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Thrombolytic Therapy vs Primary Percutaneous Coronary Intervention for Myocardial Infarction in Patients Presenting to Hospitals Without On-site Cardiac Surgery (JAMA, 2002;287:1943-1951) Supplement to the 'Methods' section The following is an outline of the Atlantic C-PORT primary angioplasty development program used in the course of the first C-PORT primary angioplasty trial (the prospective, randomized trial). This outline is not the program; it is a supplement to the "Methods" section of the article appearing in the Journal of the American Medical Association on April 17, 2002 . This document should not be used to develop a primary angioplasty program. I. Standards Facilities: The Clinical Practice Guideline Number 10 "Unstable Angina: Diagnosis and Management" published by the Agency for Health Care Policy and Research will be used to guide the definition of adequacy of clinical care environments (practitioners and institutions) that will be involved in the medical treatment of patients. To be considered adequate, patient entry points (emergency departments or chest pain centers) "should be continuously staffed by personnel competent in performing an ECG, initial evaluation and treatment of patients with" acute ischemic syndromes including myocardial infarction and unstable angina. This includes equipment and training in cardiac monitoring and advanced cardiac life support (ACLS). "Such a facility should be able to provide routine laboratory testing and radiographic studies". The intensive or cardiac care unit will have a " cardiac monitoring; immediate access to persons trained in ACLS; and capabilities for arterial line and pulmonary artery catheter placement, temporary pacemaker placement, and mechanical ventilation." All institutions will have facilities for intra-aortic balloon placement by study design. "This unit can handle all forms of vasoactive continuous IV infusion. Nurses are competent in the recognition and treatment of arrhythmias and evaluation of ischemic symptoms." The intermediate care unit has a "lower nurse to patient ratio than an ICU. It can provide continuous ECG monitoring and prompt access to personnel trained in ACLS. Personnel are competent in recognition of arrhythmias and evaluation of ischemic symptoms. Patients on some forms of vasoactive drips (e.g., low-dose dopamine, dobutamine, or nitroglycerin (NTG) infusion) or with a temporary pacemaker already in place may be cared for in this unit." "A standard hospital unit typically has a nurse to patient ratio greater than 1:5. ECG telemetry may or may not be available, but the nurses must be competent in recognition of unstable angina and its initial management. Access to cardiac resuscitation is via a code cart on the floor and a designated code team. Nursing personnel on the floor are trained in basic life support (BLS). Continuous heparin infusions may be used, but usually vasoactive drug infusions are not permitted." Care Providers - general: The employment and privileges granted to physicians and nurses at a facility certified by the State will serve as evidence of competence of physician and nursing personnel practicing in each of these environments. This ensures that community standards are applied where no national standards exist. Care Providers - interventional cardiology The American Heart Association/American College of Cardiology Joint Task Force guidelines for percutaneous transluminal coronary angioplasty serve as the basis for practitioner standards. These standards set an average of > 75 angioplasty cases per year as the minimum number required to maintain clinical competence. The guidelines further suggest that 50 cases per year represent an absolute yearly minimum. Therefore, the C-PORT trial will require that practitioner-investigators perform an average of 75 or more angioplasty cases per year. In no event will a practitioner-investigator be allowed to participate if he/she performs fewer than 50 angioplasties per year in any one year. Laboratory Standards: The guidelines and policies defined by the Society for Cardiac Angiography and Intervention guide development of laboratory standards. All centers involved will have as a minimum a diagnostic cardiac catheterization laboratory. The existence of such a catheterization laboratory and its certification by the State of Maryland will constitute evidence of adequacy as a catheterization laboratory. In laboratories in which coronary angioplasty is not currently performed, these laboratories must meet the following requirements:
II. Training Catheterization Laboratory Staff: Employment of staff (nurses and technicians) at a State-certified diagnostic catheterization and/or angioplasty laboratory will constitute evidence of competency to work in a diagnostic cardiac catheterization laboratory. Hospital Staff: In hospitals in which angioplasty is not currently performed, the nursing and technical staff in both the catheterization laboratory and in the pre-procedure and post-procedure care units will require additional training. Additional training will include familiarization with: angioplasty equipment (guide catheters, guide wires and angioplasty catheters including balloons and stents); commonly used drugs, such as heparin and GpIIb/IIIa antagonists, assessment and monitoring of the state of anticoagulation; intra-aortic balloon counterpulsation equipment; patient transfer to and from the laboratory; and the multitude of issues related to pre-procedure, intra-procedure and post-procedure care. The C-PORT trial has developed a formal training program for technical and nursing staff working at hospitals without angioplasty capability. At a minimum this training will include:
