Effect of Increasing the Intensity of Implementing Pneumonia Guidelines

Context The effects of intensified efforts to translate guidelines into practice are poorly understood. Content Thirty-two emergency departments were randomly assigned to low-intensity, moderate-intensity, and high-intensity strategies for implementing guidelines for community-acquired pneumonia. More low-risk patients were appropriately treated as outpatients in moderate-intensity and high-intensity implementation sites. Adherence to recommended processes of care was better with the high-intensity intervention. Mortality rates, hospitalization after initial outpatient treatment, and inpatient medical complications were similar irrespective of guideline implementation strategy. Implications The most intense guideline implementation strategy resulted in the highest adherence to recommended processes of care. The Editors Physicians frequently overestimate the probability of death in low-risk patients with pneumonia, leading to potentially unnecessary, costly hospitalizations instead of outpatient treatment, which is often preferred (1-3). The Pneumonia Severity Index (PSI) accurately identifies patients at low risk for short-term mortality (4). Two effectiveness trials have demonstrated that implementation of the PSI reduces the proportion of low-risk patients admitted to the hospital from the emergency department (5, 6). A more recent efficacy trial showed equivalent health outcomes and greater satisfaction with medical care among patients in PSI risk classes II and III who were randomly assigned to outpatient treatment (7). However, the best methods to implement the PSI into clinical practice remain unclear. Observational studies have linked performance of blood cultures (8, 9), rapid initiation of antibiotic therapy (9, 10), and appropriate selection of antibiotic therapy with improved short-term survival for patients hospitalized for pneumonia (11, 12). Other studies have identified the assessment of arterial oxygenation as a salient process of care because of its prognostic value and pivotal role in site-of-treatment decisions (1, 13). These advances have contributed to the development of evidence-based practice guidelines for pneumonia that typically recommend all of these initial processes of care for hospitalized patients and a subset of them for outpatients (14-16). The Centers for Medicare & Medicaid Services and the Joint Commission on Accreditation of Healthcare Organizations have adopted these processes of care as pneumonia quality indicators, and the latter organization uses these indicators as a part of its national hospital accreditation program (17, 18). Despite these advances, the overall quality of care for pneumonia ranks 20th among 25 common adult ambulatory care problems (19). Although quality improvement studies demonstrate increased adherence to several processes of care, such as timely initiation of antibiotic therapy and performance of blood cultures for inpatients (8, 20-22), these studies are of limited usefulness because they were performed in few study sites or featured nonrandomized designs. We compared the effectiveness and safety of 3 pneumonia guideline implementation strategies. We hypothesized that a high-intensity intervention, in comparison with moderate-intensity and low-intensity interventions, would increase the number of low-risk patients treated as outpatients and the number of higher-risk patients hospitalized for care and that patient safety would not be compromised with these approaches. We also wanted to determine whether a high-intensity or moderate-intensity intervention would improve the performance of the recommended processes of care. Methods Study Design and Patient Eligibility We conducted a cluster-randomized trial at emergency departments in Connecticut (n= 16) and Pennsylvania (n= 16). Our nonrandom criteria for participation of study sites were 1) location in southwestern Pennsylvania or Connecticut; 2) annual volume of more than 15000 patient visits; and 3) willingness to be randomly assigned to any of the 3 study interventions. All relevant institutional review boards approved the trial, and all enrolled patients provided informed consent. We previously reported the study methods (23). Emergency department medical providers recruited patients 7 days per week between 15 January 2001 and 31 December 2001. Eligible patients were 18 years of age or older with a clinical diagnosis of pneumonia and a new pulmonary infiltrate that had been identified on radiography by the emergency department provider or an on-site radiologist. We excluded patients who were considered to have hospital-acquired pneumonia; immunosuppression; specified comorbid conditions (such as cystic fibrosis or pulmonary tuberculosis) that were distinguishable from pneumonia; or psychosocial conditions or substance abuse problems that were incompatible with outpatient treatment, enrollment, or follow-up. We also excluded patients who were