Recommendations for Improving the Quality of Care Through Stroke Centers and Systems: An Examination of Stroke Center Identification Options
Multidisciplinary Consensus Recommendations from the Advisory Working Group on Stroke Center Identification Options of the American Stroke Association
The American Stroke Association (ASA) assembled a multidisciplinary group of experts to develop recommendations regarding the potential effectiveness of establishing an identification program for stroke centers or stroke systems. In February 2001, ASA, with the support of the Stroke Council’s Executive Committee, began evaluating the potential impact of stroke center identification. The term “identification” refers to the full spectrum of models for assessing and recognizing a standard of quality care provided to patients by centers or systems, including self-assessment, verification, certification, and accreditation programs.
ASA selected HealthPolicy R&D1 to prepare a comprehensive report on the desirability, feasibility, and potential effectiveness of establishing a stroke center identification program with a primary focus on whether and how any form of stroke center identification might improve patient access to quality care and patient outcomes. The primary goal of this initial report was to assist ASA in developing a position on stroke center identification.
Following an October 2001 presentation of this report’s findings, the Advisory Working Group on Stroke Center Identification developed consensus recommendations. This advisory group included recognized experts in neurology, emergency medicine, emergency medical services, neurological surgery, neurointensive care, vascular disease, and stroke program planning.
This effort is particularly timely in light of (1) the Brain Attack Coalition’s (BAC) recommendations for primary stroke centers and other activities; (2) ASA’s new strategic alliance with federal agencies2; (3) recent efforts by federal and state legislators to enhance the quality of stroke care; (4) the success of ASA’s Operation Stroke program and other initiatives; and (5) the efforts of accreditation organizations to develop new programs in the area of stroke.
This summary of findings and recommendations of the Advisory Working Group on Stroke Center Identification consists of 3 parts. The first part, Models and Programs: Characteristics and Experiences, examines existing identification models and 10 existing programs. The models represent a continuum of options relating to the scope and intensity of program review and the consumption of resources.
The second part, Framework for Analysis, includes (1) an examination of the effectiveness of existing nonstroke identification programs; (2) guidance gleaned from interviews with thought leaders in the stroke community; (3) a review of ongoing and evolving initiatives in stroke care; (4) a review of state and federal legislative initiatives involving stroke; and (5) an initial analysis of financial considerations and resource implications.
In the final part, a series of 5 options and conclusions, including the consensus statement of ASA’s Advisory Working Group on Stroke Center Identification, is presented.
B. Models and Programs: Characteristics and Experiences
HealthPolicy R&D examined a broad range of identification programs and program types, including those that focus on single disease states, acute care, chronic care, preventive care, individual providers, comprehensive hospital review, and comprehensive system review. Key features and experiences of these existing programs offer perspectives of relevance to stroke. Nonetheless, important distinctions exist between the challenges facing existing identification programs and those challenges facing the stroke community.
I. Four Models of Identification fall along a continuum with respect to factors such as the intensity and scope of review and the consumption of resources.
Self-Assessment—This model includes a self-evaluation by the entity or individual undergoing review that may or may not be facilitated by consultation with the organization sponsoring the review program. This model is the least formal and least expensive. Self-assessment may be viewed as an initial step toward a more formal and comprehensive program.
Verification—The verification model consists of verification by an external organization for compliance with applicable guidelines, which typically are established by the verifying body. Verification may be based on review of information from some combination of certified statements, medical records, routine site visits, and random audits.
Certification—In general, this process is more formal and intensive than verification. Certified providers and organizations typically receive an award of “certified” status that remains valid for a period of time and permission to display a logo as a “seal of approval.” There may be an appeals process for organizations denied certification.
Accreditation—Accreditation is typically the most formal, intensive, and expensive of the identification models. These programs often involve review of more than one area of specialization, such as review of an entire hospital. Successful application under some accreditation programs results in “deemed” status by Medicare or other public health programs.
