Use of the Electrocardiograph-Based Thrombolytic Predictive Instrument To Assist Thrombolytic and Reperfusion Therapy for Acute Myocardial Infarction: A Multicenter, Randomized, Controlled, Clinical Effectiveness Trial

Use of the Electrocardiograph-Based Thrombolytic Predictive Instrument To Assist Thrombolytic and Reperfusion Therapy for Acute Myocardial Infarction: A Multicenter, Randomized, Controlled, Clinical Effectiveness Trial

Harry P. Selker, MD, MSPH;
Joni R. Beshansky, RN, MPH;
John L. Griffith, PhD; and
for the TPI Trial Investigators*

From Tufts–New England Medical Center, Boston, Massachusetts.

Abstract

Background: Deciding which patients should receive thrombolytic therapy or percutaneous transluminal coronary angioplasty (PTCA) for acute myocardial infarction (AMI) can be difficult, especially for less-obvious candidates and when consulting physicians are off site.

Objective: To test whether the electrocardiograph-based Thrombolytic Predictive Instrument (TPI) improves use of thrombolytic and overall reperfusion therapy.

Design: 22-month randomized, controlled, clinical effectiveness trial.

Setting: Emergency departments at 28 urban, suburban, and rural hospitals in the United States.

Patients: Persons presenting to the emergency department with AMI and ST-segment elevation on an electrocardiogram (ECG).

Intervention: TPI predictions automatically printed on ECG text headers.

Measurements: Percentages of patients receiving thrombolytic therapy, thrombolytic therapy within 1 hour of initial ECG, and overall reperfusion (thrombolytic therapy or PTCA).

Results: Of 2875 patients with AMI, 1243 (43.2%) had ST-segment elevation. Of these, 1197 were randomly assigned to study groups; 732 (61.2%) had inferior AMI, and 465 (38.8%) had anterior AMI. A total of 60.5% of controls and 62.1% of TPI patients (P = 0.2) received thrombolytic therapy, 52.5% of controls and 53.3% of TPI patients received thrombolytic therapy within 1 hour (P > 0.2), and 67.6% of controls and 70.3% of TPI patients received overall reperfusion (P = 0.2). Of patients with inferior AMI in the control group versus the TPI group, 61.1% versus 67.6% (P = 0.03) received thrombolytic therapy, 53.2% versus 58.6% (P = 0.08) received thrombolytic therapy within 1 hour, and 67.7% versus 74.7% (P = 0.03) received overall reperfusion. Of patients with anterior AMI in the control group versus the TPI group, 59.5% versus 53.9% (P > 0.2) received thrombolytic therapy, 51.4% versus 45.3% (P > 0.2) received thrombolytic therapy within 1 hour, and 67.6% versus 63.8% (P > 0.2) received overall reperfusion. Among women (n = 398) in the control group versus the TPI group, 48.1% versus 58.2% (P = 0.03) received thrombolytic therapy, 40.5% versus 48.4% (P = 0.10) received thrombolytic therapy within 1 hour, and 55.7% versus 65.7% (P = 0.04) received overall reperfusion. Of patients who required physician consultation by telephone (n = 271) in the control group versus the TPI group, 47.3% versus 63.2% (P = 0.01) received thrombolytic therapy, 41.1% versus 53.6% (P = 0.04) received thrombolytic therapy within 1 hour, and 50.7% versus 66.4% (P = 0.01) received overall reperfusion.

Conclusions: The TPI increased use of thrombolytic therapy, use of thrombolytic therapy within 1 hour, and use of overall coronary reperfusion by 11% to 12% for patients with inferior AMI, 18% to 22% for women, and 30% to 34% for patients with an off-site physician. Although its effect was minimal on patients with high baseline reperfusion rates, the TPI increased use and timeliness of reperfusion in often-missed groups and when involved physicians were off site.

*For a list of the TPI Trial Investigators, see the Appendix.

