A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol.

OBJECTIVE: This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C. METHOD: From 2007 to 2010, 255 outpatients with LDL-C>76 mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11 months. RESULTS: Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/dL, 95% CI = -3.6, 8.3, p = 0.44), nor did the odds of meeting goal LDL-C (OR = 0.95, 95% CI = 0.6, 1.7; p = 0.87). Intakes of calories (p = 0.03), total fat (p = 0.02), and saturated fat (p = 0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p = 0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR = 1.2, 95% CI = 1.0, 1.5, p = 0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups. CONCLUSION: This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.

Improving processes of hospital care during the last hours of life.

BACKGROUND: Known for excellence in care in the last days and hours of life, hospice programs can help individuals have a "good death" and lead to higher family satisfaction with quality of care. Our objective was to evaluate the effectiveness of a multicomponent palliative care intervention based on the best practices of home hospice and designed to improve the quality of care provided for patients dying in an acute care inpatient setting. METHODS: This study was a before-after intervention trial conducted between 2001 and 2003. Participants included physician, nursing, and ancillary staff on inpatient services of an urban, tertiary care Veterans Affairs medical center. The palliative care intervention included staff education and support to identify patients who were actively dying and implement care plans guided by a comfort care order set template for the last days or hours of life. Data abstracted from computerized medical records of 203 veterans who died during a 6-month period before (n = 108) and after (n = 95) intervention were used to determine the impact of intervention on symptom documentation and 5 process of care indicators. RESULTS: There was a significant increase in the mean (SD) number of symptoms documented from 1.7 (2.1) to 4.4 (2.7) (P<.001), and the number of care plans increased from 0.4 (0.9) to 2.7 (2.3) (P<.001). Opioid medication availability increased from 57.1% to 83.2% (P<.001), and do-not-resuscitate orders increased from 61.9% to 85.1% (P<.001). There were nonsignificant changes in the proportion of deaths that occurred in intensive care units (P = .17) and in the use of nasogastric tubes (P = .40), and there was a significant increase in the use of restraints (P<.001). CONCLUSION: Our results indicate that end-of-life care improved after the introduction of the palliative care program.

Post-myocardial infarction smoking cessation counseling: associations with immediate and late mortality in older Medicare patients.

PURPOSE: To assess the difference in immediate (30 and 60 days after admission) and late (2-year) mortality between those who received inpatient post-myocardial infarction smoking cessation counseling and those who did not receive counseling. METHODS: We conducted an observational study of a national random sample of inpatients from 2971 U.S. acute care hospitals participating in the Cooperative Cardiovascular Project in 1994-95. Medicare beneficiaries who were current smokers over age 65, admitted with a documented acute myocardial infarction, and who were discharged to home were included (n=16743). Our main outcome measures were early (30-, 60-day) and late (1-, 2-year) mortality. RESULTS: Smoking cessation counseling was documented during their index hospitalization for 41% of patients. Compared with those not counseled, those who received inpatient counseling had lower 30-day (2.0% vs. 3.0%), 60-day (3.7% vs. 5.6%), and 2-year mortality (25.0% vs. 30%) (logrank P <0.0001). After adjustment for demographic characteristics, comorbid conditions, APACHE score, and receipt of treatments including aspirin, reperfusion, beta-blockers, and angiotensin-converting enzyme inhibitors, those receiving counseling were less likely to die within 1 year, but the effect was lost between 1 and 2 years [hazard ratio (HR) = 0.99 (0.91-1.10)]. The greatest reduction in relative hazard (19%) was seen within 30 days [HR = 0.81 (95% confidence interval 0.65-0.99)]. CONCLUSION: Immediate and long-term mortality rates were lower among those receiving inpatient smoking cessation counseling.

A group randomized trial to improve safe use of nonsteroidal anti-inflammatory drugs.

OBJECTIVE: To determine whether audit/feedback and educational materials improve adherence to recommendations for laboratory monitoring and cytoprotective agents to detect and prevent adverse events caused by nonsteroidal anti-inflammatory agents (NSAIDs). STUDY DESIGN: Controlled, cluster-randomized trial. METHODS: Physicians commonly prescribing NSAIDs were identified within a large managed care organization and randomized to a control or an intervention group (audit/feedback with peer-derived benchmarks and continuing medical education). Medical records were examined 10 months before and after the intervention for clinical data and receipt of complete blood count (CBC), creatinine testing, and cytoprotective agents (process measures). Primary analysis compared intervention versus control physicians among those who initially performed below a peer-derived benchmark. General estimating equations accounted for patient clustering. RESULTS: Of 101 physicians initially randomized, 85 remained eligible (38 internists, 36 family physicians, 11 rheumatologists) postintervention. Mean percent change in performance between intervention and control physicians for CBC monitoring was 16% versus 10%; for creatinine monitoring, 0% versus 17%; and use of cytoprotective agents, -3% versus -1%. None of these changes were significant. Rheumatology specialty, number of NSAID prescriptions and physician visits, and patient risk factors for NSAID-related toxicity were more strongly associated with improved safety practices than the intervention. CONCLUSIONS: Audit/feedback and educational materials had no observed effect on improving NSAID-related safety practices. Potentially contributing factors include high baseline performance (ceiling effect), dilution of the intervention effect by case mix and provider factors, nonreceipt of intervention materials, and diverse indications for lab tests.

