Full Text HS-96-006
 
REFERRALS FROM PRIMARY TO SPECIALTY CARE
 
NIH GUIDE, Volume 25, Number 8, March 15, 1996
 
RFA:  HS-96-006
 
P.T. 34

Keywords: 
  Health Services Delivery 
  Health Care Economics 

 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date:  May 3, 1996
Application Receipt Date:  June 12, 1996
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) invites
applications to conduct research related to patient referrals from
primary care to specialty care.  Applications are sought for studies
that (1) describe how changes in health care organization affect
referral practices, and/or (2) measure quality of care, economic and
other outcomes resulting from decisions by primary care providers
(PCPs) who refer, or do not refer, patients to specialty providers.
 
Research under this Request for Applications (RFA) should address
issues related to referrals in the ambulatory care setting.  The
AHCPR has a particular interest in studies that evaluate outcomes of
"discretionary" referrals within public sector and/or private health
care plans as well as studies focusing on provider supply and
decisionmaking by referring providers (including nonphysician PCPs).
Outcomes of interest reflect quality of care and include measures of
patient health status, well-being, and satisfaction as well as the
financial consequences of referral or non-referral.
 
For the purpose of this RFA:  A "referral" is defined as the transfer
of all or part of the responsibility for patient care; a "specialist"
is defined as a provider with recognized knowledge and skills in a
specific area of health care; and "discretionary" referrals are
defined as those associated with nonemergent conditions, for which
there is considerable variation in practice among referring providers
and/or differences in expert opinion concerning the timing or
indications for referral.
 
The goal of this solicitation is to inform the policies related to
referral within health plans and strengthen the scientific base
underlying the evolution and use of referral protocols in ambulatory
health care settings.  Applicants are encouraged to form partnerships
or consortia involving health plans that provide (1) the data and
technical capabilities to study referral patterns, and (2) access to
delivery settings in which the outcomes of referrals can be
evaluated.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Referrals from Primary to Specialty Care, addresses several of those
objectives. Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0 or Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325; telephone
202/512-1800.
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, non-profit organizations,
public or private, including universities, clinics, units of State
and local governments, non-profit firms, and non-profit foundations.
The AHCPR by statute can make grants only to non-profit
organizations; however, for-profit organizations can participate if
the application is submitted by a non-profit organization.
Racial/ethnic minorities, women, and persons with disabilities are
encouraged to apply as Principal Investigator.
 
MECHANISM OF SUPPORT
 
This RFA will use the research project grant (R01) mechanism.
Proposed projects are to be accomplished in one to two years.  The
anticipated award date is September 1, 1996.
 
FUNDS AVAILABLE
 
Dependent upon the availability of funds, AHCPR expects to award up
to $1.5 million for the first year of projects under this RFA.  The
period of funding is not to exceed two years.  The number of awards
is dependent on the number of high quality applications and their
individual budget requirements; it is not the intent of AHCPR that
the awards be equal in size.  This is a one-time solicitation.
Funding beyond the initial budget period will depend upon annual
progress reviews by AHCPR and the availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
Historically, AHCPR has supported research that examines the
availability, quality, effectiveness, and costs of health care
services.  In the current, market-driven health care system, another
major goal of research funded by AHCPR is to understand trends in the
health care marketplace and their implications for the quality of
care and access to that care.  One of the more prominent
organizational changes resulting from the rapid growth and
proliferation of managed care health plans has been the introduction
of mechanisms to restrict direct patient access to specialty care.
Such mechanisms include gatekeeping by PCPs and increased cost
sharing for those patients wishing to self-refer to specialists.
Many plans also incorporate administrative review of referral
decisions and financial incentives that discourage high referral
rates among PCPs.
 
In September 1995, AHCPR's Center for Primary Care Research (CPCR)
convened a conference, "Research at the Interface of Primary and
Specialty Care."  The conference was attended by primary care and
specialty providers, academicians, health services researchers,
representatives of managed care organizations, consumers, employers,
and other purchasers of health care.  The purposes of the conference
were to:  (1) assess the current state of research related to
consultation and referral; and (2) obtain suggestions regarding the
most important referral-related questions to be addressed by future
research.  The presentations and discussions that occurred during the
conference were carefully considered in developing this RFA.  (The
conference is briefly reviewed in JAMA 1995;274:1419.  A more
complete summary is available from Global Exchange at the address
listed under INQUIRIES.)
 
Referrals and Cost Containment Policies
 
Cost containment efforts over the past 15 years have led to more
selective use of hospital services.  Recent policies have also
targeted out-of-hospital services, especially the increasing number
of expensive, high-technology procedures available in ambulatory
settings.  A considerable body of research focusing on clinical
practice variations has identified significant variability in the
rates at which many of these procedures are performed in one
geographic region compared to another, suggesting either under or
overutilization.  These studies, however, do not clarify the extent
to which observed variations in procedure rates are due to the
practice style of specialists or to referral patterns among PCPs.
The extent to which administrative plans and reimbursement mechanisms
affect variations in procedure rates is also unclear.
 
