econsents –the why, how and watch outs - dialog medical · econsents –the why, how and...

NCCACRPSeptember 17, 2015

eConsents – The Why, How’s and Watch‐out’s

eConsents – The Why, How and Watch‐outs

Timothy J. Kelly, MS, MBSDirector, Standard Register Healthcare

September 17, 2015

All slides in this presentation

have been copyrighted and can not be used without the presenter’s permission

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Speaker Bio – Timothy Kelly

• 25 years in the medical device/software industry including 17 years working for two different divisions of C.R. Bard, Inc. – a large medical device firm and study sponsor where his responsibilities included managing a Phase III clinical trial of a novel anti‐infective medical device

• Recently completed a prospective, randomized, multicenter study evaluating the impact of “repeat‐back” during the informed consent process

• Member of ACRP, HIMSS and ASHRM

• Hold two U.S. patents

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DescriptionHealthcare is going electronic. Reimbursement is being provided for EHRs. Informed consent for surgical procedures has become automated. It is thus inevitable that use of eConsents for research studies and clinical trials will develop and expand.

The benefits of eConsents including the potential to reduce the risk of errors and eliminate the costs inherent to paper‐based processes will be explored. Different mechanisms for implementing an eConsent process will be discussed, including: leveraging an EHR, employing forms software and utilizing an informed consent application.

Potential watch‐outs when deploying an eConsent process will be presented, including: maintaining the privacy and security of e‐documentation, ensuring compliance with FDA requirements, confirming subject understanding of key study aspects and addressing potential concerns of the IRB.

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Disclosures

I have relevant financial relationship(s) with respect to this educational activity with the following organizations (list here):

Organization Role

Standard Register Healthcare Employee

Tractionable Solutions Group Principal

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Learning Objectives

• Discuss the benefits of automating the process of obtaining informed consent for clinical trials and research studies

• Identify three different approaches to designing and deploying an e‐consent system

• Analyze the potential challenges associated with deploying an electronic system for facilitating the research consent process

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eConsents

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Who here is taking notes electronically?



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Are we ready for eConsents?

EHR Incentive Program• Incentive payments to hospitals and eligible providers to adopt, implement and demonstrate meaningful use of certified electronic health record (EHR) technology

• $30.9 billion paid through May 2015

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Source: Medicare & Medicare EHR Incentive Programs, Centers for Medicare & Medicaid Services. http://www.cms.gov/Regulations‐and‐Guidance/Legislation/EHRIncentivePrograms/Downloads/May2015_SummaryReport.pdf Accessed 7/27/15.



Environment for eConsents

• 54 percent of physicians have demonstrated “Meaningful Use” through April 2015

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Health IT Quick‐Stat #44. dashboard.healthit.gov/quickstats/pages/FIG‐Health‐Care‐Professionals‐EHR‐Incentive‐Programs.php. July 2015.


• 95 percent of hospitals have demonstrated “Meaningful Use” through April 2015

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Health IT Quick‐Stat #45. dashboard.healthit.gov/quickstats/pages/FIG‐Health‐Care‐Professionals‐EHR‐Incentive‐Programs.php. July 2015.




18%

30%

40%

43%

44%

57%

62%

0% 25% 50% 75% 100%

Submit a job application

Take a class or geteducational content

Look up governmentservices or info

Look up info about a job

Look up real estate listingsor info about a place to live

Do online banking

Get info about ahealth condition

Percent of Smartphone Owners Who Used Their Phone To:

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35%

64%

0%

20%

40%

60%

80%

100%

Mar. 2011 Oct. 2014

Percent of U.S. Adults Who Own a Smartphone

Pew Research Center, “The Smartphone Difference,” April, 2015 http://www.pewinternet.org/2015/04/01/ us‐smartphone‐use‐in‐2015/ Accessed 7/27/15.

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Why consider moving to eConsents for clinical trials and research studies?



Benefits of an eConsent Process

• Have you ever lost or misplaced a consent form or other study document?

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• 66 percent of the time, procedure and treatment consents were missing at the time of surgery

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0%

20%

40%

60%

80%

100%


100%

Automating Clinical ConsentsPercent of Consents Meeting Each Criteria

100%92% 88%

Traditional (paper) consent process

Automated consent process

100%

6%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.

Consent in the EHR

Accurate Note in the

EHR

Treatment Description Present

0%

20%

40%

60%

80%

100%


100%

Automating Research ConsentsPercent of Consents

100%97% 95%Observed issues with paper consents

Expected results with an automated process (not measured)

100%89%

Parrington DJ, Kelly TJ. Automate Consent to Enhance Safety and Efficiency of Clinical Trials. ACRP 2012 Global Conference. Orlando: April 16, 2012.