Article and Author Information

Acknowledgments: The authors thank the regional and site coordinators at the study hospitals: Del Blank, RN, MBA, Regional Coordinator, Franklin Medical Center, Mary Lane Hospital, Cooley Dickinson Hospital, and Noble Hospital; Patricia Mitchell, RN, Regional Coordinator, Boston City Hospital, Carney Hospital, and University Hospital; David Kwon, Site Coordinator, Cedars-Sinai Medical Center; Marge Erwin, RN, Regional Coordinator, Bess Kaiser Medical Center and Sunnyside Medical Center; M. Elizabeth Hearon, Site Coordinator, New England Medical Center; Donna Cimini, RN, Site Coordinator, Rhode Island Hospital; Mary Frances Ward, RN, Regional Coordinator, North Shore University Hospital–Glen Cove, Huntington Hospital, and University Hospital–Stony Brook; Mary Jensen, RN, Regional Coordinator, Presbyterian/St. Luke's Medical Center and Swedish Hospital; and Tami Owen, RN, BSN, Rural Regional Coordinator, Regional West Medical Center, Chadron Community Hospital, Box Butte General Hospital, Lincoln Community Hospital, Plains Medical Center, Silverheels Health Center, Timberline Medical Center, Memorial Hospital, Southeast Colorado Hospital, Decatur County Hospital, and Memorial Health Center.
They also thank the staff of the study hospitals: Mary Guzik, RN, Mary Lane Hospital; Noeline Woolrich, RN, Cooley Dickinson Hospital; Sophie Killips, Noble Hospital; Sheilah Bernard, MD, Clara Berty Safi, RN, and Sue Fish, PharmD, MPH, Boston City Hospital; John Kim, Prediman K. Shah, MD, Joel Geiderman, MD, Linda Verraster, RN, and Mary Flores, RN, Cedars-Sinai Medical Center; Marlene McKenzie, RN, Debbie Towery, RN, Judi Donnelly, MS, RN, CCRN, and Michael Blahnik, MD, Bess Kaiser Medical Center; Jeremy K. Ota, MD, Kenneth Nisbet, MD, and Arthur Hayward, MD, Sunnyside Medical Center; Jo Anne Capobianco, RN, and Elayne Palumbo, Rhode Island Hospital; Doreen O'Grady, RN, North Shore University Hospital–Glen Cove; Kathy Stark, RN, and Lynne Streekre, RN, Huntington Hospital; Sharon Valentine, RN, University Hospital–Stony Brook; Linda Hackley, Presbyterian/St. Luke's Medical Center and Swedish Hospital; Brett Hoppes, Bonin Lager, RN, Alice Maupin, Ward Krichau, Dee Vogel, RN, BSN, and Kathy Jacobson, RN, BSN, Regional West Medical Center; Jean Martin, CRT, RCP, and Harold Krueger Sr., Chadron Community Hospital; Jan Hoffman Loomis, RN, T.J. Padden, Vicki Mentele, and Carolyn Jones, Box Butte General Hospital; Gwen Schroeder and Mary Thompson, Lincoln Community Hospital; Linda Messer and Debbie Olesen, Plains Medical Center; Patty Schoville, NP, and Judy Peck, RN, Silverheels Health Center; Sally Hartman, RN, and Deborah Marshbanks, RN, Timberline Medical Center; Rebecca Warren, RN, David Moore, Anna James, and Annessa Cook, Memorial Hospital; Marla Baxter, RN, and Annie Dukes, BSN, MBA, JD, Southeast Colorado Hospital; Linda Stanley, RN, Doreen Olson, and Kim Hardman, Decatur County Hospital; and Larry Kelly, Mray Pettit, and Rex Walker, Memorial Health Center.
The authors thank the members of the Data Monitoring and Safey Committee: Alexa Beiser, PhD; Costas T. Lambrew, MD; and Tohmas J. Ryan, MD, Chair. They also thank Jame D. Scott, ScD, U.S. Agency for Healthcare Research and Quality (formerly U.S. Agency for Health Care Policy and Research), Project Officer, for support; Daniel B. Stryer, MD, for suggestions on the manuscript; and Julie Burt for manuscript preparation.
Grant Support: By grant R01 HS 08212 from the Agency for Healthcare Research and Quality and in part by grant M01 RR00054 from the General Clinical Research Center at New England Medical Center funded by the National Center for Research Resources, National Institutes of Health.
Requests for Single Reprints: Harry P. Selker, MD, MSPH, Tufts–New England Medical Center, Division of Clinical Care Research, 750 Washington Street #63, Boston, MA 02111; e-mail, hselker{at}lifespan.org.
Current Author Addresses: Drs. Selker and Griffith and Ms. Beshansky: Tufts–New England Medical Center, Division of Clinical Care Research, 750 Washington Street #63, Boston, MA 02111.
Author Contributions: Conception and design: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Analysis and interpretation of the data: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Drafting of the article: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Critical revision of the article for important intellectual content: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Final approval of the article: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Provision of study materials or patients: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Statistical expertise: H.P. Selker, J.R. Beshansky.
Obtaining of funding: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Administrative, technical, or logistic support: H.P. Selker, J.R. Beshansky, J.L. Griffith.
Collection and assembly of data: H.P. Selker, J.R. Beshansky, J.L. Griffith.