Adherence to Oral Medications for Hypertension and Diabetes in Veterans with Comorbid Airflow Limitation.

RATIONALE: Diabetes and hypertension are common among patients with airflow limitation and contribute to cardiovascular (CV) mortality, one of the leading causes of death among patients with airflow limitation. OBJECTIVES: Our goal was to examine the association of severity of airflow limitation with adherence to medications for hypertension and diabetes. METHODS: We identified 7,359 veterans with hypertension and/or diabetes in the Veterans Integrated Service Network-20. Entry date into the cohort was defined as the date of a patient's first pulmonary function testing (PFT). Diagnostic codes (ICD-9), PFT, and pharmacy data were available via the electronic medical record or via direct interrogation of PFT equipment. Our primary exposure was airflow limitation defined as FEV1 ≥ 80% predicted (normal), 80 > FEV1 ≥ 50% predicted (mild/moderate), 50 > FEV1 ≥ 30% predicted (severe), and FEV1 < 30% predicted (very severe). We assessed adherence using a validated method based on electronic pharmacy refill data and defined adherence as ≥ 80% medication possession for the period 6-12 months after enrollment. Medications of interest included ß-blockers, calcium channel blockers, thiazides, and angiotensin-converting-enzyme inhibitors for patients with hypertension, and metformin and sulfonylureas for patients with diabetes. We used logistic regression models to assess the association between severity of airflow limitation and adherence, adjusted for demographics, health behaviors, and comorbidities. MEASUREMENTS AND MAIN RESULTS: Overall adherence was poor (44.6-55.1%). Among patients with hypertension, when compared with subjects with normal FEV1, subjects with each category lower of FEV1 were less adherent to ß-blockers, with an odds ratio (OR) of 0.87 (95% confidence interval [CI], 0.80-0.95); calcium channel blockers, with an OR of 0.83 (95% CI, 0.74-0.93); and angiotensin-converting-enzyme inhibitors with an OR of 0.91 (95% CI, 0.84-0.99). Airflow limitation was not associated with adherence to thiazides. Among patients with diabetes, we found no significant association of FEV1 with adherence, although a similar lower trend with increasing airflow limitation. In a sensitivity analysis limited to patients with chronic obstructive pulmonary disease, we found a nonstatistically significant trend for decreased adherence to ß-blockers, calcium channel blockers, and angiotensin-converting-enzyme inhibitors in subjects with higher GOLD (Global Initiative for Chronic Obstructive Lung Disease) stage. CONCLUSIONS: Severity of airflow limitation is associated with decreased adherence to ß-blockers, calcium channel blockers, and angiotensin-converting-enzyme inhibitors. The decreased adherence to these medications may be related to adverse effects on symptoms in patients with lung disease, and may partially explain excess CV mortality in these patients.

The association of weight with the detection of airflow obstruction and inhaled treatment among patients with a clinical diagnosis of COPD.

BACKGROUND: Most patients with a clinical diagnosis of COPD have not had spirometry to confirm airflow obstruction (AFO). Overweight and obese patients report more dyspnea than normal weight patients, which may be falsely attributed to AFO. We sought to determine whether overweight and obese patients who received a clinical diagnosis of COPD were more likely to receive a misdiagnosis (ie, lack of AFO on spirometry) and be subsequently treated with inhaled medications. METHODS: The cohort comprised US veterans with COPD (International Classification of Diseases, 9th Revision, code; inhaled medication use; or both) and spirometry measurements from one of three Pacific Northwest Veterans Administration Medical Centers. The measured exposures were overweight and obesity (defined by BMI categories). Outcomes were (1) AFO on spirometry and (2) escalation or deescalation of inhaled therapies from 3 months before spirometry to 9 to 12 months after spirometry. We used multivariable logistic regression with calculation of adjusted proportions for all analyses. RESULTS: Fifty-two percent of 5,493 veterans who had received a clinical diagnosis of COPD had AFO. The adjusted proportion of patients with AFO decreased as BMI increased (P < .01 for trend). Among patients without AFO, those who were overweight and obese were less likely to remain off medications or to have therapy deescalated (adjusted proportions: normal weight, 0.69 [95% CI, 0.64-0.73]; overweight, 0.62 [95% CI, 0.58-0.65; P = .014]; obese, 0.60 [95% CI, 0.57-0.63; P = .001]). CONCLUSIONS: Overweight and obese patients are more likely to be given a misdiagnosis of COPD and not have their inhaled medications deescalated after spirometry demonstrated no AFO. Providers may be missing potential opportunities to recognize and treat other causes of dyspnea in these patients.

