PRIMARY CARE AND HEALTH CARE REFORM

NIH GUIDE, Volume 22, Number 10, March 12, 1993



PA NUMBER:  PA-93-063



P.T. 34



Keywords:

  Health Care Administration 

  Health Services Delivery 



Agency for Health Care Policy and Research



PURPOSE



The Agency for Health Care Policy and Research (AHCPR) supports and

conducts research, demonstration projects, and evaluations of health

care services and systems delivering such services.  The AHCPR

believes the current national policy interest in health care reform

provides an important opportunity to enhance the understanding of the

relationships between primary care and health care costs, access, and

quality.  This program announcement (PA) emphasizes a need for short

term research (producing results within one to three years) to assess

ways in which primary care services can contribute to health care

reform.



A major AHCPR responsibility is support for research that focusses on

problems of immediate concern to policy makers at the Federal and

State levels.  Consistent with this charge, the AHCPR encourages

research addressing questions raised in formulating policy changes to

deal with significant problems in the health care sector, and

specifically through this PA, in the primary care field.



To generate the required analytical effort on primary care in health

care reform, the AHCPR encourages investigators to use strategies

that avoid primary data collection efforts, and focus instead on

designs and methods that produce results quickly, such as the use of

existing data, microsimulations, and rigorous syntheses.



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 program

announcement, Primary Care and Health Care Reform, is related to the

objectives of broadening access to timely and effective preventive

services.  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

202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign non-profit

organizations, public and private, including universities, clinics,

units of State and local governments, non-profit firms, and non-

profit foundations.  Applications from minority and women

investigators are encouraged.



MECHANISM OF SUPPORT



This program announcement will use the research project grant (R01).

Responsibility for the planning, direction, and execution of the

proposed project will be solely that of the applicant.  It is

anticipated that projects will be accomplished in one to three years.

This PA is in effect through July 1, 1994.



RESEARCH OBJECTIVES



Background.  In response to continued growth in the cost of health

care and the increasing numbers of persons without access to basic

health care services, public attention is now focussed on major

health care reform efforts.  The experience of other developed

countries that provide universal access to care for a substantially

lower per capita cost than the U.S. argues strongly that careful

consideration of the organization and delivery of primary care

services will be an essential component of resolving the current

health care dilemma.



States and a number of regional coalitions have already initiated

reform programs.  These programs provide natural laboratories for

assessing the effects of specific organizational, financial, and

regulatory mechanisms on utilization, costs, and access to primary

care services.  Reform initiatives related to primary care that are

in place or under development include:  expanded Medicaid benefits

for women and children, approaches that encourage or require Medicaid

beneficiaries to enroll in managed care programs, the use of school

based clinics to provide services to children and adolescents, and

the establishment of primary care clinics in underserved areas.

Analysis and evaluation of the relationship between the delivery of

primary care services, and the overall effects of such programs on

costs, quality, and access, are critical for informing further

decisions regarding national health care reform.



Policy Issues and Research Priorities



Primary care includes:  first contact care, care that is

longitudinal, care that is person centered rather than disease or

problem specific, and care that is comprehensive. It addresses the

most common problems in the population by providing preventive,

curative, or rehabilitative services to maximize health and well

being.  The U.S. does not have a clearly defined system of primary

care delivery.  Primary care services are provided by physicians in

multiple specialties as well as nonphysician providers, predominately

nurse practitioners, certified nurse midwives, and physician

assistants, in a variety of settings.  While the majority of persons

identify one provider as their usual source of care, a substantial

number obtain primary care services from multiple providers.  Some

individuals obtain specialized services when referred by a primary

care provider, while others seek specialists' care directly.



Studies have shown that access to primary care services is associated

with improved health outcomes.  Primary care providers also use fewer

resources in the care of patients with chronic diseases than

specialists, after adjusting for severity of illness.  However,

existing studies are limited, and additional studies that isolate the

effects of distinct organizational and provider characteristics on

overall costs and patient outcomes are essential to inform health

care reform.



A broad array of research questions are relevant to primary care and

health care reform.  Three research areas emerge as AHCPR priorities

because of their relevance to the development of effective health

care reform programs:  (1) the effectiveness of primary care and

overall costs; (2) the cost and quality implications of different

modes of access to primary care; and (3) the organization of primary

care providers.



