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E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
E-Consents 101 – The Why, How and Watch-Outs
of Moving to Electronic Consent for Clinical Trials
E-Consents 101 – The Why, How
and Watch-Outs of Moving to
Electronic Consent for Clinical Trials
Timothy J. Kelly, MS, MBA
Vice President
Dialog Medical, a Standard Register Healthcare Company
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 1
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Electronic Consents
Does(do) the facility(ies ) that you are associated
with automate their clinical consents?
• Survey question –
Yes – 5%
Unsure – 2%
2012 ACRP
No
Conference
Yes
Parrington DJ, Kelly TJ. Automate Consent to
Enhance Safety and Efficiency of Clinical Trials. ACRP
2012 Global Conference. Orlando: April 16, 2012.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
No – 93%
Unsure
N=43
Page 2
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Why Consider Moving to an
Electronic Consent Process for
Clinical Trials and Research Studies?
Benefits of an E-Consent Process
Background: Clinical Consents
• A review of 540 written consent forms, from
157 hospitals, found the necessary elements
of informed consent (purpose, risks, benefits,
& alternatives) in only 26% of the documents.
Bottrell MM, et al. Archives of Surgery. 2000;135:26-33.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 3
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Benefits of an E-Consent Process
Background: Clinical Consents
• A review of 89 written consent forms for radical
prostatectomy:
– The potential need for blood transfusion was
disclosed on 88.8% of the consent forms.
– HOWEVER, proper consent for blood products was
ONLY obtained in 25.8% of the cases.
– 92.1% of patients ultimately received a transfusion.
Issa MA, et al. The Journal of Urology. 2006;176:694-699.
Benefits of an E-Consent Process
Automating Clinical Consents
Percent of Consents Meeting
Each Criteria
Traditional
100%
(paper)
consent
process
80%
Automated
consent
process
40%
100%
100%
100%
88%
60%
20%
0%
O’Hara R. Electronic Support for Patient Decisions –
Automating and Integrating the Informed Consent Process.
TEPR ’05 Annual Conference. Salt Lake City: May 17, 2005.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
92%
6%
Consent in
the EHR
Accurate
Note in
the EHR
Treatment
Description
Present
Page 4
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Benefits of an E-Consent Process
Automating Research Consents
Percent of Consents
Audit of 2,768
research consents
completed 1/1/08
through 5/31/11
Parrington DJ, Kelly TJ.
Automate Consent to
Enhance Safety and
Efficiency of Clinical
Trials. ACRP 2012 Global
Conference. Orlando:
April 16, 2012.
100%
Observed
issues with
paper
consents
Expected
results
with an
automated
process
(not
measured)
97% 100%
100%
89%
95%
100%
80%
60%
40%
20%
0%
Consent in
the EHR
Accurate
Note in
the EHR
Consent is
Error-Free
Benefits of an E-Consent Process
What is the total issue rate with your research
consents – include form deficiencies, filing issues
and problems with any supplemental notes?
• Survey question – 40%
N=38
30%
2012 ACRP
20%
Conference
Parrington DJ, Kelly TJ. Automate
Consent to Enhance Safety and Efficiency
of Clinical Trials. ACRP 2012 Global
Conference. Orlando: April 16, 2012.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
10%
0%
<5%
10-15% 20-25%
5-10%
15-20%
>25%
Unsure
Page 5
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Benefits of an E-Consent Process
Automating Clinical
Consents
• No missed sections
– Data fields
– Signatures
– Dates/times
• Access limited to
appropriate
personnel
Benefits of an E-Consent Process
Ability to Deliver
Collateral Material
• Brochures
• Images
• Video
• Links to interactive
websites
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 6
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Benefits of an E-Consent Process
Sharing and Storage
Flexibility
• Print
• Email
• Save to EHR and/or
other systems
Benefits of an E-Consent Process
Support “Green Initiatives”
The VA’s automation of
clinical contents and patient
education materials saved
1,600 trees in 2011…
Blum-Eisa L. Executive Insight. Posted 2/13/2012.
http://healthcare-executiveinsight.advanceweb.com/Features/Articles/TheGreen-Side-of-Patient-Safety-Efficiency.aspx.
