: The objectives of this study were to examine the proportion of study participants screening positive for insomnia disorder and/or sleep apnea in veterans engaged in routine health care and known to be at risk for cardiovascular disease and to compare these proportions with those previously documented in medical records. METHODS: This was a cross-sectional analysis of baseline data from a randomized clinical intervention trial for patients at risk of cardiovascular disease and a review of study participants' medical records. Participants were veterans ≥ 40 years of age, enrolled in Veterans Affairs primary care, and diagnosed with hypertension and/or hypercholesterolemia. Self-report outcomes were the proportion of patients screening positive for an insomnia disorder and sleep apnea, self-reporting a sleep apnea diagnosis, and endorsing undertreated sleep apnea. Medical record outcomes were the proportion of patients diagnosed with insomnia and sleep apnea. RESULTS: Participants (n = 420) were veterans (84.8% male) with a mean age of 61.1 years. More than half of the sample (52.1%) screened positive for sleep apnea without prior self-reported diagnosis. More than one-third of the sample (39%) screened positive for an insomnia disorder. Medical records revealed considerably lower rates, with 3.8% diagnosed with insomnia, 20.5% diagnosed with sleep apnea, and about 1% diagnosed with both conditions. CONCLUSIONS: Undiagnosed and undertreated sleep disorders are common among veterans at risk for cardiovascular disease. Most of the sample (82%) screened positive for, or met, study criteria for sleep apnea or an insomnia disorder. Limitations include the use of self-reported sleep apnea treatment adherence, an insomnia disorder diagnosis based on questionnaire score, and a sample comprised primarily of male veterans. Routine sleep disorders screening in veterans at risk for cardiovascular disease could help to identify those at even greater risk because of the adverse effects of undiagnosed or undertreated sleep disorders. CLINICAL TRIAL REGISTRATION: Registry; ClinicalTrials.gov; Name: Cardiovascular Intervention Improvement Telemedicine Study; URL: https://clinicaltrials.gov/ct2/show/NCT01142908; Identifier: NCT01142908.

Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial.

OBJECTIVE: Compare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness. METHOD: Primary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace. RESULTS: Average age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference -0.4 [95% CI, -1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference -0.2 [95% CI, -1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, -1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference -1.0 [95% CI, -2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales. DISCUSSION: In early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.

Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program.

BACKGROUND: Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs. METHODS: Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals. RESULTS: Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled). CONCLUSIONS: Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out. TRIAL REGISTRATION: ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

A data-driven examination of which patients follow trial protocol.

Protocol adherence in behavioral intervention clinical trials is critical to trial success. There is increasing interest in understanding which patients are more likely to adhere to trial protocols. The objective of this study was to demonstrate the use of a data-driven approach to explore patient characteristics associated with the lowest and highest rates of adherence in three trials assessing interventions targeting behaviors related to lifestyle and risk for cardiovascular disease. Each trial included a common set of baseline variables. Model-based recursive partitioning (MoB) was applied in each trial to identify participant characteristics of subgroups characterized by these baseline variables with differences in protocol adherence. Bootstrap resampling was conducted to provide optimism-corrected c-statistics of the final solutions. In the three trials, rates of protocol adherence varied from 56.9% to 87.5%. Evaluation of heterogeneity of protocol adherence via MoB in each trial resulted in trees with 2-4 subgroups based on splits of 1-3 variables. In two of the three trials, the first split was based on pain in the past week, and those reporting lower pain were less likely to be adherent. In one of these trials, the second and third splits were based on education and employment, where those with lower education levels and who were employed were less likely to be adherent. In the third trial, the two splits were based on smoking status and then marriage status, where smokers who were married were least likely to be adherent. Optimism-corrected c-statistics ranged from 0.54 to 0.63. Model-based recursive partitioning can be a useful approach to explore heterogeneity in protocol adherence in behavioral intervention trials. An important next step would be to assess whether patterns hold in other similar studies and samples. Identifying subgroups who are less likely to be adherent to an intervention can help inform modifications to the intervention to help tailor the intervention to these subgroups and increase future uptake and impact. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01828567, NCT02360293, and NCT01838226.

Comprehensive support of family caregivers: Are there health system cost offsets?

OBJECTIVES: To examine the effect of the Department of Veterans Affairs' (VA) Program of Comprehensive Assistance for Caregivers (PCAFC) on total VA health care costs for Veterans. DATA SOURCES: VA claims. STUDY DESIGN: Using a pre-post cohort design with nonequivalent control group, we estimated the effect of PCAFC on total VA costs up through 6 years. The treatment group included Veterans (n = 32 394) whose caregivers enrolled in PCAFC. The control group included an inverse probability of treatment weighted sample of Veterans whose caregivers were denied PCAFC enrollment (n = 38 402). DATA EXTRACTION: May 2009-September 2017. PRINCIPAL FINDINGS: Total VA costs pre-PCAFC application date were no different between groups. Veterans in PCAFC were estimated to have $13 227 in VA costs in the first 6 months post-PCAFC application, compared to $10 806 for controls. Estimated VA costs for both groups decreased in the first 3 years with a narrowing, but persistent and significant, difference, through 5.5 years. No significant difference in VA health care costs existed at 6 years, approximately $10 000 each, though confidence intervals reflect significant uncertainty in cost differences at 6 years. CONCLUSIONS: Increased costs arose from increased outpatient costs of participants. Sample composition changes may explain lack of significance in cost differences at 6 years because these costs comprise of early appliers to PCAFC. Examining 10-year costs could elucidate whether there are long-term cost offsets from increased engagement in outpatient care.

Short-Term VA Health Care Expenditures Following a Health Risk Assessment and Coaching Trial.

BACKGROUND: Short-term health care costs following completion of health risk assessments and coaching programs in the VA have not been assessed. OBJECTIVE: To compare VA health care expenditures among veterans who participated in a behavioral intervention trial that randomized patients to complete a HRA followed by health coaching (HRA + coaching) or to complete the HRA without coaching (HRA-alone). DESIGN: Four-hundred seventeen veterans at three Veterans Affairs (VA) Medical Centers or Clinics were randomized to HRA + coaching or HRA-alone. Veterans randomized to HRA-alone (n = 209) were encouraged to discuss HRA results with their primary care team, while veterans randomized to HRA + coaching (n = 208) received two brief telephone-delivered health coaching calls. PARTICIPANTS: We included 411 veterans with available cost data. MAIN MEASURES: Total VA health expenditures 6 months following trial enrollment were estimated using a generalized linear model with a gamma distribution and log link function. In exploratory analysis, model-based recursive partitioning was used to determine whether the intervention effect on short-term costs differed among any patient subgroups. KEY RESULTS: Most participants were male (85%); mean age was 56, and mean body mass index was 34. From the generalized linear model, 6-month estimated mean total VA expenditures were similar ($8665 for HRA + coaching vs $9900 for HRA-alone, p = 0.25). In exploratory subgroup analysis, among unemployed veterans with good sleep and fair or poor perceived health, mean observed expenditures in the HRA + coaching group were higher than in the HRA-alone group ($12,814 vs $7971). Among unemployed veterans with good sleep and good general health, mean observed expenditures in the HRA + coaching group were lower than in the HRA-alone group ($5082 vs $11,612). CONCLUSIONS: Compared to completing and receiving HRA results, working with health coaches to set actionable health behavior change goals following HRA completion did not reduce short-term health expenditures. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01828567.