Which patient and clinician characteristics are associated with high-quality communication among veterans with chronic obstructive pulmonary disease?

The authors evaluated associations of patient and clinician characteristics with high-quality communication among patients with chronic obstructive pulmonary disease. Using a cross-sectional analysis from patients with chronic obstructive pulmonary disease enrolled in a clinical trial, the authors evaluated the association of patient and clinician characteristics with patient-reported communication quality. The authors measured these associations using general estimating equations and adjusted odds ratios for best imagined communication quality. Most patient and clinician characteristics, including age, race/ethnicity, mental health attributes, and clinician specialty, were not associated with communication quality. Patient-reported clinician expertise (OR = 2.10, 95% CI [1.52, 2.88], p < .001) was associated with increased communication quality, while the patient not being married was associated with decreased quality (OR = 0.52, 95% CI [0.27, 0.99], p = .047). Only one modifiable characteristic, patient-reported clinician expertise, was associated with best imagined communication quality. This characteristic may be important to include as a potential intermediate outcome in future communication intervention studies. Predictors and outcomes of communication quality are not uniform across patient populations and settings. To maximize the effectiveness of communication interventions, it is important to have a thorough understanding of which patient, clinician, and system factors are associated with communication quality.

Preferences for death and dying among veterans with chronic obstructive pulmonary disease.

RATIONALE: Studies identify common factors important for a "good death." However, it is important for clinicians to individualize end-of-life care by eliciting patients' preferences. We sought to determine preferences for death and dying among veterans with chronic obstructive pulmonary disease (COPD) by performing a cross-sectional study. Participants (n = 376) completed a preferences about death and dying questionnaire. RESULTS: Common themes ranked as most important by veterans include health care costs (86.6%) and avoiding strain on loved ones (78.8%). Unique items include being unafraid of dying (67.1%) and having discussed your treatment preferences with your clinician (59.3%). CONCLUSION: Preferences for death and dying are consistent among individuals with life-limiting illness, thus should be incorporated as core components in all end-of-life care planning. We identified unique preferences important to patients with COPD. This study suggests that clinicians need to engage in end-of-life discussions to learn about individual preferences to improve the patients' dying experience.

Combination antihypertensive therapy among patients with COPD.

BACKGROUND: COPD and hypertension both increase the risk of congestive heart failure (CHF). Current clinical trials do not inform the selection of combination antihypertensive therapy among patients with COPD. We performed a comparative effectiveness study to investigate whether choice of dual agent antihypertensive therapy is associated with risk of hospitalization for CHF among patients with these two conditions. METHODS: We identified a cohort of 7,104 patients with COPD and hypertension receiving care within Veterans Administration hospitals between January 2001 and December 2006, with follow-up through April 2009. We included only patients prescribed two antihypertensive medications. We used Cox proportional hazard models for statistical analysis. RESULTS: Compared with ß-blockers plus an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker, patients prescribed a thiazide diuretic plus a ß-blocker (adjusted hazard ratio [HR], 0.49; 95% CI, 0.32-0.75), a thiazide plus an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (adjusted HR, 0.50; 95% CI, 0.35-0.71), and a thiazide plus a calcium channel blocker (adjusted HR, 0.55; 95% CI, 0.35-0.88) had a significantly lower risk of hospitalization for CHF. After stratification by history of CHF, we found that this association was isolated to patients without a history of CHF. Adjustment for patient characteristics and comorbidities had a small effect on risk of hospitalization. Choice of antihypertensive medication combination had no significant association with risk of COPD exacerbation. CONCLUSIONS: Among patients with comorbid hypertension and COPD requiring two antihypertensive agents, combination therapy that includes a thiazide diuretic was associated with a significantly lower risk of hospitalization for CHF among patients without a history of CHF.

