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Nov 3, 2013 (4 years and 4 days ago)

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UCSF Research Participant Management System

2012 Sautter Award Proposal









University of California, San Francisco

Research Participant Management System (RPMS)



May 15, 2012



UCSF Research Participant Management System

2012 Sautter Award Proposal


May 15, 2012



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Project
Title

UCSF Research Participant Management System

Submitter

Nariman
Nasser, Director

Participant Recruitment Service

Clinical & Translational Science Institute

Univers
ity of California
,

San Francisco

415.514.8517 Phone / 415.412.9070 Mobile

nariman.nasser@ucsf.edu

Project Team



Nariman Nasser, Director, Participant Recruitment Service (
Project Leader
)



Jocel Dumlao, Technical Recruitment Specialist, PRS



Elia Gonzales, Medical/Technical Writer, PRS



David Thompson, SalesForce.com Analyst, ISU



Kimberly Bartlo, Senior

Programmer, ISU



Cynthia Piontowski, Web Producer,
CTSI

Summary

The R
esearch
P
articipant
M
anagement
System is

a cloud
-
computing tool that automates a campus
-
wide
recruitment
service, whose aim is to
facilitate enrollment of participants into clinical studies at UCSF.
Prospective participants use a public portal to submit an online form that registers them to be contacted
about clinical studies they may be interested in, and the sponsoring department
queries the database to
identify recruitment cohorts on behalf of researchers. The HIPAA
-
compliant and IRB
-
approved RPMS
stores

potential participant data from
the Research Participant Registry and integrates participant data
from other
sources, tracks m
arketing and outreach campaigns in support of specific clinical studies, and
provides recruitment metrics by
measur
ing

screening and enrollment outcomes.

UCSF Research Participant Management System

2012 Sautter Award Proposal


May 15, 2012



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P
roject
Description

With more than 5000 actively enrolling studies at UCSF, the Clinical & Transla
tional Science Institute
saw
the need to form the Participant Recruitment Service (PRS) and charge it with creating a

centralized
technology
-
based recruitment
system to

facilitate participant enrollment in clinical trials.
PRS set about
to create the Resea
rch Participant Management System, and its public component, the Research
Participant Registry to fulfill these
two aims
: First is to create public awareness of the positive
contributions that volunteer participants make toward their own health, the healt
h of friends and
family, and the well
-
being of the community. On the
investigator

side,
to
support researchers
who
request recruitment assistance by providing them
with the tools and services needed to identify and
communicate with potential participants

for their studies
.

Before the
PRS
, principal

investigator
s

depended on do
-
it
-
yourself recruitment

activities
, which

included

laborious query
-
building procedures for data extraction, and
paper
-
based tracking tools or
shared
Excel
sheets

with manual data en
try
. Without a uniform recruitment process,
university
administrators were

unable to accurately
evaluat
e

a study’s recruitment
activities
,
including
marketing costs or enrollment
outcomes.


The solution was to build a Participant Recruitment Management Sys
tem (PRMS) that integrates a
secure IRB
-
approved and HIPAA
-
compliant registry website and database with the PRS recruitment
workflow. With the RPMS, PRS is able to track participant, marketing, and study data to create an
effective campus
-
wide
recruitment

service.

T
echnology

The
RPMS

is built

with commercially available cloud
-

computing enterprise products from SalesForce:


the
Force.com platform,
a
customer relationship management (CRM)
application, and VisualForce.

By
customizing the CRM

application as a
healthcare application, the team was able to build the
RPMS

with
minimal development time
.


Before choosing a cloud
-
based application

for the RPMS
, t
he team evaluated several technology
options
, but found them unsuitable:




Inhouse resourc
es did not have the expandability needed for a centralized recruitment workflow.




A dedicated application, due to its costs and uncertainties, was not ideal.

UCSF Research Participant Management System

2012 Sautter Award Proposal


May 15, 2012



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Many off
-
the
-
shelf applications required programming skills and implementation costs that were
be
yond PRS expertise or budget.

An

enterprise cloud
-
based product was chosen for
these

reasons.



Being able to access data from anywhere at anytime was an advantage.



By using vendor servers, PRS would not have the burden of buying and maintaining a datab
ase
server.




We also felt that the

vendor
’s

experience in the

cloud
-
computing market
meant that the
safeguards

they had

in place
were sufficient

to meet federal and local regulations for privacy
protection and data security.



Also,
by buying a product lic
ense, we could have access to various features that we could
customize as our “business” increased and more investigators requested our services
.



Financial impact of building the RPMS was trimmed considerably through a donation of time and
developer skill
s from a team of SalesForce volunteers and a license discount from the SalesForce
Foundation.

User Access


With the
native
application’s ability to be partitioned into virtual spaces
, the

RPMS administrator can set
permissions and data visibility for the two user types:
PRS

staff
(RPMS users)
and the public (registry
users).

UCSF Research Participant Registry


Individuals interested in being contacted about specific clinical studies register online by providing
contact and health information.

Access to the public portal is through a secure login website built on
the Force.com Customer Portal and Force.com Site
s:
www.registry.ucsf.edu
.

The team

created these functions
for the

interactive

registry
website
, which is linked to the RPMS
:



Landing page modeled on UCSF design standards



Email address authentication



Electro
nic consent process



Online self
-
registration form



Health survey with branching logic


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2012 Sautter Award Proposal


May 15, 2012



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Potential Participant Data

Contact Information

The native contact object was used to collect and store participant data.
Contact
information (i.e.,
name, addr
ess, phone, email address) about the potential participant is stored in a native Force.com
object called Contacts.