(Accessed 2/28/2013).
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 7
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Benefits of an E-Consent Process
Support “Green Initiatives”
…Automating clinical trial
consents would be
equivalent to saving an
additional 500 trees each
year.
Parrington DJ, Kelly TJ. Automate Consent to
Enhance Safety and Efficiency of Clinical Trials. ACRP
2012 Global Conference. Orlando: April 16, 2012.
E-Consent Options
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 8
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
E-Consent Options
Home-grown Systems
• Word / SharePoint
• Adobe Professional /
Secure Server1
1
Goldsmith L. An (Almost) Paperless, (Almost) Free Clinical Trial Management System. ACRP 2012
Global Conference. Session S027. April 14, 2012. [See also S006, Monday at 2:45pm.]
E-Consent Options
E-Forms Solutions
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 9
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
E-Consent Options
Automated Informed
Consent Solutions
E-Consent Options
Electronic
Health Records
• 405 EHR
Vendors
Source: Green C. Numbers
Don’t Lie – The EHR Market
Must Consolidate. The Health
Care Blog. August 6, 2012.
thehealthcareblog.com/blog/20
12/08/06/numbers-dont-liethe-ehr-market-mustconsolidate/ (Accessed 2/28/13).
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 10
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Watch-Outs
Watch-Outs: Adoption of HIT
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 11
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Watch-Outs: Adoption of HIT
Hospital Adoption of EHR Systems has more
than Tripled Since 2009
Charles D, King J, Patel V,
Furukawa MF. “Adoption of
Electronic Health Record
Systems among U.S. Nonfederal Acute Care Hospitals:
2008-2012,” ONC Data Brief,
no 9. Washington, DC: Office
of the National Coordinator
for Health Information
Technology. March 2013.
Watch-Outs: Privacy and Security
HIPAA Complaints Lodged with OCR
(Through Jan. 31, 2013)
1,100
1,000
900
800
700
600
500
400
300
200
100
N D
2010
J
F M A M J J A
2011
S
O N D
J
F M A M J J
2012
A
S
O N D
J
2013
HIPAA & Breach Enforcement Statistics. Produced by Health Information Privacy/Security Alert.
Melamedia, LLC. www.melamedia.com/HIPAA.Stats.home.html (Accessed 2/28/13).
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 12
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Watch-Outs: Privacy and Security
Top Reasons for HIPAA Breaches Under HITECH
• Theft
• Unauthorized Access/Disclosure
• Loss
• Hacking/IT Incident
Source: Health Information Privacy/Security Alert Analysis of HHS Office for Civil Rights Data as of
February 17, 2013. www.melamedia.com/HIPAA.Stats.home.html (Accessed 2/28/13).
Watch-Outs: e-Signatures
Electronic Signatures
• Ensure date and time stamps
• Verifiably bound to document
• Complete audit trail
• Full document security
• Consider hand-drawn
signatures for subjects
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 13
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Watch-Outs: e-Signatures
Electronic Signatures
• Witness/attestation signatures
may be helpful
• System must have the
technical controls for 21 CFR
Part 11 compliance
Watch-Outs: Subject Understanding
• Meta analysis of 30 articles involving consent for
clinical research found adequate understanding of:
– Aim in 54% of the studies (14 of 26)
– Voluntarism in 47% of the relevant studies (7 of 15)
– Withdrawal in 44% of the relevant studies (7 of 16)
– Risks in 50% of the relevant studies (8 of 16%)
Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and
what do patients understand? Am J Surg. 2009;198:420-425.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 14
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead
Looking Ahead: Subject Understanding
NQF Safe Practice 5
• Ask each patient or legal
surrogate to “teach-back,” in
his or her own words, key
information about the
proposed treatments or
procedures for which he or
she is being asked to provide
informed consent.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 15
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: Subject Understanding
Latest Evidence for “Teach-Back”
• A prospective, randomized,
controlled trial of “teach-back”
(“repeat-back”)
– 575 subjects
– 7 sites
Fink AS, Prochazka AV, Henderson WG, et al.
Ann Surg 2010;252:27-36.
