Provider-Based: Address Look-Up

National Children’s Study (NCS)/Coordinating Center

Address Lookup Tool
General Requirements for Providers and Vanguard Centers

Prepared for:

Prepared by:

NCS Program Office

WESTAT

Rockville, Maryland

Address Lookup Tool: General Requirements for Providers and Vanguard Centers

Table of Contents
1

ADDRESS LOOKUP TOOL OVERVIEW ............................................................................................ 1

2

HIPAA REQUIREMENTS .................................................................................................................... 1

3

PROCEDURES FOR HEALTHCARE PROVIDER USE OF ADDRESS LOOKUP TOOL ................. 2

4

PROCEDURES FOR VC USE OF ADDRESS LOOKUP TOOL ......................................................... 3

5

GENERAL REQUIREMENTS .............................................................................................................. 3
5.1

USER BASE ................................................................................................................................... 3

5.2

ACCESS......................................................................................................................................... 4

5.3

PASSWORD POLICY ........................................................................................................................ 4

5.4

DEACTIVATION ............................................................................................................................... 4

5.5

SPECIFICITY ................................................................................................................................... 4

5.6

DATA LOAD AND REFRESHMENT ..................................................................................................... 4

5.7

MESSAGES .................................................................................................................................... 4

5.8

MATERIALS .................................................................................................................................... 5

5.9

USER SUPPORT ............................................................................................................................. 5

5.10

REPORTS....................................................................................................................................... 5

5.11

ACCESS AGREEMENTS ................................................................................................................... 5

5.12

MAIN STUDY CONSIDERATIONS: ...................................................................................................... 6

Appendix A. Draft Screen Shots
Appendix B. Draft Healthcare Provider Agreement Letter

Address Lookup Tool: General Requirements for Providers and Vanguard Centers

1 ADDRESS LOOKUP TOOL OVERVIEW
The Address Lookup Tool is primarily designed to support healthcare providers in recruiting
women into the NCS by providing them with a capability to determine whether the woman's
primary residence is in a selected NCS segment. The tool and associated procedures are
designed to encourage use by reducing the healthcare provider’s level of effort as much as
possible and ensuring use of the tool is as intuitive as possible.
The Address Lookup Tool may also be used by VCs to verify the healthcare provider’s
search results using the same matching algorithm.
Users will enter a patient's street address and match it against known addresses in
selected segments, both those that have already been released and those that are selected
but not yet released. The tool will only provide information on address eligibility and will not
alert a user as to whether or not a woman is already enrolled in the NCS or other eligibility
requirements.

2 HIPAA REQUIREMENTS
The use of the Address Lookup Tool by the healthcare provider and procedures the
provider will follow to release patient Personal Health Information (PHI) (e.g., name and
contact information) to the VC are dependent upon the healthcare provider’s relationship to
the VC and upon Privacy Board/IRB approvals for research relationships and HIPAA
authorizations. VC Principal Investigators (PIs) must adhere to their local Study Center
HIPAA policies and requirements and work with healthcare providers to obtain approval of
the required HIPAA waivers or authorizations as necessary.
We anticipate the following HIPAA-related situations that the VCs will need to consider:
1)

The health care provider is employed by a practice or facility that with the Study
Center are considered part of the same covered entity for HIPAA purposes. The
health care provider may look up the patient’s address in the Address Lookup
Tool without the need for a HIPAA waiver. If there is a match, the healthcare
provider may request and obtain the verbal permission of the patient to share the
patient’s name and contact information with the researcher without obtaining a
Waiver of HIPAA Authorization or a HIPAA Authorization under review
preparatory to research provision of the HIPAA rule.

2)

The healthcare provider is not employed by the VC as a covered entity and does
not have a HIPAA waiver or a signed HIPAA authorization to release patient
name to the VC. The healthcare provider has agreed to help the VC with
recruitment and this has been approved by the VC IRB. In this situation, the
provider may submit the patient’s address to the Address Lookup Tool and if the
patient is potentially eligible, give the patient information about the study and
invite the patient to call the VC.

3)

The healthcare provider does not work for the same covered entity as the
investigator but the healthcare provider has obtained a HIPAA waiver from a
privacy board/IRB allowing him/her to release her name and contact information
to the NCS. In this situation, the provider may submit the patient’s address to the
Address Lookup Tool and release his/her name to the VC. We suggest that as a

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courtesy the healthcare provider ask permission to the patient to release the
name and contact information to the NCS.
4)

The healthcare provider is not employed by the VC as a covered entity but the
healthcare provider has obtained a HIPAA waiver from a privacy board/IRB to
look at the patient’s address for purposes of the NCS and has also obtained
approval of a HIPAA Authorization for the patient to sign is she agrees to release
contact information for purposes of the NCS. The provider may submit the
participant’s information to the Address Lookup Tool. If there is a match, the
patient will be asked to sign a HIPAA authorization form allowing the physician to
release her PHI (name and contact information) to the NCS. The health care
provider will send the name and contact information for potentially eligible
participants to the VC.

