Full Text NR-93-01

RESEARCH ON CLINICAL CARE IN NURSING HOMES

NIH GUIDE, Volume 21, Number 37, October 16, 1992

RFA:  NR-93-01

P.T. 34

Keywords: 
  Nursing 
  Health Services Delivery 


National Center for Nursing Research

Letter of Intent Receipt Date:  November 24, 1992
Application Receipt Date:  January 26, 1993

PURPOSE

The National Center for Nursing Research (NCNR) invites research
applications to study the impact of contextual factors in nursing
homes on the quality of care that is provided, and to examine those
and other factors influencing the effectiveness of clinical
interventions for older persons residing in nursing homes.

The goal of this Request for Applications (RFA) is to enhance quality
of care and quality of life of nursing home residents by increasing
understanding of the influences of contextual factors and by
determining clinical strategies that increase independence and self
management among residents, maintain family participation in care,
and encourage discharge to home whenever possible.

Contextual factors include structural and organizational factors,
such as rehabilitation resources, staff to resident ratios, safety
measures, and methods of care delivery.  The clinical focus is on
intervention strategies to ameliorate clinical problems, such as
incontinence or sleep difficulties, to maintain or improve functional
abilities, to avoid the onset of further disabilities, and to
increase health-related quality of life.

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,
Research on Clinical Care in Nursing Homes, is related to the
priority areas of older persons as a targeted group and to
chronically disabling conditions.  Potential applicants may obtain a
copy of the "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, for-profit and
nonprofit, public and private, organizations such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.
Applicants must demonstrate access to nursing homes appropriate to
the study proposed.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the
applicant.  This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to
customary peer review procedures.  The total project period for
applications submitted in response to the present RFA may not exceed
four years.  Because the nature and scope of the research proposed in
response to the RFA may vary, it is anticipated that the size of an
award will vary also.  The anticipated average direct cost of an
award is $150,000.  The anticipated award date will be July 1, 1993.

FUNDS AVAILABLE

It is estimated that up to $1.0 million will be available to fund the
first-year total costs of applications submitted in response to this
RFA.  It is anticipated that four to five applications will be
funded.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the NCNR, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

1.  Determine the influence of structural and organizational factors
on the effectiveness of clinical interventions.

2.  Examine the effectiveness of specific clinical interventions for
older persons in nursing homes in terms of clinical quality (e.g.,
related to changes in functional status and quality of life) and
related fiscal (e.g., related to changes in costs) outcomes.

3.  Identify linkages among clinical assessments conducted in nursing
homes, clinical interventions, and anticipated clinical and fiscal
outcomes.

Applications must address objective one and either two or three.

Background

This initiative builds directly on the work of a panel of scientific
experts on long-term care convened as part of the development of the
National Nursing Research Agenda. Publication of the report of the
panel's work is anticipated in the latter part of 1992.

With the increasing longevity of our population, the number of older
persons is steadily increasing.  This is also true of the oldest old,
those 85 years and older who are more frequent residents of nursing
homes than younger older persons.  These individuals may have
disabilities due to chronic illness or acute medical problems that
require hospitalization with recovery in a nursing home.  The reasons
for admission to a nursing home for older persons are many but
frequently are related to previous hospitalization, a chronic
disability with a precipitating event such as the onset of urinary
incontinence, caregiver fatigue or disability, or absence of a
caregiver in the home.  Admission to a nursing home can often be
perceived as a terminal event for many older persons, rather than as
a useful health care setting for those who need subacute
institutional care for a period of time.  The time after admission
may be a unique time period for nursing home residents that needs to
taken into consideration in planning clinical interventions and in
examining effectiveness of clinical care.

Individualized care that avoids induced dependency and immobility
while incorporating an individual's daily habits as much as possible
has been described as important in preventing decline after admission
to a nursing home.  Interest has focused on residents in nursing
homes being able to achieve or maintain functional independence and
self management, independent choice about their care, satisfactory
quality of life, and active participation with their family.  How
best to assess and plan clinical interventions to meet individual
requirements of nursing home residents needs to be addressed.
Appropriate regularly occurring assessments, such as the use of the
Long Term Care Minimum Data Set and other clinical assessment
instruments, have been recognized as important in identifying
functional and life status factors that indicate status changes which
may require targeted interventions.  The relationship of assessment
strategies to clinical interventions and outcomes requires further
investigation.

Clinical interventions may be similar or different for short stay and
for longer stay nursing home residents. Investigations that include
examination of the differences among those with varying anticipated
lengths of stay are needed.  Also, examinations are needed of
clinical intervention strategies for residents who have the potential
for discharge home or improvement in their health status, as well as
those who are not expected to survive.  A number of clinical problems
have been identified as occurring among older adults requiring
long-term care at home or in nursing homes.  Among these are
confusion, behavior changes such as with dementias, changes in
mobility and agility, skin integrity, urinary incontinence, and sleep
disturbances.  Studies of the effectiveness of clinical interventions
for each of these clinical problems are needed.  It is important that
applicants carefully and clearly define clinical interventions in
terms of their purpose, composition, means of implementation, and
anticipated effect.

Structural and organizational factors may have a direct influence on
nursing home residents and on effectiveness of clinical intervention
strategies that are implemented.  It is important that the natural
clinical setting be examined for these influences on the
effectiveness of intervention strategies.  These factors can have
marked influence on clinical and fiscal outcomes, and identifying
clinical strategies that overcome them should lead to improved
clinical care.

