Diabetes Distress Among Dyads of Patients and Their Health Supporters: Links With Functional Support, Metabolic Outcomes, and Cardiac Risk.

BACKGROUND: Patients with diabetes (PWD) often experience diabetes distress which is associated with worse self-management and glycemic control. In contrast, PWD who receive support from family and friends (supporters) have better diabetes outcomes. PURPOSE: To examine the associations of PWD diabetes distress and supporters' distress about PWDs' diabetes with supporters' roles and PWD cardiometabolic outcomes. METHODS: We used baseline data from 239 adults with Type 2 diabetes and their supporters participating in a longitudinal trial. PWD and supporter diabetes distress (high vs. low) were determined using the Problem Areas in Diabetes Scale-5. Outcomes included PWD-reported help from supporters with self-care activities, supporter-reported strain, PWD metabolic outcomes (glycemic control [HbA1c], systolic blood pressure [SBP], and non-HDL cholesterol) and 5 and 10 year risk of cardiac event (calculated using the United Kingdom Prospective Diabetes Study algorithm). RESULTS: PWDs with high diabetes distress were more likely to report that their supporters helped with taking medications, coordinating medical care, and home glucose testing (p's < .05), but not more likely to report help with diet or exercise. High supporter distress was associated with greater supporter strain (p < .001). High supporter diabetes distress was associated with higher PWD HbA1c (p = .045), non-HDL cholesterol (p = .011), and 5 (p = .002) and 10 year (p = .001) cardiac risk. CONCLUSIONS: Adults with high diabetes distress report more supporter help with medically focused self-management but not with diet and exercise. Supporter distress about PWD diabetes was consistently associated with worse outcomes. PWD diabetes distress had mixed associations with their diabetes outcomes.

Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections.

BACKGROUND: Health care-associated infections with methicillin-resistant Staphylococcus aureus (MRSA) have been an increasing concern in Veterans Affairs (VA) hospitals. METHODS: A "MRSA bundle" was implemented in 2007 in acute care VA hospitals nationwide in an effort to decrease health care-associated infections with MRSA. The bundle consisted of universal nasal surveillance for MRSA, contact precautions for patients colonized or infected with MRSA, hand hygiene, and a change in the institutional culture whereby infection control would become the responsibility of everyone who had contact with patients. Each month, personnel at each facility entered into a central database aggregate data on adherence to surveillance practice, the prevalence of MRSA colonization or infection, and health care-associated transmissions of and infections with MRSA. We assessed the effect of the MRSA bundle on health care-associated MRSA infections. RESULTS: From October 2007, when the bundle was fully implemented, through June 2010, there were 1,934,598 admissions to or transfers or discharges from intensive care units (ICUs) and non-ICUs (ICUs, 365,139; non-ICUs, 1,569,459) and 8,318,675 patient-days (ICUs, 1,312,840; and non-ICUs, 7,005,835). During this period, the percentage of patients who were screened at admission increased from 82% to 96%, and the percentage who were screened at transfer or discharge increased from 72% to 93%. The mean (±SD) prevalence of MRSA colonization or infection at the time of hospital admission was 13.6±3.7%. The rates of health care-associated MRSA infections in ICUs had not changed in the 2 years before October 2007 (P=0.50 for trend) but declined with implementation of the bundle, from 1.64 infections per 1000 patient-days in October 2007 to 0.62 per 1000 patient-days in June 2010, a decrease of 62% (P<0.001 for trend). During this same period, the rates of health care-associated MRSA infections in non-ICUs fell from 0.47 per 1000 patient-days to 0.26 per 1000 patient-days, a decrease of 45% (P<0.001 for trend). CONCLUSIONS: A program of universal surveillance, contact precautions, hand hygiene, and institutional culture change was associated with a decrease in health care-associated transmissions of and infections with MRSA in a large health care system.

Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial.