Contact information

from participants who enter through the UCSF Registry
is

automatically stored

in the RPMS database
. Contact data for par
ticipants identified through other
sources are entered manually by recruitment staff.

Health Information


An online health survey is part of the registration process for the public.
Health information from the
online
registration form responses lives in m
ultiple custom objects
, which

can be
further
customized
based on regular evaluations of the data by PRS.


Registry Call Center


For callers who do not want to self
-
register online, PRS provides registration assistance on the
telephone. The native
activity object is used by recruitment staff to conduct telephone registration
interviews for new registry members or to provide technical support to existing registry members. Staff
enters caller responses into the registration form and health survey,
an
d then

submits the participant
data to the RPMS database. Both PRS and external vendors, such as a call center, can track
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2012 Sautter Award Proposal


May 15, 2012



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communication with potential participants using the Activities function. This function also allows users
to track tasks and followup

items.

Cohort Identification

Native report functionality

is used

to query the registry database and compile a list of potential
participants who match prescreening criteria for a specific UCSF study.
Only PRS has IRB approval to
conduct database searches

and extract participant data.


Study Marketing


The
native marketing module

is used to track marketing and outreach campaigns launched in support of
specific studies.

Once a list of potentially eligible participants is compiled, PRS can track which
participants have been contacted via mailers through a native Force.com object called Campaigns. This
function can also be used to track the distribution of other PRS recruitment materials such
as radio

ads,
newsletters, and bus banners.
Staff uses the
native
Leads function to associate registry and non
-
registry participants to marketing and outreach efforts (Subcampaigns)
. The
Campaigns function
is used
to associate Subcampaigns

(e.g., direct mail, print ads)

to a specific study
.

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2012 Sautter Award Proposal


May 15, 2012



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Recruitment
Tracking

Dashboard widgets to track
recruitment

performance
and c
ustom templates to report recruitment
metrics

are part of a custom recruitment object in the RPMS. The PRS Recruitment app

gauge
s

the
success of recruitment
campaigns for specific studies.
PRS is able

to track those registrants who were
contacted about a specific study and subsequently pre
-
screened. The custom recruitment object tracks
the following data:



Contact name





Study name




Enrollment number




Referral for screening visits



Screening date




Scr
een result




Reason for failure




Study consent



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2012 Sautter Award Proposal


May 15, 2012



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Cloud Security

The
RPMS is

host
ed on
SalesForce.com servers
, and the vendor provides these security safeguards
:



Secure data centers with continuous security monitoring



Secure transmission and sessions



Network protection



Backups and disaster recovery



Internal and third
-
party testing and assessments

Communication and Collaboration

The
PRS makes ample use
of Chatter

to communicate and collaborate on projects
. The Chatter tool
,
which

is part of the
enterprise application,

has some of the features of popular social media and allows
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2012 Sautter Award Proposal


May 15, 2012



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staff

to upload files

and post messages
. By keeping all project details visible and not hampering
ourselves with the additional task of searching and forwarding emails and

file attachments
, we have

improved
staff efficiency
.

The native Mail Merge function is used to process direct mail from contact lists created during the
cohort identification process.

Another native function,
Libraries, is used as a one
-
level knowledge
ma
nagement system.

I
mplementation

Timeline

Nov 2010



Definition of functional requirements


Mar

2011


Build registry website and customize CRM to create RPMS

Aug
-
Dec 2011


Fine
-
tune custom objects and conduct user testing

Feb

2012


Receives IRB approval

Mar 2012


Soft launch

Apr 2012

Over 200 participants registered and recruitment cohorts identified for 5
enrolling studies

July 2012


Production launch


Customer Satisfaction

The RPMS is accessed and used by PRS staff to provide services to UCSF investi
gators

who request
recruitment assistance.

Although

investigators and their study teams do not have access to the RPMS
,
they do receive indirect benefit from its use as a campus
-
wide recruitment tool. Investigators are
certainly able to

reap the benefits
of the registry
, an RPMS component
:



“As an investigator new to clinical trials, I have found that the most difficult
part of conducting the trial is designing and implementing an effective
recruitment plan. Although I have been on faculty for the last 8
years, I still lack
a comprehensive understanding of potential arenas where patients can be
identified and recruited for clinical studies. As such, providing resources to help
investigators identify and reach out to potential research subjects, and to
bett
er understand how the UCSF research system works, are vital for the
continuing success of our research endeavors. Such a resource would help us
conduct ongoing research projects, and be attractive when preparing grant
applications.”

--

Margaret C. Fang, MD
, MPH

Medical Director, UCSF Anticoagulation Clinic

Associate Professor of Medicine


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2012 Sautter Award Proposal


May 15, 2012



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“It’s critical that investigators have access to a registry of potential research
subjects that is quick and easy to use and represents the populations needed
for their sa
mples. Much time is lost screening patients who may or may not
meet study inclusion criteria and relying on busy care providers to refer their
own and other patients to studies. Patients may have good intentions about
contacting investigators to learn more

about studies but all too often forget to
make the contact. Having a large repository of volunteers who have indicated
a willingness to be contacted for future studies eliminates much of this
inefficient use of time and reduces the burden on busy clinicia
ns to screen and
refer patients;”

--

Claudia M. West, RN, MS

Clinical Professor

Department of Physiological Nursing