Supporting Statement - Patient Navigator Demonstration Program Evaluation

Supporting Statement
Health Resources and Services Administration/Bureau of Health Professions
Evaluation of the Patient Navigator Outreach and Chronic Disease Prevention
Demonstration Program
A.

JUSTIFICATION

1.

Circumstances of Information Collection

This is a request for Office of Management and Budget (OMB) approval to conduct the
Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program
evaluation (OMB No. 0915-NEW). This program is authorized under the Patient
Navigator Outreach and Chronic Disease Prevention Act of 2005, P.L. 109-18, Section
340 A of the Public Health Service Act (42 U.S.C.256a.).
The Public Health Service Act (Act 109-18, H.R. 1812) was amended in 2005 to include
Patient Navigation Services, authorizing the Secretary of the Department of Health and
Human Services to conduct a demonstration program to promote model “patient
navigator” programs to improve the health care outcomes for individuals with cancer or
other chronic diseases, with a specific emphasis on health disparity populations. The
Patient Navigator Outreach and Chronic Disease Prevention (PN) Demonstration
Program is authorized under the Patient Navigator Outreach and Chronic Disease
Prevention Act of 2005, P.L 109-18, Section 340A of the Public Health Service Act.
Six grants have been awarded to eligible entities for the development and operation of
demonstration programs to provide patient navigator services to improve health care
outcomes. Preference was given to grant applicants who target those populations in
greatest need utilizing patient navigators to overcome barriers related to access and
accessibility of quality health care ultimately reducing health care disparities and
improving health care outcomes as required by law. The PN program requires defined
measures and outcomes but does not require compliance with a specific structure or
model for the applicant program or community organization (See Attachment A – Data
Dictionary for defined measures and outcomes). Furthermore, there is little programmatic
guidance on PN competencies and the supervisory and administrative processes for these
demonstration projects. The diversity of communities and variety of settings in which
similar programs have been managed successfully at the local level suggests that a “one
size fits all” standardized approach for this program is not advisable. A hallmark of the
program is the guiding principle of a significant degree of local control and design over
the development and implementation of the grant. This includes locally defined, but
Federally approved, policies on program recruitment, design in services, credentialing,
and training or certification and PN program structure.
Eligible entities for receiving patient navigator grants include:
- Public or nonprofit private health centers
- Community Health Centers
- A facility operated by or pursuant to a contract with the Indian Health Service

-

A hospital
A cancer center
A rural health clinic
An academic health center
A nonprofit entity that enters into a partnership or coordinates referrals with such
health care facilities to provide patient navigator services

The IOM report, “Unequal Treatment: Confronting Racial and Ethnic Disparities in
Health Care,” recommends the use of community-based health workers to help patients,
specifically those from minority neighborhoods, navigate the health care system. In
addition, the 2000-2001 President’s Cancer Panel report, “Voices of a Broken System:
Real People, Real Problems,” supports funding for community-based programs, including
patient navigator programs, that help people obtain cancer information, screening,
treatment, and supportive services. The focus on quality improvement is not only for inpatient hospital care, but also for primary care settings to decrease morbidity and
mortality. Improving the quality of chronic disease management can improve a
community’s health and decrease emergency room visits and hospital admissions.
The Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program
should demonstrate how local initiatives can potentially reduce the burden of cancer and
other chronic diseases such as obesity, diabetes, asthma and others by reducing the
barriers related to accessing high quality health care services. This evaluation consists of
two parts: 1) an evaluation of the patient navigators themselves; and 2) an evaluation of
health outcomes of the patients who will be navigated.
The authorizing legislation for the PN program requires that the Secretary conduct an
evaluation of the program and submit to the Congress a report on such results. The
evaluation of PN program is required to include an analysis of baseline and benchmark
measures and aggregate information about the patients served and program activities (See
Attachment A Table 9 for baseline measures). The report to Congress is also stipulated
to include recommendations on whether patient navigator programs could be used to
improve patient outcomes in other public health areas.
2.

Purpose and Use of Information

The PN program is a quality improvement initiative focused on chronic disease
management. Patient navigators will facilitate safe, timely, effective, efficient, patientcentered, and equitable care in order to best provide support and guidance to cancer and
chronic disease patients throughout the disease care continuum. The patient navigator
grants should provide added value or new community services without duplicating
programs or efforts that would qualify for funding under current law. Geographic
isolation, cultural and linguistic barriers, limited transportation services, lack of health
insurance and information about health options, and socioeconomic status are a few of
the significant barriers faced by some communities that a patient navigator will help in
addressing.