INTRODUCTION: US military veterans have disproportionately high rates of diabetes and diabetes-related morbidity in addition to being at risk of comorbid stress-related conditions. This study aimed to examine the effects of a technology-supported mindfulness intervention integrated into usual diabetes care and education on psychological and biobehavioral outcomes. RESEARCH DESIGN AND METHODS: Veterans (N=132) with type 1 or 2 diabetes participated in this two-arm randomized controlled efficacy trial. The intervention arm received a one-session mindfulness intervention integrated into a pre-existing program of diabetes self-management education and support (DSMES) plus one booster session and 24 weeks of home practice supported by a mobile application. The control arm received one 3-hour comprehensive DSMES group session. The primary outcome was change in diabetes distress (DD). The secondary outcomes were diabetes self-care behaviors, diabetes self-efficacy, post-traumatic stress disorder (PTSD), depression, mindfulness, hemoglobin A1C (HbA1C), body weight, and blood pressure. Assessments were conducted at baseline, 12 weeks, and 24 weeks. Participant satisfaction and engagement in home practice were assessed in the intervention group at 12 and 24 weeks. RESULTS: Intention-to-treat group by time analyses showed a statistically significant improvement in DD in both arms without significant intervention effect from baseline to 24 weeks. Examination of distal effects on DD between weeks 12 and 24 showed significantly greater improvement in the intervention arm. Improvement in DD was greater when baseline HbA1C was <8.5%. A significant intervention effect was also shown for general dietary behaviors. The secondary outcomes diabetes self-efficacy, PTSD, depression, and HbA1C significantly improved in both arms without significant intervention effects. Mindfulness and body weight were unchanged in either group. CONCLUSIONS: A technology-supported mindfulness intervention integrated with DSMES showed stronger distal effects on DD compared with DSMES control. Examination of longer-term outcomes, underlying mechanisms, and the feasibility of virtual delivery is warranted. TRIAL REGISTRATION NUMBER: NCT02928952.

Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial.

Importance: More than 75% of US adults with diabetes do not meet treatment goals. More effective support from family and friends ("supporters") may improve diabetes management and outcomes. Objective: To determine if the Caring Others Increasing Engagement in Patient Aligned Care Teams (CO-IMPACT) intervention improves patient activation, diabetes management, and outcomes compared with standard care. Design, Setting, and Participants: This randomized clinical trial was conducted from November 2016 to August 2019 among participants recruited from 2 Veterans Health Administration primary care sites. All patient participants were adults aged 30 to 70 years with diabetes who had hemoglobin A1c (HbA1c) levels greater than 8% of total hemoglobin (to convert to proportion of total hemoglobin, multiply by 0.01) or systolic blood pressure (SBP) higher than 150 mm Hg; each participating patient had an adult supporter. Of 1119 recruited, 239 patient-supporter dyads were enrolled between November 2016 and May 2018, randomized 1:1 to receive the CO-IMPACT intervention or standard care, and followed up for 12 to 15 months. Investigators and analysts were blinded to group assignment. Interventions: Patient-supporter dyads received a health coaching session focused on dyadic information sharing and positive support techniques, then 12 months of biweekly automated monitoring telephone calls to prompt dyadic actions to meet diabetes goals, coaching calls to help dyads prepare for primary care visits, and after-visit summaries. Standard-care dyads received general diabetes education materials only. Main Outcomes and Measures: Intent-to-treat analyses were conducted according to baseline dyad assignment. Primary prespecified outcomes were 12-month changes in Patient Activation Measure-13 (PAM-13) and UK Prospective Diabetes Study (UKPDS) 5-year diabetes-specific cardiac event risk scores. Secondary outcomes included 12-month changes in HbA1c levels, SBP, diabetes self-management behaviors, diabetes distress, diabetes management self-efficacy, and satisfaction with health system support for the involvement of family supporters. Changes in outcome measures between baseline and 12 months were analyzed using linear regression models. Results: A total of 239 dyads enrolled; among patient participants, the mean (SD) age was 60 (8.9) years, and 231 (96.7%) were male. The mean (SD) baseline HbA1c level was 8.5% (1.6%) and SBP was 140.2 mm Hg (18.4 mm Hg). A total of 168 patients (70.3%) lived with their enrolled supporter; 229 patients (95.8%) had complete 12-month outcome data. In intention-to-treat analyses vs standard care, CO-IMPACT patients had greater 12-month improvements in PAM-13 scores (intervention effect, 2.60 points; 95% CI, 0.02-5.18 points; P = .048) but nonsignificant differences in UKPDS 5-year cardiac risk (intervention effect, 1.01 points; 95% CI, -0.74 to 2.77 points; P = .26). Patients in the CO-IMPACT arm also had greater 12-month improvements in healthy eating (intervention effect, 0.71 d/wk; 95% CI, 0.20-1.22 d/wk; P = .007), diabetes self-efficacy (intervention effect, 0.40 points; 95% CI, 0.09-0.71 points; P = .01), and satisfaction with health system support for the family supporter participants' involvement (intervention effect, 0.28 points; 95% CI, 0.07-0.49 points; P = .009); however, the 2 arms had similar improvements in HbA1c levels and in other measures. Conclusions and Relevance: In this randomized clinical trial, the CO-IMPACT intervention successfully engaged patient-supporter dyads and led to improved patient activation and self-efficacy. Physiological outcomes improved similarly in both arms. More intensive direct coaching of supporters, or targeting patients with less preexisting support or fewer diabetes management resources, may have greater impact. Trial Registration: ClinicalTrials.gov Identifier: NCT02328326.

