Enhancing Efficiency and Enhancing Efficiency and Patient Satisfaction Patient Satisfaction ––

Automating the Informed Automating the Informed Consent ProcessConsent Process

Neil H. Baum, M.D.Neil H. Baum, M.D.Associate Clinical Professor of UrologyAssociate Clinical Professor of UrologyTulane Medical SchoolTulane Medical SchoolLouisiana State University Medical SchoolLouisiana State University Medical School

BackgroundBackground

Necessary Elements of Informed Necessary Elements of Informed Consent Consent (AMA)(AMA)

DiagnosisPurpose of treatment or procedure Risks and benefits of treatment or procedureAlternatives includes risk and benefitsThe risks and benefits of not receivingtreatment

Standards Applicable to Standards Applicable to Informed ConsentInformed Consent

JCAHOJCAHOCMSCMSIndividual Hospital PolicyIndividual Hospital PolicyState LawState Law

Texas and Louisiana require disclosure of Texas and Louisiana require disclosure of specific risksspecific risks

How Are We Doing?How Are We Doing?

Physicians typically do a good job with Physicians typically do a good job with the the verbal communicationverbal communication aspects aspects Documentation is usually inadequateDocumentation is usually inadequate

Traditional Informed Traditional Informed ConsentConsent

Traditional Written Consent FormTraditional Written Consent Form

Note:Note:Limited descriptionsIllegible handwritingUse of unacceptable abbreviations

Limitations of Traditional Limitations of Traditional Informed Consent DocumentsInformed Consent Documents

A review of 540 written consent forms, A review of 540 written consent forms, from 157 hospitals, found the from 157 hospitals, found the necessary elements of informed necessary elements of informed consent (consent (purpose, risks, benefits, & purpose, risks, benefits, & alternatives) in alternatives) in only 26%only 26% of the of the documentsdocumentsArchives of Surgery. 2000;135:26-33.

Challenges with the Traditional Challenges with the Traditional Current Consent FormCurrent Consent Form

TimeTime--consumingconsumingDetails may be limitedDetails may be limitedContent varies from provider to Content varies from provider to providerproviderRisk of missing sections, signatures or Risk of missing sections, signatures or datesdatesInvolves paperInvolves paper

Often lost or misplacedOften lost or misplaced

Legal ImplicationsLegal Implications

Potential Legal Impact of Potential Legal Impact of Informed ConsentInformed Consent

Study of medical malpractice claims Study of medical malpractice claims against urologistsagainst urologists11

Postoperative complications most common Postoperative complications most common claim of negligenceclaim of negligence

Malpractice premiumsMalpractice premiums for urologists for urologists have have increased 57%increased 57% during the past during the past three yearsthree years22

1 The Journal of Urology. 2001;165:1638:1642.2 The Journal of Urology. 2004;172:1241.

Predictors for Malpractice Predictors for Malpractice LawsuitsLawsuits

““One of the strongest is the doctor's ability to One of the strongest is the doctor's ability to communicate effectively with the patient. communicate effectively with the patient. Informed consent problems are more likely to Informed consent problems are more likely to arise for a doctor who doesn't communicate wellarise for a doctor who doesn't communicate well..But perhaps even more importantly, a doctor But perhaps even more importantly, a doctor who doesn't communicate well is not likely to who doesn't communicate well is not likely to build a healthy relationship with a patient such build a healthy relationship with a patient such that if a bad outcome did happen in medical that if a bad outcome did happen in medical care, the patient would be inclined to forgive care, the patient would be inclined to forgive rather than sue.rather than sue.””Michelle Mello, PhD, JD, Assistant Professor of Health Policy and Law, Harvard School of Public Health. NPR Radio Interview: January 15, 2005.

Patient SafetyPatient Safety

Patient SafetyPatient Safety

Incomplete or not fully comprehended Incomplete or not fully comprehended informed consent is a significant patient informed consent is a significant patient safety issuesafety issueBetter informed patients Better informed patients ““are less likely are less likely to experience medical errors by acting to experience medical errors by acting as another layer of protectionas another layer of protection””

Making Health Care Safer, Agency for Healthcare Research and Quality; 2001. Evidence Report/Technology Assessment No. 43; AHRQ publication 01-E058.

