The Commonwealth of Massachusetts

Executive Office of Health and Human Services
Department of Public Health
Bureau of Health Care Safety and Quality
99 Chauncy Street, 2nd Floor, Boston, MA 02111
617-753-8000 

DEVAL L. PATRICK
GOVERNOR
TIMOTHY P. MURRAY
LIEUTENANT GOVERNOR
JUDYANN BIGBY, MD
SECRETARY
JOHN AUERBACH
COMMISSIONER	
Circular Letter:  DHCQ 09-06-512

To: 		Chief Executive Officers
		Massachusetts Primary Stroke Service Hospitals

From: 		Paul I. Dreyer, Ph.D., Director
		
Subject:	Public Release of Aggregate Data on Primary Stroke Services 
                    and Primary Stroke Service Updates

Date:		June 29, 2009

The purpose of this letter is to inform you of the Department of Public Health’s plan for the public release of data on the performance of licensed Primary Stroke Services and to provide stroke program updates.  Enclosed is a copy of the draft narrative section of the report for your information (Attachment A).  The associated data can be accessed from a link (Primary Stroke Service Consumer Information) scheduled to be posted on the Division of Health Care Quality’s website www.mass.gov/dph/dhcq in early July.

This initial report contains aggregate information about the performance of Primary Stroke Service hospitals on a number of stroke measures, including the percentage of stroke patients receiving brain imaging within specified timeframes, and the percentage of eligible patients receiving intravenous (IV) tissue plasminogen activator (tPA).

We hope that this report reinforces for hospitals the importance of maintaining their Primary Stroke Service at the highest possible level of performance.  Our goal is to follow the July aggregate report with an updated aggregate report in September using more current data, and a hospital specific report early in 2010.

In addition to the report, we would like to take this opportunity to provide two additional updates for Primary Stroke Services.  

1.	Expansion of the Window for Treatment of Ischemic Stroke 
Current American Heart Association/American Stroke Association (AHA/ASA) Guidelines for the management of acute ischemic stroke patients recommend the administration of IV tPA within 3 hours of stroke symptom onset.  However, the AHA/ASA has recently issued a Science Advisory regarding expansion of the time window for the treatment of acute ischemic stroke with IV tPA for select patients (Attachment B).  Results of the new studies show supportive evidence of an expanded time window
between 3.0 to 4.5 hours for select patients experiencing acute stroke symptoms.  The Advisory also notes that delays in evaluation and initiation of therapy should be avoided, because the opportunity for improvement is greater with earlier treatment.  Hospitals should therefore continue to strive to treat eligible patients with IV tPA as soon as possible after symptom onset.  

Intravenous tPA is approved by the FDA for treatment up to 3 hours.  Administration of IV tPA in the expanded time frame would be considered “off-label” use.  The Department does not have the authority to recommend or prohibit the use of IV tPA within the extended time frame.  However, we wish to rescind the statement, “No ischemic stroke patient should be treated with IV tPA after 3 hours from symptom onset or ‘last seen well time’ unless the IV tPA is administered under an Institutional Review Board approved protocol” from the Department Circular Letter #04-4-440 issued in April 2004.  The new clinical guidelines supersede this guidance.  Each hospital will need to decide if and how it will expand the window for its tPA eligible patients and develop the appropriate clinical tools and processes to implement the change.

Please carefully review the attached Advisory or view it online at 
http://stroke.ahajournals.org/cgi/reprint/STROKEAHA.109.192535v1

2.	Revision of Primary Stroke Service Time Target Recommendations 
The Department has recently reviewed and revised the “Emergency Department Process Measure Assessment” guideline originally issued in Department Circular Letter #04-4-440.  The measures (time targets) were based on nationally accepted standards developed as a guideline to help hospitals assess the timeliness of activities related to stroke evaluation and diagnosis, with a goal of initiating IV tPA within one hour of the time of patient arrival in the Emergency Department.  The guideline was recently revised to prioritize the time targets into two categories (Attachment C).  As part of the hospital’s quality improvement process, data are to be collected and reviewed for the two time targets in Category I for all patients.  When Category I outliers are identified, Category II process time targets should be selectively collected and reviewed to identify barriers that may be contributing to treatment delays.  Not all targets apply to all patients.

Please note the time target related to brain imaging was revised to indicate time from door to CT versus time from order to CT.  The rationale for using arrival time relates to the feasibility for data collection and is recommended in the article “Recommendations for the Establishment of Primary Stroke Centers,” JAMA 2000; 283:3102-3109. 

We encourage you to circulate this information to appropriate medical, nursing and other personnel involved in the delivery of Primary Stroke Services.

Please contact Gail Palmeri at 617-753-8230 or email gail.palmeri@state.ma.us if you have any questions about this letter, or Phil Mello at 617-753-8182 or email phil.mello@state.ma.us regarding the content of the Primary Stroke Services Data Report.

Attachments:
(A) DPH Stroke Data Report
(B) AHA/ASA Science Advisory
(C) Time Target Recommendations