Session Objectives Improve the safety of your patients Ensure - - PDF document

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Automating Informed Consent – Are You Overlooking a Safety Opportunity?

Neil H. Baum, MD

Associate Clinical Professor of Urology Tulane Medical School Louisiana State University Medical School

Timothy Kelly, MS, MBA

Vice President, Dialog Medical

Session Objectives

Improve the safety of your patients Ensure compliance with regulatory

• rganizations

Reduce your Med/Mal risk Generate significant cost savings Endear yourself to your physicians

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Origins and Evolution

• f Informed Consent

Doctrine

Origin of Informed Consent

Protection against battery. Justice Brown, Appellate Court of Illinois, 1905: Under a free government at least, the free citizen's first and greatest right, which underlies all others—the right to the inviolability of his person, in other words, his right to himself—is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, advise, and prescribe (which are at least the necessary first steps in treatment and care), to violate without permission the bodily integrity of his patient by a major or capital operation, placing him under an anesthetics for that purpose, and operating on him without his consent or knowledge. . .

Pratt v. Davis, 118 Ill. App. 161, 1905 WL 1717 (Ill. App. 1 Dist.)

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Origin of Informed Consent

Spelled out in statutes

and case law in ALL 50 states.

Examples of State Statutes

Texas and Louisiana both have Medical

Disclosure Panels that specify specific risks that must be disclosed for certain procedures.

Pennsylvania law requires that

physicians disclose their professional credentials, training or experience if so asked by a patient.

TX LA PA

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Necessary Elements of Informed Consent

Diagnosis Purpose of treatment or procedure Risks and benefits of treatment or

procedure

Alternatives including risks and benefits The risks and benefits of not receiving

treatment

American Medical Association, Office of the General Counsel, Division of Health Law, www.ama-assn.org, accessed 11-1-05.

Current Status of Informed Consent

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

How Are We Doing?

Best-Case Reality

Physicians typically do a good job with the one-

way verbal communication aspect.

Documentation is usually inadequate.

Worst-Case Reality

“…informed consent is often seen as simply a

burdensome administrative practice that involves

• btaining a signature on a form for the legal

protection of physicians and institutions.” 1

Improving Patient Safety Through Informed Consent for Patients with Limited ith Limited Health Literacy. 2005. Washington DC: National Quality Forum. Health Literacy. 2005. Washington DC: National Quality Forum.

Traditional Consent Forms

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Traditional Written Consent Form

Note:

Limited

descriptions

Illegible

handwriting

Use of

unacceptable abbreviations

Limitations of Traditional Informed Consent Documents

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.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Limitations of Traditional Consent – VA Experience

A review of 91 written consent forms for

radical prostatectomy:

Issa MM, et al. AVAS Scientific Symposium, Houston, April 2002.

• The potential need for blood

transfusion was disclosed on 90%

• f the consent forms.
• HOWEVER, proper consent for

blood products was ONLY obtained in 18% of the cases.

Patient Safety and Informed Consent

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Patient Safety

IOM Report – To Err Is Human

More than 1 million injuries and nearly 100,000

deaths occur annually in the United States due to mistakes in medical care.

Agency for Healthcare Research and Quality

Evidence Report

Identified 79 evidence-based patient safety

practices (e.g. use of perioperative Beta-blockers, use

• f CPOE, use of antimicrobial impregnated CVC

catheters, active management of ICU patients by intensivists, etc.)

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

Patient Safety

The AHRQ Evidence Report identified 11

practices that were rated most highly in terms of strength of evidence – one of the 11 – Enhanced Informed Consent

Incomplete or not fully comprehended

informed consent is a significant patient safety issue.

Better informed patients “are less likely to

experience medical errors by acting as another layer of protection.”

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Patient Safety

National Quality Forum Safe Practices

30 healthcare practices that should be

universally utilized in applicable clinical care settings to reduce the risk of harm to patients.

Safe Practice No. 10 – Enhanced Informed

Consent.

