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).

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.

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.

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.

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.

Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

BACKGROUND: Evidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs. OBJECTIVE: To examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA). DESIGN: Randomized controlled trial. (ClinicalTrials.gov: NCT02653768). SETTING: 2 U.S. Department of Veterans Affairs sites. PARTICIPANTS: 345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis. INTERVENTION: Participants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks. MEASUREMENTS: Primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models. RESULTS: In the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement. LIMITATION: Participants were mostly male veterans, and follow-up was limited. CONCLUSION: Veterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis. PRIMARY FUNDING SOURCE: Department of Veterans Affairs, Health Services Research and Development Service.

Heterogeneity of Treatment Effects Among Patients With Type 2 Diabetes and Elevated Body Mass Index in a Study Comparing Group Medical Visits Focused on Weight Management and Medication Intensification.

BACKGROUND: Illuminating heterogeneity of treatment effect (HTE) within trials is important for identifying target populations for implementation. OBJECTIVE: The aim of this study was to examine HTE in a trial of group medical visits (GMVs) for patients with type 2 diabetes and elevated body mass index. RESEARCH DESIGN AND MEASURES: Participants (n=263) were randomized to GMV-based medication management plus low carbohydrate diet-focused weight management (WM/GMV; n=127) or GMV-based medication management alone (GMV; n=136) for diabetes control. We used QUalitative INteraction Trees, a tree-based clustering method, to identify subgroups with greater improvement in hemoglobin A1c (HbA1c) and weight from either WM/GMV or GMV. Subgroup predictors included 32 baseline demographic, clinical, and psychosocial factors. Internal validation was conducted to estimate bias in the range of mean outcome differences between arms. RESULTS: QUalitative INteraction Trees analyses indicated that for patients who had not previously attempted weight loss, WM/GMV resulted in better glycemic control than GMV (mean difference in HbA1c improvement=1.48%). For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%). No treatment-subgroup effects were identified for weight. Internal validation resulted in moderate corrections in mean HbA1c differences between arms; however, differences remained in the clinically significant range. CONCLUSION: This work represents a novel step toward targeting care approaches for patients to maximize benefit based on individual patient characteristics.

Comparing Mortality of Peritoneal and Hemodialysis Patients in an Era of Medicare Payment Reform.

BACKGROUND: Prior studies have shown peritoneal dialysis (PD) patients to have lower or equivalent mortality to patients who receive in-center hemodialysis (HD). Medicare's 2011 bundled dialysis prospective payment system encouraged expansion of home-based PD with unclear impacts on patient outcomes. This paper revisits the comparative risk of mortality between HD and PD among patients with incident end-stage kidney disease initiating dialysis in 2006-2013. RESEARCH DESIGN: We conducted a retrospective cohort study comparing 2-year all-cause mortality among patients with incident end-stage kidney disease initiating dialysis via HD and PD in 2006-2013, using data from the US Renal Data System and Medicare. Analysis was conducted using Cox proportional hazards models fit with inverse probability of treatment weighting that adjusted for measured patient demographic and clinical characteristics and dialysis market characteristics. RESULTS: Of the 449,652 patients starting dialysis between 2006 and 2013, the rate of PD use in the first 90 days increased from 9.3% of incident patients in 2006 to 14.2% in 2013. Crude 2-year mortality was 27.6% for patients dialyzing via HD and 16.7% for patients on PD. In adjusted models, there was no evidence of mortality differences between PD and HD before and after bundled payment (hazard ratio, 0.96; 95% confidence interval, 0.89-1.04; P=0.33). CONCLUSIONS: Overall mortality for HD and PD use was similar and mortality differences between modalities did not change before versus after the 2011 Medicare dialysis bundled payment, suggesting that increased use of home-based PD did not adversely impact patient outcomes.

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.

Discharge Information and Support for Patients Discharged from the Emergency Department: Results from a Randomized Controlled Trial.

BACKGROUND: Little research has been done on primary care-based models to improve health care use after an emergency department (ED) visit. OBJECTIVE: To examine the effectiveness of a primary care-based, nurse telephone support intervention for Veterans treated and released from the ED. DESIGN: Randomized controlled trial with 1:1 assignment to telephone support intervention or usual care arms (ClinicalTrials.gov: NCT01717976). SETTING: Department of Veterans Affairs Health Care System (VAHCS) in Durham, NC. PARTICIPANTS: Five hundred thirteen Veterans who were at high risk for repeat ED visits. INTERVENTION: The telephone support intervention consisted of two core calls in the week following an ED visit. Call content focused on improving the ED to primary care transition, enhancing chronic disease management, and educating Veterans and family members about VHA and community services. MAIN MEASURES: The primary outcome was repeat ED use within 30 days. KEY RESULTS: Observed rates of repeat ED use at 30 days in usual care and intervention groups were 23.1% and 24.9%, respectively (OR = 1.1; 95% CI = 0.7, 1.7; P = 0.6). The intervention group had a higher rate of having at least 1 primary care visit at 30 days (OR = 1.6, 95% CI = 1.1-2.3). At 180 days, the intervention group had a higher rate of usage of a weight management program (OR = 3.5, 95% CI = 1.6-7.5), diabetes/nutrition (OR = 1.8, 95% CI = 1.0-3.0), and home telehealth services (OR = 1.7, 95% CI = 1.0-2.9) compared with usual care. CONCLUSIONS: A brief primary care-based nurse telephone support program after an ED visit did not reduce repeat ED visits within 30 days, despite intervention participants' increased engagement with primary care and some chronic disease management services. TRIALS REGISTRATION: ClinicalTrials.gov NCT01717976.

Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.

BACKGROUND: Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. DESIGN: The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. SUMMARY: AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

Implementation of a group physical therapy program for Veterans with knee osteoarthritis.

BACKGROUND: A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function compared with traditional individual PT. Based on these findings the Group PT program was implemented in a Department of Veterans Affairs Health Care System. The objective of this study was to evaluate implementation metrics and changes in patient-level measures following implementation of the Group PT program. METHODS: This was a one-year prospective observational study. The Group PT program involved 6 weekly sessions. Implementation metrics included numbers of referrals and completed sessions. Patient-level measures were collected at the first and last PT sessions and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; self-report of pain, stiffness and function (range 0-96)) and a 30-s chair rise test. RESULTS: During the evaluation period, 152 patients were referred, 80 had an initial session scheduled, 71 completed at least one session and 49 completed at least 5 sessions. The mean number of completed appointments per patient was 4.1. Among patients completing baseline and follow-up measures, WOMAC scores (n = 33) improved from 56.8 (SD = 15.8) to 46.9 (SD = 14.0); number of chair rises (n = 38) completed in 30 s increased from 10.4 (SD = 5.1) to 11.9 (SD = 5.0). CONCLUSIONS: Patients completing the Group PT program in this implementation phase showed clinically relevant improvements comparable to those observed in the previous clinical trial that compared group and individual PT for knee osteoarthritis. These results are important because Group PT can improve efficiency and access compared with individual PT. However, there were some limitations with respect to attendance and completion rates, and program adaptations may be needed to optimize these implementation metrics. Larger, longer-term studies are required to more fully evaluate the effectiveness of this program.

Survival among Veterans Obtaining Dialysis in VA and Non-VA Settings.

BACKGROUND: Outcomes of veterans with ESRD may differ depending on where they receive dialysis and who finances this care, but little is known about variation in outcomes across different dialysis settings and financial arrangements. METHODS: We examined survival among 27,241 Veterans Affairs (VA)-enrolled veterans who initiated chronic dialysis in 2008-2011 at (1) VA-based units, (2) community-based clinics through the Veterans Affairs Purchased Care program (VA-PC), (3) community-based clinics under Medicare, or (4) more than one of these settings ("dual" care). Using a Cox proportional hazards model, we compared all-cause mortality across dialysis settings during the 2-year period after dialysis initiation, adjusting for demographic and clinical characteristics. RESULTS: Overall, 4% of patients received dialysis in VA, 11% under VA-PC, 67% under Medicare, and 18% in dual settings (nearly half receiving dual VA and VA-PC dialysis). Crude 2-year mortality was 25% for veterans receiving dialysis in the VA, 30% under VA-PC, 42% under Medicare, and 23% in dual settings. After adjustment, dialysis patients in VA or in dual settings had significantly lower 2-year mortality than those under Medicare; mortality did not differ in VA-PC and Medicare dialysis settings. CONCLUSIONS: Mortality rates were highest for veterans receiving dialysis in Medicare or VA-PC settings and lowest for veterans receiving dialysis in the VA or dual settings. These findings inform institutional decisions about provision of dialysis for veterans. Further research identifying processes associated with improved survival for patients receiving VA-based dialysis may be useful in establishing best practices for outsourced veteran care.

Adaptation and Implementation of a Family Caregiver Skills Training Program: From Single Site RCT to Multisite Pragmatic Intervention.

PURPOSE: We describe an approach to rapidly adapt and implement an education and skills improvement intervention to address the needs of family caregivers of functionally impaired veterans-Helping Invested Families Improve Veterans' Experience Study (HI-FIVES). DESIGN: Prior to implementation in eight sites, a multidisciplinary study team made systematic adaptations to the curriculum content and delivery process using input from the original randomized controlled trial (RCT); a stakeholder advisory board comprised of national experts in caregiver education, nursing, and implementation; and a veteran/caregiver engagement panel. To address site-specific implementation barriers in diverse settings, we applied the Replicating Effective Programs implementation framework. FINDINGS: Adaptations to HI-FIVES content and delivery included identifying core/noncore curriculum components, reducing instruction time, and simplifying caregiver recruitment for clinical settings. To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely. Curriculum materials were standardized and packaged to reduce the time required for implementation and to promote fidelity to the intervention. CONCLUSIONS: The emphasis on flexible intervention delivery and standardized materials has been identified as strengths of the adaptation process. Two key challenges have been identifying feasible impact measures and reaching eligible caregivers for intervention recruitment. CLINICAL RELEVANCE: This systematic implementation process can be used to rapidly adapt an intervention to diverse clinical sites and contexts. Nursing professionals play a significant role in educating and supporting caregivers and care recipients and can take a leading role to implement interventions that address skills and unmet needs for caregivers.

STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial.

BACKGROUND: Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions. METHODS / DESIGN: Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA. DISCUSSION: STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Cognitive Mediators of Change in Physical Functioning in Response to a Multifaceted Intervention for Managing Osteoarthritis.

PURPOSE: Although non-pharmacological interventions have been shown to improve physical functioning in individuals with osteoarthritis (OA), the mechanisms by which this occurs are often unclear. This study assessed whether changes in arthritis self-efficacy, perceived pain control, and pain catastrophizing mediated changes in physical functioning following an osteoarthritis intervention involving weight management, physical activity, and cognitive-behavioral pain management. METHOD: Three hundred Veteran patients of 30 primary care providers with knee and/or hip OA were cluster randomized to an OA intervention group or usual care. The OA intervention included a 12-month phone-based patient behavioral protocol (weight management, physical activity, and cognitive-behavioral pain management) plus patient-specific OA treatment recommendations delivered to primary care providers. RESULTS: Using linear mixed models adjusted for provider clustering, we observed that baseline to 6-month changes in arthritis self-efficacy and pain control partially mediated baseline to 12-month physical functioning improvements for the intervention group; catastrophizing did not. CONCLUSION: Findings of a mediating role of arthritis self-efficacy and pain control in intervention-related functional changes are consistent with hypotheses and align with theoretical assertions of the role of cognitions in cognitive and behavioral interventions for chronic pain. However, contrary to hypotheses, catastrophizing was not found to be a mediator of these changes.

Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis.

BACKGROUND: Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans' characteristics associated with insomnia and OSA symptoms. METHODS: Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. RESULTS: Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (ß (SE) = - 0.09 (0.04), 95% confidence interval [CI] = - 0.16, - 0.02), having a PTSD diagnosis (ß (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (ß (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (ß (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). CONCLUSIONS: Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. TRIAL REGISTRATION: NCT01130740 .

Pain coping skills training for African Americans with osteoarthritis study: baseline participant characteristics and comparison to prior studies.

BACKGROUND: The Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA. METHODS: A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities' Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies. RESULTS: The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61-86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62-66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m2 (SD = 8.2), was higher than all other studies (30-34 kg/m2). STAART participants' mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7-17). CONCLUSIONS: Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants' high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach. TRIAL REGISTRATION: NCT02560922.

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

BACKGROUND: A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. OBJECTIVE: To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. DESIGN: Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). SETTING: 10 Duke University Health System community-based primary care clinics. PARTICIPANTS: 537 outpatients with symptomatic hip or knee osteoarthritis. INTERVENTION: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. MEASUREMENTS: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. RESULTS: No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. LIMITATIONS: The study involved 1 health care network. Data on provider referrals were not collected. CONCLUSION: Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. PRIMARY FUNDING SOURCE: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Internet Use and Technology-Related Attitudes of Veterans and Informal Caregivers of Veterans.

BACKGROUND: Healthcare systems are interested in technology-enhanced interventions to improve patient access and outcomes. However, there is uncertainty about feasibility and acceptability for groups who may benefit but are at risk for disparities in technology use. Thus, we sought to describe characteristics of Internet use and technology-related attitudes for two such groups: (1) Veterans with multi-morbidity and high acute care utilization and (2) informal caregivers of Veterans with substantial care needs at home. MATERIALS AND METHODS: We used survey data from two ongoing trials, for 423 Veteran and 169 caregiver participants, respectively. Questions examined Internet use in the past year, willingness to communicate via videoconferencing, and comfort with new technology devices. RESULTS: Most participants used Internet in the past year (81% of Veterans, 82% of caregivers); the majority of users (83% of Veterans, 92% of caregivers) accessed Internet at least a few times a week, and used a private laptop or computer (81% of Veterans, 89% of caregivers). Most were willing to use videoconferencing via private devices (77-83%). A majority of participants were comfortable attempting to use new devices with in-person assistance (80% of Veterans, 85% of caregivers), whereas lower proportions were comfortable "on your own" (58-59% for Veterans and caregivers). Internet use was associated with comfort with new technology devices (odds ratio 2.76, 95% confidence interval 1.70-4.53). CONCLUSIONS: Findings suggest that technology-enhanced healthcare interventions are feasible and acceptable for Veterans with multi-morbidity and high healthcare utilization, and informal caregivers of Veterans. In-person assistance may be important for those with no recent Internet use.