The Canadian Adverse Events Study: the incidence of adverse events in hospitalized

patients in Canada

ENSP-FIOCRUZ May 31, 2006

Peter NortonProfessor and HeadDepartment of Family MedicineUniversity of CalgaryCanada

Brazil Canada

Area (sq km) 8,511,965 9,984,670

Population 188,078,227 33,098,932

Density per sq km 20 3.5

Life expectancy 72.0 80.2

% of GNP spent on health (2003)

7.6% 9.9%

MDs per 1000 1.15 2.14

The Canadian Adverse Events Study: the incidence of adverse events in hospitalized

patients in Canada

CMAJ May 25, 2004

• Authors

• From

G. Ross Baker, Peter G. Norton, Virginia Flintoft,

Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells,

William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne,

Luz Palacios-Derflingher, Robert Reid, Sam Sheps, Robyn Tamblyn

The Universities of Toronto, Alberta, British Columbia, Calgary, L’Université de Montreal, McGill University and Dalhousie University  

Reviewers

Nova Scotia: Brenda Brownell, Dr. Tom Casey, Dr. John Fraser, Kelly Goudey, Dr. Ron Gregor, Celeste Latter, and Dr. Allan ShlossbergQuébec : Dr. Edouard Bastien; Dr. Richard Clermont, Evelyne Jean, Cécile Lavoie, Dr. André Rioux. Julie Robindaine, and Daphney St-GermainOntario: Dr. Ed Etchells, Virginia Flintoft, Wilhelmine Jones Dr. Peter Kopplin, Dr. David MacPherson, and Elaine ThielAlberta: Fatima Chatur, Dr. Leslie Cunning, Dr. Peter Hamilton, Dr. Narmin Kassam and Carolyn NilssonBritish Columbia: Karen Cardiff, Dr. Robert Crossland, Dr. Iain Mackie, Cheryl Marr, Dr. Jacob Meyerhoff, Eva Somogyi and Dr. Robert Wakefield

The CAES

• First national study of the incidence of adverse events in Canadian healthcare

• Based on methods used in the Harvard Medical Practice Study, developed further in the Australia and UK studies

• Uses reviews of hospital records to identify adverse events and assess whether these events might be prevented

• Study initiated in 2002 and data collection was completed Fall 2003

• Study funded by CIHI and CIHR• Paper published in the CMAJ May 25, 2004

Study Goals1. To identify the incidence of adverse events in a

representative sample of Canadian hospitals2. To compare the incidence between medical

and surgical patients and between different types of hospitals

3. To compare the incidence to results from similar studies in England, Australia, New Zealand and elsewhere

4. To compare results from chart based review obtained from administrative data and hospital incident reporting systems (not reported in initial article)

Adverse Event

• Bad outcomes from care

• An adverse event is “an unintended injury or complication which results in disability, death or prolonged hospital stay and is caused by health care management” (Wilson et al.)

• Some AEs are not preventable

• Some errors do not cause AEs

• Adverse event = focus on outcome and patient experience

• Error = focus on process and often on the practitioner

AdverseEvents

Errors

Penicillin given at a dose of 500mg when 250 mg ordered and patient progresses as expected

Chart indicates penicillin allergybut pen ordered and given andpatient has severe allergic reaction

No history of penicillin allergyand pen ordered and given andpatient has severe allergic reaction

What was known when we started

Previous studies

Country N Publication year

Incidence of AE

Incidence of Error

USA (HMPS) 30,121 1990 3.7% -

Australia 14,000 1995 16.6% 51%

USA (Utah & Colorado)

15,000 2000 2.9% -

England 1014 2001 11.7% 50%

New Zealand 1326 2001 10.7% 71.8%

Denmark 1097 2001 9.0% 40.4%

Methods

• Five Province - BC, AB, ON, QC and NS

• 1 teaching, 1 large and two small hospitals from each

• Randomly selected charts for adult patients from fiscal 2000 – 230 for large and teaching– 142 for small

• Obstetrics or psychiatry were excluded

Methods

• Five Province - BC, AB, ON, QC and NS

• 1 teaching, 1 large and two small hospitals from each

• Randomly selected charts for adult patients from fiscal 2000 – 230 for large and teaching– 142 for small

• Obstetrics or psychiatry were excluded

Methods

• Five Province - BC, AB, ON, QC and NS

• 1 teaching, 1 large and two small hospitals from each

• Randomly selected charts for adult patients from fiscal 2000 – 230 for large and teaching– 142 for small

• Obstetrics or psychiatry were excluded

• This sample has the power to detect a real difference in AE rates of at least 3% between these types of hospitals, assuming an incidence of 9% (range 6.9%–11.1%, α = 0.05, β = 0.1)

Methods

• Five Province - BC, AB, ON, QC and NS

• 1 teaching, 1 large and two small hospitals from each

• Randomly selected charts for adult patients from fiscal 2000 – 230 for large and teaching– 142 for small

• Obstetrics or psychiatry were excluded

First Stage Chart Review

• Nurses first reviewed and selected those with one or more of 18 “triggers” for MD reviews

• Triggers included (partial list):– Unplanned admission before index admission– Unplanned readmission after discharge from index admission– Hospital incurred patient injury– Adverse drug reaction– Unplanned transfer from general care to intensive care– Unplanned return to OR– Development of neurological deficit not present on admission– Unexpected death

• 40.8% of charts were positive for one or more of the triggers

Physician Review

• First determined if an adverse event had occurred– Was there an unintended injury or complication?– If so, did it result in disability, death or prolonged hospital stay?– If so, was it caused by health care management?

