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Improving Patient Care |

Effect of Increasing the Intensity of Implementing Pneumonia Guidelines: A Randomized, Controlled Trial

Donald M. Yealy, MD; Thomas E. Auble, PhD; Roslyn A. Stone, PhD; Judith R. Lave, PhD; Thomas P. Meehan, MD, MPH; Louis G. Graff, MD; Jonathan M. Fine, MD; D. Scott Obrosky, MS; Maria K. Mor, PhD; Jeff Whittle, MD, MPH; and Michael J. Fine, MD, MSc*
[+] Article and Author Information

From University of Pittsburgh and the Veterans Affairs Center for Health Equity Research and Promotion, Pittsburgh, Pennsylvania; Qualidigm, Middletown, Connecticut; Yale University School of Medicine, New Haven, Connecticut; New Britain General Hospital, New Britain, Connecticut; Norwalk Hospital, Norwalk, Connecticut; University of Connecticut, Storrs, Connecticut; and Clement J. Zablocki Veterans Administration Medical Center and Medical College of Wisconsin, Milwaukee, Wisconsin.


Grant Support: By the Agency for Healthcare Research and Quality (grant number R01 HS10049). Dr. M.J. Fine received support from the National Institute of Allergy and Infectious Diseases (grant number K24 AI001769).

Potential Financial Conflicts of Interest: Consultancies: M.J. Fine (University of Pennsylvania, GeneSoft Pharmaceuticals Inc.); Honoraria: M.J. Fine (Zynx Health Corporation, STA Healthcare Communications Inc., University of Alberta, Maine Medical Center); Expert testimony: M.J. Fine (Stephen Lynn Klein, Kellogg & Siegelman, Swanson, Martin, & Bell, William J. Burke, Chad McGowan, Chernett, Wasserman, Yarger, Pasternak, LLC); Grants received: M.J. Fine (Pfizer Inc.); Royalties: M.J. Fine (Up-to-Date).

Requests for Single Reprints: Michael J. Fine, MD, MSc, Veterans Administration Pittsburgh Healthcare System (151-C-U), Center for Health Equity Research and Promotion, University Drive C, Building 28, 1A102, Pittsburgh, PA 15240; e-mail, Michael.Fine@va.gov.

Current Author Addresses: Drs. Yealy and Auble: Department of Emergency Medicine, University of Pittsburgh, 230 McKee Place, Suite 500, Pittsburgh, PA 15213.

Dr. Stone: Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Suite 304, Pittsburgh, PA 15261.

Dr. Lave: Department of Health Services Administration, Graduate School of Public Health, University of Pittsburgh, Room A649, Pittsburgh, PA 15261.

Dr. Meehan: Qualidigm, 100 Roscommon Drive, Middletown, CT 06457.

Dr. Graff: Department of Emergency Medicine, New Britain General Hospital, 100 Grand Street, New Britain, CT 06050.

Dr. J.M. Fine: Norwalk Hospital, Maple Street, Norwalk, CT 06856.

Mr. Obrosky: Veterans Administration Pittsburgh Healthcare System (151-C-U), Center for Health Equity Research and Promotion, University Drive C, Suite 1A126, Pittsburgh, PA 15240.

Dr. Mor: Veterans Administration Pittsburgh Healthcare System (151-C-U), Center for Health Equity Research and Promotion, University Drive C, Suite 1A110, Pittsburgh, PA 15240.

Dr. Whittle: Clement J. Zablocki Veterans Administration Medical Center (00/PC), 5000 W. National Avenue, Milwaukee, WI 53295.

Dr. M.J. Fine: Veterans Administration Pittsburgh Healthcare System (151-C-U), Center for Health Equity Research and Promotion, University Drive C, Building 28, Suite 1A102, Pittsburgh, PA 15240.


Ann Intern Med. 2005;143(12):881-894. doi:10.7326/0003-4819-143-12-200512200-00006
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We initially enrolled 3615 (80.2%) of 4506 eligible patients (Figure 1); a median of 113 patients (interquartile range, 101 to 123) were enrolled per site. Compared with nonenrolled eligible patients, participants were younger (median age, 79 vs. 68 years) and less likely to reside in a nursing home (35.7% vs. 5.7%). We excluded 396 enrolled patients from the site-of-treatment analysis, most frequently because we discovered the presence of an exclusion criterion after enrollment or because of protocol or consent violations. Relatively fewer eligible patients were enrolled and more patients were excluded following enrollment in the low-intensity intervention group. The study samples consisted of 3219 (71.4%) patients (1901 low-risk and 1318 higher-risk) for site-of-treatment and 3201 (71.0%) patients (1125 outpatients and 2076 inpatients) for process-of-care analyses.

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Figure 1.
Patient enrollment.

Overall, 4506 eligible patients were identified, of which 3615 (80.2%) were initially enrolled. Following enrollment, 396 patients were excluded because of discovery of 1 or more clinical exclusion criteria not recognized at presentation (  = 163), enrollment protocol or informed consent violations (  = 163), patient withdrawal or death in the emergency department before an initial site of treatment was assigned (  = 33), and incomplete information required to assign risk class (  = 37). The most common protocol violations were enrollment of patients 1) managed by a study co-investigator in the low-intensity group (  = 47); 2) previously enrolled in the study (  = 32); and 3) participating in a competing research protocol (  = 29). The study population to assess the site of treatment consisted of 3219 (71.4%) patients, and the study population to assess initial processes of care consisted of 3201 (71.0%) patients.

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Figure 2.
Adjusted pairwise comparisons of intervention groups for the effectiveness outcomes.

The solid circles, squares, and triangles represent the adjusted odds ratios (ORs) for the effectiveness outcomes, and the corresponding bars represent the 95% CIs for these estimates. Pairwise comparisons of outpatient treatment by intervention group are made separately for low-risk and higher-risk patients, adjusting for state and severity of illness (risk class and arterial oxygen desaturation). Pairwise comparisons of the processes of care for outpatients and inpatients by intervention group are adjusted for state and severity of illness (low risk vs. higher risk) at presentation. An OR greater than 1.0 indicates a greater likelihood of outpatient treatment or having the recommended process of care performed. Low denotes low-intensity group, Moderate denotes moderate-intensity group, High and denotes high-intensity group.

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Figure 3.
Adjusted pairwise comparisons of intervention groups for safety outcomes.

The solid circles, squares, and triangles represent the adjusted odds ratios (ORs) for the safety outcomes, and the corresponding bars represent the 95% CIs for these estimates. Pairwise comparisons of these outcomes by intervention group are made separately for relevant subgroups of patients, adjusting for state and severity of illness. An OR greater than 1.0 indicates a greater likelihood of a given outcome. Low denotes low-intensity group, Moderate denotes moderate-intensity group, and High denotes high-intensity group.

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Summary for Patients

Comparison of 3 Strategies To Improve the Care of Patients with Pneumonia Treated in the Emergency Department

The summary below is from the full report titled “Effect of Increasing the Intensity of Implementing Pneumonia Guidelines. A Randomized, Controlled Trial.” It is in the 20 December 2005 issue of Annals of Internal Medicine (volume 143, pages 881-894). The authors are D.M. Yealy, T.E. Auble, R.A. Stone, J.R. Lave, T.P. Meehan, L.G. Graff, J.M. Fine, D.S. Obrosky, M.K. Mor, J. Whittle, and M.J. Fine.

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