Relationship between adult and family supporter health literacy levels and supporter roles in diabetes management.

INTRODUCTION: Among adults with Type 2 diabetes, low health literacy (HL) is a risk factor for negative health outcomes. Support from family and friends can improve adults' self-management and health-related outcomes. We examined whether supporters provided unique help to adults with diabetes and low HL and whether HL was associated with adults' perception of supporter helpfulness. METHODS: We used cross-sectional baseline survey data from 239 adult patients with diabetes enrolled in a randomized controlled trial with a support person. Patients reported level of supporter involvement with self-management roles. HL among patients and supporters was assessed using a validated HL screening tool. Patient perception of supporter helpfulness was assessed with a single item. We used multivariable logistic regression to examine associations of patient and supporter HL levels with supporter roles and patients' perception of supporter helpfulness. RESULTS: Patients with low HL were more likely to have a supporter with low HL (39% vs. 26%, p = .04). Patients with low HL had higher odds of receiving supporter help with calling health care providers (adjusted odds ratio [AOR] = 2.09, 95% CI [1.00, 4.39]), remembering medical appointments (AOR = 2.24, 95% CI [1.07, 4.69]), and giving directions when blood sugars were low (AOR = 2.51, 95% CI [1.20, 5.37]). Neither patient nor supporter HL was significantly associated with patients' perception of supporter helpfulness. DISCUSSION: Adults with diabetes and low HL reported more supporter involvement with specific self-management tasks than patients with adequate HL. Providers could consider targeted involvement of supporters to assist patients with chronic diseases and low HL, although they should be aware that supporters may be challenged by low HL. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Patient and supporter factors affecting engagement with diabetes telehealth.

OBJECTIVES: To assess what patient, family supporter, and call characteristics predicted whether patients completed automated and coach-provided calls in a telehealth diabetes intervention. STUDY DESIGN: A total of 123 adults with type 2 diabetes and high glycated hemoglobin A1c (HbA1c) or blood pressure, enrolled with a family supporter, received automated interactive voice response (IVR) and coach-provided visit preparation calls over 12 months. METHODS: Data from baseline surveys and diabetes-related clinical information from patient medical records were entered into multilevel, multivariate regression models of associations between participant and call characteristics with call completion. RESULTS: A total of 76.3% of 2784 IVR calls and 75.8% of 367 visit preparation calls were completed. For IVR calls, patients with recent call-triggered provider alerts had higher odds of call completion (adjusted odds ratio [AOR], 3.5; 95% CI, 2.2-5.5); those with depressive symptoms (AOR, 0.4; 95% CI, 0.2-0.9), higher HbA1c (AOR, 0.8; 95% CI, 0.6-0.99), and more months in the study (AOR, 0.9; 95% CI, 0.87-0.94 per month) had lower odds. For visit preparation calls, higher patient activation scores predicted higher call completion (AOR, 1.4; 95% CI, 1.1-1.9); patient college education predicted less call completion (AOR, 0.3; 95% CI, 0.2-0.6). Supporter help taking medications predicted less completion of both call types. Patient age did not predict call completion. CONCLUSIONS: Patients of all ages completed telehealth calls at a high rate. Automated IVR calls were completed more often when urgent issues were identified to patients' providers, but less often if patients had high HbA1c or depression. Visit preparation call content should be tailored to patient education level. Family help with medications may identify patients needing additional support to engage with telehealth.

Reasons why emergency department providers do not rely on the pneumonia severity index to determine the initial site of treatment for patients with pneumonia.