• When an adverse event was present– Nature of the adverse event– How care might have contributed to AE– Effects of AE on patient and use of hospital resources– Factors contributing to the nature of AE– Preventability

Results• In the 3745 charts reviewed 858 (22.9%) were found to have

1133 injuries or complications• In 401 charts one or more injuries resulted in death, disability

at the time of discharge or prolonged hospitalization• 255 hospitalizations had one or more of these that rated 4 or

higher on the 6-point causation scale – i.e. an AE• The total number of AEs was 289 - twenty-seven (10.6%) of

the hospitalizations with AEs had more than one AE• After weighting for the sample frame, the overall AE rate was

7.5% [CI 5.7 -9.3] – this means 1 in 13 had an AE• After correcting for case mix teaching hospital had

significantly more AEs than did either large or small hospitals• Preventable AE rates were the same across the 3 hospital

types (~ 3%)

Disabilities and LOS

• 65% of AEs resulted in either no disability or minimal and moderate impairment with recovery within 6 months

• 5% of AEs (N=15) resulted in permanent disability• 40 patients who had a total of 46 AEs died• An estimated total 1.6% of people hospitalized in

Canadian hospitals in 2000 died and had an AE [CI =0.9 to 2.2%]

• Physician reviewers estimated that the 255 patients with AEs required an additional 1521 days in hospital directly related to their adverse event

Extrapolation

• Our results suggest that in fiscal year 2000 between 141,250 and 232,250 acute care hospitalizations could have been associated with an AE out of 2,500,000 similar hospitalizations in Canada

• The number of patients who had preventable adverse events and later died ranged from 9,250 to 23,750

Comparisons

• Our rates are lower than those found in several other large studies of AEs outside of the US

• The number of AEs associated with death or permanent disability is similar in this study to the recent UK, New Zealand and Australian studies

• The 2001 UK study of two teaching hospitals identified a rate of AEs(10.8%)that is nearly identical to the rate identified in the five Canadian teaching hospitals in this study (10.9%)

Types of Adverse Events  Most Responsible Service  

Type of AE Medicine Surgery Other Total

Diagnostic 26 11 1 38 10.6%

Surgical 6 115 2 123 34.2%

Fractures 2 5 1 8 2.2%

Anaesthesia 1 6 0 7 1.9%

Obstetric 0 1 0 1 0.3%

Medical Procedure 16 9 1 26 7.2%

Drug/Fluid 69 15 1 85 23.6%

Other Clinical Management

30 11 2 43 11.9%

Adverse Events not covered elsewhere 9 8 1 18 5.0%

System Event 3 4 4 11 3.1%

Total162 185 13 360  

45.0% 51.4% 3.6%    

Types of Adverse Events

• By examining the individual stories of the AEs we determined that that the most common are:– failures in diagnosis– prescription of contraindicated drugs– incorrect management of organ failure

Where do the AEs occur?

• Just over 40% of the AEs are classified as having occurred on the ward

• 27% occur in the OR

• 17% in out patient settings

Is the number right?• The CAES as designed gave a systematic underestimate of the

rates • The reasons:

– The first level review selected 40% of charts for second review which determined if AEs had occurred. This was done using triggers that select charts with higher probability for AEs however some of the charts not selected will have AEs

– The reviewers only had access to the chart. Many AEs occur and are not recorded in the charts

– Some of the charts randomly selected for review were not available to the reviewers (others were substituted). The reasons charts are not available include being in the hands of lawyers and coroners, being in the hands on management who are dealing with complaints or incidents and that the patient has been readmitted. All of these increase the likelihood that that chart contained an AE.

• Both the literature and experts believe that the methods used in the CAES find between ⅓ and ¼ of the actual AEs

Dissemination and Impact

• Paper was downloaded over 25,000 times in the first four days

• Over 40 national and regional media contacts in the first 4 weeks

• Multiple presentations over the next year

• Acceleration of patient safety initiatives in Canada

What happened in the media?

• “Medical errors kill 24,000 per year; rates double those of US”

– National Post May 21 2004

1. Study estimate is 16,500 not 24,000

2. Rates not directly comparable to US studies

Canada vs US

• Quality• Exclude low risk• Events detected 12

months after index• Events occurring 12

mos prior to index• 2000

• Medicolegal• No• No

• No: 6 months if under 65

• 1984 & 1992

The Globe and Mail

• “Study shows that medical mistakes affect about 7.5% of patients”

– Picture of 4 yr old who died

No:

2.8% preventable adverse events

Why did we do a Canadian study?

