NIH Guide: ADOPTION OF ALCOHOL RESEARCH FINDINGS IN CLINICAL PRACTICE

This Program Announcement expires on March 31, 2004, unless reissued.

ADOPTION OF ALCOHOL RESEARCH FINDINGS IN CLINICAL PRACTICE

Release Date: February 27, 2001

PA NUMBER: PA-01-058

National Institute on Alcohol Abuse and Alcoholism

THIS PA USES THE “MODULAR GRANT” AND “JUST-IN-TIME” CONCEPTS, IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites
applications to support studies of the adoption in clinical practice of
scientific advances in the treatment of alcohol dependence and abuse. It is
hoped that a better understanding of these adoption processes will strengthen
effective communication between researchers and providers, thereby
facilitating the adoption of emergent research-based advances. Specific
areas of research encouraged herein include: studies that prepare findings
from efficacy trials for real-world clinical adoption, studies of
communication channels between the scientific community and the provider
community, studies of adoption trials, naturalistic studies of knowledge
adoption, contributions toward the theory of the adoption process, studies of
organizational change, and studies of the resources required for the adoption
of treatment improvements.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS
led national activity for setting priority areas. This Program Announcement
(PA), Adoption of Alcohol Research Findings in Clinical Practice, is related
to one or more of the priority areas. Potential applicants may obtain a copy
of "Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal Government. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as principal
investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project
grant (R01) and exploratory/developmental grant (R21) award mechanisms.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. Applications for R01s may
request support for up to 5 years. Facilities and Administrative (F&A) costs
will be awarded based on the negotiated rate at the time of the award. More
detailed information on the R21 mechanism can be found at
https://grants.nih.gov/grants/guide/pa-files/PA-99-131.html.
Exploratory/developmental grants cannot be renewed: however, a no-cost
extension of up to one year may be granted prior to expiration of the project
period. Investigators are encouraged to seek continued support after
completing an exploratory/developmental grant project through a research
project grant (R01).

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

BACKGROUND

A gap in communication between alcoholism treatment providers and alcoholism
treatment researchers has become a significant concern. On the one hand,
research advances have not been transmitted to practitioners in such a way
that routine adoption into clinical practice can be assumed. On the other
hand, research projects are designed and conducted without the participation
of non-academically based providers, who consequently have little influence
on the research agenda.

This gap was the subject of an influential Institute of Medicine Report (Lamb
et al. 1998) and has prompted constructive responses from several Federal
agencies. For example, the recently released National Treatment Plan of the
Center for Substance Abuse Treatment (CSAT) devotes a major section to
“Connecting Services and Research,” in which a new mechanism for improved
coordination among CSAT, NIAAA, the National Institute on Drug Abuse (NIDA),
and relevant State and local partners is proposed (CSAT 2000). Such programs
as CSAT’s Addiction Technology Transfer Centers and its Practice Research
Collaboratives, NIAAA’s Research to Practice Forums and its Researcher in
Residence Program, and NIDA’s Clinical Trials Network all have been
established to address one or another aspect of the overall problem.

Yet an understanding of a key piece of this problem, the process by which
research advances become adopted in clinical practice, has a weak scientific
base, being little studied within the context of alcoholism and drug abuse
treatment. In more general contexts, studies of research dissemination,
knowledge adoption, and technology transfer have an established history.
Readers can trace this history in Backer (1988 and 1991), Dunn and Holzner
(1988), Glaser et al. (1983), NIDA (1995), Rogers (1983), and Zaltman (1973).
Two basic lessons have emerged from this work. First, it has become
recognized that a focus on organizational change was an important complement
to a focus on change at the individual level (change in the behavior of
targeted individual clinicians). Second, it has been recognized that
research dissemination strategies that relied on the spread of written
materials alone might not be effective and that other personal contact might
be needed in addition.

Despite these advances, validated models of the research adoption process in
the alcoholism and drug abuse fields have yet to emerge. Brown’s recent
review of the topic (2000) suggests six factors (relevance, timeliness,
clarity, credibility, replicability, and reduction of staff concerns) that
should be related to effective knowledge transfer, but empirical tests of
this nascent theory have not yet been conducted.