Does writing about suicidal thoughts and feelings reduce them?

To assess whether writing with cognitive change or exposure instructions reduces depression or suicidality, 121 undergraduates screened for suicidality wrote for 20 minutes on 4 days over 2 weeks. They were randomly assigned to reinterpret or to write and rewrite traumatic events/emotions, or to write about innocuous topics. The three groups (N = 98) who completed pre-, post-, and 6-week follow-up were not different on suicidality or depression. All subjects reported fewer automatic negative thoughts over the 2 weeks; they also reported higher self-regard but more health center visits at follow-up. Suicidal thoughts may be more resistant than physical health to writing interventions.

Inappropriate nonsteroidal anti-inflammatory drug use: prevalence and predictors.

INTRODUCTION: Inappropriate nonsteroidal anti-inflammatory drug (NSAID) use can occur by using more than one prescription or over-the-counter NSAID or exceeding the manufacturer's recommended dosage. There are risks associated with inappropriate NSAID use; however, the prevalence and predictors of inappropriate NSAID use are unknown. The study objectives are to estimate the prevalence of inappropriate NSAID use and identify characteristics associated with inappropriate use. METHODS: We identified 6877 patients at 2 Veterans Affairs Medical Centers through pharmacy records who filled 3 or more NSAID prescriptions in 6 months. We randomly selected 2535 patients and mailed them a survey about NSAIDs, gastroprotective medications, gastrointestinal (GI) symptoms, and pain. Inappropriate NSAID users either took 2 or more NSAIDs for 3 days or more or exceeded the maximum daily recommended dosage of 1 or more NSAID in the past week. Data were also collected from medical records. RESULTS: Approximately 1572 patients (62%) returned the survey, and 1250 reported NSAID use in the past week. Approximately 32% (n = 400) used NSAIDs inappropriately, including taking 2 or more NSAIDs (n = 173), exceeding the highest daily recommended dosage (n = 161) or both (n = 66). Being a minority (odds ratio = 1.62, P < 0.001) and having an income of $20,000 (odds ratio = 1.70, P < 0.001) or lesser both predicted inappropriate NSAID use. Inappropriate NSAID use was associated with more GI symptoms (ß = 0.57, P < 0.001) and higher levels of pain (ß = 0.85, P < 0.001). CONCLUSIONS: Inappropriate NSAID use is prevalent. Providers should consider counseling all patients about NSAID use, especially patients with GI problems or pain problems.

Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial.

BACKGROUND: Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. METHODS: Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. DISCUSSION: Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00321789.

Association of health-related quality of life with dual use of prescription and over-the-counter nonsteroidal antiinflammatory drugs.

OBJECTIVE: Inadequate prescription therapy pain management, lack of doctor-patient communication about over-the-counter (OTC) medications, and easy accessibility of OTC medications may contribute to patients using more than 1 medication to manage pain. It is well established that taking multiple nonsteroidal antiinflammatory drugs (NSAIDs) can lead to serious gastrointestinal problems. Little is known about whether use of more than 1 NSAID (i.e., dual use) is related to patient self-reported outcomes, specifically health-related quality of life (HRQOL). We hypothesized that dual use of NSAIDs would be associated with reduced HRQOL. METHODS: Patients from a managed care organization who filled > or =1 NSAID prescription over a 6-month period were eligible for a telephone interview focusing on NSAID use, which included the Short Form 12 (SF-12) Health Survey. Dual use was defined as taking 2 NSAIDs, either prescription or OTC, at least twice weekly during the past month. A multivariable linear regression model examined the association between dual use and the Physical Component Summary score (PCS-12) from the SF-12. RESULTS: Dual use was associated with lower PCS-12 scores indicating poorer HRQOL, after controlling for clinical and demographic factors. CONCLUSION: Patients may self-manage their pain to improve their daily activities by taking more than 1 NSAID. However, by attempting to obtain symptom relief, patients may be putting themselves at risk for complications. Providers are likely unaware of patients' risk. Future research should evaluate the causal factors contributing to dual use.

Health-related quality of life among self-reported arthritis sufferers: effects of race/ethnicity and residence.