II. Existing Identification Programs span a wide range of organizational structures, definitions, and experiences. HealthPolicy R&D selected 10 existing identification programs to highlight characteristics with potential applicability to the stroke community. These programs fall along the continuum of models discussed above.
Health Care Quality Improvement Program (Self-Assessment): Medicare peer review organizations (PROs) monitor the efficiency, quality, and utilization rates of services provided to Medicare beneficiaries. In 1992, the PROs initiated the Health Care Quality Improvement Program, which focuses on 6 clinical areas, including stroke. Quality indicators to measure performance for stroke patients currently include whether patients with atrial fibrillation receive warfarin on discharge, whether ischemic stroke patients are prescribed antithrombotics at discharge, and whether sublingual nifedipine is avoided during acute stroke. ASA currently collaborates closely with many of the PROs. As a result of these efforts, for example, discussions are underway with the PRO in Florida potentially to adopt parameters and procedures from AHA’s Get with the Guidelines program.
Practice Statements and Technology Assessments (Self-Assessment): AHA and ASA develop statements and guidelines for providers’ self-assessment. The American Academy of Neurology also publishes a series of practice statements and technology assessments, which are available to members for self-assessment and to improve quality of care.
Trauma System Program (Verification): The American College of Surgeons (ACS) established initial guidelines in 1976 for the development, operation, and identification of trauma centers and later, trauma systems. ACS consults with individual trauma centers to assist with efforts to meet its guidelines. ACS also verifies trauma capabilities and, in some instances, designates trauma centers and systems on request. The ACS guidelines identify 4 levels of trauma centers based on the volume of trauma patients and the level of resources available. Depending on the trauma center level, the various standards are considered “essential,” “desired,” or “not expected.” Although the trauma center remains a key element of the ACS approach, ACS emphasizes a comprehensive system of care.
Research Funding Programs (Verification): The National Cancer Institute’s Cancer Center program qualifies hospitals and research centers for federal grants. Cancer centers are selected through a competitive process using peer review assessment of the written application and a site visit.
Disease Management Programs (Certification): The Joint Committee on the Accreditation of Healthcare Organizations (JCAHO) and the National Committee on Quality Assurance (NCQA) have publicly announced their intentions to implement separate disease management programs for several chronic illnesses in 2002. Development of disease management certification programs for stroke is under active consideration by both organizations.
Provider Recognition Programs (Certification): The American Diabetes Association’s (ADA) Provider Recognition Program is a voluntary certification program for individual physicians or groups who provide care to patients with diabetes. The ADA examines information about the practices, medical record abstracts, and administrative systems data submitted by applicants based on 9 evidence-based performance criteria developed in collaboration with NCQA.
Centers of Excellence (Certification): The US Department of Health and Human Services is conducting a demonstration project to evaluate the effect of treatment volume on quality of care and mortality rates for coronary artery bypass surgery. The demonstration project now includes cardiac valve procedures, angioplasty, diagnostic catheterizations, and knee and hip replacements. Applicants for centers of excellence status are selected based on evidence of high quality of care and patient satisfaction, as well as on efficiency and cost-effectiveness.
NCQA Accreditation Activities (Accreditation): The NCQA accredits managed care organizations on the basis of more than 50 standards in 5 areas: access and service, qualified providers, staying healthy, getting better, and living with illness. These assessments now include the use of a standard performance measurement set, NCQA’s Health Plan Employer Data and Information Set (HEDIS).
JCAHO Hospital Activities (Accreditation): The JCAHO evaluates and accredits health care programs and providers. JCAHO accreditation, while voluntary, can result in federal deemed status for the purposes of receiving reimbursement under Medicare. Performance is evaluated in a number of functional areas, resulting in awards of 1 of 7 accreditation levels. With the launch of ORYX in 1997, these assessments include a standardized system for measuring performance and patient outcomes.