BACKGROUND: Many emergency department (ED) providers do not follow guideline recommendations for the use of the pneumonia severity index (PSI) to determine the initial site of treatment for patients with community-acquired pneumonia (CAP). We identified the reasons why ED providers hospitalize low-risk patients or manage higher-risk patients as outpatients. METHODS: As a part of a trial to implement a PSI-based guideline for the initial site of treatment of patients with CAP, we analyzed data for patients managed at 12 EDs allocated to a high-intensity guideline implementation strategy study arm. The guideline recommended outpatient care for low-risk patients (nonhypoxemic patients with a PSI risk classification of I, II, or III) and hospitalization for higher-risk patients (hypoxemic patients or patients with a PSI risk classification of IV or V). We asked providers who made guideline-discordant decisions on site of treatment to detail the reasons for nonadherence to guideline recommendations. RESULTS: There were 1,306 patients with CAP (689 low-risk patients and 617 higher-risk patients). Among these patients, physicians admitted 258 (37.4%) of 689 low-risk patients and treated 20 (3.2%) of 617 higher-risk patients as outpatients. The most commonly reported reasons for admitting low-risk patients were the presence of a comorbid illness (178 [71.5%] of 249 patients); a laboratory value, vital sign, or symptom that precluded ED discharge (73 patients [29.3%]); or a recommendation from a primary care or a consulting physician (48 patients [19.3%]). Higher-risk patients were most often treated as outpatients because of a recommendation by a primary care or consulting physician (6 [40.0%] of 15 patients). CONCLUSION: ED providers hospitalize many low-risk patients with CAP, most frequently for a comorbid illness. Although higher-risk patients are infrequently treated as outpatients, this decision is often based on the request of an involved physician.

Assessing processes of care to promote timely initiation of antibiotic therapy for emergency department patients hospitalized for pneumonia.

BACKGROUND: A mixed-methods quality improvement (QI) project for patients with pneumonia hospitalized from the emergency department (ED) was undertaken to (1) delineate the basic steps in the flow of patient care from presentation in the ED to time to first antibiotic dose (TFAD), (2) identify perceived barriers to and facilitators of reduced TFAD within these steps, (3) describe QI strategies to improve TFAD rates, and (4) identify perceived strategies for facilities to enhance performance. METHODS: The QI project was conducted at 10 lower- and 10 higher-performing Veterans Affairs hospitals on the basis of the proportion of patients whose TFAD was within four hours of presentation. An ED physician, an ED nurse, a radiologist, a pharmacist, and a quality manager from each site were invited to participate in a survey and focus group. RESULTS: Of the 82 survey participants, 59 (72%) perceived that ordering and performing the chest radiograph was the step most frequently resulting in TFAD delays. Medical provider assessment, chest radiograph interpretation, ordering/obtaining blood cultures, and ordering/administering initial antibiotic therapy also caused TFAD delays. The most commonly perceived barriers were patient and x-ray equipment transportation delays and communication delays between providers. The most frequently used strategies to reduce TFAD were stocking antibiotics in the ED and physician education. Focus groups emphasized the importance of multifaceted QI approaches and a top-down hospital leadership style to improve TFAD performance. DISCUSSION: TFAD relies on a series of complex, stepwise processes of care that involve numerous hospital departments and is often delayed by well-described barriers. Addressing these barriers, as well as involving facility leadership in setting institutional QI goals, could possibly improve performance on this pneumonia quality measure.

SMART-COP: a tool for predicting the need for intensive respiratory or vasopressor support in community-acquired pneumonia.

BACKGROUND: Existing severity assessment tools, such as the pneumonia severity index (PSI) and CURB-65 (tool based on confusion, urea level, respiratory rate, blood pressure, and age >or=65 years), predict 30-day mortality in community-acquired pneumonia (CAP) and have limited ability to predict which patients will require intensive respiratory or vasopressor support (IRVS). METHODS: The Australian CAP Study (ACAPS) was a prospective study of 882 episodes in which each patient had a detailed assessment of severity features, etiology, and treatment outcomes. Multivariate logistic regression was performed to identify features at initial assessment that were associated with receipt of IRVS. These results were converted into a simple points-based severity tool that was validated in 5 external databases, totaling 7464 patients. RESULTS: In ACAPS, 10.3% of patients received IRVS, and the 30-day mortality rate was 5.7%. The features statistically significantly associated with receipt of IRVS were low systolic blood pressure (2 points), multilobar chest radiography involvement (1 point), low albumin level (1 point), high respiratory rate (1 point), tachycardia (1 point), confusion (1 point), poor oxygenation (2 points), and low arterial pH (2 points): SMART-COP. A SMART-COP score of >or=3 points identified 92% of patients who received IRVS, including 84% of patients who did not need immediate admission to the intensive care unit. Accuracy was also high in the 5 validation databases. Sensitivities of PSI and CURB-65 for identifying the need for IRVS were 74% and 39%, respectively. CONCLUSIONS: SMART-COP is a simple, practical clinical tool for accurately predicting the need for IRVS that is likely to assist clinicians in determining CAP severity.