The purpose of this announcement is to stimulate a program of research on the
process of adopting research findings in treatment practice, which should
provide essential guidance to efforts to improve the delivery of alcohol
treatment services.

AREAS OF RESEARCH INTEREST

Studies are encouraged in seven areas under the terms of this announcement:

o Studies that prepare the findings from efficacy trials for real-world
clinical adoption. Moving knowledge from efficacy studies into effectiveness
studies is a principal goal of health services research (NIAAA 1997).
Clinical trials often exclude subjects seeking repeated episodes of treatment
or having compounding drug abuse or mental health comorbidities. In
consequence, clinical subject populations are often not representative of
typical client populations. Similarly, clinical trials subjects typically
must agree to random assignment to treatment condition; whereas, clinic
patients typically self-select among treatment options. These differences
can have implications for the generalizability of research findings (see
Weisner et al. 2000). Similar differences emerge because clinical trials
tend to be conducted in academic treatment clinics and because treatment
protocols may focus on individual rather than group delivery of therapy.

o Studies of communication channels between the scientific community and the
provider community. Publishing findings in scientific journals alone has not
proven an effective way to communicate those results to treatment providers.
Processes by which knowledge is transmitted between the scientific and the
provider community require further study. It is important to note, in this
regard, that communications ideally should flow between these communities in
both directions (Lamb et al. 1998). Researchers need to hear from clinicians
about clinical problems and emerging trends in care delivery that require
examination. Studies are needed to assess how effectively these channels of
communication operate, whether there are significant barriers to
communication, and whether effective means to reduce these barriers can be
identified.

o Studies of adoption trials. A significant need is the need for
evaluations of specific efforts to stimulate clinical adoption of improved
treatment practices. Ultimately, progress in this field will be built
through a case-by-case accretion of successes and failures as different
approaches are tried and their outcomes are observed, over both the short and
long term. Studies of this sort might include such things as: “horse race”
comparisons between specific approaches; comparisons between “literature
only” and “personal instruction” approaches; comparisons between consultant
approaches and workshop approaches (Brown 2000); studies of the effectiveness
of specific manuals, videotapes, or other tools; and studies of the relative
effectiveness of instruction provided by clinicians versus instruction
provided by researchers.

o Naturalistic studies of knowledge adoption. While experimental or quasi-
experimental trials to conduct studies described in the above section hold
the greatest promise for moving this field forward, the paucity of current
knowledge makes it likely that naturalistic studies could also make important
contributions. These might include descriptive studies of natural variation
in treatment innovativeness as well as the networks and processes of
diffusion, adoption, and communication. Also important would be comparisons
between early adopters and late adopters.

o Contributions toward the theory of the adoption process. Ultimately, the
field hopes to build a theory of the adoption process. This theory will, in
turn, help us design more effective adoption strategies. Studies might test
the adequacy of general theories of the adoption process. For example, they
might test the implicit theory suggested by Brown (2000), which identifies
six factors as key influences on adoption: relevance, timeliness, clarity,
credibility, replicability, and reduction of staff concerns. Other models
can be found in Green et al. (1987) and Oldenburg et al. (1997). The field
could also benefit from more modest studies that focus on one or two factors
thought to either facilitate or impede adoption.

o Studies of organizational change. Most successful practice improvements
go beyond the level of changing the knowledge or skill of individual
clinicians and also require changes in the operation of the treatment
organization. Studies here could address how organizational change to
facilitate practice improvement is best accomplished and managed. Included
would be studies that identify which organizational forms or management
approaches do the best job of facilitating innovativeness.

o Resources and treatment finance. We can not expect that improvements in
treatment will be free. Significant time and resource expenditures will be
needed. Studies are needed of the availability and adequacy of resources to
support practice improvement. Also relevant are studies of the role and
functioning of incentives to improve practice, studies that estimate the
financial arrangements most facilitative of practice improvement, studies
estimating the size of resource barriers to treatment improvement, and
studies of how innovation can be secured for the least cost (cost
effectiveness studies). Similarly, studies estimating the potential cost
savings or increased cost effectiveness (or cost offsets) of treatment due to
the adoption of particular treatment improvements are encouraged.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit. Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e, as plans for the study are being developed. Furthermore, the application
must obtain agreement from the IC staff that the IC will accept the
application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
https://grants.nih.gov/grants/guide/notice-files/not98-030.html.