Radiology and Laboratory Programs (Accreditation): The American College of Radiology (ACR) serves as the primary accreditation body for implementation of the 1992 Mammography Quality and Standards Act, which requires that all mammography facilities be accredited by an FDA-approved body. Facilities seeking accreditation must show compliance with standards in a number of areas pertaining to facility operation. Other organizations provide accreditation for laboratories. For example, the Intersocietal Accreditation Commission assesses the quality of medical laboratories in 4 areas: vascular, echocardiography, nuclear medicine, and magnetic resonance laboratories. The accreditation process includes a detailed self-evaluation on various aspects of laboratory operation and random site visits.
III. Observations—these identification programs demonstrate several common features.
Increasing Use of Evidence-Based Measures and Continuous Quality Improvement. These efforts include the PROs’ Health Care Quality Improvement Project, the ADA’s Diabetes Quality Improvement Project, NCQA’s HEDIS program, and JCAHO’s ORYX program.
Disease Management Programs for Stroke Are Evolving. Both NCQA and JCAHO staff report the possible development of new stroke initiatives in 2002.
Most Approved Identification Applicants Receive Benefits. These include recruiting and marketing advantages.
Few Restrictions Are Placed on the Number of Applicants. An open application process encourages the delivery of quality care in as many venues as possible.
Various Levels of Identification Provide Flexibility. This practice may permit and encourage all providers to meet at least a minimum standard of care. In some instances, this flexibility permits the identification program to send clear signals about the need for specific change without withholding full identification status entirely, such as accreditation.
Automated Procedures Are Instrumental. Identification programs increasingly use automated procedures to assist and evaluate applicants.
C. Framework for Analysis
In analyzing whether or how to develop and implement an identification program for stroke, relevant considerations include the potential clinical impacts of such programs, the receptivity and opinions of the stroke community and the general public, the ongoing stroke initiatives, the political environment, and financial issues.
I. The Effectiveness of Existing Identification Programs: The largest body of literature on existing identification programs involves the trauma center system and the ACS’s program. According to a review of the literature, most studies find a 15% to 20% reduction in mortality.3 Surprisingly, other well-established programs have few clinical data on the impact of such efforts on patient outcomes.
Individual Trauma Centers: At least 2 studies indicate that the use of trauma center techniques can improve the trauma-related mortality rates for individual hospitals.4 For 1 level II trauma center, investigators reported reductions in preventable motor vehicle deaths from 42% to 14%, surgeon response time from 31 minutes to 11 minutes, and time between arrival to initiation of surgical intervention from 3.6 hours to 1.9 hours. Another study found improvements in mortality rates following establishment of a dedicated trauma program. In that study, the hospital appointed a full-time trauma director, dedicated a trauma and critical care division, provided 6 full-time trauma faculty, and made in-house surgical faculty available 24 hours a day.5
Trauma Systems and Regions: In 11 studies on whether trauma systems improve patient outcomes, all but 1 study demonstrated improved mortality rates with the implementation of trauma systems.6–15 Various investigators attributed significant positive changes in mortality rates to improved EMS procedures, integration between prehospital and early hospital care, and improved surgical staffing and response times.
Trauma Centers versus Non-Identified Centers: In another series of studies, investigators concluded that trauma centers demonstrate better patient outcomes than non-identified centers.16–20
Additional Studies: Studies conducted in other health areas generally support the positive impact of identification programs. For example, investigators used surveys to examine the impact of mammography facility accreditation by the ACR. Investigators found that certified systems provide care for a higher volume of patients (greater volume is associated with higher quality), use greater use of quality assurance procedures, and demonstrate improvements in other parameters associated with quality care.21
II. Leadership Interviews—Guidance from the Stroke Community
HealthPolicy R&D conducted interviews with selected thought leaders in the stroke community. These leaders shared their opinions and experiences regarding 2 primary issues: (1) ongoing initiatives to improve stroke care; and (2) potential new efforts to pursue stroke center identification. For consistency, the same HealthPolicy R&D senior investigator interviewed all survey participants and used a standardized survey instrument.