Grantees have recruited, assigned, and trained patient navigators who have a direct
knowledge of the communities they serve. Patient navigators will facilitate the care of
individuals by performing each of the six duties as outlined in the legislation. Those
duties include:
1. Act as contacts, including by assisting the coordination of health care services
and provider referrals, for individuals who are seeking prevention or early detection
services for, or who following a screening, abnormal finding, or diagnosis of,
cancer or other chronic diseases.
2. Facilitating the involvement of community organizations in assisting individuals
who are at risk for or who have cancer or other chronic diseases to receive better
access to high-quality health care services.
3. Notify individuals of clinical trial and, on request, facilitate enrollment of
eligible individuals in these trials.
4. Anticipate, identify, and help patients to overcome barriers within the health care
system to ensure prompt diagnostic and treatment resolution of an abnormal finding
of cancer or other chronic diseases.
5. Coordinate with the relevant health insurance ombudsman programs to provide
information to individuals who are at risk for or who have cancer or other chronic
diseases about health coverage, including private insurance, health care savings
accounts, and other publicly funded programs.
6. Conduct ongoing outreach to health disparity populations, including the
uninsured, rural population, and other medically underserved populations in
addition to assisting other individual who are at risk for or who have cancer or other
chronic diseases to seek preventative care.
The term “patient navigator” as used in this program represents a concept. The grantee
determines which term best applies to their target community. Many patient navigator
programs use trained community health workers who may be full-time employees or
volunteers. Community health workers are also known as community health advisors,
lay health advocates, and promotores de salud. In addition to community health workers,
some health care navigator programs utilize trained social workers, nurses and/or nurse
practitioners. Navigation spans the period from community outreach, preventive
services, health literacy, education of chronic diseases and the health care system, an
abnormal finding via a detection procedure, through necessary diagnostic tests, to
completion of the treatment and other health care services through the life of the patient.
Once a relationship has formed between an individual and a patient navigator, the
program extends to helping the individual and family through the health care system.
For the purposes of this program, a patient navigator is a person with direct knowledge of
the local community who functions as a “guide” and offers assistance to community
members in “navigating” the health care system and accessing related social and financial
services to improve chronic disease detection and treatment. A primary function of the
navigator is to establish and help maintain communication between patients, their
families, physicians, and the health care system while offering additional assistance.

Examples of Patient Navigator activities may include:
o Identifying and scheduling appointments with culturally competent
caregivers;
o Arranging for needed language translation or interpretation services;
o Assisting in coordination of transportation to and child/elder care during
scheduled diagnosis and treatment appointments;
o Helping patients and their families access support systems;
o Helping patients understand treatment options, diagnoses, and preventive
behaviors;
o Providing emotional support and related information; and
o Facilitating access to available financial support and assisting with related
paperwork.
Grantees collect much of the standard healthcare administrative and demographic
information to be utilized in the Patient Navigator program as standard business practice.
This evaluation will focus on the legislative requirements to report on patient outcomes
impacted by navigation services and on the demographic characteristics and activities of
the patient navigators themselves. These data will be collected through the following
data elements: Patient Tracking Log (Attachment B), Patient Navigator SocioDemographic Characteristics (Attachment A – Table 3), Alternative Appointment Data
(Attachment A – Table 5 and 6), and Health Care Coverage (Attachment A – Table 1).
Congress specified the measures that should be collected in this evaluation. The
Committee recommended that the evaluation collect and include the following data in the
final report to Congress: the patient’s insurance status, income, education level, gender,
age, race and ethnicity, the number of patients navigated, demographic coverage area,
screening location and date, type and stage of diagnosis, point at which the navigator was
brought into the process, type of navigator (lay or professional), barriers the patient
encountered and how the were resolved, compliance rate for appointments and follow-up
exams, number of patient referred and follow-up outcomes, time interval between
diagnosis or referral and resolution date, and the final outcome or result. For applicants
who are providing training for patient navigators, the Committee recommended that the
Secretary include the plan for such training and the outcomes.
3.

Use of Improved Information Technology

Improved information technology is utilized where appropriate. The grant program
maintains an online “virtual office” at www.healthdisparities.net to share information and
data about the various patient navigator sites between the sites and HRSA. Collection of
all data measures will occur electronically, on a quarterly basis (Attachment C).
4.

Efforts to Identify Duplication

The information collected through the Patient Navigator Outreach and Chronic Disease
Prevention Demonstration Program performance evaluation tools is not available from
any other source. The required information can only be supplied by the grantees.

5.

Involvement of Small Entities

Due to the demonstration designation and small scale of this grant program, the data
collection activities do not significantly impact small entities. However, most
information requested in these documents is information that grantees already maintain
for clinical and management purposes. This minimizes the burden on the respondents.
6.