In general, specialists have been shown to use significantly more
resources (tests, procedures, hospitalizations) than PCPs, even after
adjusting for severity of illness (Greenfield S, Nelson EC, Zubkoff
M, et al. Variations in resource utilization among medical
specialties and systems of care: results of the Medical Outcomes
Study. JAMA 1992;267:1624-30).  Since primary care is the major
source of referrals to specialists, the referral practices of PCPs in
the ambulatory setting may therefore be a critical step on the
pathway to increased intensity of care, despite the fact that such
higher-intensity care has not been consistently linked with improved
patient outcomes.
 
On the assumption that patients of PCPs who have a greater propensity
to refer to specialists generate substantially greater health
expenditures than patients of PCPs who are less likely to refer,
newer health care plans and reimbursement mechanisms are monitoring
closely the referral practices of PCPs and offering incentives to
discourage high referral rates.  Certain plans conduct referral
"profiling" of PCPs and evaluate intraprovider variation in referral
practices.  Such profiling analyses have been shown, however, to be
highly problematic in the absence of adequate measures of case-mix or
standard units of analysis (Salem- Schatz S, Moore G, Rucker M,
Pearson SD.  The case for case-mix adjustment in practice profiling.
JAMA 1994;272:871-4).
 
Delayed Referrals
 
While excessive referrals may result in extra costs as well as
exposure of patients to needless invasive and risky procedures,
delayed referral or non-referral may also result in adverse outcomes,
including delayed or missed diagnosis, delayed treatment, and the
eventual need for more expensive interventions.  The quality of care
provided certain populations, such as patients insured through
Medicaid/Medicare, disabled persons, and children with special needs,
may be particularly vulnerable to policies that restrict referral.
Research is needed that compares the outcomes of referred care to
care for the same condition provided within the primary care setting.
Also needed are studies to elucidate the effect of the timing of
referral for specified conditions on overall costs and patient
outcomes.
 
Provider Role Ambiguity
 
A major limitation of much of the referrals research to date is the
considerable overlap and ambiguity in the roles and responsibilities
of PCPs and specialists in the United States.  In the absence of
clearly defined boundaries, specialists have traditionally provided a
substantial amount of primary care, and the profile of primary care
practice has been shown to vary widely.  Many of the newer health
care plans require that providers in the plan assume the role of
either primary care or specialist provider, and feature separate
reimbursement mechanisms for each type of provider.  Certain
specialty groups have responded by asserting that they are better
suited than PCPs to provide "principal care" for patients affected by
diseases within their area of specialty.  Few studies however have
yet compared the quality and costs of "principal care" provided by
specialists to care for comparable patients treated routinely in the
primary care setting.
 
Limited data exist on the relative expenditures incurred with
referral to one type of specialist to another for the same condition
(e.g., referral to a chiropractor vs neurologist vs orthopedist or
other provider for low back pain); and whether the propensity to
refer is related to PCP characteristics (e.g., knowledge, skills,
training), patient characteristics (e.g., attitudes, preferences,
socioeconomic status), financial incentives for patient or provider,
or the specific condition itself.  The referral activities of
advanced practice nurses and physician assistants need further
attention.  Of interest are studies that help define how these
practitioners can best interact with physicians when more specialized
services are required.  Studies of the unique referral issues for
children, whose utilization of specialists is likely to be quite
different from adults, based on disease epidemiology and availability
of pediatric specialists, are particularly encouraged.
 
Variability in Referral Practices
 
Research from as early as the 1970s indicates that rates of referral
and consultation vary widely among PCPs, suggesting a high level of
provider uncertainty about appropriate referral practices, at least
for some patient conditions (Calman NS, Hyman RB, Licht W.
Variability in consultation rates and practitioner level of
diagnostic certainty. J Fam Pract 1992;35:31-8).  Those conditions
associated with the greatest variation in referrals to specialists
have yet to be identified.  However, certain PCP observers contend
that there is a set of conditions for which referral to a specialist
is likely to be considered "discretionary" by the PCP.  (Chao J,
Galazka S, Stange K, Fedirko T. A prospective review system of
nonurgent consultation requests in a family medicine residency
practice. Family Med 1993;25:570-5). These are non-urgent conditions
for which there is a lack of consensus among experts on the
appropriate timing or indications for referral to a specialist.  It
is reasoned that financial or other incentives discouraging referrals
by PCPs have the most restrictive impact on these "discretionary"
referrals as opposed to referrals for emergent or life-saving
treatment beyond the usual range of primary care practice.  Further
research is needed to clarify whether such incentives decrease access
to beneficial services.
 