A summary of consistent messages and findings follows:
Primary Goal: The primary goal of the stroke community is to significantly reduce the mortality and morbidity resulting from stroke.
Barriers to Care: Significantly reducing the mortality and morbidity resulting from stroke is difficult because barriers to optimizing care are numerous and multifactorial and, in some cases not well understood. Strategies necessary to overcome these barriers are evolving.
Partnering: Collaboration, cooperation, and partnering of stakeholders are critical to improving care for stroke patients. Implementation, if any, should be incremental and phased in based on cooperation among stakeholders.
Benefits versus Drawbacks: The benefits of stroke center identification outweigh the potential drawbacks. There is value in establishing some form of identification program for stroke.
Systems versus Centers: The distinction between identification of “stroke systems” and “stroke centers” should be explored.
Patient Care and Outcomes: A stroke center identification program should be designed to improve and measure patient care and outcomes.
Primary Stroke Centers: The BAC’s recommendations for primary stroke centers provide a critical foundation for stroke center identification.
Voluntary Participation: A stroke center identification program should be voluntary, not mandatory. Any model adopted should be flexible to respond to evolving treatments and standards of care.
Role for Government: State and federal governments should play a minimal role in identification.
Political, Logistical, and Financial Difficulties: Stroke center identification will pose political, logistical, and financial difficulties. Resistance should be expected from some providers. Relationships with organizations experienced in identification and quality improvement programs should be explored to aid the development of an identification program (PROs, NCQA, or JCAHO).
Administration of a New Program: A number of different organizations, including ASA, might be appropriate to administer a stroke center identification program.
Leadership and Resources: ASA could effectively lead a new programmatic effort regarding stroke center identification. If ASA chooses to implement a stroke center identification program, resources will be needed. The impact of a new identification program on other AHA and ASA programs should be considered, particularly as it relates to achieving AHA’s impact goal of achieving a 25% reduction in coronary heart disease, stroke, and risk by 2010.
III. Ongoing Initiatives in Stroke
A number of ongoing initiatives in stroke represent significant progress toward improving the quality of care for stroke patients. Viewed in the aggregate, these efforts represent many of the component parts necessary to build a basic stroke center identification program.
Operation Stroke: ASA launched the Operation Stroke program in 1997 as a system-based approach to improve the “stroke chain of survival.” Eighty-seven metropolitan areas across the nation have implemented Operation Stroke, representing approximately two-thirds of the US hospital population. Educational campaigns target healthcare providers, EMS personnel, and community residents. Since publication of the BAC’s recommendations for primary stroke centers, Operation Stroke has included specific efforts and materials to assist hospitals in following the recommendations. In August 2000, St. Louis-area hospitals experimented with a local initiative to add a verification component to the Operation Stroke program. Evaluators conducted site visits and awarded plaques to hospitals meeting the recommendations. In the grant proposals for the pilot stage of the Coverdell National Stroke Registry, an important step in collecting better data on stroke care, the majority of grant recipients referenced Operation Stroke as a component of their implementation strategy.
BAC Initiatives: The BAC published recommendations for primary stroke centers in June 2000.22 The recommendations for primary stroke centers include (1) forming an acute stroke team; (2) using written care protocols; (3) training EMS personnel and integration of EMS systems with stroke centers; (4) improving emergency department capabilities to handle stroke patients; (5) establishing a stroke unit; (6) providing neurosurgical services, if needed; (7) obtaining commitment and support from the medical organization; (8) providing necessary neuroimaging services; (9) providing necessary laboratory services; (10) collecting and tracking data regarding stroke care outcomes and quality improvement; and (11) educating stroke center staff about cerebrovascular disease. A recent survey of stroke community attitudes toward the recommendations suggests significant familiarity with the recommendations—but only minimal progress in implementation.