Missing potential opportunities to reduce repeat COPD exacerbations.

INTRODUCTION: Long-acting beta-agonists (LABA) and/or inhaled corticosteroids (ICS) have been shown to reduce COPD exacerbation risk. Using data from a large integrated health-care system, we sought to examine whether these medication classes were initiated after an exacerbation of COPD. METHODS: We identified patients who experienced an inpatient or outpatient COPD exacerbation within the Veterans Affairs Integrated Service Network (VISN)-20. We assessed the addition of a new inhaled therapy (an ICS, LABA or both) within 180 days after the exacerbation. We assessed independent predictors of adding treatment using logistic regression. RESULTS: We identified 45,780 patients with COPD, of whom 2,760 patients experienced an exacerbation of COPD. Of these individuals, 2,570 (93.1 %) were on either none or only one long-acting medication studied (LABA or ICS). In the subsequent 180-day period after their exacerbation, only 875 (34.1 %) patients had at least one of these additional therapies dispensed from a VA pharmacy. Among patients who were treated in the outpatient setting, older age [OR 0.98/year, 95 % CI (0.97-0.99)], current tobacco use [OR 0.74, 95 % CI (0.60-0.90)], greater use of ipratropium bromide [OR 0.97/canister, 95 % CI (0.96-0.98)], prior COPD exacerbation [OR 0.55, 95 % CI (0.46-0.67)], depression [OR 0.77, 95 % CI (0.61-0.98)], CHF [OR 0.74, 95 % CI (0.57-0.97)], and diabetes (OR 0.77 (0.60-0.99)] were associated with lower odds of additional therapy. Patients who were treated in the hospital had similar associated predictors. CONCLUSION: Among patients treated for an exacerbation of COPD, we found relatively few were subsequently prescribed inhaled therapies known to reduce exacerbations.

Predictors of adherence to inhaled medications among Veterans with COPD.

BACKGROUND: Factors contributing to medication nonadherence among patients with chronic obstructive pulmonary disease (COPD) are poorly understood. OBJECTIVES: To identify patient characteristics that are predictive of adherence to inhaled medications for COPD and, for patients on multiple inhalers, to assess whether adherence to one medication class was associated with adherence to other medication classes. DESIGN: Cohort study using data from Veteran Affairs (VA) electronic databases. PARTICIPANTS: This study included 2,730 patients who underwent pulmonary function testing between 2003 and 2007 at VA facilities in the Northwestern United States, and who met criteria for COPD. MAIN MEASURES: We used pharmacy records to estimate adherence to inhaled corticosteroids (ICS), ipratropium bromide (IP), and long-acting beta-agonists (LABA) over two consecutive six month periods. We defined patients as adherent if they had refilled medications to have 80 % of drug available over the time period. We also collected information on their demographics, behavioral habits, COPD severity, and comorbidities. KEY RESULTS: Adherence to medications was poor, with 19.8 % adherent to ICS, 30.6 % adherent to LABA, and 25.6 % adherent to IP. Predictors of adherence to inhaled therapies were highly variable and dependent on the medication being examined. In adjusted analysis, being adherent to a medication at baseline was the strongest predictor of future adherence to that same medication [(Odds ratio, 95 % confidence interval) ICS: 4.78 (3.21-7.11); LABA: 6.56 (3.89-11.04); IP: 13.96 (9.88-19.72)], [corrected] but did not reliably predict adherence to other classes of medications. [corrected]. CONCLUSIONS: Among patients with COPD, past adherence to one class of inhaled medication strongly predicted future adherence to the same class of medication, but only weakly predicted adherence to other classes of medication.