It is the responsibility of the VC PIs and their staff to determine how they will work with
their healthcare providers. VC staff will develop the procedures that their healthcare
providers will follow for discussing the NCS with the patient as appropriate to the
healthcare provider’s HIPAA status. As discussed in the scenarios above, the
healthcare provider will either release the woman’s name to the VC for recruitment of the
woman, or the provider will present the woman with Study documentation, inform her
that she may be eligible to join the Study, and invite her to call the VC site office to learn
more about the Study. The path to be followed by each healthcare provider working with
the VC will be dependent on the relationship between the healthcare provider and the
VC and will be negotiated by the VC PI or their staff.

3 PROCEDURES FOR HEALTHCARE PROVIDER USE OF ADDRESS
LOOKUP TOOL
The Coordinating Center (CC) will develop a Quick Start Guide for healthcare provider use
of this Tool. The Quick Start Guide will describe the tool, and provide technical directions
for its use.
To use the tool, the healthcare provider will enter the woman’s address. The tool will
identify a match to a released segment or a yet to be released segment based on address.
a) If there is a match for a potentially eligible woman in a segment, the following
message will be displayed:
Message: The address is a match. Your patient is potentially eligible to
participate in the National Children’s Study. Please refer to the NCS
Address Lookup User Guide for guidelines on discussing the NCS with
your patient.
b) There is no matching address:
Message: Your patient’s address did not match to an address in our
system. There is no need to discuss the study with your patient at this
time.
The Address Lookup Tool will only return the match result message on-screen; it will not
retain (at the address level) the result of the match, it will not retain the address entered
by the healthcare provider, and it will not return matched results to the Study.
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As noted above in section 2, the VC staff will work with their local healthcare providers to
delineate how they will communicate information regarding women identified as matches
using the Address Lookup Tool to the VC site office. VC staff are required to develop,
provide, and train their healthcare providers in the use of the Address Lookup Tool and
these locally developed procedures.
Once contacted, the VC staff will need to conduct additional research using the Study
Management System (SMS) to determine the current status of data collection at the
address identified as a match by the Address Lookup Tool. The VC will be responsible
for determining whether or not the woman has been enumerated, screened, or
consented, and will evaluate all prior contacts with the woman prior to attempting to
contact her.

4

PROCEDURES FOR VC USE OF ADDRESS LOOKUP TOOL
The CC will develop a VC version of the Quick Start Guide for the tool. The Quick Start
Guide will describe the tool, provide directions for its use and provide guidelines for
interpretation of the match/no-match results.
The VC will use the tool the same as the healthcare provider (presented in section 3.4)
and the messages will be the same as for the healthcare provider. The VC will be
presented with two additional variables on the screen for each match:
a) Segment ID: identifier of the segment associated with the matched
address.
b) Release Date: Date segment was released or, for segments not yet
released, listing date.
Any followup with the healthcare provider or contact of the potential participant will be
dependent on the relationship between the healthcare provider and the Study Center
and /or negotiations between VC and healthcare provider.

5 GENERAL REQUIREMENTS
5.1

USER BASE
The NCS Address Lookup Tool is primarily designed for use by healthcare providers and
their staff members. The tool can be used by a healthcare provider to Look up the
address of any woman in his/her practice. It may also be used by a birthing center to look
up any woman checking in to deliver her child.
The tool will also be used by VC staff to monitor usage by their healthcare providers and
confirm results of address matches using the same algorithm as used by the providers.

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5.2

ACCESS
For the Version 1 release, only an internet-based application will be provided. Other
needs will be explored with VCs after this has been in use for several months.
Each VC will receive a list of valid provider IDs. Each VC will also be assigned one
generic password for all healthcare providers associated with that VC. VCs are
responsible for assigning provider IDs and passwords and responding to user questions
from healthcare providers. This information will be loaded into the access control for the
application and will not require CC user administration.
VCs are expected to retain ID assignments to monitor and facilitate usage of the tool by
participating healthcare providers.
The VC will be assigned a single VC ID and generic password for use by VC staff. This
information will also be loaded into the access control for the application and will not
require CC user administration.

5.3

PASSWORD POLICY
To encourage use by healthcare providers, the password policy will be simplified:
strong passwords will not be enforced (e.g. use of upper/lower case and special
characters/numbers), passwords will not expire, and users will not be locked out on
failed attempts.

5.4

DEACTIVATION
For Version 1, the VC will call the NCS Support Desk if they want to deactivate a
healthcare provider or change the VC password. The CC will deactivate/change VC
passwords behind the scenes.