Effectiveness of Primary Care and Overall Costs



In a health care system with a clearly defined primary care

infrastructure, the decisions of primary care practitioners have

important implications for the total expenditures for health care.

Recent studies demonstrate that a lack of access to outpatient care

can result in potentially avoidable hospital admissions.  These

studies suggest that improving the effectiveness of patient care may

lead to substantial cost savings while improving the health status of

the American people.



Of particular interest are studies of referral to specialty services.

Further research is needed to develop and test mechanisms by which

consultation and referral can be accomplished without disrupting

continuity or coordination of care.



Illustrative research questions include:



o  Can the provision of primary care services decrease the incidence

of avoidable hospitalizations?  Which primary care services,

providers, and organizational models are most effective in reducing

avoidable hospitalizations?  How is provider training related to the

effectiveness of primary care services delivered to specific groups

of patients, such as children, the elderly, and those residing in

underserved areas?



o  What proportion of variations in costs and use of expensive

technologies is attributable to variations in referral by primary

care providers?  Are observed variations attributable to provider

training, availability of specialists, patient characteristics, or

other factors?  Can improved referral practices result in more

appropriate use of expensive technologies?



o  How do nonphysician providers in a variety of settings refer

patients to specialists, and what arrangement of physician backup is

most effective?



Cost and Quality Implications of Different Modes of Access to Primary

Care



Four general patterns of primary care include: episodic care from a

hospital emergency room or urgent care center; longitudinal care from

a "usual care" provider who may be a primary care provider or

specialist; specialist provided primary care through direct (self)

referral; and primary care from multiple providers.  Most research

confounds patient and practitioner characteristics, features of the

organization, and reimbursement mechanisms.



Studies that examine the quality and cost implications of receiving

ongoing primary care from a specialist compared to a primary care

provider are important.  Of particular relevance to women's health

care are the cost and quality implications of using one or two

primary care providers.  Studies are also needed that examine the

cost and quality implications of restriction of self referral to

specialty care.  Isolating the confounding effects of cost sharing,

provider training, and patient characteristics is essential. Research

that uses existing data to develop or refine case mix measures for

application to ambulatory problems is also needed.



Illustrative research questions include:



o  What are the effects on cost and quality of care of receiving

primary care from a primary care provider compared with multiple

providers or specialists?



o  What are the effects on cost and quality of limiting direct access

to specialists for continuity care?  Are there differential effects

on patient outcomes for patients with special needs, such as persons

with disabilities and persons with chronic diseases?



o  Will recent changes in Medicare reimbursement that increase

payment for some primary care services enhance the delivery of

primary care services to all persons?



Organization of Primary Care Providers



Managed care organizations, particularly health maintenance

organizations (HMOs), have a clearly defined system for delivering

primary care services.  Research on staff model HMOs, in which the

ratio of primary care providers to specialists is higher than for the

health care system as a whole, suggests that this type of

organization provides more cost effective care than traditional fee

for service practice.  Studies that isolate the specific components

of these arrangements that are most effective (e.g., type of primary

care providers, staffing ratios, mechanisms for utilization review)

could provide important guidance to policy makers.  Recent State

initiatives to enroll Medicaid recipients in managed care programs

may offer the potential for studies using existing data to evaluate

the effects of these programs on health outcomes, health costs, and

utilization of services.  In particular, information that links the

effects of State regulations on the scope of practice of advanced

practice nurses and physician assistants to the effective delivery of

primary care services is urgently needed.



Research is also needed on organizational characteristics that

enhance the outcomes of primary care.  Additional research that

examines the relationship of continuity, accessibility, and

comprehensiveness of primary care on cost, quality, and access in

health care is critical for planning and organizing more effective

and efficient services.



Illustrative research questions include:



o  What organizational characteristics or administrative

interventions enhance coordination and continuity of care across

settings?   How are continuity, coordination, and comprehensiveness

best measured?



o  What are the effects of social, legal, and economic barriers to

the scope of practice of advanced practice nurses and physician

assistants, and the effects of these restrictions on patient

outcomes?



o  How well do community based organizations, including public health

departments and school based clinics, assure the integration of

services?  What are the effects of categorical programs, such as

vaccination programs or family planning clinics, on continuity and

coordination of care?