Consent in the EHR

Accurate Note in the

EHR

Consent is Error‐Free

Audit of 2,768 research consentscompleted 1/1/08 through 5/31/11




What is the total issue rate with your research consents – include form deficiencies, filing issues and problems with any supplemental notes?

• Survey question – 2012 ACRP Conference

<5%0%

10%

20%

30%

40%

10‐15%15‐20%

20‐25%

>25%5‐10%Unsure

N=38

Source: Parrington DJ, Kelly TJ. Automate Consent to Enhance Safety and Efficiency of Clinical Trials. ACRP 2012 Global Conference. Orlando: April 16, 2012.


Automating Clinical Consents• No missed sections– Data fields– Signatures– Dates/times

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Automating Clinical Consents• Precise version control

• Access limited to appropriate personnel

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Ability to Deliver Collateral Material

• Brochures

• Images

• Videos

• Links to interactive websites

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Sharing and Storage Flexibility• Print• Email• Portal• Web• Mobile App• Save to EHR and/or other systems

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eConsents Options



eConsent Options

Home‐grown Systems

• Word / SharePoint

• Adobe Professional / Secure Server1

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1Goldsmith L. An (Almost) Paperless, (Almost) Free Clinical Trial Management System. ACRP 2012 Global Conference. Session S027. April 14, 2012.

eConsent Options

E‐Forms Solutions

• Searching “eForms” yields 18 companies

• Also search “E‐Forms” and “electronic forms”

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http://healthcareinformationtechnologydirectory.com/



eConsent Options

Automated Informed Consent Solutions

• Examine both clinical and research solutions

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eConsent Options

Automated Informed Consent Solutions

• Searching “informed consent” yields 27 companies

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http://healthcareinformationtechnologydirectory.com/



eConsent Options

Electronic Health Records (EHRs) / Electronic Medical Records (EMRs)

• Over 400 EHR Vendors

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Watch‐Outs



Watch‐Outs: Privacy and Security

HIPAA Breaches (affecting 500 or more individuals)

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18

197 192 192

249

278

150

0

50

100

150

200

250

300

‐

10,000,000

20,000,000

30,000,000

40,000,000

50,000,000

60,000,000

70,000,000

80,000,000

90,000,000

100,000,000

2009 2010 2011 2012 2013 2014 2015 (thruJuly 22)

Number of Breaches

Individuals Affected

U.S. Department of Health and Human Services. Breach Portal: Notice to the Secretary of HHS Breach of Unsecured Protected Health Information. https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf (Accessed 7/27/15).

Watch‐Outs: Privacy and Security

Top Reasons for HIPAA Breaches Under HITECH

Theft

Loss

Unauthorized Access/Disclosure

Incorrect Mailing

Hacking/IT Incident

Improper Disposal

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Source: Hourihan C, Cline B. A Look Back: U.S. Healthcare Data Breach Trends. Health Information Trust Alliance (HITRUST). December 2012.



Watch‐Outs: eSignatures

Electronic Signatures

• Ensure date and time stamps

• Verifiably bound to document

• Complete audit trail

• Full document security

• Consider hand‐drawn signatures for subjects

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• Witness/attestation signatures may be helpful

• System must have the technical controls for 21 CFR Part 11 compliance

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• Strongly recommend use of a stylus and not a subject’s finger

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Watch‐Outs: ComplianceLook for Certified Health Information Technology

• Certified Health IT Product List (CHPL)

• More prescriptive than 21 CFR Part 11 as well as tested and verified

• http://oncchpl.force.com/ehrcert

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Watch‐Outs: ComplianceONC Certification• Privacy and security criteria:– Access control– Emergency access– Automatic log‐off– Audit log– Integrity– Authentication– General encryption– Encryption when exchanging health information

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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)

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Source: 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.




Text‐based research consent forms were completed most quickly

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Chalil K, Koikkara R, Dorlette-Paul M, et al. An investigation of format modifications on the comprehension of information in consent form when presented on mobile devices. Proceedings of the Human Factors and Ergonomics Society 56th Annual Meeting. October 26, 2012:921-925.

Text‐based

Text Being Read Out

Video‐based

Video‐based with Subtitles

Mean Tim

e (m

inutes)

Consent Form Completion Time


Video‐based research consents with subtitles appear to enhance comprehension

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Chalil K, Koikkara R, Dorlette-Paul M, et al. An investigation of format modifications on the comprehension of information in consent form when presented on mobile devices. Proceedings of the Human Factors and Ergonomics Society 56th Annual Meeting. October 26, 2012:921-925.