OBJECTIVE: We evaluated differences in health-related quality of life (HRQoL) for African Americans and Caucasians with self-reported arthritis residing in rural and urban areas of a southern state. METHODS: 1,191 individuals completed a telephone survey, which included the 12-Item Short Form Health Survey (SF-12). Participants were stratified into groups: African American/rural, Caucasian/rural, African American/urban, and Caucasian/urban. We evaluated differences and associations in HRQoL for the four groups. RESULTS: Multivariable linear regression models revealed that being an African American rural resident was associated with worse self-reported mental health on the SF-12 even after adjusting for multiple confounding variables. In contrast, multivariable linear regression models revealed that being a Caucasian rural resident was associated with worse physical health SF-12 scores. CONCLUSIONS: The study revealed differences in HRQoL on the mental and physical health functioning scales of the SF-12 for African American rural and Caucasian rural residents. Researchers assessing HRQoL in arthritis patients should consider using a race/residence product term in their analyses.

Agreement and validity of pharmacy data versus self-report for use of osteoporosis medications among chronic glucocorticoid users.

PURPOSE: Pharmacy and linked claims databases are commonly used to determine medication receipt as a measure of quality of care. However, these data sources have not been previously compared with self-reported data for receipt of medications used for glucocorticoid-induced osteoporosis (GIOP). METHODS: Using databases from a national managed care organization (MCO), we identified 6282 chronic glucocorticoid users (60+ days in 18 months). We compared self-reported current use of alendronate, risedronate, calcitonin, and raloxifene (reference standard) to different intervals of preceding pharmacy data to determine agreement, sensitivity, specificity, and positive and negative predictive values of the pharmacy data. RESULTS: Survey respondents (n = 2363) were mean +/- SD age 53 +/- 14 years old, 70% women, and 78% Caucasian. Agreement between self-reported and pharmacy data ranged from Kappa = 0.64 (95%CI 0.53-0.75) (calcitonin) to 0.80 (0.76-0.84) (alendronate). The positive predictive value of a filled prescription in the pharmacy database in the prior 6 months exceeded 90% compared to the reference standard of self-reported current bisphosphonate use. However, the 6-month interval of pharmacy data failed to capture >25% of self-reported current bisphosphonate users. The optimal interval of pharmacy data to distinguish between current and past bisphosphonate users was 120-180 days. CONCLUSIONS: Among chronic glucocorticoid users enrolled in managed care, underreporting of current osteoporosis medication use was uncommon, and agreement between self-report and pharmacy data was high. Use of pharmacy data alone is unlikely to underestimate quality of osteoporosis care, but different intervals of pharmacy data have important implications on the ability to identify current users of osteoporosis medications.

Population-based assessment of adverse events associated with long-term glucocorticoid use.

OBJECTIVE: The frequency of many adverse events (AEs) associated with low-dose glucocorticoid use is unclear. We sought to determine the prevalence of glucocorticoid-associated AEs in a large US managed care population. METHODS: Using linked administrative and pharmacy claims, adults receiving >or=60 days of glucocorticoids were identified. These individuals were surveyed about glucocorticoid use and symptoms of 8 AEs commonly attributed to glucocorticoid use. RESULTS: Of the 6,517 eligible glucocorticoid users identified, 2,446 (38%) returned the mailed survey. Respondents were 29% men with a mean +/- SD age of 53 +/- 14 years; 79% were white and 13% were African American. Respondents had a mean +/- SD of 7 +/- 3 comorbid conditions and were prescribed a mean +/- SD prednisone-equivalent dosage of 16 +/- 14 mg/day. More than 90% of individuals reported at least 1 AE associated with glucocorticoid use; 55% reported that at least 1 AE was very bothersome. Weight gain was the most common self-reported AE (70% of the individuals), cataracts (15%) and fractures (12%) were among the most serious. After multivariable adjustment, all AEs demonstrated a strong dose-dependent association with cumulative glucocorticoid use. Among users of low-dose therapy (

Differing symptoms of abused versus nonabused women in obstetric-gynecology settings.

OBJECTIVE: The purpose of this study was to document the prevalence rates of reported abuse in obstetric/gynecology settings and to characterize physical symptoms, function, and psychologic distress of women who report abuse. STUDY DESIGN: This was a descriptive study of 118 patients who reported physical or sexual abuse in the past year and 2800 patients who reported no abuse at seven obstetric/gynecology practices. The Patient Health Questionnaire measured psychiatric diagnoses, somatic complaints, and psychosocial stressors. The Medical Outcomes Study Short Form 20 assessed health status, and self-reported health care use was measured. RESULTS: Four percent of women reported recent abuse. Patients who reported abuse had more psychiatric diagnoses, more severe psychologic distress, more somatic symptoms, more psychosocial stressors, more physician visits, and poorer reported health status compared with nonreporters of abuse. CONCLUSION: Enhanced recognition of possible abuse through screening may identify women in need of intervention and help to reduce the need for continued medical intervention.