Effect of a Positive Psychological Intervention on Pain and Functional Difficulty Among Adults With Osteoarthritis: A Randomized Clinical Trial.

Importance: Positive psychological interventions for improving health have received increasing attention recently. Evidence on the impact of such interventions on pain, and racial disparities in pain, is limited. Objective: To assess the effects of a positive psychological intervention on pain and functional difficulty in veterans with knee osteoarthritis. Design, Setting, and Participants: The Staying Positive With Arthritis Study is a large, double-blinded randomized clinical trial powered to detect race differences in self-reported pain in response to a positive psychological intervention compared with a neutral control intervention. Data were collected from 2 urban Veterans Affairs medical centers. Participants included non-Hispanic white and non-Hispanic African American patients aged 50 years or older with a diagnosis of osteoarthritis. Mailings were sent to 5111 patients meeting these criteria, of whom 839 were fully screened, 488 were eligible, and 360 were randomized. Enrollment lasted from July 8, 2015, to February 1, 2017, with follow-up through September 6, 2017. Interventions: The intervention comprised a 6-week series of evidence-based activities to build positive psychological skills (eg, gratitude and kindness). The control program comprised similarly structured neutral activities. Programs were delivered via workbook and weekly telephone calls with interventionists. Main Outcomes and Measures: The primary outcomes were self-reported pain and functional difficulty measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range 0-100). Secondary outcomes included affect balance and life satisfaction. Results: The sample included 180 non-Hispanic white patients and 180 non-Hispanic African American patients (mean [SD] age, 64.2 [8.8] years; 76.4% were male). Mean (SD) baseline scores for WOMAC pain and functional difficulty were 48.8 (17.6) and 46.8 (18.1), respectively. Although both decreased significantly over time (pain: χ23 = 49.50, P < .001; functional difficulty: χ23 = 22.11, P < .001), differences were small and did not vary by treatment group or race. Exploratory analyses suggested that the intervention had counterintuitive effects on secondary outcomes. Conclusions and Relevance: The results of this randomized clinical trial do not support the use of positive psychological interventions as a stand-alone treatment for pain among white or African American veterans with knee osteoarthritis. Adaptations are needed to identify intervention components that resonate with this population, and the additive effect of incorporating positive psychological interventions into more comprehensive pain treatment regimens should be considered. Trial Registration: ClinicalTrials.gov Identifier: NCT02223858.

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis.

Comparison of outcomes for low-risk outpatients and inpatients with pneumonia: A propensity-adjusted analysis.

BACKGROUND: Low-risk patients with community-acquired pneumonia are often hospitalized despite guideline recommendations for outpatient treatment. METHODS: Using data from a randomized trial conducted in 32 emergency departments, we performed a propensity-adjusted analysis to compare 30-day mortality rates, time to the return to work and to usual activities, and patient satisfaction with care between 944 outpatients and 549 inpatients in pneumonia severity index risk classes I to III who did not have evidence of arterial oxygen desaturation, or medical or psychosocial contraindications to outpatient treatment. RESULTS: After adjusting for quintile of propensity score for outpatient treatment, which eliminated all significant differences for baseline characteristics, outpatients were more likely to return to work (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.5 to 2.6) or, for nonworkers, to usual activities (OR, 1.4; 95% CI, 1.1 to 1.8) than were inpatients. Satisfaction with the site-of-treatment decision (OR, 1.1; 95% CI, 0.7 to 1.8), with emergency department care (OR, 1.4; 95% CI, 0.9 to 1.9), and with overall medical care (OR, 1.1; 95% CI, 0.8 to 1.6) was not different between outpatients and inpatients. The overall mortality rate was higher for inpatients than outpatients (2.6% vs 0.1%, respectively; p < 0.01); the mortality rate was not different among the 242 outpatients and 242 inpatients matched by their propensity score (0.4% vs 0.8%, respectively; p = 0.99). CONCLUSIONS: After adjusting for the propensity of site of treatment, outpatient treatment was associated with a more rapid return to usual activities and to work, and with no increased risk of mortality. The higher observed mortality rate among all low-risk inpatients suggests that physician judgment is an important complement to objective risk stratification in the site-of-treatment decision for patients with pneumonia.