incarcerated, homeless, pregnant, previously enrolled, or enrolled in a competing research protocol (23). Practice Guideline The study practice guideline consisted of recommendations for the initial site of treatment and processes of care after presentation to the emergency department (23) (Table 1). We developed the guideline with assistance from national experts in pneumonia with clinical backgrounds in internal and family medicine, emergency medicine, pulmonary medicine, and infectious disease. The guideline was based on expert consensus reached through a systematic review of the literature and was approved by medical providers at all participating emergency departments. Table 1. Summary of Guideline Recommendations for the Initial Site of Treatment and Processes of Care for Patients with Pneumonia We used the level of arterial oxygenation and PSI risk class (Table 1) to determine site-of-treatment recommendations (4, 23). Patients without any of the 11 prognostic factors in the first step of the PSI were assigned to risk class I. The remaining patients were assigned to risk classes II through V on the basis of their total risk points for the 20 PSI variables. Missing data for all prognostic factors were assumed to be normal (4). Outpatient therapy was recommended for all low-risk patients, defined as those in risk classes I through III who had no evidence of clinically significant arterial oxygen desaturation (oxygen saturation <90% or PO2 <60 mm Hg) at presentation; the guideline specified medical and psychosocial contraindications to outpatient treatment of this group of patients (Table 1). Inpatient therapy was recommended for all higher-risk patients, defined as those with documented arterial oxygen desaturation or those in risk classes IV or V. The guideline recommended an assessment of all patients' arterial oxygenation by pulse oximetry or measurement of arterial blood gas level (Table 1). According to the guidelines, the first dose of antibiotic therapy was to be given in the emergency department for outpatients and within 4 hours of presentation to the emergency department for inpatients (10, 15). For inpatients, 2 blood cultures were to be obtained before antibiotic therapy was initiated (14-16). The recommended antibiotic agents for all patients were consistent with current medical specialty society guideline recommendations (14-16). The definition of guideline-compliant antibiotic therapy varied by nursing home residence for outpatients (both in the emergency department and on discharge) and by admission to the intensive care unit for inpatients. Randomization and Study Interventions After stratifying emergency departments by state, teaching status, and annual volume, our statistician randomly assigned these departments to low-intensity, moderate-intensity, and high-intensity guideline implementation strategies in the ratio of 2:3:3, respectively. All interventions were implemented at the emergency department level and were conducted in collaboration with the state quality improvement organizations in Pennsylvania and Connecticut. The low-intensity strategy (used by 8 emergency departments) reflected the quality improvement methods typically used by the collaborating quality improvement organizations. During the year before patient enrollment, these organizations collected hospital-specific performance data for a national pneumonia quality improvement program; reports containing these data were then distributed to all emergency department and quality improvement directors (17). These baseline data included the proportion of hospitalized Medicare patients who were at low risk for short-term mortality on the basis of PSI class and who received each of the 4 inpatient processes of care shown in Table 1. The state-specific quality improvement organizations asked each of the hospital directors to develop a quality improvement plan that addressed the guideline-recommended processes of care. Because participation was voluntary, hospital directors could decide that such a plan was unwarranted and were not required to implement or evaluate their plans. Sites that did not provide plans received follow-up letters that pointed out areas for pneumonia quality improvement and effective approaches to achieve such improvements. In addition, the research team mailed the practice guideline and supporting literature to all medical providers at these emergency departments. The 12 emergency departments in the moderate-intensity arm received all of the low-intensity strategies. In addition, the state-specific quality improvement organizations asked that each hospital's plan address the initial site of treatment for pneumonia. Before patient enrollment, the research team also conducted an on-site educational session to teach medical providers how to use the PSI to guide the initial site of treatment and to reinforce all guideline recommendations. The 12 emergency departments in the high-intensity group received all low-intensity and moderate-intensity strategies,