Trends and Rural-Urban Differences in the Initial Prescription of Low-Value Inhaled Corticosteroids among U.S. Veterans with Chronic Obstructive Pulmonary Disease.

Rationale: Guidelines recommend inhaled corticosteroids (ICS) for patients with chronic obstructive pulmonary disease (COPD) and select indications, including asthma history, high exacerbation risk, or high serum eosinophils. ICS are commonly prescribed outside of these indications, despite evidence of harm. We defined a "low-value" ICS prescription as the receipt of an ICS without evidence of a guideline-recommended indication. ICS prescription patterns are not well characterized and could inform health system interventions to reduce low-value practices. Objectives: To evaluate the national trends in initial low-value ICS prescriptions in the U.S. Department of Veterans Affairs and to determine whether rural-urban differences in low-value ICS prescribing exist. Methods: We performed a cross-sectional study between January 4, 2010, and December 31, 2018, identifying veterans with COPD who were new users of inhaler therapy. We defined low-value ICS as prescriptions in patients with 1) no asthma, 2) low risk of future exacerbation (Global Initiative for Chronic Obstructive Lung Disease group A or B), and 3) serum eosinophils <300 cells/µl. We performed multivariable logistic regression to evaluate trends in low-value ICS prescription over time, adjusting for potential confounders. We performed fixed effects logistic regression to assess rural-urban prescribing patterns. Results: We identified a total of 131,009 veterans with COPD starting inhaler therapy, 57,472 (44%) of whom were prescribed low-value ICS as initial therapy. From 2010 to 2018, the probability of receiving low-value ICS as initial therapy increased by 0.42 percentage points per year (95% confidence interval, 0.31-0.53). Compared with urban residence, rural residence was associated with a 2.5-percentage-point (95% confidence interval, 1.9-3.1) higher probability of receiving low-value ICS as initial therapy. Conclusions: The prescription of low-value ICS as initial therapy is common and increasing slightly over time for both rural and urban veterans. Given the widespread and persistent nature of low-value ICS prescribing, health system leaders should consider system-wide approaches to address this low-value prescribing practice.

Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.

Rationale: Patients discharged from the hospital for chronic obstructive pulmonary disease (COPD) exacerbation have impaired quality of life and frequent readmission and death. Clinical trials to reduce readmission demonstrate inconsistent results, including some demonstrating potential harms. Objectives: We tested whether a pragmatic proactive interdisciplinary and virtual review of patients discharged after hospitalization for COPD exacerbation would improve quality of life, using the Clinical COPD Questionnaire, and reduce all-cause 180-day readmission and/or mortality. Methods: We performed a stepped-wedge clinical trial. We enrolled primary care providers and their patients after hospital discharge for COPD at two Department of Veterans Affairs medical centers and 10 outpatient clinics. A multidisciplinary team reviewed health records and developed treatment recommendations delivered to primary care providers via E-consult. We facilitated uptake by entering recommendations as unsigned orders that could be accepted, modified, or canceled. Providers and patients made all final treatment decisions. Measurements and Main Results: We enrolled 365 primary care providers. Over a 30-month period, 352 patients met eligibility criteria, with 191 (54.3%) patients participating in the control and 161 (45.7%) in the intervention. The intervention led to clinically significant better Clinical COPD Questionnaire scores (-0.47; 95% confidence interval [CI], -0.85 to -0.09; 52.6% missing) but did not reduce 180-day readmission and/or mortality (adjusted odds ratio, 0.83; 95% CI, 0.49 to 1.38), in part because of wide CIs. Among the 161 patients in the intervention group, we entered 519 recommendations as unsigned orders, of which 401 (77.3%) were endorsed. Conclusions: A pragmatic health system-level intervention that delivered proactive specialty supported care improved quality of life but did not reduce 180-day readmission or death. Clinical trial registered with www.clinicaltrials.gov (NCT02021955).

Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.

Role of Comorbidities in Treatment and Outcomes after Chronic Obstructive Pulmonary Disease Exacerbations.