Adherence to long-acting inhaled therapies among patients with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Long-acting inhaled medications are an important component of the treatment of patients with chronic obstructive pulmonary disease (COPD), yet few studies have examined the determinants of medication adherence among this patient population. OBJECTIVE: We sought to identify factors associated with adherence to long-acting beta-agonists (LABA) and inhaled corticosteroids (ICS) among patients with COPD. METHODS: We performed secondary analysis of baseline data collected in a randomized trial of 376 Veterans with spirometrically confirmed COPD. We used electronic pharmacy records to assess adherence, defined as a medication possession ratio of ≥0.80. We investigated the following exposures: patient characteristics, disease severity, medication regimen complexity, health behaviors, confidence in self-management, and perceptions of provider skill. We performed multivariable logistic regression, clustered by provider, to estimate associations. RESULTS: Of the 167 patients prescribed LABA, 54% (n = 90) were adherent to therapy while only 40% (n = 74) of 184 the patients prescribed ICS were adherent. Higher adherence to LABA and ICS was associated with patient perception of their provider as being an "expert" in diagnosing and managing lung disease [For LABA: OR = 21.70 (95% CI 6.79, 69.37); For ICS OR = 7.93 (95% CI 1.71, 36.67)]. Factors associated with adherence to LABA, but not ICS, included: age, education, race, COPD severity, smoking status, and confidence in self-management. CONCLUSIONS: Adherence to long-acting inhaled medications among patients with COPD is poor, and determinants of adherence likely differ by medication class. Patient perception of clinician expertise in lung disease was the factor most highly associated with adherence to long-acting therapies.

The effect of end-of-life discussions on perceived quality of care and health status among patients with COPD.

BACKGROUND: Despite strong preferences for discussions about end-of-life care, patients with COPD do not often have these discussions with their providers. Our objective was to determine whether patients who reported having end-of-life discussions also reported higher perceived markers of quality of care and health status. METHODS: A cross-sectional study of data collected at baseline for a trial to improve the occurrence and quality of end-of-life communication in patients with COPD was conducted. The primary exposure was self-reported acknowledgment of having discussions about end-of-life planning with their physicians. The primary outcome measures were patient-reported quality of care and satisfaction with care, which were dichotomized as best imaginable quality of care vs other ratings of quality and highest satisfaction vs other ratings of satisfaction. We adjusted for confounding factors, including patient and provider characteristics, using logistic regression clustered by provider. RESULTS: Three hundred seventy-six patients were enrolled, of whom 55 (14.6%) reported having end-of-life discussions. Individuals who reported having end-of-life discussions with their physicians were significantly more likely to rate their quality of care as the best imaginable (OR, 2.07; 95% CI, 1.05-4.09) and to be very satisfied with their medical care (OR, 1.98; 95% CI, 1.10-3.55). Discussions were more likely to have occurred among patients with worse health status as measured by St. George Respiratory Questionnaire total and impact scores. CONCLUSIONS: Patients who reported having end-of-life care discussions with their physicians had higher perceived quality of care and satisfaction with their physicians. Discussing end-of-life care with patients who have COPD may improve their perceived overall quality of and satisfaction with care.

Implementing collaborative care for depression treatment in primary care: a cluster randomized evaluation of a quality improvement practice redesign.

BACKGROUND: Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. METHODS: The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM.For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. RESULTS: Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003). CONCLUSIONS: Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00105820.

Patient-clinician communication about end-of-life care topics: is anyone talking to patients with chronic obstructive pulmonary disease?

BACKGROUND: Reports describe patient and health care system benefits when clinicians engage in end-of-life conversations with patients diagnosed with life-limiting illnesses, yet most clinicians focus on life-preserving treatments and avoid conversations about end-of-life care. We describe patient-clinician communication practices about end-of-life care in patients with chronic obstructive pulmonary disease (COPD) using self-report questionnaires to: (1) characterize the content of patient-clinician communication about end-of-life care from the patient perspective, including topics that were not addressed and ratings of the quality of the communication for topics discussed and (2) determine whether clinician characteristics was associated with the absence of specific communication items addressed. METHODS: Cross-sectional study of outpatients (n = 376) who completed the Quality of Communication (QOC) questionnaire (outcome measure). The primary exposure was clinician training. We used logistic regression. All tests were two-tailed and p < 0.05 was considered significant. RESULTS: Clinicians (n = 92) were staff physicians (33.7%), physician trainees (35.9%), and advanced practice nurses (30.4%). Patients were older (mean age, 69.4 years, standard deviation [SD] 10.0); white (86%) men (97%) with severe COPD (mean forced expiraory volume in 1 second [FEV(1)] percent predicted 50%, SD 20). All end-of-life topics were underaddressed. Four topics were not addressed 77%-94% of the time. None of the QOC items varied significantly by clinician type in adjusted logistic regression. CONCLUSIONS: All end-of-life communication topics were underaddressed by clinicians, regardless of training, with four topics particularly unlikely to be discussed. End-of-life topics that are important to patients should be targeted for an intervention to facilitate improvement in clinicians' communication skills and practice and may improve patient satisfaction with clinician communication.

