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1 Slides on Improving Patient Safety Using Other-Than-Evidence- Based-Practices Noel Eldridge, MS May 28, 2008 (edited again on May 9, 2012) (As promised as a follow up to those who were interested in what I said at the 2008 NPSF Annual Meeting) VA Website: http://www.patientsafety.gov/

Improving Patient Safety Using Other-Than-"Evidence-Based" Practices

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Looks at PS and what has been done in other areas (like auto safety) to improve safety. Argues that action should be taken in the absence of surety that the action will work - based on prior rigorous scientific studies.

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Page 1: Improving Patient Safety Using Other-Than-"Evidence-Based" Practices

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Slides on Improving Patient Safety Using Other-Than-Evidence-Based-Practices

Noel Eldridge, MS

May 28, 2008 (edited again on May 9, 2012)(As promised as a follow up to those who

were interested in what I said at the

2008 NPSF Annual Meeting)

VA Website: http://www.patientsafety.gov/

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How to Improve Healthcare Outcomes• Basic Scientific Method applied to Health Services Research in

Plain English: Do the same thing that another group did that improved an outcome where they did their thing (when based on a paper with good p-values in the peer-reviewed literature)

• Problems applying this good concept to patient safety… – Assumes that patient safety interventions are like taking pills by

mouth, i.e., it doesn’t really matter how you swallow them: one at a time, two at a time, with water, with a Coca-Cola, etc. (just avoid grapefruit juice for some meds, and take others with food).

– Patient Safety interventions like implementing Rapid Response Teams or a multifaceted hand hygiene improvement project are not like pills: it does matter how you administer them, and it also matters if you try hard to make them work; for example

• by identifying and eliminating problems that are making them not work as you proceed (which is not really allowed in controlled scientific endeavors), and

• by providing and demonstrating committed leadership that makes it clear that the implementation project will not be dropped even when the first, second, and third excuses to drop it arise.

– Patient Safety Improvement assessment methods are almost always hopelessly and inherently confounded (in epidemiologist-speak) and suffer from low quality data… the scientific method is the ideal but one needs to recognize that we need to be able to make progress despite confounded and low-quality data.

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What else is there?

Q: If we don’t improve patient safety primarily based on standard evidence-based-medicine, then what do we do?

A: Depend primarily on the combined findings of, and responses to, many accident investigations. Why? Because this is the primary way that safety has been improved in other areas where safety has actually been improved in recent decades.

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What is Safety?

• Safety is Freedom from Accidental Injury.

• Patient Safety Improvement is dedicated to making patients free from accidental injury as they receive healthcare.– Not performing the wrong operation– Not accidentally putting MRSA bacteria onto a

patient’s skin– Preventing fall injuries, etc.

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Where Does a Culture of Safety Exist?

• Would you agree to fly on a bankrupt airline to save $100?

• Would you agree to get elective surgery at a bankrupt hospital to save $100?

• Are your answers different? If so, why?– Think about it – you’ve probably already flown on a

bankrupt airline without even thinking about it.• Do you trust the airline “system” of regulators, managers,

pilots, and mechanics in a different way than you trust the healthcare “system”?

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A BASIC QUESTION…

• How has safety been improved in other settings?

– Let’s look at things that were formerly unsafe and are now a lot safer and see how they became safer… Isn’t this obvious?

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Where Else Has Safety Improved?

• From 1966 to 1999 Automobile Fatality Rate went down 68% (shown). Down ~75% thru 2004.

• How was this done?

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Car Safety Statistics• In 1966 the death rate was 5.5 deaths per 100

million vehicle miles. (1 in 36 chance of dying for 500,000 miles.)

• It was 3.0 in 1982, 1.75 in 1992, and is now about 1.5 per 100 million vehicle miles.

• This is a ~ 70% reduction over 40 years.• Seat belt use was 11% in 1981 and 68% in

1997. – By 1989 34 states had mandatory seat belt laws.– Allowing police stops for seatbelt-only infractions

increases compliance greatly – 91% in Calif.• One other behavioral change has been the

reduction in drunk driving. (The drunk driving death rate was 1.6 in 1982 and 0.6 in 2002.)

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Do We Know How it Improved? • Did we know that laws on drunk driving and on

the use of seat belts would work?• Many simultaneous technology improvements

were implemented, based on…– Scientific “evidence”?– Reviewing the results of accident investigations?– “Common-sense?”– Public pressure/horror stories/lobbying?– Laboratory studies/simulations?– Cost/benefit analyses/Business cases?