The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there
is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.) The total direct costs must be
requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.

o Under Personnel, list all project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/organizations with whom consortium or
contractual arrangements have been made, the percent effort of all personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three pages
may be used for each person. A sample biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page:
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A costs for the initial budget period and all
future budget years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

The title and number of the program announcement 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 five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?

(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

Additional consideration pertinent to the review of Exploratory/Developmental
Grant (R21) applications:

Pilot feasibility studies may contain little or no preliminary data. Review
should focus on whether the rationale for the study is well developed and
whether the proposed research is likely to generate data that will lead to a
regular research project grant or full-scale clinical trial. Adequate
justification for the proposed work may be provided through literature
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
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 priority.

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Mike Hilton, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-8753
FAX: 301- 443-8774
Email: mhilton@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Edward Ellis
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-4703
FAX: 301- 443-0788
Email: eelis@willco.niaaa.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.273. Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 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, and 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.

REFERENCES

Backer TE. Drug Abuse Technology Transfer. DHHS Publication No. (ADM) 91-
1764, Rockville, MD: National Institute on Drug Abuse, 1991.

Backer TE. “Research utilization and managing innovation in rehabilitation
organizations.” Journal of Rehabilitation, 54:18-22, 1988.

Brown BS. “From research to practice: The bridge is out and the water’s
rising.” Pp. 345-365 in Levy JA, Stephens RC, and McBride DC, Advances in
Medical Sociology, Volume 7. Greenwich, CT: JAI Press, 2000.

Center for Substance Abuse Treatment. Improving Substance Abuse Treatment:
The National Treatment Plan Initiative. DHHS Publication No. (SMA) 00-3479,
Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and
Mental Health Services Administration, 2000.

Dunn WN and Holzner B. “Anatomy of an emergent field.” Knowledge in Society
1:3-26, 1988.

Glaser EM, Ableson H, and Garrison KN. Putting Knowledge to Use. San
Francisco, CA: Jossey-Bass, 1983.

Green LW, Gottleib NH, and Parcel GS. “Diffusion Theory Extended and
Applied.” Pp. 91-117 in Ward WB (ed.) Advances in Health Education and
Promotion. Greenwich, CT: JAI Press, 1987.

Lamb S, Greenlick MR, and McCarty, D. (eds.). Bridging the Gap Between
Practice and Research: Forging Partnerships with Community-Based Drug and
Alcohol Treatment. Institute of Medicine. Washington, DC: National Academy
Press, 1998.

National Institute on Drug Abuse. Reviewing the Behavioral Science Knowledge
Base on Technology Transfer. NIH Publicatoin No. 95-4035. Rockville, MD:
National Institute on Drug Abuse, National Institutes of Health, Public
Health Service, 1995.

National Institute on Alcohol Abuse and Alcoholism. Improving the Delivery
of Alcohol Treatment and Prevention Services: A National Plan for Alcohol
Health Services Research. NIH Publication No. 97-4223. Rockville, MD:
National Institute on Alcohol Abuse and Alcoholism, National Institutes of
Health, Public Health Service, 1997.

Oldenburg B, Hardcastle DM, and Kok G. “Diffusion of Innovations.” Pp. 270-
286 in Glantz K and Lewis FM (eds.). Health Behavior and Health Education.
San Francisco, CA: Jossey-Bass, 1997.

Rogers EM. Diffusion of Innovations. New York: Free Press, 1983.

Weisner C, Mertens J, Parthasarathy S, Moore C, Hu TW, Hunkeler E, and Selby
J. “Outcome and cost of alcohol and drug treatment in an HMO: Day hospital
versus traditional outpatient.” Health Services Research, 35:791-810, 2000.

Zaltman G, Duncan R, and Holbek J. Innovations and Organizations. New York:
Wiley, 1973.

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