Patient SafetyPatient Safety

Providing informed consent information Providing informed consent information to patients in to patients in written formwritten form increases the increases the patientspatients’’ comprehension of the comprehension of the procedureprocedure

Better informed patients are more Better informed patients are more compliant, are less anxious and are compliant, are less anxious and are more satisfiedmore satisfied

UrolUrol Radiol. Radiol. 1986;8:351986;8:35--9.9.

University of Cambridge: University of Cambridge: The Informed Patient Study ReportThe Informed Patient Study Report. 2003.. 2003.

Cost of Lost or Misplaced Cost of Lost or Misplaced Consent DocumentsConsent Documents

Study of Missing Consent Study of Missing Consent Documents Documents (Two VA Medical Centers)(Two VA Medical Centers)

0%

20%

40%

60%

80%

100%

Progress Note inthe Patient Chart

Consent Form inthe Patient Chart

100%Percent of Procedures 100%

6%

92%

Traditional (paper) consent process

Automated consent process

O’Hara R. Electronic Support for Patient Decisions: Automating and IntegraElectronic Support for Patient Decisions: Automating and Integrating the Informed ting the Informed Consent Process. Presented at the 21Consent Process. Presented at the 21stst Annual TEPR Conference, Salt Lake City, May 17, 2005.Annual TEPR Conference, Salt Lake City, May 17, 2005.

Take Home Message:Take Home Message:

8% of the time the consent 8% of the time the consent document was lost or missing document was lost or missing

from the patientfrom the patient’’s chart!s chart!

Cost of Lost or Misplaced Cost of Lost or Misplaced Consent DocumentsConsent Documents

Cost of OR time = $20 per minuteCost of OR time = $20 per minuteTime to find or reTime to find or re--obtain lost consent obtain lost consent document ~ 10 minutesdocument ~ 10 minutesCost per case = Cost per case = $200!$200!

Annual Cost of Lost or Misplaced Annual Cost of Lost or Misplaced Consent DocumentsConsent Documents

212,000,000212,000,000 Procedures performed in the U.S. each yearProcedures performed in the U.S. each year11

8%8% Percentage of consents that are lost or misplacedPercentage of consents that are lost or misplaced22

16,960,00016,960,000 Approx. number of lost or misplaced documentsApprox. number of lost or misplaced documents

10 minutes10 minutes OR time spent replacing a lost/misplaced consentOR time spent replacing a lost/misplaced consent2,826,667 2,826,667 Hours of wasted OR time each yearHours of wasted OR time each year

$1,200$1,200 Average cost of OR time per hourAverage cost of OR time per hour33

$3,392,000,000$3,392,000,000 Cost of lost or misplaced consent documents in U.S. Cost of lost or misplaced consent documents in U.S.

5,7645,764 Number of U.S. hospitalsNumber of U.S. hospitals44

$588,480$588,480 Average Cost per U.S. hospital due to lost or Average Cost per U.S. hospital due to lost or misplaced consent documentsmisplaced consent documents

1Inpatient Surgery, Data for the U.S. for 2002, National Center for Health Statistics (NCHS)NHAMCS: 2001 Outpatient Department Summary. 2002 Emergency Department Summary.

2Pilot Study of iMedConsent - Report to the Health Systems Committee and the Informatics and Data ManagementCommittee, Veterans Health Administration. (Data on File, Dialog Medical)

3Salvati, E.A. and Wright, T.M. J Bone Joint Surg Am 85(3):428, 2003. Brodsky, J.B. Anesthesiology 88(3):834, 1998.4AHA Hospital Statistics. 2004.