RATIONALE: Hospital readmissions are an important cause of morbidity and mortality among patients with chronic obstructive pulmonary disease (COPD). Although comorbidities are associated with outcomes in COPD, it is unknown how they affect treatment choices. OBJECTIVES: We sought to examine whether comorbidity was associated with readmission, mortality, and delivery of in-hospital treatment for COPD exacerbations. METHODS: We performed a cohort study of veterans hospitalized with a COPD exacerbation to six Veterans Affairs hospitals between 2005 and 2011. We collected comorbidities in the year before hospitalization. We defined our primary outcome as readmission and/or mortality within 30 days of discharge, and treatment quality as receipt of systemic corticosteroids and respiratory antibiotics during the index hospitalization. RESULTS: A total of 2,391 patients were included. Each one-point increase in Charlson index was associated with greater odds of readmission or death (adjusted odds ratio [aOR], 1.24; 95% confidence interval [CI], 1.18-1.30) and reduced odds of receiving treatment with steroids and antibiotics (aOR, 0.90; 95% CI, 0.85-0.95), in adjusted analyses. Patients with comorbid congestive heart failure (aOR, 0.64; 95% CI, 0.52-0.79), coronary artery disease (aOR, 0.73; 95% CI, 0.60-0.89), and chronic kidney disease (aOR, 0.74; 95% CI, 0.55-0.99) were less likely to receive corticosteroids and antibiotic treatment than patients without those comorbidities. We did not identify any comorbidity that was associated with increased odds of receiving appropriate therapies. CONCLUSIONS: Comorbidity was associated with 30-day readmission and mortality, and with delivery of fewer treatments known to be beneficial among patients with COPD exacerbation.

Quality of Care Delivered to Veterans with COPD Exacerbation and the Association with 30-Day Readmission and Death.

Quality of chronic obstructive pulmonary disease (COPD) care is thought to be an important intermediate process to improve the well-being of patients admitted to hospital for exacerbation. We sought to examine the quality of inpatient COPD care and the associations with readmission and mortality. We performed a cohort study of 2,364 veterans aged over 40 and hospitalized for COPD between 2005 and 2011 at five Department of Veterans Affairs hospitals. We examined whether patients received six guideline recommended care items including short-acting bronchodilators, corticosteroids, antibiotics, positive-pressure ventilation (in cases of acute hypercarbic respiratory failure), chest imaging, and arterial blood gas measurement. Our primary outcome was all-cause hospital readmission or death within 30 days. Overall quality of care was not significantly associated with readmission or death (acute care aOR 0.98; 95% CI 0.87-1.11; ICU aOR 0.89; 95% CI 0.71-1.13). Delivery of corticosteroids and antibiotics was associated with reduced odds of readmission and death (aOR 0.77; 95% CI 0.61-0.92). Few patients received all of the recommended care items (18% of acute care, 38% of ICU patients). Quality of care did not vary by race or sex but did vary significantly across sites and did not improve over time. Our composite measure of COPD care quality was not associated with readmission or death. Further efforts are needed to improve care delivery to patients hospitalized with COPD.

Predictors of Pharmacotherapy for Tobacco Use Among Veterans Admitted for COPD: The Role of Disparities and Tobacco Control Processes.

BACKGROUND: Many smokers admitted for chronic obstructive pulmonary disease (COPD) are not given smoking cessation medications at discharge. The reasons behind this are unclear, and may reflect an interplay of patient characteristics, health disparities, and the receipt of inpatient tobacco control processes. OBJECTIVES: We aimed to assess potential disparities in treatment for tobacco use following discharge for COPD, examined in the context of inpatient tobacco control processes. PARTICIPANTS: Smokers aged ≥ 40 years, admitted for treatment of a COPD exacerbation within the VA Veterans Integrated Service Network 20, identified using ICD-9 discharge codes and admission diagnoses from 2005-2012. MAIN MEASURES: The outcome was any tobacco cessation medication dispensed within 48 hours of discharge. We assessed potential predictors administratively up to 1 year prior to admission. We created the final logistic regression model using manual model building, clustered by site. Variables with p < 0.2 in biviariate models were considered for inclusion in the final model. RESULTS: We identified 1511 subjects. 16.9 % were dispensed a medication at discharge. In the adjusted model, several predictors were associated with decreased odds of receiving medications: older age (OR per year older 0.96, 95 % CI 0.95-0.98), black race (OR 0.34, 95 % CI 0.12-0.97), higher comorbidity score (OR 0.89, 95 % CI 0.82-0.96), history of psychosis (OR 0.40, 95 % CI 0.31-0.52), hypertension (OR 0.75, 95 % CI 0.62-0.90), and treatment with steroids in the past year (OR 0.80, 95 % CI 0.70-0.90). Inpatient tobacco control processes were associated with increased odds of receiving medications: documented brief counseling at discharge (OR 3.08, 95 % CI 2.02-4.68) and receipt of smoking cessation medications while inpatient (OR 5.95, 95 % CI 3.19-11.10). CONCLUSIONS: Few patients were treated with tobacco cessation medications at discharge. We found evidence for disparities in treatment, but also potentially beneficial effects of inpatient tobacco control measures. Further focus should be on using novel processes of care to improve provision of medications and decrease the observed disparities.