Looking Ahead: Subject Understanding
Teach-Back Study: Results
• Significantly higher patient comprehension in
the group exposed to repeat-back
• Majority of providers also reported a belief that
use of Safe Practice 5 improved patient
understanding
• The repeat-back process took only 2.6
additional minutes on average
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 16
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: Subject Understanding
Implementation of
Teach-Back for a
clinical trial consent
Looking Ahead: HITECH Certification
ONC Certification
• Certifies privacy and
security requirements
• Ensures that eligible
providers and
hospitals can attest to
meeting Meaningful
Use requirements
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 17
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: HITECH Certification
ONC Certification
• Privacy and security criteria:
–
–
–
–
–
–
–
–
Access control
Emergency access
Automatic log-off
Audit log
Integrity
Authentication
General encryption
Encryption when exchanging
health information
Looking Ahead: Meaningful Use
Stage 1
Stage 2
Stage 3
2011-2013
Data Capture and
Sharing
2014-2015
Advance Clinical
Processes
2016Improve Outcomes
Source: HealthIT.gov. EHR Incentives & Certification. Meaningful Use Definition & Objectives.
www.healthit.gov/providers-professionals/meaningful-use-definition-objectives (Accessed 2/28/13)
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 18
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: Meaningful Use
Hospital Capability to
Meet MU Objectives
Charles D, King J, Furukawa MF, Patel
V. “Hospital Adoption of Electronic
Health Record Technology to Meet
Meaningful Use Objectives: 20082012,” ONC Data Brief, no. 10.
Washington, DC: Office of the
National Coordinator for Health
Information Technology. March 2013.
Looking Ahead: Meaningful Use
Percent of non-federal acute care hospitals with
capability to meet the Patient List Stage 1 objective
2011
70%
2012
89%
Change
27%
Charles D, King J, Furukawa MF, Patel V. “Hospital Adoption of Electronic Health Record Technology
to Meet Meaningful Use Objectives: 2008-2012,” ONC Data Brief, no. 10. Washington, DC: Office of
the National Coordinator for Health Information Technology. March 2013.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 19
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: Meaningful Use
Stage 1 – Menu Objective
• Generate lists of patients by specific conditions to
use for quality improvement, reduction of disparities,
research or outreach
Stage 1 Measure
• Generate at least one report listing patients of the EP,
eligible hospital or CAH with a specific condition.
Looking Ahead: Meaningful Use
Stage 2 – Core Objective
• Generate lists of patients by specific conditions to
use for quality improvement, reduction of disparities,
research or outreach
Stage 2 Measure
• Generate at least one report listing patients of the EP,
eligible hospital or CAH with a specific condition.
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 20
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: MU Stage 3
• Certification Criteria: Capability for EHR to
query research enrollment systems to identify
available clinical trials.1
• EHR could use the infobutton standard
to identify patient-specific clinical trials.2
1
Department of Health and Human Services. Office of the National Coordinator for Health
Information Technology. Health Information Technology; HIT Policy Committee: Request for
Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records (EHRs).
2
Meaningful Use Workgroup Subgroup 2. Christine Bechtel, Chair. September 26, 2012.
Looking Ahead: Subject Recruitment
Identifying Subjects
• Ability to identify
potential study
subjects via the
EHR or other
systems
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 21
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Looking Ahead: Subject Recruitment
Identifying Subjects
• For example,
inquire if the
subject is
interested in
learning more
about a study
• Subject to IRB
concurrence
E-Consent Checklist
Yes No
Version control?
Access Control?
Hierarchical?
Audit Capability?
Security?
Hardware support?
Easy to read as
paper?
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL







Yes No
Can the patient easily
get a copy of the
signed consent?
Enhance recruitment?
Interface with other
systems?
Compatible with IRB
process/systems?




Page 22
E-Consents 101 – The Benefits and Potential Obstacles
Associated with Electronic Consent for Clinical Trials
Questions?
Tim Kelly
timothy.kelly@standardregister.com
tkelly@dialogmedical.com
Dialog Medical, a Standard Register Healthcare Company
www.standardregisterhealthcare.com
www.dialogmedical.com
www.engagingpatients.org
Session S030 Room W231 A-C
April 13, 2013 4:00pm
ACRP 2013
Orlando, FL
Page 23