Patient Safety

Leapfrog Group

Made up of more than 170 companies and

• rganizations that buy health care –

represent >36 million covered lives and

• ver $67 billion in healthcare spending.

Enhanced Informed Consent is a key

component of The Leapfrog Group Hospital Quality and Safety Survey.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Patient Safety – The Leapfrog Group

Less than one-third of all hospitals

responding to the Leapfrog Group’s 2004 survey (287 out of 862 institutions

• r 33%) reported that they had fully

implemented programs to help meet the goals of Safe Practice 10.

Implementing a National Voluntary Consensus Standard for Informed Consent – A User’s Guide for Healthcare Professionals. 2005. Washington DC: National Quality Forum.

Enhanced informed consent is a component

• f the Safe

Practices Score

www.leapfroggroup.org Accessed 11-1-05.

The Leapfrog Group Hospital Quality and Safety Survey

Did not yet meet Leapfrog’s criteria for a good early stage effort.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

An opportunity to improve upon the informed consent process.

The Leapfrog Group Hospital Quality and Safety Survey

www.leapfroggroup.org Accessed 11-1-05.

2 of 8 points (25%)

Other Costs Associated with Inadequate or Traditional Informed Consent

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Informed Consent Costs

Medical malpractice/legal liability costs Transcription costs Costs associated with a paper-based

process

Document scanning costs Impact of lost or misplaced documents

Medical Malpractice/Legal Liability Costs

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Malpractice Expenses and Informed Consent

Inadequate informed consent is often

used as a secondary cause in malpractice complaints – studies have shown this strategy was pursued in more than 90%

• f ophthalmologic malpractices cases.

Kiss CG, et al. Archives of Ophthalmology 2004;122:94-98.

Potential Legal Impact of Informed Consent

Study of medical malpractice claims

against urologists1

Postoperative complications most common

claim of negligence

Malpractice premiums for urologists

have increased 57% during the past three years2

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Predictors for Malpractice Lawsuits

“One of the strongest is the doctor's ability to

communicate effectively with the patient. Informed consent problems are more likely to arise for a doctor who doesn't communicate well. But perhaps even more importantly, a doctor who doesn't communicate well is not likely to build a healthy relationship with a patient such that if a bad outcome did happen in medical care, the patient would be inclined to forgive rather than sue.”

Michelle Mello, PhD, JD, Harvard School of Public Health. NPR Radio Interview: January 15, 2005.

Litigation Risk

Lack of adequate informed consent is

• ne of the top 10 most common reasons

for hospital malpractice claims.

A signed consent form is a minimum

standard, but it's not an adequate substitute for a note recording the detailed informed consent discussion in the patient’s chart.

Glabman M. Trustee. 2004;57(2):12-16. Rice B. Medical Economics. July 8, 2005. Bhattacharyya T, Yeon H, Harris MB. J Bone Joint Surg Am. 2005; 87:2395-2400.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Paper Costs Costs of Handling Paper

Costs associated with scanning consent

documents:

O’Hara R. 21 21st

Annual TEPR Conference, Salt Lake City, May 17, 2005.

Annual costs of scanning consent forms

and advanced directives at 3 VA facilities ~$80,000 per facility.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Cost of Lost or Misplaced Consent Documents

Study of Missing Consent Documents (Two VA Medical Centers)

0% 20% 40% 60% 80% 100% Progress Note in the Patient Chart Consent Form in the Patient Chart

100% Percent of Procedures 100% 6% 92%

Traditional (paper) consent process Automated consent process

O’Hara R. 21 21st

Annual TEPR Conference, Salt Lake City, May 17, 2005.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Take Home Message:

8% of the time, the consent document was lost or missing from the patient’s chart!

Cost of Lost or Misplaced Consent Documents

Cost of OR time = $20 per minute Time required to find missing consent

• r obtain replacement consent from

patient or surrogate ~ 10 minutes

Cost per case = $200!