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND

MINORITIES IN RESEARCH STUDY POPULATIONS



The AHCPR requires all applicants for research grants to include

minorities and women in study populations so that research findings

can be of benefit to all persons at risk of the disease, disorder, or

condition under study.  Special emphasis must be placed on the need

to include minorities and women in studies of diseases, disorders,

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in research, a

clear and compelling rationale should be provided.



This policy applies to all AHCPR research grants.  The AHCPR will not

award grants for applications which do not comply.  If the required

information is not contained in the application, the application will

be returned without review.



The compositions of the proposed study population must be described

in terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information should be included in the form PHS 398

in Sections 1 to 4 of the Research Plan and summarized in Section 5,

Human Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

AHCPR recognizes that it may not be feasible or appropriate in all

research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., American

Indians/Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics).

Where appropriate, the applicant must provide the rationale for

studies on single minority population groups.



For foreign awards, the policy on inclusion of women applies fully;

because the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



Peer reviewers will address specifically whether the applicant's

research plan conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific questions(s) addressed and the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 09/91), and will be accepted at the standard application

deadlines as indicated in the application kit.  State and local

governments may use form PHS 5161 and submit an original and two

copies of the application.



Application kits are available at most institutional offices of

sponsored research; from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301-496-7441; and from the

Office of Scientific Review, Agency for Health Care Policy and

Research, 2101 East Jefferson Street, Suite 602, Rockville, MD 20852,

telephone 301-227-8449.  The title and number of the announcement

must be typed in Section 2a on the face page of the application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



The Division of Research Grants (DRG) will not accept any application

in response to this announcement that is essentially the same as one

currently pending initial review, unless the applicant withdraws the

pending application.  The DRG will not accept any application that is

essentially the same as one already reviewed.  This does not preclude

the submission of substantial revisions of applications already

reviewed, but such applications must include an introduction

addressing the previous critique.



Applicants are encouraged to apply by the earliest possible

submission date.  The first due date is June 1, 1993.  Thereafter,

the due dates for application are October 1, 1993, February 1, 1994,

and June 1, 1994.  Applications for R01 grants must be received by

the Division of Research Grants, NIH.  An application received after

the deadline may be acceptable if it carries a legible proof of

mailing date assigned by the carrier and the proof of mailing date is

not later than 1 week prior to the deadline data.



REVIEW PROCEDURES



Upon receipt, applications will be reviewed for completeness and

responsiveness.  Incomplete applications will be returned to the

applicant without further consideration.  Review criteria for grant

applications are significance and originality from a scientific and

technical viewpoint; adequacy of the method to carry out the project;

availability of data or the 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.



Applications will be evaluated in accordance with the criteria stated

above for scientific/technical merit by an appropriate peer review

group.  Applications assigned to the AHCPR and requesting total

direct costs in excess of $50,000 may be reviewed by the National

Advisory Council for Health Care Policy, Research, and Evaluation

Council for policy relevance and research value.  Funding will be

based on recommendations from the peer review and an appropriate

Council.



AWARD CRITERIA



Applications will compete for available funds with all other

applications.  The following will be considered in making funding

decisions: quality of the proposed project as determined by peer

review; availability of funds; and program balance among research

areas of the announcement.  The anticipated dates of award for

applications are 10 months from the date of submission.



INQUIRIES



Those considering an application in response to this PA are strongly

encouraged to discuss their project with AHCPR program administrators

before formal submission.  The AHCPR welcomes the opportunity to

clarify any issues or questions from potential applicants.  Copies of

a Grant Announcement based upon this PA will be available from the

AHCPR Publications Clearinghouse, PO Box 8547, Silver Spring, MD

20907, (1-800-358-9295) after April 30, 1993.



Direct inquiries regarding programmatic issues to:



Carolyn Clancy, M.D.

Center for General Health Services Extramural Research

Agency for Health Care Policy and Research

Executive Office Center, Suite 502

2101 East Jefferson Street

Rockville, MD  20852-4908

Telephone:  (301) 227-8357



Direct inquiries regarding fiscal matters to:



Ralph Sloat

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852-4908

Telephone: (301) 227-8447



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.180 and 93.226.  Awards are made under

authorization of the Public Health Service Act, Title IX, as amended

(Public Laws 101-239 and 102-410) and administered under PHS grants

policies and Federal Regulations 42 CFR 67, Subpart A and 45 CFR Part

74 (45 CFR Part 92 for State and local governments).  This program is

not subject to the intergovernmental review requirements of Executive

Order 12372.



.

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