A prediction rule to identify low-risk patients with pulmonary embolism.

BACKGROUND: A simple prognostic model could help identify patients with pulmonary embolism who are at low risk of death and are candidates for outpatient treatment. METHODS: We randomly allocated 15,531 retrospectively identified inpatients who had a discharge diagnosis of pulmonary embolism from 186 Pennsylvania hospitals to derivation (67%) and internal validation (33%) samples. We derived our rule to predict 30-day mortality using classification tree analysis and patient data routinely available at initial examination as potential predictor variables. We used data from a European prospective study to externally validate the rule among 221 inpatients with pulmonary embolism. We determined mortality and nonfatal adverse medical outcomes across derivation and validation samples. RESULTS: Our final model consisted of 10 patient factors (age > or = 70 years; history of cancer, heart failure, chronic lung disease, chronic renal disease, and cerebrovascular disease; and clinical variables of pulse rate > or = 110 beats/min, systolic blood pressure < 100 mm Hg, altered mental status, and arterial oxygen saturation < 90%). Patients with none of these factors were defined as low risk. The 30-day mortality rates for low-risk patients were 0.6%, 1.5%, and 0% in the derivation, internal validation, and external validation samples, respectively. The rates of nonfatal adverse medical outcomes were less than 1% among low-risk patients across all study samples. CONCLUSIONS: This simple prediction rule accurately identifies patients with pulmonary embolism who are at low risk of short-term mortality and other adverse medical outcomes. Prospective validation of this rule is important before its implementation as a decision aid for outpatient treatment.

Racial differences in 30-day mortality for pulmonary embolism.

OBJECTIVES: Previous studies reported a higher incidence of in-hospital mortality for Black patients who had pulmonary embolism than for White patients. We used a large statewide database to compare 30-day mortality (defined as death within 30 days from the date of latest hospital admission) for Black and White patients who were hospitalized because of pulmonary embolism. METHODS: The study cohort consisted of 15531 discharged patients who had been treated for pulmonary embolism at 186 Pennsylvania hospitals between January 2000 and November 2002. We used random-effects logistic regression to model 30-day mortality for Black and White patients, and adjusted for patient demographic and clinical characteristics. RESULTS: The unadjusted 30-day mortality rates were 9.0% for White patients, 10.3% for Blacks, and 10.9% for patients of other or unknown race. When adjusted for severity of disease using a validated clinical prognostic model for pulmonary embolism, Black patients had 30% higher odds of 30-day mortality compared with White patients at the same site (adjusted odds ratio = 1.3; 95% confidence interval, 1.1,1.6). Neither insurance status nor hospital volume was a significant predictor of 30-day mortality. CONCLUSION: Black patients who had pulmonary embolism had significantly higher odds of 30-day mortality compared with White patients.

Effect of increasing the intensity of implementing pneumonia guidelines: a randomized, controlled trial.

BACKGROUND: Despite the development of evidence-based pneumonia guidelines, limited data exist on the most effective means to implement guideline recommendations into clinical practice. OBJECTIVE: To compare the effectiveness and safety of 3 guideline implementation strategies. DESIGN: Cluster-randomized, controlled trial. SETTING: 32 emergency departments in Pennsylvania and Connecticut. PATIENTS: 3219 patients with a clinical and radiographic diagnosis of pneumonia. INTERVENTIONS: The authors implemented a project-developed guideline for the initial site of treatment based on the Pneumonia Severity Index and performance of evidence-based processes of care at the emergency department level. Guideline implementation strategies were defined as low (n = 8), moderate (n = 12), and high intensity (n = 12). MEASUREMENTS: Effectiveness outcomes were the rate at which low-risk patients were treated on an outpatient basis and the performance of recommended processes of care. Safety outcomes included death, subsequent hospitalization for outpatients, and medical complications for inpatients. RESULTS: More low-risk patients (n = 1901) were treated as outpatients in the moderate-intensity and high-intensity groups than in the low-intensity group (high-intensity group, 61.9%; moderate-intensity group, 61.0%; low-intensity group, 37.5%; P = 0.004). More outpatients (n = 1125) in the high-intensity group received all 4 recommended processes of care (high-intensity group, 60.9%; moderate-intensity group, 28.3%; low-intensity group, 25.3%; P < 0.001); more inpatients (n = 2076) in the high-intensity group received all 4 recommended processes of care (high-intensity group, 44.3%; moderate-intensity group, 30.1%; low-intensity group, 23.0%; P < 0.001). No statistically significant differences in safety outcomes were observed across interventions. LIMITATIONS: Twenty percent of eligible patients were not enrolled, and data on effectiveness outcomes were not collected before the trial. CONCLUSIONS: Both moderate-intensity and high-intensity guideline implementation strategies safely increased the proportion of low-risk patients with pneumonia who were treated as outpatients. The high-intensity strategy was most effective for increasing the performance of the recommended processes of care for outpatients and inpatients.