Utilization and effectiveness of pharmacotherapy for tobacco use following admission for exacerbation of COPD.

BACKGROUND: Patients admitted for chronic obstructive pulmonary disease (COPD) commonly continue to smoke. The utilization and effectiveness of tobacco cessation medications after discharge is largely unknown. We sought to examine whether pharmacologic treatment of tobacco use following admission for COPD was associated with smoking cessation at 6 to 12 months. METHODS: Multivariable logistic regression analysis of a cohort of 1334 smokers, discharged from hospital with a COPD exacerbation between 2005 and 2012, identified administratively within the Veterans Affairs Veterans Integrated Service Network-20, adjusted for variables chosen a priori. Our primary exposure was treatment with any 1 or combination of smoking cessation medications within 90 days of discharge determined from pharmacy records, with the outcome of smoking cessation at 6 to 12 months after discharge. MEASUREMENTS AND MAIN RESULTS: Four hundred fifty (33.7%) of the patients were dispensed a smoking cessation medication, with 53.4% receiving a nicotine patch alone. Overall, 19.8% of patients reported quitting smoking at 6 to 12 months. Compared to those not receiving medications, the odds of quitting were not greater among patients dispensed any single or combination of smoking cessation medications within 90 days of discharge (odds ratio [OR]: 0.88, 95% confidence interval [CI]: 0.74-1.04). Among patients treated with medications compared to nicotine patch alone, varenicline (OR: 2.44, 95% CI: 1.48-4.05) was associated with increased odds of cessation, and short-acting nicotine replacement therapy alone (OR: 0.66, 95% CI: 0.51-0.85) was associated with decreased odds of cessation. CONCLUSIONS: Treatment was provided to a minority of subjects and was not associated with cessation, with potential differences observed in effectiveness between medications. Systems-based changes may improve delivery of this key intervention.

Hearing aid effectiveness after aural rehabilitation: individual versus group trial results.

We designed this noninferiority randomized trial to determine (1) if group hearing aid fitting visits and group hearing aid follow-up visits were at least as effective as individual visits in terms of hearing-related function (measured with the Inner Effectiveness of Auditory Rehabilitation [EAR] scale) and adherence, and (2) if group visits were less costly over the 6 mo post-fitting period. For 644 participants randomized to receive their hearing aid visits in an individual or group format at the Department of Veterans Affairs Puget Sound Health Care System, 6 mo outcomes showed no significant differences in Inner EAR scores between individual and group fitting (p = 0.53) or follow-up (p = 0.11), or in the number of hours per day hearing aids were worn between individual and group fitting (p = 0.90) or follow-up (p = 0.24). We found significantly higher cost for individual compared with group fitting (p < 0.001) and follow-up (p < 0.001). We conclude that outcomes for group hearing aid fitting and hearing aid follow-up visits were not inferior to individual hearing aid fitting and follow-up visits, with group fitting and follow-up visits yielding cost savings.

Long-term cost-effectiveness of screening strategies for hearing loss.

Routine hearing screening can identify patients who are motivated to seek out and adhere to treatment, but little information exists on the cost-effectiveness of hearing screening in a general population of older veterans. We compared the cost-effectiveness of three screening strategies (tone-emitting otoscope, hearing handicap questionnaire, and both together) against no screening (control group) in 2,251 older veterans. The effectiveness measure for each group was the proportion of hearing aid use 1 year after screening. The audiology cost measure included costs of hearing loss screening and audiology care for 1 year after screening. Incremental cost-effectiveness was the audiology cost of additional hearing aid use for each screening group compared with the control group. The mean total audiology cost per patient was $77.04, $122.70, $121.37, and $157.08 for the control, otoscope, questionnaire, and dual screening groups, respectively. The tone-emitting otoscope appears to be the most cost-effective approach for hearing loss screening, with a significant increase in hearing aid use 1 year after screening (2.8%) and an insignificant incremental cost-effectiveness of $1,439.00 per additional hearing aid user compared with the control group. For this population of older veterans, screening for hearing loss with the tone-emitting otoscope is cost-effective.