No-suicide contracts: an overview and recommendations.

No-suicide contracts, in their various forms, can deepen commitment to a positive action, strengthen the therapeutic alliance, facilitate communication, lower anxiety, aid assessment, and document precautions. Conversely, they can anger or inhibit the client, introduce coercion into therapy, be used disingenuously, and induce false security in the clinician. Research on no-suicide contracts (frequency surveys, assessments of behavior after contracting, and opinions of users) has limitations common to naturalistic studies, and is now ready for more rigorous methods. Mental health professions should be trained to deal with suicidal individuals, including how to use no-suicide contracts. Good contracts are specific, individualized, collaborative, positive, context-sensitive, and copied. However, they are not a thorough assessment, a guarantee against legal liability, nor a substitute for a caring, sensitive therapeutic interaction. No-suicide contracts are no substitute for sound clinical judgment.

Nonsteroidal antiinflammatory drug toxicity monitoring and safety practices.

OBJECTIVE: Nonsteroidal antiinflammatory drug (NSAID) related gastrointestinal (GI) and renal adverse events are commonly reported. Although published guidelines recommend periodic laboratory monitoring, NSAID safety practices of physicians have not been investigated at a population level. We examined the associations of physician specialty and patient characteristics with NSAID safety practices. METHODS: Using administrative data and medical record review from a regional managed care organization, we studied a retrospective cohort of 373 frequent NSAID users (> or = 3 consecutive NSAID prescriptions and > or = 1 month of continuous NSAID use and followup). NSAID safety measures included: complete blood count (CBC) testing, creatinine testing, use of GI cytoprotective agents, and lack of simultaneous prescriptions for different NSAID (NSAID overlap). RESULTS: The mean duration of cumulative NSAID use was 14.4 +/- 7.7 months/patient, patient age was 62.0 +/- 11.4 years, and 63% were women. About two-thirds of patients received CBC (238, 63.8%) and creatinine monitoring (263, 70.5%), one-third (120, 32.2%) were prescribed cytoprotective agents, and one-fourth (97, 26%) had at least one NSAID overlap. After multivariable adjustments, concomitant use of disease-modifying antirheumatic drugs (OR 2.5, 95% CI 1.1-5.8), longer NSAID exposure (OR 1.3, 95% CI 1.1-1.4), and a greater number of physician visits/year (OR 1.1, 95% CI 1.0-1.2) were significantly associated with receipt of a CBC. A history of hypertension (OR 2.0, 95% CI 1.2-3.2), longer NSAID exposure (OR 1.3, 95% CI 1.2-1.4), and more physician visits/year (OR 1.1, 95% CI 1.0-1.2) were significantly associated with serum creatinine testing. Rheumatologists, and to a lesser extent internists, trended toward more NSAID toxicity monitoring than family/general practitioners. However, family/general practitioners and internists were more likely to monitor creatinine than rheumatologists among patients with renal risk factors. CONCLUSION: While rheumatologists and internists trended toward more CBC and creatinine testing, visit frequency, duration of NSAID use, and comorbidities were the factors most consistently associated with safety monitoring.

The effects of physician specialty and patient comorbidities on the use and discontinuation of coxibs.

OBJECTIVE: To examine the effects of physician specialty and comorbidities on cyclooxygenase 2-selective nonsteroidal antiinflammatory drugs (NSAIDs; coxibs) utilization. METHODS: Medical records of 452 patients from a regional managed care organization with >/=3 consecutive NSAID prescriptions from June 1998 to April 2001 were abstracted. Multivariable adjusted associations between coxib initiation and discontinuation and patient and provider characteristics were examined. RESULTS: A total of 1,142 NSAID prescriptions were written over 9,398 total patient-months of followup. Compared with patients seeing family or general practitioners, patients seeing rheumatologists (odds ratio [OR] 3.4, 95% confidence interval [95% CI] 2.1-5.7) and internists (OR 2.3, 95% CI 1.5-3.6) were significantly more likely to receive a coxib, as well as patients with a history of osteoarthritis (OR 2.6, 95% CI 1.7-3.8), gastrointestinal disease (OR 2.3, 95% CI 1.2-4.5), and congestive heart failure (OR 4.1, 95% CI 1.0-16.4). Although specialists were more likely than generalists to prescribe coxibs, only family or general practitioners were significantly more likely to selectively use coxibs among their patients with a history of gastrointestinal disease. Fifty-four percent of NSAID prescriptions were discontinued, and coxibs were significantly less likely to be discontinued than were traditional NSAIDs (OR 0.6, 95% CI 0.5-0.8). CONCLUSION: Our findings suggest significantly greater, but perhaps less selective use of coxibs among specialists, even after accounting for important covariates. The initiation and discontinuation of coxibs was influenced by physician specialty and by patient risk factors.