REDCap for Nurse

ResearchersLinda Cowan, PhD, ARNP, FNP-BC, CWS, Associate Chief Nursing Service/Research,

Tampa VA, linda.cowan@va.gov

Slande Alliance, MPH, MCHES, Grants Specialist, Center of Innovation on Disability and Rehabilitation Research, Project Management Fellow, North Florida/South Georgia

VHS, Slande.Alliance@va.gov

Bonnie Paris, PhD, Data Knowledge Analyst & VA REDCap Project Manager, VA Information Resource Center (VIReC): Bonnie.Paris@va.gov

Disclosures

• Linda Cowan has the following financial disclosures related to this

presentation:

• Biomonde, Inc – Industry sponsored randomized controlled trial

• VHA Office of Nursing Services (ONS) funded studies

• Slande Alliance has no financial conflicts to disclose

• Bonnie Paris has no financial conflicts to disclose

Objectives

• Define REDCap

• Describe differences between REDCap and VA REDCap

• Identify limitations and requirements related to using VA REDCap

• Describe how to get started using VA REDCap

• Discuss examples of projects using VA REDCap

What is REDCap?

Research Electronic Data Capture:

• Is a tool for building online databases and surveys.

• Can capture almost any type of data, for any purpose.

• A REDCap project is an electronic webpage, used for data entry.

• Data entry happens through project menu’s data collection section.

• Data can be entered into database by a researcher who is logged in, or

• Data can be entered by the subject through the REDCap online survey (without logging in) which records survey answers directly into database (for VA REDCap, respondent has to be on the VA network)

Data Entry for REDCap

What is REDCap good for?

• REDCap supports prospective and retrospective studies and

multicenter clinical trials very well.

• Has been used from bench studies to community-based research.

• Longitudinal studies and research projects having limited number

of well-defined time points can also be designed in REDCap.

What is REDCap not so good for?

• May not be ideal for single studies using small sample sizes with

complicated structure.

• Existing large data sets in a different file format.

• Existing data being imported for analysis in REDCap.

REDCap

• Can be accessed from any computer through a website

• Can be used for non-VA research for non-VA participant surveys

• Need approval for off-site data collection and storage if used for VA research

VA REDCap

• Behind the VA firewall

• Must access through VA Intranet

• Available to VA employees FREE

• Data manager trouble shooting

• Work with local ISO if having Veterans complete surveys electronically

Differences between

REDCap and VA REDCap

REDCap• TRM does not apply

• If there is a University study which uses REDCap for study participant and staff surveys, you cannot add VA staff or Veteran participants to the existing non-VA REDCap database without a ‘data use agreement,’ memorandum of understanding (MOU), all appropriate approvals, and de-identified data.

VA REDCap• Must comply with conditions for use in the TRM,

so is configured as intranet application and therefore does not allow anyone outside VA network to complete survey.

• VA employees can take surveys directly in VA REDCap

• You need to work with your local ISO for Veterans to complete surveys electronically.

• The local ISO does not need to be consulted if surveys are completed on paper and later entered into VA REDCap by VA staff.

Differences between

REDCap and VA REDCap

Similarity between

REDCap and VA REDCap

• You need to work with your local ISO for Veterans to complete surveys

electronically using a VA device (computer, tablet, kiosk, etc.)

• The local ISO does not need to be consulted on the data collection process

if VA staff are entering the data:

• Surveys are completed by Veterans on paper and later entered into REDCap by study

staff

• Surveys are administered verbally by VA study staff and the staff member enters the

responses into the system as each response is given

Benefits of using VA REDCap

(points to include on your IRB submission)

• Specifically designed for human subject research• Installed and accessible only on VA network• Login requires VA Network ID• Housed on a VA Informatics and Computing Infrastructure (VINCI)

server at the Austin Information Technology Center (AITC)• Data is backed-up every 12 hours & to tape nightly• Provides data de-identification features• Captures audit trails and logging with individualized user rights

management• Restricts access to data at user-level• Limits access between different sites’ data within multi-site studies

Describing VA REDCap in grant submissions

• Example: “VA REDCap (Research Electronic Data Capture) is a web-based application hosted and maintained by the VA Informatics and Computing Infrastructure (VINCI) and VA Information Resource Center (VIReC). It is housed on a VINCI server physically located at the VA Austin Information Technology Center (AITC) in Austin, Texas and is available only on the VA network. REDCap data collection and management projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting process. This includes a study-specific user rights management system administered by the Project Owner or Principal Investigator. REDCap (www.project-redcap.org) was developed specifically around HIPAA-Security guidelines. REDCap has been disseminated for use locally at other institutions and currently supports 1,700+ academic/non-profit consortium partners on six continents and over 305,000 research end-users.”

• Source: http://vaww.virec.research.va.gov/REDCap/FAQs.htm

Requirements related to using VA REDCap

• Cite REDCap as the data instrument used:

• “Study data were collected and managed using REDCap electronic data capture tools hosted at the Department of Veterans Affairs.1 REDCap(Research Electronic Data Capture) is a secure, Web application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.”

1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) - A

metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

Getting started with VA REDCapContact virec@va.gov about using REDCap in VA research

• REDCap’s Webinars and Online Tutorials provide information about getting started

• VIReC offers live VA REDCap Feature Presentations

• For example, in March, Mark Pabst, MPH, presented on Administering Veteran Surveys Using VA REDCap on iPad Minis

• Schedule and Feature Presentation Archive is available at https://vhacdwweb05.vha.med.va.gov/surveys/?s=83JAXH9P8P

• Weekly VA REDCap Hour Thursdays from 3-4pm Eastern Time

• Live Q&A with VIReC REDCap Support Team

• Attendees can use their computer's speakers and microphone or dial into our VANTS line at 1-800-767-1750 Code 89026#

for audio access. Join us online at http://va-eerc-ees.adobeconnect.com/redcap/

• Email the VIReC REDCap HelpDesk with any questions VIReCREDCapSupport@va.gov

Getting started with VA REDCap

• Project starts out in “Development” status.