Automating the Informed Automating the Informed Consent ProcessConsent Process

iMedConsentiMedConsent™™ ApplicationApplication

Automatically generates procedureAutomatically generates procedure--specific consents for every urologic specific consents for every urologic procedureprocedureComprehensive librariesComprehensive libraries

Education documentsEducation documentsPatient instructionsPatient instructionsAnatomical diagrams and imagesAnatomical diagrams and images

Standard of Care in all 158 VA Medical Standard of Care in all 158 VA Medical CentersCenters

DemonstrationDemonstration

iMedConsentiMedConsent™™ ApplicationApplication

Select SpecialtySelect Specialty

Select ProcedureSelect Procedure

Patient Selected from DatabasePatient Selected from Database

Provider Selected from DatabaseProvider Selected from Database

Consent is PopulatedConsent is Populated

ProcedureProcedure--Specific Consent Specific Consent Document is CreatedDocument is Created

Benefits and Risks are Benefits and Risks are Automatically PopulatedAutomatically Populated

Alternative and PrognosisAlternative and Prognosis--ifif--Rejected are Automatically AddedRejected are Automatically Added

Signatures are Digitally Signatures are Digitally CapturedCaptured

Signatures are Automatically Signatures are Automatically Date and Time StampedDate and Time Stamped

A Progress Note is Automatically A Progress Note is Automatically Posted to the Hospital or Practice EMRPosted to the Hospital or Practice EMR

Progress Note for Chart or EMR

Education Documents are Education Documents are Available to Provide to the PatientAvailable to Provide to the Patient

Education Documents are Education Documents are Available to Provide to the PatientAvailable to Provide to the Patient

Patient Instructions are Available Patient Instructions are Available to Provide to the Patientto Provide to the Patient

Patient Instructions are Available Patient Instructions are Available to Provide to the Patientto Provide to the Patient

Pictures and Diagrams are Pictures and Diagrams are Available to Explain ProceduresAvailable to Explain Procedures

Pictures and Diagrams are Pictures and Diagrams are Available to Explain ProceduresAvailable to Explain Procedures

Annotated Diagram, Inserted in Annotated Diagram, Inserted in Document, with Patient SignatureDocument, with Patient Signature

Drug Information Documents Drug Information Documents are Availableare Available

Drug Information Documents Drug Information Documents are Availableare Available

Response to the Response to the ImedImedConsent ApplicationConsent Application

M.D.M.D. Satisfaction and Ease of Satisfaction and Ease of Learning Learning (Emory Outpatient Urology Clinic)(Emory Outpatient Urology Clinic)

0

1

2

3

4

5

Overall Satisfaction Ease of Learning

Very Satisfied/Very Easy

Somewhat Satisfied/Easy

Neither Satisfied/Easy nor Dissatisfied/Difficult

Somewhat Dissatisfied/Difficult

Very Dissatisfied/Very Difficult

4.94.7

Ritenour C. Experience with an Automated Informed Consent Solution Experience with an Automated Informed Consent Solution –– Impact on Clinical Workflow Impact on Clinical Workflow and Patient Satisfactionand Patient Satisfaction . Presented at the 21. Presented at the 21stst Annual TEPR Conference, Salt Lake City, May 17, 2005.Annual TEPR Conference, Salt Lake City, May 17, 2005.

PatientPatient SatisfactionSatisfaction(Emory Outpatient Urology Clinic)(Emory Outpatient Urology Clinic)

0

1

2

3

4

5

SatisfactionCompared to

Traditional Consent

Overall Satisfaction

Very Satisfied

Somewhat Satisfied

Neither Satisfied nor

Dissatisfied

Somewhat Dissatisfied

Very Dissatisfied

4.74.5

Ritenour C. Experience with an Automated Informed Consent Solution Experience with an Automated Informed Consent Solution –– Impact on Clinical Workflow Impact on Clinical Workflow and Patient Satisfactionand Patient Satisfaction . Presented at the 21. Presented at the 21stst Annual TEPR Conference, Salt Lake City, May 17, 2005.Annual TEPR Conference, Salt Lake City, May 17, 2005.

ConclusionsConclusions

An automated informed consent An automated informed consent solution can benefit your practice by:solution can benefit your practice by:

Ensuring more complete informed consent Ensuring more complete informed consent documentationdocumentationEnhancing patient safetyEnhancing patient safetyAvoiding lost or misplaced consent Avoiding lost or misplaced consent documentsdocumentsImproving patient satisfactionImproving patient satisfactionImprove your efficiency and efficiency of Improve your efficiency and efficiency of your ORyour OR……ANDAND

May or likely to protect you May or likely to protect you from a malpractice suitefrom a malpractice suite

ANDANDITIT’’S GOOD MEDICINE!S GOOD MEDICINE!