• It appears that a critical element for accelerating safety work is that a country has its own data

• However the number is an underestimate and so the method cannot be used as an outcome measure for safety

• We believe that modeling can be carried out on the data to delineate:– Possible areas for improvement – High hazard situations– Management opportunities

Additional results from the CAES

Possible areas for improvement

What about age?

Percent of types of AEs by age category

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

30-49 50-69 70+

Age

Preventable

Permanent disability

Note: 1. There were only 215 files reviewed for patients with ageless than 30 and only 8 had AEs. Due to these small numbers we have chosen not display these data. 2. The differences in the permanent disability by age is significant (chi-square = 12.1, 2 df, p = 0.002)

Relationship of LOS and AE occurrence

• We reported that those with AEs had longer LOS (small = 7.7, large = 3.6 and teaching = 6.2 days)

• We asked if LOS increase was associated with increased risk of AE

• When should we review patient as LOS increases?

LOS (days)

0-2 3 4-5 6-7 8-11 12 or more

AE No Count 509 489 771 538 579 600

% 96.4% 97.0% 96.3% 94.1% 92.1% 84.9%

Yes Count 19 15 30 34 50 107

% 3.6% 3.0% 3.7% 5.9% 7.9% 15.1%

Total Count 528 504 801 572 629 707

LOS (days)

0-2 3 4-5 6-7 8-11 12 or more

AE No Count 509 489 771 538 579 600

% 96.4% 97.0% 96.3% 94.1% 92.1% 84.9%

Yes Count 19 15 30 34 50 107

% 3.6% 3.0% 3.7% 5.9% 7.9% 15.1%

Total Count 528 504 801 572 629 707

Pearson Chi-Square = 111.2, 5 df, p<0.0001Linear-by-Linear Association = 83,3, 1 df, p<0.001

LOS -days

So what is next?

The research

• Additional studies are underway now– Family medicine (community based care)– Home care– Mental health– Long term care

– How and why institutions learn from AEs

Applied researchQuality improvement

Improving the system

Safer Healthcare Now!

• A grassroots campaign

• Implementation of six targeted and proven interventions in hospital based patient care

• Credible evidence that these six interventions can make a real difference in reducing avoidable adverse events and lead to reduced mortality and morbidity

• All are ‘low tech’

6 Key Interventions

• Deployment of Rapid Response Teams

• Delivery of reliable, evidenced based care for acute myocardial infarctions

• Prevention of ADEs

• Prevention of central line infections

• Prevention of surgical site infections

• Prevention of ventilator- associated pneunomia

Eg. Surgical Site Infections

• Four specific activities– Don’t shave the skin but clip the hair– Make sure prophylactic antibiotics are given

(and stopped) on time– Carefully monitor and control the blood sugar

during the operation– Carefully monitor and control the body

temperature during surgery

A Canadian Campaign

• Informed by the American effort• Launched on April 12, 2005• Goal was to enroll 100 or more frontline teams

to work on improvement and safety December 2006

• Four regional nodes• National faculties for each intervention • National coordinating group• Support for measurement

– National and local

Key Campaign Principles

• “Some is not a number; soon is not a time.”

• Welcome anyone at any level.

• We do this together (i.e. we are forming ‘communities of practice’)

Campaign Elements

• Platform – The scientific basis for our work

• Measurement – How we measure our progress (both process and outcomes)

• Field Operations – How we spread the Campaign across the country and implement improvements successfully

• Communications - How we publicize the Campaign’s progress and successes

Who is involved?• Administration: Approves and

provides organizational support for the SHN campaign

• Teams: Frontline healthcare providers who intend to implement the initiatives

• Patients and Families: Provide feedback and information to teams

• Communication Teams: Raise awareness of the campaign both internally and externally

• Safer Healthcare Now!: Provide ongoing support to teams within their jurisdiction

Safer Healthcare Now!

Communicators

Administration Patients and

Families

Teams

Progress• Current enrollment of 409 teams enrolled from 152

health care organizations across Canada• Nodal activities include the following:

– Raising awareness of the campaign – Promoting enrollment – Facilitating educational opportunities – Coordinating clinical quality improvement and assistance

measurement– Sharing information among the nodes – Monitoring progress and facilitating resolution of challenges

within the geographic node • National activities

– Coordination– Measurement– Sustainability

Some sucesses

• Sevearal organizations with no VAP for six months

• Several pediatic hospitals with no CL infections for six months

• Early indications of reduced mortality in the ICUs of several hospitals

Why Participate in SHN?“To not participate is not an option, It is not about spending additional

health care dollars, rather it is about our obligation to provide a safe clinical experience for the patients who walk through our doors and put their trust in us.” David Rowe, Senior Vice-President, Credit Valley Hospital, Ontario.

“The SHN has provided us with leadership and coordination of the interventions. As well, there has been excellent information sharing and collaboration with those participating in the interventions within and across the nodes.” Kim Cook, Vice-President of Patient Services & Chief Nursing Officer, Headwaters Health Care Centre, Alberta.

Safety is not a program, it is a

way of life