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Annual Cost of Lost or Misplaced Consent Documents

212,000,000 Procedures performed in U.S. each year 8% Consents that are lost or misplaced 16,960,000 Apprx. number of lost/misplaced documents 10 minutes OR time spent replacing lost/misplaced consents 2,826,667 Hours of wasted OR time each year $1,200 Average cost of OR time per hour $3,392,000,000 Cost of lost or misplaced consent forms 5,764 Number of U.S. hospitals $588,480 Average Cost per U.S. hospital due to lost

• r misplaced consent documents

Bottom Line…What are the Costs?

OR delays Increased risk of malpractice Scanning and paper costs

and most important of all…

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

…Cost of Losing a Physician

Priceless

Opportunity: Automating the Informed Consent Process

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Key Advantages to Automating the Informed Consent Process

Leverage existing Healthcare IT

investments

EMR Document Management System

Address the latest guidelines and

requirements

Patient Safety Regulatory/Compliance/Reimbursement

Latest Guidelines and Requirements

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

NQF Safe Practice 10 – Comprehension

Ask each patient or legal surrogate to

recount what he or she has been told during the informed consent process

Comprehension

Fully informed consent is a rare

phenomenon – occurring only 9% of the time in one study.

Most patients (60%) do not understand

the information contained in the typical informed consent form.

Braddock CH, Edwards KA, Hasenberg NM, et al. JAMA 1999;282(24):2313-2320. Parker R. Health Promotion International 2000;15(4):277-283.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Other Research on Informed Consent and Patient Safety

Providing informed consent information

to patients in written form increases the patients’ comprehension of the procedure.

Better informed patients are more

compliant, are less anxious and are more satisfied.

Winfield AC, et al. Urologic Radiology 1986;8:35-9. University of Cambridge: The Informed Patient Study Report. 2003.

Accreditation/Compliance

Critical Access Hospital Standards

Specifies that an institution must have a

policy for informed consent – which procedures, process, how documented, surrogate decision makers, etc.

Specifies the exact elements that must be

part of the informed consent discussion.

JCAHO Standard RI.2.40

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Accreditation/Compliance

CMS Interpretive

Guidelines for Informed Consent [§482.51(b)(2)]

Documentation of all

practitioner names and “significant surgical tasks” on the informed consent form

Automated Informed Consent Demonstration

Constructing a Consent for a CABG (with multiple providers) Comprehension Evaluation

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Experience with Automated Informed Consent Applications Electronic Support for Patient Decisions Initiative

September 2004 – Department of

Veterans Affairs announced the Electronic Support for Patient Decisions initiative

As of September 2005, an automated

informed consent solution – is in use in ALL 162 VA medical centers

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

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

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

4.9 4.7

Ritenour C. 21 21st

Annual TEPR Conference, Salt Lake City, May 17, 2005.

Patient Satisfaction

(Emory Outpatient Urology Clinic) 1 2 3 4 5

Satisfaction Compared to Traditional Consent Overall Satisfaction Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Somewhat Dissatisfied Very Dissatisfied

4.7 4.5

Ritenour C. 21 21st

Annual TEPR Conference, Salt Lake City, May 17, 2005.

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

What Healthcare Institutions Can Do

Review Your Current Informed Consent Process

JCAHO

Are you following your own procedures?

Audit your forms – on a regular basis!

Review for completeness Check consistency provider-to-provider Confirm signatures and dates

CMS

Documenting all practitioners and tasks

Are there notes in the chart or EMR?

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Automating Informed Consent Automating Informed Consent – – Are You Overlooking a Safety Opportunity? Are You Overlooking a Safety Opportunity?

2006 Annual HIMSS Conference February 12-16, 2006 San Diego

Evaluate Standardized or Automated Solutions

Does your state mandate a particular

form or documentation of procedure- specific risks?

Visit a VA facility

Excellent examples of standardization and

EMR integration

Research providers of automated

informed consent solutions

Conclusions

An automated informed consent solution

can benefit your institution by:

Enhancing patient safety Ensuring more complete informed consent

documentation

Avoiding lost or misplaced consent

documents

Improving the efficiency of your staff and

the efficiency of your OR

Improving patient and physician satisfaction