The emergency department triage of community-acquired pneumonia project data and documentation systems: a model for multicenter clinical trials.

Multicenter clinical trials are complex undertakings that require significant resources to ensure efficient, high quality research. This paper describes the goals, design, and implementation of a multicenter clinical trial database management system to support this aim. A large number of study sites or patients, and the goal of automatically generating large portions of data management infrastructure from common metadata, motivated the development of the system. This paper also describes extensions for a generalized project documentation system, and discusses plans for further extensions and improvements based on observed strengths, limitations, and anticipated technological change.

Prospective comparison of three validated prediction rules for prognosis in community-acquired pneumonia.

PURPOSE: We assessed the performance of 3 validated prognostic rules in predicting 30-day mortality in community-acquired pneumonia: the 20 variable Pneumonia Severity Index and the easier to calculate CURB (confusion, urea nitrogen, respiratory rate, blood pressure) and CURB-65 severity scores. SUBJECTS AND METHODS: We prospectively followed 3181 patients with community-acquired pneumonia from 32 hospital emergency departments (January-December 2001) and assessed mortality 30 days after initial presentation. Patients were stratified into Pneumonia Severity Index risk classes (I-V) and CURB (0-4) and CURB-65 (0-5) risk strata. We compared the discriminatory power (area under the receiver operating characteristic curve) of these rules to predict mortality and their accuracy based on sensitivity, specificity, predictive values, and likelihood ratios. RESULTS: The Pneumonia Severity Index (risk classes I-III) classified a greater proportion of patients as low risk (68% [2152/3181]) than either a CURB score <1 (51% [1635/3181]) or a CURB-65 score <2 (61% [1952/3181]). Low-risk patients identified based on the Pneumonia Severity Index had a slightly lower mortality (1.4% [31/2152]) than patients classified as low-risk based on the CURB (1.7% [28/1635]) or the CURB-65 (1.7% [33/1952]). The area under the receiver operating characteristic curve was higher for the Pneumonia Severity Index (0.81) than for either the CURB (0.73) or CURB-65 (0.76) scores (P <0.001, for each pairwise comparison). At comparable cut-points, the Pneumonia Severity Index had a higher sensitivity and a somewhat higher negative predictive value for mortality than either CURB score. CONCLUSIONS: The more complex Pneumonia Severity Index has a higher discriminatory power for short-term mortality, defines a greater proportion of patients at low risk, and is slightly more accurate in identifying patients at low risk than either CURB score.

Using randomized controlled trial data, the agreement between retrospectively and prospectively collected data comprising the pneumonia severity index was substantial.

OBJECTIVE: To assess the agreement between prospectively and retrospectively determined variables comprising the Pneumonia Severity Index (PSI), assignment to PSI risk class, and designation as low risk, based on these two methods of data collection. STUDY DESIGN AND SETTING: We analyzed data from a randomized trial of patients with community-acquired pneumonia managed in 32 hospital emergency departments (EDs). For all enrolled patients, the 20 PSI variables were collected prospectively by ED providers and retrospectively by medical record abstractors. We examined the agreement for each of the 20 PSI variables, assignment to the five PSI risk classes, and classification of patients as low (classes I-III) vs. high (classes IV and V) risk. Agreement was measured using total percent agreement and the kappa statistic. RESULTS: Among the 3,220 enrolled patients, percent agreement was >90% for 18 of the 20 variables comprising the PSI, with most unweighted kappa's being >0.6. Agreement was substantial for assignment to PSI risk class (percent agreement: 92.7%; weighted kappa: 0.79) and for classification as low vs. high risk (percent agreement: 88.5%; unweighted kappa: 0.74). CONCLUSION: There was substantial agreement between retrospective and prospective assignment to PSI risk class, classification as low vs. high risk, and the determination of most individual variables that constitute the PSI.