Consequences If Information Collected Less Frequently

Performance data will be collected on a quarterly basis. Because the project period is
limited, data will be collected five times from the grantees. Collecting data on a quarterly
basis, starting in the fall of 2009, is frequent enough to provide information regarding the
program performance while reducing the burdens of compiling, collating, and editing the
data for the grantees. Furthermore, stringent data collection mechanisms are necessary to
satisfy the requirement of the authorizing legislation to produce a Congressional report
with specific data outcome measures.
7.

Consistency with the Guidelines in 5 CFR 1320.5(d)(2)

This information collection fully complies with 5 CFR 1320.5(d)(2).
8.

Consultation Outside the Agency

The notice required in 5 CFR 1320.8(d) was published in Volume 73, No. 229, pages
72064-72065 of the Federal Register on November 26, 2008. There were no comments
from the public.
The following three Patient Navigator Outreach and Chronic Disease Prevention
Demonstration Project grantee project directors were consulted on the clarity and overall
burden of the data collection tools. The respondents thought the data collection measures
were clear and the requested information was reasonable and available within their
respective organizations.
Christina Esperat
Project Director, PNDP
Texas Tech University Health Science Center
3610 4th St.
Lubbock, TX 79430
806-743-3052
[email protected]
April Hicks
Program Supervisor, PNDP
Goodwin Community Health Center Coastal Medical Access Project
PO Box 1357 2605 Parkwood Dr.

Brunswick GA 31520
912-554-3559
[email protected]
Debra Rosen
Project Director, PNDP
Northeast Valley Health Corporation
531 5th St.
San Fernando, CA 91340
818 898-3480
[email protected]
9.

Remuneration of Respondents

Participants in the PN Demonstration Project evaluation will not be remunerated.
10.

Assurance of Confidentiality

Participating individuals and institutions will be informed that the information collected
by the patient navigator will be kept secure and will be protected. This information will
be collected from patients or their designated caregiver, patient navigators, and PN
program administrators. HRSA will not collect personally identifiable information;
patients’ health status and demographic information will be collected for this evaluation.
However, maintaining privacy of all information is a priority and data collection and
disclosure processes will abide by Health Insurance Portability and Accountability Act
(HIPPA) Privacy Rule provisions and procedures.
11.

Questions of Sensitive Nature

Information regarding health care services and conditions will be collected. No data
regarding substance abuse or illegal activities will be collected.
12.

Estimates of Annualized Hour Burden

Form
Navigated Patient1
Data Intake Form
SubTotal-Patient
Burden
Patient Navigator
Demographic
Information
Patient Navigator
Encounter/Tracking

Number of
Respondents

Responses
per
Respondent

Total
Responses

Hours
per
Response

Total
Burden
Hours

6000

1

6000

0.5

3,000

6000

1

6000

0.5

3,000

30

1

30

0.25

7.5

30

750

22,500

0.25

5,625

Log2
SubTotal -Patient
Navigator
Burden
Grantee PN
Administrative
Records3
Patient Medical
Record and Clinic
Data4
Clinic Rates
(Baseline Measures)
Quarterly Report
SubTotal -Grantee
Burden
TOTAL
AVERAGE
ANNUAL
BURDEN

30

751

22,530

0.5

5,633

6

1

6

.5

3

6

1,000

6,000

2

12,000

6

1

6

4

24

6

4

24

1

24

6

1,005

6,036

3.5

12,060

6,048

1,757

34,566

4.5

20,693

These estimates are based on the total number of patients expected to be navigated over
the project period based on the grantees applications.
13.

Estimates of Annualized Cost Burden to Respondents

There should be no cost to the respondents for this activity.
14.

Estimates of Annualized Cost to the Government

An estimated 2 FTEs at the GS 12 level are needed to review and process applications,
provide technical assistance to grantees, and serve as project officers for this grant
program at an estimated cost of $146,200 annually. In addition, HRSA maintains a
contract with NOVA Research, Inc. at an annual cost of $249,480 to provide technical
assistance and develop performance measures for the grant program.
15.

Changes in Burden

As this is a new grant program, there are no changes in burden.
16.

Time Schedule, Publication and Analysis Plans

According to statute, The Patient Navigator Outreach and Chronic Disease Prevention
Act of 2005 (Attachment D) mandates that these data be collected, analyzed, and reported

to Congress in the form of a report no later than March 30, 2011. The analyses for the
Congressional report will include simple statistics and comparison of means for specific
health outcomes.
17.

Exemption for Display of Expiration Data

No exemption is requested and the expiration date will be displayed.
18.

Certifications

This information collection fully complies with the guidelines in 5 CFR 1320.9. The
certifications are included in the package.
ATTACHMENTS
Data Dictionary
Patient Tracking Log
Quarterly Report
Patient Navigator Act of 2005
Data Element Summary
Logic Model
Evaluation Matrix