Automate Consent to Enhance Safety and Efficiency of Clinical Trials
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1 1 Automate Consent to Enhance Safety Automate Consent to Enhance Safety 2 Diane J. Parrington, PhD Deputy Associate Chief of Staff / Research Phoenix VA Health Care System Timothy J. Kelly, MS, MBA Vice President Dialog Medical ACRP 2012 Houston, TX Page 1
2 Disclosure Diane J. Parrington, PhD I have no relevant financial relationship in relation to this educational activity The contents do not represent the views of the Department of Veterans Affairs or the U.S. Government. Timothy J. Kelly, MS, MBA I have relevant financial relationship(s) with respect to this educational activity with the following organization(s): Dialog Medical Role: Vice President 3 Research Informed Consent: Time for an Automated Process? vs. 4 ACRP 2012 Houston, TX Page 2
3 Background Clinical Consents 5 Issues with 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: ACRP 2012 Houston, TX Page 3
4 Issues with 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: Background Automating Clinical Consents 8 ACRP 2012 Houston, TX Page 4
5 Automating Clinical Consents 9 The Department of Veterans Affairs conducted a Pilot Study of an Automated Informed Consent Software tool in two facilities: Hines VA Medical Center, Chicago Atlanta VA Medical Center, Atlanta Compared a sampling of patient records after implementation of the automated process (January 2004) to a control group employing paper consents (January 2003) Automating Clinical Consents 10 Percent of Consents 100% 100% 100% 100% 92% 88% Traditional (paper) consent process Automated consent process 80% 60% 40% 20% 0% Consent in Accurate Treatment the EHR Note in Description the EHR Present O Hara R. Electronic Support for Patient Decisions Automating and Integrating the Informed Consent Process. TEPR 05 Annual Conference. Salt Lake City: May 17, % ACRP 2012 Houston, TX Page 5
6 Automating Clinical Consents The Department of Veterans Affairs standardized on an automated process for completing clinical consents in Automating Clinical Consents Patient Experience: 96 percent of patients preferred the electronic process to the traditional process Issa MA, et al. The Journal of Urology. 2006;176: ACRP 2012 Houston, TX Page 6
7 Consenting for Procedures and Studies Ensuring Patient Understanding 13 Confirming Understanding 14 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. ACRP 2012 Houston, TX Page 7
8 Confirming Understanding The latest evidence 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: Confirming Understanding Repeat-Back Study: Two arms An automated informed consent software application that produces detailed, procedurespecific consent forms The same system with a series of six repeat-back (teach-back) prompts based on NQF-recommended language and a mechanism for documenting the patient s response 16 ACRP 2012 Houston, TX Page 8
9 Confirming Understanding Screen shot from the Repeat- Back Study 17 Confirming Understanding Repeat-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 18 ACRP 2012 Houston, TX Page 9
10 Confirming Understanding Implementation of teach-back (repeat-back) for a research consent 19 Patient Experience: Automated 20 Readability Adjustable font size Understanding Visualize procedures with pictures or video Safety Consent is digitally stored upon signature for immediate access by clinical staff Less chance for privacy breech or loss of consent related to scanning ACRP 2012 Houston, TX Page 10
11 Department of Veterans Affairs Current Regulations and Potential Workflows 21 Automation of Informed Consent 22 ACRP 2012 Houston, TX Page 11
![Current VHA Regulations 23 [The informed consent software tool] must be used to document](/docs-images/73/68717041/images/12-3.jpg "prior consent for treatments or procedures that require signature consent [The informed")
![consent software tool] must not be used to document consent for research, except as](/docs-images/73/68717041/images/12-4.jpg "specifically authorized by the Office of Research and Development.")
12 Current VHA Regulations 23 [The informed consent software tool] must be used to document prior consent for treatments or procedures that require signature consent [The informed consent software tool] must not be used to document consent for research, except as specifically authorized by the Office of Research and Development. 24 ACRP 2012 Houston, TX Page 12
13 Research Team Experience Consent discussion by PI or CRC employing a computer 25 Depending on the consent there may be additional prompts for: Clinical procedure consents HIPAA authorization Photography consents Pictures and Video 26 ACRP 2012 Houston, TX Page 13
14 27 Subject & witness digitally sign consent form 28 ACRP 2012 Houston, TX Page 14
15 PI or CRC digitally sign consent form 29 Progress note automatically generated & document is digitally stored 30 ACRP 2012 Houston, TX Page 15
16 Research Consents Resource Utilization and Process Challenges 31 Resource Utilization 32 Minimum cost: ~$25.00 >40% of consents will cost more L Licensed N Non-licensed <45 minutes L: $31-48 N: $19 >2 hours L: $84->128 N: $ min L: $31-64 N: $ min L: $42-80 N: $ min L: $52-96 N: $ hrs L: $ N: $ hrs L: $ N: $44-50 ACRP 2012 Houston, TX Page 16
17 Observed vs. Expected Accuracy of Consent Process Documentation Percent of Consents 97% 100% 100% 100% 95% 100% 89% Observed issues with paper consents 80% 60% Expected results with an automated process 40% 20% (not measured) 0% Consent in the EHR Accurate Note in the EHR Consent is Error-Free Audit of 2,768 research consents completed 1/1/08 through 5/31/11 33 The Potential Impact Automating Consents for Research and Clinical Trials 34 ACRP 2012 Houston, TX Page 17
18 Regulatory and Compliance Impact RCO MCD 35 ACOS/R VISN Director IRB / R&DC Resource Utilization Impact ,832 VHA Research Consents (2011) Original + 3 copies ~ 8100 Reams of Paper Minimum: $41, per year (paper) ACRP 2012 Houston, TX Page 18
19 The Environmental Impact 37 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/ res/articles/the-green-side-of- Patient-Safety-Efficiency.aspx. (Accessed 2/28/2012). The Environmental Impact 38 Automating clinical trial consents would be equivalent to saving an additional 500 trees each year. ACRP 2012 Houston, TX Page 19
20 Research Informed Consent Options for Automation 39 Automation Options 40 Evaluate your EHR Does it offer forms capability? Does it allow for capture digitized signatures? Are there adequate administrative controls? Resources Talk to your informatics or HIM group Visit your CIO or CMIO of ACRP 2012 Houston, TX Page 20
21 Automation Options HITECH Act Earmarked significant incentive funds for Electronic Health Record (EHR) adoption and use Hospitals and Eligible Providers (physicians) will both be eligible for incentives different rules apply Meaningful Use CMS issued the notice of proposed rulemaking for the Stage 2 meaningful Use requirements on February 22, Automation Options Use of your EHR for research satisfies a Meaningful Use objective 42 ACRP 2012 Houston, TX Page 21
22 Research Informed Consent Conclusion ACRP 2012 Houston, TX Page 22
23 Questions? 45 ACRP 2012 Houston, TX Page 23
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