Causes of death for patients with community-acquired pneumonia: results from the Pneumonia Patient Outcomes Research Team cohort study.

BACKGROUND: To our knowledge, no previous study has systematically examined pneumonia-related and pneumonia-unrelated mortality. This study was performed to identify the cause(s) of death and to compare the timing and risk factors associated with pneumonia-related and pneumonia-unrelated mortality. METHODS: For all deaths within 90 days of presentation, a synopsis of all events preceding death was independently reviewed by 2 members of a 5-member review panel (C.M.C., D.E.S., T.J.M., W.N.K., and M.J.F.). The underlying and immediate causes of death and whether pneumonia had a major, a minor, or no apparent role in the death were determined using consensus. Death was defined as pneumonia related if pneumonia was the underlying or immediate cause of death or played a major role in the cause of death. Competing-risk Cox proportional hazards regression models were used to identify baseline characteristics associated with mortality. RESULTS: Patients (944 outpatients and 1343 inpatients) with clinical and radiographic evidence of pneumonia were enrolled, and 208 (9%) died by 90 days. The most frequent immediate causes of death were respiratory failure (38%), cardiac conditions (13%), and infectious conditions (11%); the most frequent underlying causes of death were neurological conditions (29%), malignancies (24%), and cardiac conditions (14%). Mortality was pneumonia related in 110 (53%) of the 208 deaths. Pneumonia-related deaths were 7.7 times more likely to occur within 30 days of presentation compared with pneumonia-unrelated deaths. Factors independently associated with pneumonia-related mortality were hypothermia, altered mental status, elevated serum urea nitrogen level, chronic liver disease, leukopenia, and hypoxemia. Factors independently associated with pneumonia-unrelated mortality were dementia, immunosuppression, active cancer, systolic hypotension, male sex, and multilobar pulmonary infiltrates. Increasing age and evidence of aspiration were independent predictors of both types of mortality. CONCLUSIONS: For patients with community-acquired pneumonia, only half of all deaths are attributable to their acute illness. Differences in the timing of death and risk factors for mortality suggest that future studies of community-acquired pneumonia should differentiate all-cause and pneumonia-related mortality.

Implementation of an evidence-based guideline to reduce duration of intravenous antibiotic therapy and length of stay for patients hospitalized with community-acquired pneumonia: a randomized controlled trial.

PURPOSE: Patients with pneumonia often remain hospitalized after they are stable clinically, and the duration of intravenous antibiotic therapy is a rate-limiting step for discharge. The purpose of this study was to determine whether implementation of an evidence-based guideline would reduce the duration of intravenous antibiotic therapy and length of stay for patients hospitalized with pneumonia. METHODS: In a seven-site, cluster randomized clinical trial, we enrolled 325 control and 283 intervention patients who were admitted by one of 116 physician groups. Within site, physician groups were assigned randomly to receive a practice guideline alone (control arm) or a practice guideline that was implemented using a multifaceted strategy (intervention arm). The effectiveness of guideline implementation was measured by the duration of intravenous antibiotic therapy and length of stay; differences in the rates of discontinuation and hospital discharge were assessed with proportional hazards models. Medical outcomes were assessed at 30 days. RESULTS: Intravenous antibiotic therapy was discontinued somewhat more quickly in the intervention group (hazard ratio [HR] =1.23; 95% confidence interval [CI]: 1.00 to 1.52; P = 0.06) than in the control group. Intervention patients were discharged more quickly, but the difference was not statistically significant (HR = 1.16; 95% CI: 0.97 to 1.38; P = 0.11). Fewer intervention (55% [157/283]) than control (63% [206/325]) patients had medical complications during the index hospitalization (P = 0.04), with no differences in other medical outcomes, including mortality, rehospitalization, and return to usual activities, between treatment arms. CONCLUSIONS: The multifaceted guideline implementation strategy resulted in a slight reduction in the duration of intravenous antibiotic therapy and a nonsignificant reduction in length of stay, without affecting patient outcomes.