• This is when you can change anything you want, from the text to the way the project works. You can still test and collect test data while your project is in Development (strongly encouraged).

• After you work out all the “bugs” and are completely satisfied with how data looks while testing, then change to “Production status.”

• Production is the last step before you start collecting real or live data.

• Don’t have to manually delete any test data; REDCap prompts you when you change to Production. If you have not tested or collected any test data you should NOT change project to Production status.

• “Production Status” keeps the user(s) from accidentally corrupting the database and the live data that may be within.

Adding team members to your VA REDCap

• Principal Investigators (PIs) and project owners with existing

REDCap projects can request VA REDCap access for additional

study team members by completing the Additional Study Team

Members Request Form at: https://vhacdwweb05.vha.med.va.gov/surveys/?s=uI8JUWMBxk

• The team member must have a va.gov email address

• You assign the team member rights to your project

Examples of projects using REDCap

• Secondary data analysis

• Longitudinal studies

• Clinical Trials

• Quality Improvement Projects

• Clinical Demonstration Projects

Secondary Analysis: Data Collection Tool sample questions:

Age in years ___ (ages >85 will just be recorded as "85 or older")

Gender (circle) Male / Female / Not listed

Ethnicity (circle) African American / Caucasian / Other

Was GS Colon Clinical Pathway Utilized? YES / NO

Admission BMI: BMI <18 BMI 18 - 25 BMI 26-35 BMI over 35

ASA score (pre-op): 1 2 3 4 5

Type of Surgical procedure: ____

Operating room time in minutes: _____

Length of ICU stay in days (after surgery): _____

Did patient experience any of following during hospitalization prior to surgery? (circle all that apply):

Wound dehiscence Wound infection Infectionelsewhere N/V Ileus Bowel Ischemia Perforation MI Sepsis UTI Pneumonia/pneumonitis Acute urinary retention Acute significant changes in BUN/Creatinine (renal insult) Respiratory Failure

Maggot Randomized Controlled Trial (RCT)

Wound Documentation Form Group___________________

Day 0 Day 4 Day 7

(Sharp Only)

Day 8

Date (mm-dd-yyyy)

DVPRS Level before

debridement procedure

Wound length cm

Wound width cm

Wound depth cm

Undermining cm

Tunneling cm

Redness around wound? ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Edema around wound?

⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Warmth around wound? ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Fever?

⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Maceration or callus

around wound?

⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Does wound appear to be

improved since last visit?

⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO ⃝ YES ⃝ NO

Percent necrotic tissue

Amount of exudate

N=None, S=Small,

M=Moderate, L=Large

• Quality Improvement

• Patient safety manager fall/ injury QI project

Examples of projects using REDCap

Clinical Demonstration Project

• Veteran Initiated Electronic Care Coordination, PI: Carolyn Turvey

• A 10 site Clinical demonstration project that included medication

reconciliation, provider interview, patient interview, and documentation of

multiple milestones

Examples of projects using REDCap

VA REDCap Home Page

• Project listing

• Training information

My Projects

• My Project

Overviews

• Public Projects

Project Setup Page

• Project settings

• Online Designer

• Optional Modules

• Associated Apps

• Calendar

• User rights

• Data

comparison

Development VS Production

Thoroughly Test before Production

Changes submitted for Review in Production

VA REDCap Review

Limitations

• VA IntRAnet application:

• No custom code or external links

allowed

• No public-facing survey capability

• Not approved for storage of

PHI/PII

Benefits

• Secure web application for research

data collection provided by ORD

• Free accounts

• You control your project

• Education and user support from

VIReC REDCap Support Team

Other Survey Resources

• Guidance for Surveys used for VA Operational and Research Purposes (updated 2016) on ORD website: https://www.research.va.gov/resources/oasc.cfm

• New VA Approved Survey Resource: Westat FISMA High Enclave (FHE)

• Comprehensive survey capability and addition of Authority to Operate (ATO) for FISMA-HIGH work with sensitive data

• High performance LINUX and Windows servers for database, statistical, web and other services

• Network disk space for data protection of sensitive files, full tape backup and recovery

• Export of data back to VA investigator ( www.westat.com )

Westat FAQsQ: Is this already available to VHA researchers?

A: Yes – the Westat company has several VHA Research customers and is able to handle more

Q: Will each research project need an individual contract, or will there be an enterprise-wide contract that the research project contributes funds to, or would funding be provided from central office?

A: Right now, each research project would create and fund the Westatcontract. We will have to work on an enterprise contract but expect that to take time. (Dr. James Breeling, MD, VHA ORD Director of Bioinformatics)

Q: How would the Westat service be administered, i.e., how would an individual research project go about

requesting a survey and database, etc.?

A: Software as a Service and written into the terms of the contract

Q: Would the survey results be exportable to SAS, SPSS, Excel, R?

A: Yes, data is exportable – in multiple formats

Q: Do projects have to use the Westat services to configure their surveys, or do they have the ability to build and

conduct the survey themselves?

A: Only Westat employees who have the requisite security clearances background checks etc., are

permitted to access enclave resources and develop public facing survey applications on behalf of a

research studies. Researchers may create their own surveys through a process of collaboration with

Westat reps.

Q: What are the terms of the service contract?

A: Each investigation can define items such as cost and features, which can be negotiated by the

investigator

Questions?