Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial.

Introduction: Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods: Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results: The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2-2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions: A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413.

Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study.

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach.Trial Registration: NCT04587336.

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 ).

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain.

OBJECTIVE: The purpose of this study was to describe the referrals and use of a hybrid care model for low back pain that includes on-site care by physical therapists, physical activity training, and psychologically informed practice (PiP) delivered by telehealth in the Improving Veteran Access to Integrated Management of Low Back Pain (AIM-Back) trial. METHODS: Data were collected from November 2020 through February 2023 from 5 Veteran Health Administration clinics participating in AIM-Back, a multisite, cluster-randomized embedded pragmatic trial. The authors extracted data from the Veteran Health Administration Corporate Data Warehouse to describe referral and enrollment metrics, telehealth use (eg, distribution of physical activity and PiP calls), and treatments used by physical therapists and telehealth providers. RESULTS: Seven hundred one veterans were referred to the AIM-Back trial with 422 enrolling in the program (consult-to-enrollment rate = 60.2%). After travel restrictions were lifted, site visits resulted in a significant increase in referrals and a number of new referring providers. At initial evaluation by on-site physical therapists, 92.2% of veterans received pain modulation (eg, transcutaneous electrical nerve stimulation, manual therapy). Over 81% of enrollees completed at least 1 telehealth physical activity call, with a mean of 2.8 (SD = 2.0) calls out of 6. Of the 167 veterans who screened as medium to high risk of persistent disability, 74.9% completed at least 1 PiP call, with a mean of 2.5 (SD = 2.0) calls out of 6. Of those who completed at least 1 PiP call (n = 125), 100% received communication strategies, 97.6% received pain coping skills training, 89.6% received activity-based treatments, and 99.2% received education in a home program. CONCLUSION: In implementing a hybrid care pathway for low back pain, the authors observed consistency in the delivery of core components (ie, pain modulation, use of physical activity training, and risk stratification to PiP), notable variability in telehealth calls, high use of PiP components, and increased referrals with tailored provider engagement. IMPACT: These findings describe variability occurring within a hybrid care pathway and can inform future implementation efforts.

Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial.

BACKGROUND: Knee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT. METHODS: In this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted. DISCUSSION: To our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT. TRIAL REGISTRATION: This study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).

Implementation intensification to disseminate a skills-based caregiver training program: protocol for a type III effectiveness-implementation hybrid trial.

BACKGROUND: Family caregiver training decreases caregiver psychological burden and improves caregiver depressive symptoms and health-related quality of life. Caregivers FIRST is an evidence-based group skills training curriculum for family caregivers and was announced for national dissemination in partnership with the Veterans Health Administration (VHA) National Caregiver Support Program (CSP). Previous evaluations of Caregivers FIRST implementation highlighted that varying support was needed to successfully implement the program, ranging from minimal technical assistance to intensive assistance and support. However, we do not know the optimal level of support needed to inform cost-effective national scaling of the program. We describe a protocol for randomizing 24 non-adopting VA medical centers 1:1 to a tailored, high-touch implementation support or a standard, low-touch implementation support to test the primary hypothesis that high-touch support increases Caregivers FIRST penetration, fidelity, and adoption. Additionally, we describe the methods for evaluating the effect of Caregivers FIRST participation on Veteran outcomes using a quasi-experimental design and the methods for a business case analysis to examine cost of delivery differences among sites assigned to a low or high-touch implementation support. METHODS: We use a type III hybrid implementation-effectiveness study design enrolling VA medical centers that do not meet Caregivers FIRST adoption benchmarks following the announcement of the program as mandated within the CSP. Eligible medical centers will be randomized to receive a standard low-touch implementation support based on Replicating Effective Programs (REP) only or to an enhanced REP (high-touch) implementation support consisting of facilitation and tailored technical assistance. Implementation outcomes include penetration (primary), fidelity, and adoption at 12 months. Mixed methods will explore sites' perceptions and experiences of the high-touch intensification strategy. Additional analyses will include a patient-level effectiveness outcome (Veteran days at home and not in an institution) and a business case analysis using staffing and labor cost data. DISCUSSION: This pragmatic trial will lead to the development and refinement of implementation tools to support VA in spreading and sustaining Caregivers FIRST in the most efficient means possible. TRIAL REGISTRATION: This study was registered on April 8, 2022, at ClinicalTrials.gov (identifier NCT05319535).