Long-term effectiveness of screening for hearing loss: the screening for auditory impairment--which hearing assessment test (SAI-WHAT) randomized trial.

OBJECTIVES: To evaluate the effect of hearing screening on long-term hearing outcomes in a general population of older veterans. DESIGN: Hearing loss in the elderly is underdetected and undertreated. Routine hearing screening has been proposed, but it is not clear whether screening identifies patients who are sufficiently motivated to adhere to treatment. A four-arm randomized clinical trial was conducted to compare three screening strategies with no screening in 2,305 older veterans seeking general medical care. SETTING: Veterans Affairs Puget Sound Health Care System. INTERVENTIONS: The screening strategies were a tone-emitting otoscope, a widely used questionnaire about hearing handicap, and a combination of both tools. MEASUREMENTS: Hearing aid use 1 year after screening. RESULTS: Of participants who underwent screening with the tone-emitting otoscope, questionnaire, and combined testing, 18.6%, 59.2%, and 63.6%, respectively, screened positive for hearing loss (P<.01 for test of equality across three arms). Patients proceeded to formal audiology evaluation 14.7%, 23.0%, and 26.6% of the time in the same screening arms, compared with 10.8% in the control arm (P<.01 for test of equality across four arms). Hearing aid use 1 year after screening was 6.3%, 4.1%, and 7.4% in the same arms, compared with 3.3% in the control arm (P<.01). Hearing aid users experienced significant improvements in hearing-related function and communication ability. CONCLUSION: In older veterans, screening for hearing loss led to significantly more hearing aid use. Screening with the tone-emitting otoscope was more efficient. The results are most applicable to older populations with few cost barriers to hearing aids.

Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics.

BACKGROUND: Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. METHODS: Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. DISCUSSION: A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms.Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication. TRIAL REGISTRATION: NCT00260663.

Effectiveness of group versus individual hearing aid visits.

Demand for hearing aid services in the Veterans Health Administration increased over 300% from 1996 to 2005, challenging the delivery of timely, high-quality care. Using group visits may help meet these needs, but whether this approach would still provide high-quality rehabilitation is unclear. This study determined whether group visits worsen hearing aid outcomes. It included a retrospective observational cohort in veterans seeking hearing aids at the Department of Veterans Affairs Puget Sound Health Care System from September 2004 to March 2005, when the clinic was using both individual and group visits. Medical records were reviewed for all new hearing aid patients seen during this period. Hearing-related outcome questionnaires were compared between patients seen for individual versus group fitting and/or follow-up visits. Results revealed that hearing thresholds were similar between patients seen individually and in groups. Of 74 patients who returned self-administered questionnaires after the follow-up, those who received both fitting and follow-up in a group format reported similar hearing handicap and better hearing-related function, satisfaction, and adherence than patients who received individual visits. Group visits did not appear to yield worse outcomes in this nonrandomized retrospective chart review. Definitive statements must await randomized comparisons.

Screening for Auditory Impairment-Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics.

BACKGROUND: Effective screening programs should not merely detect presence of disease, but also lead to long-term benefit. We describe the rationale and design of the first randomized clinical trial to study the long-term effects of routine screening for hearing loss. We also describe the baseline characteristics of the randomized cohort. METHODS: We randomized 2305 veterans age 50 years or older to a control arm without screening, or to screening with: physiologic testing (AudioScope), a self-administered questionnaire (Hearing Handicap Inventory for the Elderly-Screening version [HHIE-S]), or both tests. The primary outcome measure will be hearing aid use one year after screening. We will also study a number of secondary outcomes, including appointments made with and visits to an audiologist, cases of aidable hearing loss, hearing aids dispensed, self-rated communication ability, and hearing-related quality of life. RESULTS: Baseline demographic and health status measures were evenly distributed across the screening arms. The percentage of patients who screened positive for hearing loss was 18.6%, 59.2%, and 63.6% for the AudioScope, HHIE-S, and combined screening arms, respectively. IMPLICATIONS: Long-term results are needed to gain insight into whether the AudioScope is associated with high rates of false negative screening, the HHIE-S is associated with high rates of false positive screening, or a combination of both. Identifying the best screening program will depend on determining which strategy leads to successful hearing aid use.