Text‐based

Text Being Read Out

Video‐based

Video‐based with Subtitles

Mean Comprehen

sion Score

Comprehension Score




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

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Latest Evidence for “Teach‐Back”• A prospective, randomized, controlled trial of “teach‐back” (“repeat‐back”)– 575 subjects

– 7 sites

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Fink AS, Prochazka AV, Henderson WG, et al. Ann Surg 2010;252:27‐36.




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

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Implementation of Teach‐Back for a clinical trial consent

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Looking Ahead

Subject Recruitment

• Sisyphean Challenge

– Very difficult

– Struggle with it again and again

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Subject Recruitment

• My Personal Odyssey

– 2003‐subject study

– 4 years and 4 months

– 54 sites

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Photo:C.R. Bard, Inc.

Kollef MH, Afessa B, Anzueto A, et al. Silver‐coated endotracheal tubes and incidence of ventilator‐associated pneumonia: the NASCENT randomized trial. JAMA. 2008;300(7):805‐13.

Subject Recruitment

• One of the top four barriers to subject recruitment:

– “The tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs.”

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Adams M, Caffrey L, Mckevitt C. Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre. Health Res Policy Syst. 2015;13:8.



Subject Recruitment

• Opportunities:

– Employ existing EHR reporting capability

• Clinical trial alert systems are becoming increasingly common1,2,3

– Leverage other systems

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1Embi PJ, Jain A, Harris CM. Physicians' perceptions of an electronic health record‐based clinical trial alert approach to subject recruitment: a survey. BMC Med Inform Decis Mak. 2008;8:13.

2Grundmeier RW, Swietlik M, Bell LM. Research Subject Enrollment by Primary Care Pediatricians Using an Electronic Health Record. AMIA Annu Symp Proc. 2007; 2007: 289–293.

3Embi PJ, Jain A, Clark J, Harris CM. Development of an Electronic Health Record‐based Clinical Trial Alert System to Enhance Recruitment at the Point of Care. AMIA Annu Symp Proc. 2005; 2005: 231–235.

Looking Ahead: Subject Retention

• Most EHRs can be configured to run periodic reports

• Be sure to:

– Secure IRB approval

– Exclude “opt out” records

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Identifying Subjects

• Ability to identify potential study subjects via the EHR or other systems

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Identifying Subjects

• For example, inquire if the subject is interested in learning more about a study or clinical trial

• Subject to IRB concurrence

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Subject Retention

• A review of 71 randomized controlled trials found a dropout rate of greater than 20 percent in 18 percent of the trials1

• An opportunity exists to leverage technology to:

– Assess subject satisfaction

– Determine any challenges with protocol compliance

– Send reminders

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1Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clinical Trials 2004;1:368‐76.

Subject Retention

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CVVV CVVV CVVV



Patient Portals

• MU Stage 2 Objective – View, Download, and Transmit to Third Party

– Must satisfy both of the following requirements:

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Source: Meaningful Use Final Stage 2 – 2014 Edition Objective.

•> 50% of those discharged from the inpatient or emergency department have their information available online within 36 hours of discharge

•> 5% of those discharged from the inpatient or ED view, download or transmit to a third party

Patient Portals

• MU Stage 3 Proposed Final Rule– > 25% of patients engage with theEHR (view/download/transmit)

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Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3. Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules.



Patient Portals

• Examine the ability of existing patient portal systems to support your subject retention and recruitment strategies

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Patient Portals

• “…we wanted to make it as easy as possible for patients to learn about our research. Now, with the click of a button, they can identify studies they may be eligible for and let the research team know they’d like to be contacted.”

Dr. Paul Taheri, deputy dean for clinical affairs and CEO of Yale Medical Group

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Source: Gruessner V. Yale Patient Portal Enhances Clinical Study Recruitment. EHR Intelligence. March 12, 2015. https://ehrintelligence.com/news/yale‐patient‐portal‐enhances‐clinical‐study‐recruitment Accessed 7/27/15.



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Summary

eConsents Checklist

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Version control?

Access Control?

Hierarchical?

Audit Capability?

Security?

Hardware support?

Easy to read as paper?

Support digitized signature capture?

Can the subject easily get a copy of the signed consent?

Enhance recruitment?

Support subject retention?

Interface with other systems?

Compatible with IRB process/systems?

Yes No

Yes No



Questions?

Thank you

Tim Kelly

[email protected]

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econsents –the why, how and watch outs - dialog medical · econsents –the why, how and...

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