Human subjects protection issues in QUERI implementation research: QUERI Series.

BACKGROUND: Human Subjects protections approaches, specifically those relating to research review board oversight, vary throughout the world. While all are designed to protect participants involved in research, the structure and specifics of these institutional review boards (IRBs) can and do differ. This variation affects all types of research, particularly implementation research. METHODS: In 2001, we began a series of inter-related studies on implementing evidence-based collaborative care for depression in Veterans Health Administration primary care. We have submitted more than 100 IRB applications, amendments, and renewals, and in doing so, we have interacted with 13 VA and University IRBs across the United States (U.S.). We present four overarching IRB-related themes encountered throughout the implementation of our projects, and within each theme, identify key challenges and suggest approaches that have proved useful. Where applicable, we showcase process aids developed to assist in resolving a particular IRB challenge. RESULTS: There are issues unique to implementation research, as this type of research may not fit within the traditional Human Subjects paradigm used to assess clinical trials. Risks in implementation research are generally related to breaches of confidentiality, rather than health risks associated with traditional clinical trials. The implementation-specific challenges discussed are: external validity considerations, Plan-Do-Study-Act cycles, risk-benefit issues, the multiple roles of researchers and subjects, and system-level unit of analysis. DISCUSSION: Specific aspects of implementation research interact with variations in knowledge, procedures, and regulatory interpretations across IRBs to affect the implementation and study of best methods to increase evidence-based practice. Through lack of unambiguous guidelines and local liability concerns, IRBs are often at risk of applying both variable and inappropriate or unnecessary standards to implementation research that are not consistent with the spirit of the Belmont Report (a summary of basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research), and which impede the conduct of evidence-based quality improvement research. While there are promising developments in the IRB community, it is incumbent upon implementation researchers to interact with IRBs in a manner that assists appropriate risk-benefit determinations and helps prevent the process from having a negative impact on efforts to reduce the lag in implementing best practices.

Urinary incontinence and hysterectomy in a large prospective cohort study in American women.

PURPOSE: We investigated the effects of hysterectomy with and without concomitant urinary incontinence repair on incontinence severity in one of the largest prospective studies of hysterectomy outcomes performed in the United States. MATERIALS AND METHODS: We administered the Urinary Symptoms Scale for Women to 1,299 women before hysterectomy done for benign conditions, and 6, 12, 18 and 24 months postoperatively to measure the presence, severity and type of urinary incontinence. RESULTS: Before hysterectomy 29.5% of participants had severe urinary incontinence, which decreased to 10% 12 and 24 months after hysterectomy. Most women with severe incontinence before hysterectomy showed improved incontinence 1 year after surgery (89.1%) and were still improved after 2 years (86.5%). The majority of women with moderate incontinence before hysterectomy showed improved incontinence 1 year after surgery (62.4%) and were still improved after 2 years (61.2%). However, some women with mild or no incontinence before hysterectomy had new onset incontinence or the condition had worsened 1 year after surgery (16.7%) and was still worse after 2 years (14.4%). A concomitant urinary incontinence repair procedure significantly increased the probability that a woman with severe incontinence would have improved incontinence 1 year after hysterectomy and significantly decreased the probability that a woman with mild or no incontinence would have worse incontinence after 2 years. CONCLUSIONS: The majority of women who undergo hysterectomy for nonmalignant indications experienced improved urinary incontinence during the first 2 years after surgery.