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Some Car Safety Improvements• Seatbelts

– Front shoulder belt• Automatic (passive) front shoulder

– Rear shoulder belt– Rear center shoulder belt– Spring-based self-tensioning – Computerized self-tensioning

• Front and rear “crumple zones”• Front air bags

– Passenger side disconnect– Side “curtain” air bags

• Padded dashboard• Padded steering wheel• Padded ceiling• Front “headrests”• Rear “headrests”• Passenger-side mirror• Safety windshield glass • Radial tires• Run-flat tires• Hands-free cell-phone capability• Intermittent front window wiper

– Variable rate intermittent wiper– Rain-sensing front window wiper

• Rear-window defogger• Rear-window wiper

– Rear-window intermittent wiper• Power brakes• Disc brakes• Anti-lock brakes• Stability control• Fog lights• Halogen headlights• Always-on headlights• Headlights with wipers• Eye-level rear-end center brake light • Passenger-side map light• Rear-seat-only map light• Mirror in passenger-side sun visor• Tire-pressure sensor and warning light• Safer electric window controls• Child-safe rear seat door locks• Latch to escape from locked trunk• Integrated child-seat• Special anchor for child seat• Front wheel drive• Four wheel drive

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Roads were getting safer too…

Side Rumble Strips (Use spreading since 1950s)

Center-line Rumble Strips(Not in widespread usebut some preliminary data suggests reduction in head-on collisions)

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Side Rumble Strip Studies and Associated Crash Reductions

State (date) Roadway Type Percent Crash Reduction

Massachusetts (1997) Turnpike, Rural 42

New Jersey (1995) Turnpike, Rural 34

Washington (1991) Six Locations 18

Kansas (1991) Turnpike, Rural 34

FHWA (1985) Five States, Rural

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note: The FHWA study included Arizona, California, Mississippi, Nevada and North Carolina

source: http://safety.fhwa.dot.gov/rumblestrips/effectiveness/wy.htm

As before: “Correlation is not causation.”

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Less Deaths in Cars: Best Guesses

1. Seat Belts Actually Being Used

2. Less Drunk Driving by All Ages & Lowering of the Drinking Age

Both of the above were accomplished by a combination of harder (police) and softer (culture change) forces.

3. Automotive Technology Improvements

4. Roadway Improvements

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Or maybe a different explanation?

• Trauma care in emergency rooms and getting people to hospitals faster is a big part of the reason why the murder rate has gone down – e.g., fewer stabbing victims die these days. Same thing for car accident victims?

• Is all this data hopelessly confounded?• But wouldn’t it be nice to have this

argument re patient safety: What has made it so much better than it used to be?

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How to Establish an Evidence Base for Fire Safety?

• Perform double-blind placebo-controlled fire extinguisher studies in restaurant kitchens?

• Build a few hundred identical nightclubs with and without sprinklers or fire extinguishers, set up a system for reporting incidents related to pyrotechnics and kitchen fires, wait 20 years for statistically significant outcomes data? Before starting the study argue for years about allowing reporting of fires caused by illegal activities (e.g., smoking) into evidence base?

• Why are these stupid ideas? Because people will die in the interim and we know the interventions are unlikely to hurt even if the cost/benefit is sometimes uncertain.

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Open Question: Is the Electronic Health Record for Hospitals and Health Care Systems like a Fire Escape in 1910?

• Do you need more proof to install it?• Do you have to see the business

case for it?• Can it cause new kinds of

accidents?• Will you build it only after everyone

else is forced to do it too?• Is a potentially better technology

coming?• Is there a way to do it sooner?

Especially since you know you will have to do it sooner or later?

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Triangle Shirtwaist Factory Fire of 1911

• March 16, 1911 A report on fire traps is published.  The report argues that many New York City buildings lack “even the most indispensable precautions necessary.”

• March 25, 1911 Shortly before quitting time, a fire breaks out on the eighth floor of the building housing the Triangle Shirtwaist factory.  The fire kills 146 victims.

• April 2, 1911 A meeting is held to discuss concerns over lack of safe working conditions in New York City's factories.  Resolutions are passed demanding new legislation.

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What a Triangle Shirtwaist Factory Fire Every Day Would be in U.S. Healthcare

• 146 x 365 = 53,290 deaths• 53,290 / 6,007 = 8.9 per year per hospital• 365 / 8.9 = 41 days between deaths

or• 53,290 / 36,600,000 = 0.15%

(1 in 675 admissions)• Not so hard to believe… but would be 2.1% of all

deaths in US (53,290 / 2,443,387)• IOM said 44,000 to 98,000 in 1999. Estimates since

have ranged from about 15,000 to over 200,000.

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Are we there yet?

“From a certain point forward there is no longer

any turning back. That is the point that must be

reached”

- Franz Kafka

“They say that time changes things, but you

actually have to change them yourself”

- Andy Warhol

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Do sweat the small stuff

• This is part of a culture of safety – not being fatalistic, cynical, or hopeless about policies, processes, and “facts” that have to be accepted; for example, that government funds can’t be used to buy tissues (“Kleenex”) that will be used by staff.