Referral Guidelines
 
Guidelines or protocols to help direct and coordinate the referral
process and possibly reduce variations in referral practices have
been developed for use in some health plans. Such protocols may
greatly influence the planning of services and possible collaboration
between PCPs and specialists within health care systems.  Currently,
however, science-based data to support the practices recommended in
these protocols are lacking.  Referral guidelines are also a major
component of the "disease management" programs evolving within
managed care plans, in which a systems approach is taken to
developing provider networks for targeted diseases of high incidence
and high cost.  The implications of disease management programs for
both clinical and economic outcomes have yet to be studied in a
scientific manner.  How best to interpret and incorporate into
referral decisions or referral guideline development the perceptions,
preferences and concerns of patients who require both primary and
specialty care and/or have multiple chronic problems is also unclear.
 
Scope and Methodological Considerations
 
The effect of specific referral practices on the health status of
patients may be difficult to measure directly and may require
long-term studies.  Given the urgent need for scientific data to
inform evolving referral policies and practices, a focus on
short-term or intermediate health outcomes, as well as economic
outcomes, is appropriate for projects under this RFA.  It is expected
that studies comparing various referral practices will examine
outcomes of care for well-defined diseases or conditions, although
more global measures of outcomes may also provide useful information.
 
Since the intended effect of most cost containment policies is to
restrict referrals, this RFA addresses the implications of such
policies for the quality of care delivered.  However, the
identification of patients with conditions that could have been
referred to a specialist but were not is a particularly challenging
methodological problem.  Investigators are encouraged to consider
innovative means of identifying "non-referrals" within their study
populations and assessing the costs and outcomes of decisions to
manage specific problems within primary care.
 
Overall, about 4.5 percent of patient contacts with PCPs result in
referral to a specialist.  To assure generalizable results, studies
involving primary data collection may therefore need to be quite
large.  The use of secondary data bases, especially data collected
within both public sector and private managed care health systems, is
encouraged. Given the relative infrequency of referrals in medical
practice, very large data sets will be needed.
 
In light of considerable ambiguity in provider roles and the
possibility of significant regional variations in provider
reimbursement arrangements, smaller studies of referrals and those
designed to gather qualitative data about referral practices need to
make explicit the organizational models of both primary and specialty
care.  Such studies should describe the operational features of those
models within their study population as well as describe in detail
the process PCPs use to direct and coordinate the care of their
patients.
 
A broad array of research questions is relevant to referral
practices.  The following questions are AHCPR priorities because of
their relevance to emerging policy issues related to referral within
health care plans:
 
o  For which conditions (or diagnoses) is there significant
variability in referral practices among PCPs?  To what extent do
different care financing mechanisms affect this variability?
 
o  What are the quality of care, cost, and other implications of
decisions by PCPs (including nonphysician PCPs) to refer or not refer
patients with specific conditions?
 
o  What are the quality of care, cost, and other implications of
referring or not referring at defined points of time in the disease
process?
 
o  What are the quality of care, cost and other implications of
"disease management" programs, when compared to care for the same
diseases delivered in a traditional PCP setting?
 
o  How is the quality of care provided to defined segments of the
population (e.g., children with special health care needs, disabled
persons) affected by policies that restrict referrals?  How do
private sector health plans coordinate the care of patients with
special health care needs for which public sector care management
programs exist?
 
o  What are the most valid, reliable ways of "profiling" a PCP's
pattern of referral?  If so, what are the quality of care, cost, and
other implications of different referral profiles?
 
o  How do changes in the supply and configuration of providers
(including nonphysician providers) within a defined health care
system affect referral practices?
 
SPECIAL REQUIREMENTS
 
Confidentiality of Data
 
Information obtained in the course of this study that identifies an
individual or entity must be treated as confidential in accordance
with section 903(c) of the Public Health Service Act.  Applicants
must describe in the Human Subjects section of the application
procedures for ensuring the confidentiality of identifying
information.
 
Rights in Data
 
The AHCPR grantees may copyright or seek patents, as appropriate, for
final and interim products and materials including, but not limited
to, methodological tools and measures, software with documentation,
literature searches, and analyses that are developed in whole or in
part with AHCPR funds.  Such copyrights and patents are subject to a
Federal government license to use these products and materials for
AHCPR purposes.  The AHCPR purposes may include, subject to statutory
confidentiality protections, making research materials, data bases,
and algorithms available for verification or replication by other
researchers; and subject to AHCPR budget constraints, final products
may be made available to the health care community and the public by
AHCPR, or its agents, if such distribution would significantly
increase access to a product and thereby produce public health
benefits.  Ordinarily, to accomplish distribution, AHCPR publishes
research findings but relies on grantee efforts to market
grant-supported products.  In keeping with AHCPR legislative mandates
to make both research results and data available, copies of all
products and materials developed under a grant supported in whole or
in part by AHCPR funds are to be made available to AHCPR promptly and
without restriction, upon request by AHCPR.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS
INVOLVING HUMAN SUBJECTS
 
It is the policy of AHCPR that women and members of minority groups
be included in all AHCPR supported research projects involving human
subjects, unless a clear and compelling rationale and justification
are provided that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research.
 