NSA Stroke Center Network: The National Stroke Association (NSA) created the Stroke Center Network (SCN) in 1998. The SCN is a forum for health care facilities to provide better community outreach, prevention services, and quality care by refining the way stroke patients move through the treatment and recovery pathways. There are approximately 135 hospitals participating in the SCN program, suggesting that only a small proportion of US hospital patients are covered by hospitals participating in this program.
Get with the Guidelines: AHA conducted a pilot test of Get with the Guidelines in 2000 and 2001, launching the program formally in August 2001. The program is designed to establish voluntary standards that help cardiovascular patients avoid recurrent attacks. Get with the Guidelines— CAD targets hospital teams to encourage the use of care maps, discharge protocols, standing orders, and continuous data measurement. AHA is working to implement 2 levels of recognition for hospitals that successfully implement Get with the Guidelines. Higher level recognition will require data collection and proof of compliance in at least 85% of patients with 5 key performance criteria (smoking cessation counseling, aspirin on discharge, beta-blocker on discharge, ACE-inhibitor on discharge, and lipid lowering therapy on discharge). Data will be reviewed by AHA. ASA is working to implement 2 levels of verification and recognition for hospitals that successfully implement Get with the Guidelines—Stroke, currently in the pilot phase.
Coverdell National Acute Stroke Registry: This new federal program is designing and pilot testing real-time data and analysis prototypes in statewide samples that will measure the delivery of care to patients with acute stroke. This project takes a system approach to the extent that comprehensive data will be collected from the onset of signs and symptoms through referral to rehabilitation. The pilot programs are beginning in 4 states, and the initial Coverdell data collection efforts in Massachusetts will coincide with the pilot there of ASA’s Get with the Guidelines—Stroke project.
Recent Study on Performance Measures: A recent study identified performance measures to evaluate stroke quality of care and outcomes in acute settings, using characteristics such as validity, feasibility, plausibility ratings, and impact on outcomes.23 The most highly rated and agreed-on performance measures included stroke units, warfarin for atrial fibrillation, antithrombotics on hospital discharge, and carotid imaging in appropriate patients.
IV. Trends and Activities of Federal and State Government
Legislative developments over the past year reflect an increasing federal and state interest in stroke and stroke-related issues. US Senators Edward Kennedy (D-Mass) and Bill Frist, MD (R-Tenn) introduced the STOP Stroke Act in August 2001 (S. 1274). In December 2001, US Representatives Lois Capps (D-Calif) and Chip Pickering (R-Miss) introduced the House version of the STOP Stroke Act.
The STOP Stroke Act would establish a prevention and education campaign, a clearinghouse to assist states in implementing stroke care systems, a grant system for states to develop and implement stroke care systems, medical education funding, and stroke research programs. States have the option to identify primary, comprehensive, and rehabilitation stroke centers. The legislation would also further the Paul Coverdell National Stroke Registry to collect data on stroke.
In addition, legislators in at least 24 states have introduced stroke legislation during the current legislative sessions. These efforts include legislation to create stroke registries, establish stroke awareness months or days, and create stroke “task forces.”
V. Financial and Resource Considerations
There are few data in the health literature on the overall costs of various identification programs, and publicly available tax statements do not provide sufficient detail. The identifying organizations that HealthPolicy R&D interviewed consider much of this information proprietary. Nonetheless, the following general observations are relevant:
Staff: A number of existing programs have relatively few permanent staff, often relying on significant pools of independent contractors or temporary employees to serve as surveyors.
Fees: The fees charged to applicants may not cover the full costs of administering certain programs.
Liability: Although HealthPolicy R&D did not conduct a legal analysis, managers of the identification programs expressed few, if any, concerns with liability. Most individuals expressed confidence in their liability insurance.
Patient Outcomes: The growing trend toward evaluating outcomes data in the context of identification programs may add additional costs to the operation of identification programs, especially for entities lacking the infrastructure to manipulate such information efficiently.