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).

Ready, set, go! The role of organizational readiness to predict adoption of a family caregiver training program using the Rogers' diffusion of innovation theory.

BACKGROUND: Caregivers FIRST is an evidence-based program addressing gaps in caregivers' skills. In 2020, the Veterans Health Administration Caregiver Support Program (CSP) nationally endorsed Caregivers FIRST, offering credit in leadership performance plans to encourage all VA medical centers (VAMCs) to implement locally. This study examines the association of organizational readiness with VAMC adoption of Caregivers FIRST. METHODS: In a cohort observational study, we surveyed CSP managers about their facilities' readiness to implement using the Organizational Readiness for Implementing Change (ORIC) instrument and compared change commitment and change efficacy domains among VAMCs "adopters" defined as delivering Caregivers FIRST within 1 year of the national announcement to those that did not ("non-adopters"). Within "adopters," we categorized time to adoption based on Rogers' diffusion of innovation theory including "innovators," "early adopters," "early majority," "late adopters," and "laggards." Organizational readiness and site characteristics (facility complexity, staffing levels, volume of applications for caregiver assistance services) were compared between "adopters," "non-adopters," and between time to adoption subcategories. Separate logistic regression models were used to assess whether ORIC and site characteristics were associated with early adoption among "adopters." RESULTS: Fifty-one of 63 (81%) VAMCs with CSP manager survey respondents adopted Caregivers FIRST during the first year. ORIC change commitment and efficacy were similar for "adopters" and "non-adopters." However, sites that adopted earlier (innovators and early adopters) had higher ORIC change commitment and efficacy scores than the rest of the "adopters." Logistic regression results indicated that higher ORIC change commitment (odds ratio [OR] = 2.57; 95% confidence interval [CI], 1.11-5.95) and ORIC change efficacy (OR = 2.60; 95% CI, 1.12-6.03) scores were associated with increased odds that a VAMC was an early adopter (categorized as an "innovator," "early adopter", or "early majority"). Site-level characteristics were not associated with Caregivers FIRST early adoption. CONCLUSIONS: To our knowledge, this study is the first to prospectively assess organizational readiness and the timing of subsequent program adoption. Early adoption was associated with higher ORIC change commitment and change efficacy and not site-level characteristics. These findings yield insights into the role of organizational readiness to accelerate program adoption. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03474380. Registered on March 22, 2018.

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.

Effect of cognitive processing therapy on markers of cardiovascular risk in posttraumatic stress disorder patients: A randomized clinical trial.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is associated with elevated risk of coronary heart disease (CHD); however, the effects of PTSD treatment on CHD biomarkers is unknown. This study examined whether cognitive processing therapy (CPT) improves 24-hourheart rate variability (HRV), a predictor of CHD mortality. METHODS: Individuals between the ages of 40 and 65 years with PTSD (n = 112) were randomized to receive 12 sessions of CPT or a Waiting List (WL) intervention comprised of 6 weekly telephone checks of emotional status. The primary outcome variable was 24-hour HRV estimated from the standard deviation of all normal R-R intervals (SDNN); secondary outcomes were the root mean square of successive differences between heart beats (RMSSD), low-frequency HRV (LF-HRV) and high-frequency HRV (HF-HRV). Secondary outcomes also included 24-hour urinary catecholamine excretion, plasma C-reactive protein (CRP), and flow-mediated dilation (FMD) of the brachial artery. For outcomes, linear mixed longitudinal models were used to estimate mean differences (Mdiff). RESULTS: Participants randomized to the CPT group did not show improved SDNN (Mdiff = 9.8; 95%CI, -2.7 to 22.3; p = 0.12), the primary outcome variable, but showed improved RMSSD (Mdiff = 3.8; 95% CI, 0.5 to 7.1; p = 0.02), LF- HRV (Mdiff =0.3; 95% CI, 0.1 to 0.5; p = 0.01), and HF-HRV (Mdiff = 0.3; 95% CI, 0.0 to 0.6; p = 0.03) compared to WL. There were no differences between groups in catecholamine excretion, FMD, or inflammatory markers. CONCLUSION: Treating PTSD may not only improve quality of life but may also help ameliorate heightened CHD risk characteristics of PTSD.