The NIH policy resulting from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43) supersedes and strengthens NIH's
previous policies (Concerning the Inclusion of Women in Study
Populations, and Concerning the Inclusion of Minorities in Study
Populations), which were in effect since 1990 and which AHCPR had
adopted.  The new NIH policy contains provisions that are
substantially different from the 1990 policies.  All investigators
proposing research involving human subjects should read the "NIH
Guidelines on the Inclusion of Women and Minorities as Subjects in
Clinical Research," which has been published in the FEDERAL REGISTER
of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.
AHCPR follows the revised NIH Guidelines, as applicable.
 
Investigators may obtain copies from those sources or from the AHCPR
contractor, Global Exchange, listed under INQUIRIES.  AHCPR program
staff may also provide information concerning this policy (See
INQUIRIES).
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by May 3, 1996, a letter
of intent that includes the names, addresses, and telephone numbers,
of the proposed Principal Investigator and other key personnel; and
the number and title of this RFA.  Although a letter of intent is not
required, is not binding, and does not enter into the consideration
of any subsequent application, the information allows AHCPR staff to
estimate the potential review workload and avoid conflicts of
interest in the review.  AHCPR will not provide responses to letters
of intent.
 
Letters of intent are to be addressed to:
 
David Lanier, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
Email:  dlanier@po3.ahcpr.gov
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  State and local government applicants
may use form PHS-5161-1, Application for Federal Assistance (rev.
9/92), and follow those requirements for copy submission.
Application Kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Extramural
Outreach and Information Resources, Office of Extramural Research,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/435-0714, email:
girg@drgpo.drg.nih.gov.
 
For further information, AHCPR applicants are encouraged to obtain
application materials from the AHCPR contractor: Global Exchange,
Inc.  (SEE INQUIRIES)
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the original
application.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review.  In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and
the YES box must be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and four signed photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by June 12, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.
 
One additional copy, labeled "Advance Copy," must be submitted
simultaneously to:
 
David Lanier, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
 
REVIEW CONSIDERATIONS
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with AHCPR peer review
procedures.  As part of the merit review, all applications will
receive a written critique, and also may undergo a process in which
only those applications deemed to have the highest scientific merit
will be discussed and assigned a priority score.  Recommendations of
the peer review committee may be reviewed subsequently by AHCPR's
National Advisory Council.
 
Review Criteria
 
Review criteria for AHCPR grant applications are: significance and
originality from a scientific and technical viewpoint; adequacy of
the method(s); availability of data or proposed plan to collect data
required for the project; qualifications and experience of the
Principal Investigator and proposed staff; adequacy of the plan for
organizing and carrying out the project; reasonableness of the
proposed budget; and adequacy of the facilities and resources
available to the applicant.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other
applications under this RFA.  The following will be considered in
making the funding decisions:  quality of the proposed project as
determined by peer review, program balance, and availability of
funds.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
Copies of this RFA and related background conference summary are
available from:
 
Global Exchange Inc.
7910 Woodmont Avenue, Suite 400
Bethesda, MD  20814-3015
Telephone:  (301) 656-3100
FAX:  (301) 652-5264
 
Copies of the RFA and the background conference summary document
(AHCPR Pub. No. 96-0034) can also be requested through AHCPR
InstantFAX at (301) 594-2800.  To use InstantFAX, you must call from
a facsimile (FAX) machine with a telephone handset.  Use the key pad
on the receiver when responding to prompts from InstantFAX.  The RFA
will be sent at the end of the ordering process.  AHCPR InstantFAX
operates 24 hours a day, 7 days a week.  For questions about this
service, call AHCPR's Division of Communications at 301/594-1364 ext.
159.
 
Direct inquiries regarding programmatic issues, including information
on the policy of inclusion of women and minorities in study
populations, to:
 
David Lanier, M.D.
Center for Primary Care Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 502
Rockville, MD  20852-4908
Telephone:  (301) 594-1357
Email:  dlanier@po3.ahcpr.gov
 
Direct inquiries regarding fiscal matters to:
 
Carol Roache
Grants Management Staff
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
Telephone:  (301) 594-1447
FAX:  (301) 594-3210
Email:  croache@po7.ahcpr.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Number 93.226.  Awards are made under authorization of
Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6).
Awards are administered under the PHS Grants Policy Statement and
Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, The Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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