5.5

SPECIFICITY
The address matching algorithm will include:

5.6

·

Exact match on house number

·

Intelligent match on street name (narrowed by exact 5-digit zip code)

DATA LOAD AND REFRESHMENT
The data will be loaded from the SMS and will include both released segments (and
updates to listing identified during enumeration) and unreleased segments (based on
quality reviewed listing data). The data will be refreshed monthly.

5.7

MESSAGES
Welcome Message: Welcome to the National Children’s Study Address Lookup
Tool. Please type in your patient’s street address, city, state and zip code. The
address should be the location where she is currently living. This tool will match
her address to the NCS database to determine if she is potentially eligible to
participate in the NCS.

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Other Messages: - See 3.4 above.

5.8

MATERIALS
The CC will provide:

5.9

•

NCS Address Lookup Quick Start Guide for healthcare providers, including any
general guidance, such as which address should be entered into the tool.

•

NCS Address Lookup Quick Start Guide for VCs, including guidelines on interpreting
both matching and no-match results and implications of segment release.

•

A field memo that outlines procedures for researching address matches in the SMS
and instructions for moving forward with data collection under a number of potential
scenarios based on the current status of data collection at the dwelling unit.

USER SUPPORT
VCs will train their healthcare providers and provide first tier user support for their
providers.

5.10 REPORTS
Reports will be developed to support VCs in monitoring usage by individual healthcare
providers and overall. Version 1 will include:
·
General website usage reports
·
Usage by provider ID (PO/CC level for all, VC level for their assigned IDs)

5.11 ACCESS AGREEMENTS
The Program Office has drafted a template letter (Appendix B) to healthcare providers
explaining our interest in their data and a request for their help. It also explains
appropriate use of the NCS Address Lookup Tool and the information it provides.
The letter will be prepared on VC letterhead, signed by the VC PI, and administered by
VC healthcare provider liaisons. Once countersigned by the healthcare provider, the letter
of agreement will be tracked and retained by the VC, in accordance with local procedures
for handling the HIPAA agreements.
It is up to the VC to administer and track these materials, as well as ensure that
healthcare providers do not access the NCS Address Lookup Tool without a signed
agreement in place.

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5.12 MAIN STUDY CONSIDERATIONS:
Healthcare providers may be associated with more than one PSU/VC. Matching shouldn't
be a problem but reports could be an issue with a single provider ID. Note: Per HIPAA
regulation patients are entitled to a list of disclosures made by the provider. We may
receive a request from a Study Center to make these reports using our electronic system

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APPENDIX A
Draft Screen Shots

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Healthcare Provider Login Screen

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Healthcare Provider Address Lookup Screen
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Address Match Successful Screen

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Unsuccessful Address Match Screen

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Appendix B
Draft Healthcare Provider Agreement Letter

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[Study Center Letterhead]

Assisting the National Children’s Study in [Study Location]
with Patient Eligibility Information
Dear Health Care Provider and Staff,
I am writing to you to ask for your help in determining possible eligibility of your patients for the
National Children’s Study (NCS). The NCS is an observational study that will help us understand the
ways in which genes and environment affect children’s health over time. It is supported by the National
Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the Centers for Disease
Control (CDC). The purpose of this Study is to better understand childhood asthma, allergies, autism and
diabetes, among many other conditions.
We are now recruiting participants for this study, and we need your help in identifying women
among your patients who may be eligible to join. We have developed a secure, web-based system that
allows a provider to determine possible eligibility simply by entering a patient’s address and receive a yes
(eligible) or no (not eligible) response. Should a patient be identified as possibly eligible to join, we ask
that you share that patient’s name and address with us at the phone number below. Our staff will then
contact that person and ask them to join the Study.
The attached sheet describes the Lookup tool procedures and guidance for physician offices with respect
to HIPAA requirements. Participation is voluntary and data are kept confidential. These activities do not
constitute engagement in human subject research and do not require additional IRB review beyond
approval already provided by [Study Center IRB] and the National Institute of Child Health and Human
Development IRB.
[Insert language describing incentives to be offered to health providers for assisting the study in this way.
Incentives can be varied across Study Centers, but should not be tied to the rate of their success in
identifying eligible patients.]
We need your help to support recruitment for this important study. If you agree to help, we ask you to
sign below and mail/fax the form to me.
Thank you for your help with the National Children’s Study. If you have any questions, please don’t
hesitate to contact me.
Sincerely,
[Study Center Principal Investigator signature block]
I agree to help identify female patients who may be eligible to join the NCS. I agree to keep this
information confidential and to use the information only for the intended scientific purpose.
Signed: ____________________ Print Name: _____________________ Date: ___________
Please fax this signed agreement to [insert contact address].

If a patient may be eligible, please call: [NCS Study Center Contact Name and Phone Number]

Original: Health Provider Staff

Pink copy: Study Center Principal Investigator