• This had become an accepted “reality” at a number of VA facilities when someone brought it to my attention and asked me to see if it was true.

• Result is on next slide.21

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Recently we have received a number of questions about whether is it legal to buy facial tissues. At issue is whether or not the facial tissues are considered personal

items. We have discussed this issue with Department logistic and financial staff as well as VHA clinical staff.

The following provides a basis for the decision that was reached: For patient-care areas and areas frequented by those who come in direct contact with patients, facial tissues should be considered similarly to other expendable supplies that VA workers may use as they perform their duties during work hours. For example, VA supplies disposable respirators, gloves, and surgical scrubs and gowns, all of which are employed by staff to protect patients from the spread of infectious agents. This type of expenditure is clearly appropriate. On the second point, recent guidance from the CDC, JCAHO, the National Health Information Center of the Department of Health and Human Services, and the American Lung Association have all included recommendations for using tissues to cover coughs and sneezes to prevent the spread of infectious agents. First among these infectious agents are viruses that cause upper respiratory infections such as cold and flu, but another agent of concern is Staph. aureus (SA), including methicillin-resistant SA (MRSA), either of which can cause skin and wound infections. Various estimates put the percentage of healthcare workers whose nasal passages are colonized with SA at about 30-40%. (The percent colonized by MRSA is not well described and seems likely to vary widely.) SA and MRSA can be expelled from the nose during a sneeze and live for days or weeks on substrates such as clothes, linens, curtains, countertops, and other environmental surfaces where they can be picked up on hands or transferred to other surfaces and eventually patients. Using a tissue to reduce the dispersion of droplets and the gross contamination of hands or clothes is imperfect but is widely recommended as a basic measure to control the spread of infectious agents.

Conclusion: Facial tissues to be used in patient care areas and areas frequented by those who come in direct contact with patients can be purchased with appropriated funds. This memo should not be

taken as a mandate to generate any new requirement to provide tissues in specific locations or at any pre-set density. Decisions on this topic should be made locally and incorporate local circumstances and considerations.

(Agreed upon by: Fiscal, Accounting, Legal, Network Clinical Managers, Public Health, Environment of Care, Infectious Diseases, Patient Safety, in about 3 weeks; then distributed.)

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END OF CORE SLIDE SET

• Some additional slides on related topics follow.

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What is a Culture of Safety?

Everyone “buys-in” to the following 3 things: 1) Safety is a topic of real consequence to the

health and perpetuation of the organization and its customers.

2) Safety can be improved and assured – we know how, in general and in particular. And each of us can influence safety as we work.

3) Mutual trust: Staff trusts management not to punish them for identifying safety problems or incidents. Management trusts staff to tell the truth and to figure out what happened and why, and to propose and implement effective fixes.

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Patients Participating in Patient Safety

• Hospital patients shouldn’t have to do a lot.• Why?

– People are sick in the hospital – even sicker than they used to be.

– Many sick people aren’t at their best mentally. (I know this firsthand)

– Sick people receiving healthcare shouldn’t have to be vigilant about it. (opinion)

– Sick people aren’t good at being vigilant without becoming paranoid or belligerent. (personal observation)

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Participating in Safety

• What do car drivers have to do?– Follow basic driving rules (pass written & road test)– Put on seatbelts, put kids in car seats– Maintain vehicle’s safety systems (e.g., brakes)

• What do bus passengers have to do?– Get on the correct bus & pay the fare– Follow basic bus rules – stay behind white line, don’t

talk to driver while bus is in motion, don’t do anything crazy like leaning out of an open window

– Keep track of where you are -- look out of the window so you can ring bell at correct place to get off

• What should patients have to do?

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What Patients Should Do (1)

• Some basics (applying to inpatients and outpatients to differing degrees)…– Participate in informed consent that is really informed

and really consent. (Think mortgage, not rental-car agreement.)

– Ask questions until you understand to the extent that you care to understand.

– Try hard not be accusatory, providers intend to help…and most of the time that’s what will happen (or at least no harm).

– Pay attention to the extent possible.

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What Patients Should Do (2)

– Tell the doctor the truth about your symptoms and history.

– Take your medicine or tell the doctor if you stop.– Willingly participate in safer systems – e.g., don’t

complain about being asked your name 3 times by 3 different people.

– Make a written list of symptoms, questions, etc., to review during visit or interaction with clinician.

– When there’s a “better” choice – actually choose the better provider, hospital, health plan, etc. However, one problem is the contradictory definitions of a better doctor – more timely, nicer, smarter, more up-to-date, safety-conscious, good listener, good referrer, gentler, etc.