Catheterization laboratory technical staff, catheterization unit nurses, and step-down (CCU) unit nurses from each participating institution that currently does not perform angioplasty must attend (1) and (2) above. Participation of as many staff members from each institution is strongly encouraged. If a member of the nursing or technical staff is to serve as a "second operator" during the angioplasty procedure, that individual must undergo additional training. This training requires "hands-on" experience performing elective angioplasty at a tertiary center under the supervision of the local principal investigator from his or her institution or his designee. Competence to perform as second operator in primary angioplasty will be determined by the training physician. As a guideline, we suggest participation in at least 25 elective angioplasty procedures before assisting in a primary angioplasty procedure. Completion of training procedures does not constitute certification of competency by any individual, institution or the C-PORT study staff of any individuals completing that training. Training means only that certain material has been reviewed and does not attest to the competency or experience of any individual undergoing that training. Care Plan Development: An important factor in the successful development of primary angioplasty capability in a hospital which does not currently perform angioplasty involves nursing care. Familiarity with the course of the angioplasty procedure itself, the devices, including stents, and drugs, including GpIIb/IIIa antagonists, utilized, anticoagulation regimens and their management, potential procedure-related complications, sheaths and intraaortic balloon pumps, closure devices, and all the many pre-procedure, intra-procedure and post-procedure care issues is critically important to successful development of primary angioplasty capability. While there is no substitute for experience, the didactic and observational training required for participation should help facilitate the transition to a primary angioplasty-capable facility. Development of pre-procedure, intra-procedure and post-procedure nursing care plans and critical pathways is also important to successful management of the primary angioplasty patient. Care plans and pathways must be in place before primary angioplasty is begun. Model plans and critical pathways are reviewed at staff training sessions and are provided by C-PORT trial staff. Following the initial didactic and observational training sessions, C-PORT study staff assist community hospital technical and nursing personnel develop detailed care plans and pathways for primary angioplasty patients. Model care plans and pathways are provided by the Clinical Coordinating Center and modified by the local community hospital as appropriate for their facility. This is done through direct contact supplemented by email, telephone and fax communication over a several week period. Formal and informal discussions and meetings between study personnel (particularly the nurse coordinator) occur during this period concerning pre-angioplasty, intra-procedure and post-procedure care, sheath pulling, monitoring, and complication management, as care plans and procedures are developed at the participating institution. Subsequently, at least weekly contact is continued to answer the many questions and address the many issues that require resolution during a clinical trial. III. Logistics Detailed logistics must be individualized for each institution, taking into account methods and customs already in place. Therefore, there are no prescriptions or standardized protocols for addressing the many issues that are involved in creating a safe and effective primary angioplasty program. The goals of this logistical infrastructure are, however, common among all institutions: 1. Primary angioplasty within 90 minutes of arrival in the emergency department 2. Thrombolytic therapy within 30 minutes of arrival in the emergency department Logistics Development: A myriad of issues must be addressed to assure the prompt, appropriate and effective application of primary angioplasty or thrombolytic therapy in the treatment of AMI. The specific plans required in each participating institution are specific to that institution, although the goal remains the same. Logistical issues that need to be addressed include: hours of operation, who obtains consent, mechanisms to gather staff, mechanisms to assure availability of staff and catheterization laboratory, plans for recurrent ischemia or infarction, plans to determine the responsible physician during and after the primary angioplasty, plans for failed angioplasty, fall-back plans for primary angioplasty system failure, and many, many additional issues. These are all addressed by the C-PORT primary angioplasty development program. On-going training: After trial start-up, on-going supplementation of initial training with frequent face-to-face meetings and telephone contact with nursing and physician study personnel continues. Our experience to date suggests that at study initiation nearly daily telephone contact is required; after several weeks, contact is less frequently required but is maintained at least weekly by telephone. During the initial phase of angioplasty program and study start-up, face-to-face meeting between study personnel and community hospital nursing and technical staff is required at least every two to three weeks. Regular meetings between study personnel from the Coordinating Center and the participating facility are used to discuss identified problem areas, to resolve such problems, to provide on-going feedback regarding study progress and quality of care, and to provide on-going training in new techniques, drugs or procedures related to the treatment of patients with AMI.
IV. Quality and Error Management Quality and Error Management: An important aspect of the C-PORT primary angioplasty program development alluded to above is quality and error management. Registry data will be "fed back" to each institution on a regular basis to describe its outcomes to date and to identify areas of strength and those areas that require additional attention. Plans for addressing problem areas will be developed in collaboration with the Clinical Coordinating Center and plans for short and long-term monitoring to assess remedial efforts are made. Special emphasis is given to minimizing, discovering, reporting and correcting error in the system of acute MI care developed at participating institutions.
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