Resources available in nursing homes can vary, as can clinical
management processes.  The professional staff are usually nurses,
physical and occupational therapists, social workers, and
nutritionists.  Physicians and other professional staff may also be
involved.  The extent to which there is collaboration among these
personnel and its influence on clinical care needs exploration.
Clinical staffing of nursing homes varies but generally nursing home
aides provide most of the direct daily care with registered nurses
providing leadership.  Exploration of clinical management strategies
to achieve staff adherence to plans of care may be important to
successful implementation of clinical interventions.  Findings from
some clinical studies in nursing homes have indicated considerable
differential between staff actions during a study and their actions
after the study was completed.  For example, a research team
conducting a clinical intervention study found staff compliance with
the intervention protocol during the study returned to baseline after
withdrawal of the team from the nursing home.

The milieu of nursing homes may directly influence the quality and
effectiveness of clinical care.  Clinical interventions that take the
resident milieu into consideration continue to require study.
Special care units in nursing homes have been proposed for the care
of those with particular clinical conditions, such as urinary
incontinence.  The effectiveness of these units still needs to be
demonstrated.

It is anticipated that the studies proposed will be prospective and
use primary data, build on existing scientific information, and that
the team of investigators will have access to nursing homes of
appropriate quality with appropriate resident populations.
Investigators are encouraged to provide specific information about
the status of the nursing homes proposed for inclusion in the study,
including Federal certification status, state licensure, ownership,
and current staffing ratios.  A multi-disciplinary approach is
encouraged.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required 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 should be placed on the need for
inclusion of 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 clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition 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
(rev. 9/91) in Sections 1-4 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, NIH 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., Native Americans (including American Indians or Alaskan
Natives), Asian/Pacific Islanders, Blacks, Hispanics].

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
disease, disorders or conditions, including, but not limited to,
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

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

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies, If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(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.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by November 24, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the names of other key personnel and consultants, the
participating institution(s), and the number and title of the RFA in
response to which an application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is extremely helpful in planning for the review of
applications.  It allows NCNR staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be sent to --

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
9000 Rockville Pike
Bethesda, MD  20892

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
to apply for these grants.  These forms are available at most
institutional business offices and from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301-496-7441.

The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page. Failure to use this label
could delay processing of the application.  In addition, on line 2a
on the face page of the application, enter "Research on Clinical Care
in Nursing Homes, NR-93-01" in the provided space and the YES box
must be marked.

Submit a signed original of the application, including the Checklist,
and three signed, exact photocopies, in one package to --

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to --

Ethel Jackson, D.D.S.
Chief, Office of Review
National Center for Nursing Research
Building 31, Room 5B25
9000 Rockville Pike
Bethesda, MD  20892

Applications must be received by January 26, 1993.  If an application
is received after that date, it will be returned to the applicant
without review.

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 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.

REVIEW CONSIDERATIONS

Applications submitted to the NIH will be reviewed according to
normal NIH peer review procedures.

Review Procedure.  Upon receipt, applications will be reviewed by
NCNR for completeness and responsiveness. Incomplete applications
will be returned to the applicant without further consideration.  If
the application is not responsive to the scientific intent identified
in the RFA or to the time frame and budget guidelines, NCNR will
return it to the applicant.

Applications may be subjected to triage by a peer review group to
determine their scientific merit relative to other applications
received in response to this RFA.  Criteria for triage will be the
same as the review criteria listed below.  The NIH will
administratively withdraw from competition those applications judged
to be noncompetitive and notify the applicant and institutional
official.

Those applications judged to be complete, responsive, and competitive
will be further evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NCNR.  The second level of review will be
provided by the National Advisory Council for Nursing Research.

Review Criteria.  Applications will be reviewed in accord with the
usual NIH peer review criteria:

o  scientific and technical significance and originality of proposed
research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the principal
investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  appropriateness of the nursing home settings for the conduct of
the study;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  where an application involves activities that could have an
adverse effect upon humans, animals, or the environment, the adequacy
of the proposed means for protecting against or minimizing such
effects.

AWARD CRITERIA

The anticipated date of award is July 1, 1993.  Decisions to make
awards are based on the scientific merit of the application reflected
in the priority score, availability of funds with NCNR for this
purpose, and NCNR research program priorities.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged
and may be directed to either of the following individuals.  The
program staff welcome the opportunity to clarify any issues or
questions from potential applicants.

Patricia Moritz, Ph.D., R.N.
Nursing Systems Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 496-0523 (for copies of the RFA)
Telephone:  (303) 844-6163 (for discussion of scientific matters)

Direct inquiries regarding fiscal matters to --

Sally Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 496-0237

SCHEDULE

Letter of Intent:          November 24, 1992
Application Receipt Date:  January 26, 1993
Initial Review:            February/March 1993
Secondary Review:          May/June 1993
Anticipated Award Date:    July 1, 1993

Other institutes and agencies are also interested in research dealing
with long-term care, including:

The National Institute on Aging; the program contacts are Marcia G.
Ory, PhD, and Katrina Johnson, PhD, Behavioral and Social Research
Program, NIA, Gateway Building, Room 2C-234, NIH, Bethesda, MD 20892,
phone (301) 496-3136.

The Agency for Health Care Policy and Research; the program contacts
are Linda Siegenthaler, PhD, and Anne Bavier, MSN, Center for General
Extramural Health Services Research, Suite 502, 2101 East Jefferson
Street, Rockville, MD, 20852, telephone (301) 227-8352.

This RFA is in addition to the ongoing program announcement on Home
Health Care and Supportive Services for Older Adults, published in
the NIH Guide for Grants and Contracts, Vol. 21, No. 18, May 15,
1992, sponsored by the National Institute on Aging, National Center
for Nursing Research, and the Agency for Health Care Policy and
Research.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.331, Nursing Research.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

.

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