STUDY OF CORONARY REVASCULARIZATION AND THERAPEUTICS EVALUATIONS (SOCRATES)

Release Date:  July 9, 1998

REQUEST FOR INFORMATION:  NHLBI-98-RFI-01

P.T.

National Heart, Lung and Blood Institute

The National Heart, Lung and Blood Institute (NHLBI) is soliciting information
for the Study of Coronary Revascularization and Therapeutics Evaluations
(SOCRATES) to determine whether capitation rates (i.e., total cost per subject
or task as a fixed rate) can be utilized for a Clinical Coordinating Center. 
Respondents are asked to study the Statement of Work located at
http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm#rfp, decide whether capitation rates
are an appropriate mechanism for reimbursement and provide information on
projected rates should the answer be affirmative.  Below is a general description
of the study.

The SOCRATES trial will assess the benefits and risks from a strategy of early
revascularization and medical anti-ischemic strategies with respect to long term
morbidity and mortality, and the information will provide a rational basis for
safe and effective therapy for these types of patients with stable CHD.  The
SOCRATES trial will also provide scientific insight into the role of ischemia in
the long-term clinical outcome of CHD patients.  Furthermore, the results will
be evaluated for significant health care cost implications.  The trial will
address two key questions of therapeutic strategy in the management of coronary
heart disease (CHD):  first, in medical management, does anti-ischemic therapy
escalated to a maximum tolerated regimen, targeted to alleviate all of the
ischemia, confer long-term morbidity and mortality benefits beyond anti-ischemic
therapy targeted just for relief of angina; and second, have advances in medical
management of CHD, i.e., particularly aggressive lipid management, anti-
thrombotic therapy, and life style risk factor modification, changed the
threshold at which mechanical revascularization is warranted?  These questions
will be addressed in patients with stable CHD and objective evidence of ischemia
who are eligible for catheter-based revascularization (such as PTCA) or surgical
revascularization with coronary artery bypass surgery (CABG).  Functional status
and health care costs related to the above strategies will also be assessed.  The
study will enroll a total of 6,000 patients with stable coronary disease (CHD)
and other eligibility and exclusion criteria detailed below, and in whom there
is equipoise between medical therapy and revascularization (catheter-based or
surgical).  The choice between the potential revascularization approach that
might be used, PTCA or CABG, will be made by physician and patient before
randomization.  The draft protocol, including study design, entry criteria,
randomization procedures, and treatment strategies are provided at the above
referenced website.  Drug regimens for medical strategies and analyses, which
will be incorporated into the final protocol will be defined collaboratively
during the implementation phase developed by a planning committee that will
include representation from the successful offeror.  The planning committee is
already in existence and will have many remaining details established before the
contract is awarded.

The respondent should provide an estimate of reimbursement costs that they
consider appropriate for the tasks involved as well as information on  how the
reimbursement was calculated.  The proposed reimbursement schedule is as follows: 
Randomization (Entry), 3 month Follow up (includes visits 1 and 2), 6 month
Follow up, Annual Follow up, and Semiannual Follow up.

The respondent should address any potential problems or concerns with
reimbursement of costs using capitation rates.  This Request For Information
(RFI) is for information and planning purposes only and shall not be construed
as a solicitation or as an obligation on the part of the Government to issue a
Request for Proposal or award a contract.  The Government does not intend to
award a contract on the basis of responses nor otherwise pay for the preparation
of any information submitted or the Government's use of such information. 
Acknowledgment of receipt of responses will not be made, nor will respondents be
notified of the Government's evaluation of the information received.  However,
should such a requirement materialize, no basis for claims against the Government
shall arise as a result of a response to this RFI or the Government's use of such
information as either part of our evaluation process or in developing
specifications for any subsequent requirement.

INQUIRIES

Responses should be identified with NHLBI No. 98-RFI-01, and are due by July 31,
1998.  Submit three copies of your response to:

William M. Stevens
Contracts Operations Branch
National Heart, Lung and Blood Institute
6701 Rockledge Drive, Room 6118, MSC 7902
Bethesda, MD  20892-7902
Telephone:  (301) 435-0345
Email: StevensW@gwgate.nhlbi.nih.gov

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