Have racial disparities in home dialysis utilization changed over time?

OBJECTIVES: The Medicare end-stage kidney disease (ESKD) prospective payment system (PPS) for maintenance dialysis, implemented in 2011, resulted in modestly increased access to both home-based peritoneal dialysis (PD) and home hemodialysis (HHD) treatment modalities, but it is unclear whether regional disparities in home dialysis (PD and HHD) were affected. We compared regional home dialysis use by White and non-White individuals over time. STUDY DESIGN: Retrospective cohort study of dialysis facilities offering home dialysis in 2006-2016 and of 1,098,579 patients with prevalent ESKD in 2006-2016. METHODS: We compared hospital referral region (HRR) utilization rates of home dialysis between White and non-White patients over time using a generalized estimating equation model with a negative binomial distribution adjusting for regional characteristics. RESULTS: The mean number of facilities offering home dialysis operating in each HRR increased from 15.6 in 2006 to 22.1 in 2016. Observed mean HRR home dialysis rates increased overall, but White patients maintained greater home dialysis use than non-White patients: 19.7% in 2006 and 26.2% in 2016 among White patients vs 13.0% in 2006 and 17.8% in 2016 among non-White patients. In adjusted analysis, there was no evidence of changes in White/non-White disparities in home dialysis use over time (P = .84) or after the Medicare ESKD PPS in 2011 (incidence rate ratio, 0.97; 95% CI, 0.92-1.02; P = .29). CONCLUSIONS: Even after modest increases in dialysis facility availability and patient utilization after the implementation of the Medicare ESKD PPS in 2011, significant racial disparities in home dialysis remain.

A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer.

BACKGROUND: Obtaining comprehensive family health history (FHH) to inform colorectal cancer (CRC) risk management in primary care settings is challenging. OBJECTIVE: To examine the effectiveness of a patient-facing FHH platform to identify and manage patients at increased CRC risk. DESIGN: Two-site, two-arm, cluster-randomized, implementation-effectiveness trial with primary care providers (PCPs) randomized to immediate intervention versus wait-list control. PARTICIPANTS: PCPs treating patients at least one half-day per week; patients aged 40-64 with no medical conditions that increased CRC risk. INTERVENTIONS: Immediate-arm patients entered their FHH into a web-based platform that provided risk assessment and guideline-driven decision support; wait-list control patients did so 12 months later. MAIN MEASURES: McNemar's test examined differences between the platform and electronic medical record (EMR) in rates of increased risk documentation. General estimating equations using logistic regression models compared arms in risk-concordant provider actions and patient screening test completion. Referral for genetic consultation was analyzed descriptively. KEY RESULTS: Seventeen PCPs were randomized to each arm. Patients (n = 252 immediate, n = 253 control) averaged 51.4 (SD = 7.2) years, with 83% assigned male at birth, 58% White persons, and 33% Black persons. The percentage of patients identified as increased risk for CRC was greater with the platform (9.9%) versus EMR (5.2%), difference = 4.8% (95% CI: 2.6%, 6.9%), p < .0001. There was no difference in PCP risk-concordant action [odds ratio (OR) = 0.7, 95% CI (0.4, 1.2; p = 0.16)]. Among 177 patients with a risk-concordant screening test ordered, there was no difference in test completion, OR = 0.8 [0.5,1.3]; p = 0.36. Of 50 patients identified by the platform as increased risk, 78.6% immediate and 68.2% control patients received a recommendation for genetic consultation, of which only one in each arm had a referral placed. CONCLUSIONS: FHH tools could accurately assess and document the clinical needs of patients at increased risk for CRC. Barriers to acting on those recommendations warrant further exploration. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336.

Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis.

BACKGROUND: Most efforts to identify caregivers for research use passive approaches such as self-nomination. We describe an approach in which electronic health records (EHRs) can help identify, recruit, and increase diverse representations of family and other unpaid caregivers. OBJECTIVE: Few health systems have implemented systematic processes for identifying caregivers. This study aimed to develop and evaluate an EHR-driven process for identifying veterans likely to have unpaid caregivers in a caregiver survey study. We additionally examined whether there were EHR-derived veteran characteristics associated with veterans having unpaid caregivers. METHODS: We selected EHR home- and community-based referrals suggestive of veterans' need for supportive care from friends or family. We identified veterans with these referrals across the 8 US Department of Veteran Affairs medical centers enrolled in our study. Phone calls to a subset of these veterans confirmed whether they had a caregiver, specifically an unpaid caregiver. We calculated the screening contact rate for unpaid caregivers of veterans using attempted phone screening and for those who completed phone screening. The veteran characteristics from the EHR were compared across referral and screening groups using descriptive statistics, and logistic regression was used to compare the likelihood of having an unpaid caregiver among veterans who completed phone screening. RESULTS: During the study period, our EHR-driven process identified 12,212 veterans with home- and community-based referrals; 2134 (17.47%) veteran households were called for phone screening. Among the 2134 veterans called, 1367 (64.06%) answered the call, and 813 (38.1%) veterans had a caregiver based on self-report of the veteran, their caregiver, or another person in the household. The unpaid caregiver identification rate was 38.1% and 59.5% among those with an attempted phone screening and completed phone screening, respectively. Veterans had increased odds of having an unpaid caregiver if they were married (adjusted odds ratio [OR] 2.69, 95% CI 1.68-4.34), had respite care (adjusted OR 2.17, 95% CI 1.41-3.41), or had adult day health care (adjusted OR 3.69, 95% CI 1.60-10.00). Veterans with a dementia diagnosis (adjusted OR 1.37, 95% CI 1.00-1.89) or veteran-directed care referral (adjusted OR 1.95, 95% CI 0.97-4.20) were also suggestive of an association with having an unpaid caregiver. CONCLUSIONS: The EHR-driven process to identify veterans likely to have unpaid caregivers is systematic and resource intensive. Approximately 60% (813/1367) of veterans who were successfully screened had unpaid caregivers. In the absence of discrete fields in the EHR, our EHR-driven process can be used to identify unpaid caregivers; however, incorporating caregiver identification fields into the EHR would support a more efficient and systematic identification of caregivers. TRIAL REGISTRATION: ClincalTrials.gov NCT03474380; https://clinicaltrials.gov/ct2/show/NCT03474380.

Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial.

Importance: Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice. Objective: To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach. Design, Setting, and Participants: This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022. Interventions: Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination. Main Outcomes and Measures: Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined. Results: The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver. Conclusions and Relevance: This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov Identifier: NCT03520413.

Cost and Quality of Life Outcomes of the STepped Exercise Program for Patients With Knee OsteoArthritis Trial.

OBJECTIVES: This study aimed to evaluate the cost-effectiveness of the randomized clinical trial STEP-KOA (STepped Exercise Program for patients with Knee OsteoArthritis). METHODS: The trial included 230 intervention and 115 control participants from 2 Veterans Affairs (VA) medical centers. A decision tree simulated outcomes for cohorts of patients receiving arthritis education (control) or STEP-KOA (intervention), which consisted of an internet-based exercise training program (step 1), phone counseling (step 2), and physical therapy (step 3) according to patient's response. Intervention costs were assessed from the VA perspective. Quality of life (QOL) was measured using 5-level EQ-5D US utility weights. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in costs divided by the difference in quality-adjusted life-years (QALYs) between arms at 9 months. A Monte Carlo probabilistic sensitivity analysis was used to generate a cost-effectiveness acceptability curve. RESULTS: The adjusted model found differential improvement in QOL utility weights of 0.042 (95% confidence interval 0.003-0.080; P=.03) for STEP-KOA versus control at 9 months. In the base case, STEP-KOA resulted in an incremental gain of 0.028 QALYs and an incremental cost of $279 per patient for an ICER of $10 076. One-way sensitivity analyses found the largest sources of variation in the ICER were the impact on QOL and the need for a VA-owned tablet. The probabilistic sensitivity analysis found a 98% probability of cost-effectiveness at $50 000 willingness-to-pay per QALY. CONCLUSIONS: STEP-KOA improves QOL and has a high probability of cost-effectiveness. Resources needed to implement the program will decline as ownership of mobile health devices increases.

Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.

BACKGROUND: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. OBJECTIVE: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. DESIGN: Mixed-methods implementation study. PARTICIPANTS: 230 patients with clinic-refractory, uncontrolled T2D. INTERVENTION: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. MAIN MEASURES: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). KEY RESULTS: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. CONCLUSIONS: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.

Factors associated with non-adherence to insulin and non-insulin medications in patients with poorly controlled diabetes.

OBJECTIVES: To evaluate differences in factors associated with self-reported medication non-adherence to insulin and non-insulin medications in patients with uncontrolled type 2 diabetes. METHODS: In this secondary analysis of a randomized trial in patients with obesity and uncontrolled type 2 diabetes, multivariable logistic regression was used to evaluate associations between several clinical factors (measured with survey questionnaires at study baseline) and self-reported non-adherence to insulin and non-insulin medications. RESULTS: Among 263 patients, reported non-adherence was 62% (52% for insulin, 55% for non-insulin medications). Reported non-adherence to non-insulin medications was less likely in white versus non-white patients (odds ratio (OR) = 0.42; 95%CI: 0.22,0.80) and with each additional medication taken (OR = 0.75; 95%CI: 0.61,0.93). Non-adherence to non-insulin medications was more likely with each point increase in a measure of diabetes medication intensity (OR = 1.43; 95%CI: 1.01,2.03), the Problem Areas in Diabetes (PAID) score (OR = 1.06; 95%CI: 1.02,1.12), and in men versus women (OR = 3.03; 95%CI: 1.06,8.65). For insulin, reporting non-adherence was more likely (OR = 1.02; 95%CI: 1.00,1.04) with each point increase in the PAID. DISCUSSION: Despite similar overall rates of reported non-adherence to insulin and non-insulin medications, factors associated with reported non-adherence to each medication type differed. These findings may help tailor approaches to supporting adherence in patients using different types of diabetes medications.

Application of Heterogeneity of Treatment-Effects Methods: Exploratory Analyses of a Trial of Exercise-Based Interventions for Knee Osteoarthritis.

OBJECTIVE: To evaluate heterogeneity of treatment effects in a trial of exercise-based interventions for knee osteoarthritis (OA). METHODS: Participants (n = 350) were randomized to standard physical therapy (PT; n = 140), internet-based exercise training (IBET; n = 142), or wait list (WL; n = 68) control. We applied qualitative interaction trees (QUINT), a sequential partitioning method, and generalized unbiased interaction detection and estimation (GUIDE), a regression tree approach, to identify subgroups with greater improvements in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 4 months. Predictors included 24 demographic, clinical, and psychosocial characteristics. We conducted internal validation to estimate optimism (bias) in the range of mean outcome differences among arms. RESULTS: Both QUINT and GUIDE indicated that for participants with lower body mass index (BMI), IBET was better than PT (improvements of WOMAC ranged from 6.3 to 9.1 points lower), and for those with higher BMI and a longer duration of knee OA, PT was better than IBET (WOMAC improvement was 6.3 points). In GUIDE analyses comparing PT or IBET to WL, participants not employed had improvements in WOMAC ranging from 1.8 to 6.8 points lower with PT or IBT versus WL. From internal validation, there were large corrections to the mean outcome differences among arms; however, after correction, some differences remained in the clinically meaningful range. CONCLUSION: Results suggest there may be subgroups who experience greater improvement in symptoms from PT or IBET, and this finding could guide referrals and future trials. However, uncertainty persists for specific treatment-effects size estimates and how they apply beyond this study sample.

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.