D. Options and Conclusions
I. Comparison of Options
A series of options with respect to stroke center identification were presented at the October 2001 meeting of ASA’s Advisory Working Group on Stroke Center Identification. These options are not mutually exclusive. Some options could be pursued on parallel tracks while others might provide 1 or more incremental steps in the evolution to a more mature identification program.
Continue ASA’s Ongoing Programs and Initiatives but Do Not Develop a Stroke Center Identification Program: This option would allow ASA to focus on other priority issues but may not result in the development of a quality stroke center identification program. ASA may lose the ability to ensure the integrity of the clinical science underlying standards developed without the leadership of ASA’s volunteers.
Allow Another Organization to Develop a Stroke Center Identification Program: While this option may result in the implementation of a stroke center identification program, it may also hinder ASA’s ability to shape future clinical standards if another organization’s identification program is widely adopted.
Consult With Existing Credentialing or Accreditation Programs as They Develop Stroke Center Identification Programs: As organizations such as JCAHO and NCQA develop stroke center identification and related products, ASA could proactively influence the development of these programs.
Collaborate With Another Organization to Design, Implement, and Administer a Stroke Center Identification Program: This option offers the ability to more formally collaborate with another organization that may have expertise in the area of identification, or alternatively, to partner with another professional health organization to jointly develop and possibly administer a stroke center identification program. Multiple considerations are required to define the relationship between ASA and another organization.
Design and Implement an Independent Stroke Center Identification Program: While designing and implementing a stroke center identification program may allow ASA to ensure the quality of the program and maintain a leadership role in this area, the process may potentially be complicated, expensive, and accompanied by risks, such as liability.
In considering an organizational position on stroke center identification, it may be useful to review this report in light of 3 fundamental questions:
What organizational position is best for the stroke patient?
What organizational position best advances science in the area of stroke?
What organizational position is best for AHA and ASA as an organization dedicated to achieving a 25% reduction in coronary heart disease, stroke, and risk by 2010?
Each question represents a critical component of the foundation on which ASA was built. The challenge is to reach a balanced and reasoned organizational position on stroke center identification that achieves the maximum benefit for each of the stakeholders above: the patient, the science, and AHA’s and ASA’s overarching objectives.
Consensus Statement of the Advisory Working Group on Stroke Center Identification, October 17, 2001
Identification of stroke center/systems competencies is in the best interest of stroke patients in the United States, and ASA should support the development and implementation of such processes. The purpose of a stroke center/systems identification program is to increase the capacity for all hospitals to treat stroke patients according to standards of care, recognizing that levels of involvement will vary according to the resources of hospitals and systems. Because of ASA’s ability to leverage the existing infrastructure of Operation Stroke, its Get with the Guidelines program, and more than 2000 local AHA offices, ASA is optimally positioned as the leader in these efforts.
The following principles should guide ASA’s participation in these efforts:
AHA’s science base should be the core of an identification program.
The stroke center/systems identification effort is only 1 component of a complete disease management program using tools of ASA.
The identification process should include monitoring of clinical outcomes and procedures to verify the resources, infrastructure and operations devoted to stroke (eg, as reflected in the BAC’s consensus statement).
ASA should seek to collaborate with an experienced organization or organizations to administer an identification program, with ASA providing scientific content and tools for hospitals and systems to meet criteria set for identification.
ASA should solicit input and involvement of the BAC and hospital groups to facilitate implementation and dissemination of information of an identification program.
This Advisory Working Group on Stroke Center Identification encourages ASA to move forward rapidly in these endeavors in an attempt to improve care for stroke patients in the United States.
- Received November 27, 2001.
HealthPolicy R&D, a policy and research firm affiliated with Powell, Goldstein, Frazer & Murphy, LLP. Washington, DC. www.pgfm.com; www.hprd.net.
ASA, CDC, NHLBI, NINDS, and the Office of Disease Prevention and Health Promotion and the Office of the Surgeon General. Healthy People 2010 Strategic Partnership Memorandum of Understanding. Bethesda, Md; 2001. www.nhlbi.nih.gov/new/press/01-02-01.htm.
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