Reduction in medical error rates when implementing a 48h EWTD-compliant

rota for junior doctors in the UK: a single-blind intervention study

FP Cappuccio1,3, A Bakewell1, FM Taggart1, G Ward1, C Ji1, JP Sullivan2,

M Edmunds3, R Pounder4, CP Landrigan1,2, SW Lockley1,2, E Peile1 on behalf of the Warwick EWTD Working Group

1Sleep, Health & Society Programme, Clinical Sciences Research Institute, Warwick Medical School, Coventry, UK; 2Harvard Work Hours Health & Safety Group, Harvard Medical School, Brigham and Women’s Hospital and Children’s Hospital, Boston, MA, USA; 3University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK; 4Royal College of Physicians, London, UK

Background (1)

• 1993 EWTD: limiting the maximum required working hours to 48/wk (average over up to 6 mo) to protect employees’ health and safety and improve patient safety

• 1998: adopted into UK law through the Working Time Regulations• Extension up to 12 yrs before full implementation• 2003 European Court ruling: resting and sleeping time during duty in

hospital should be considered as working time• Aug 2005: Changes affecting medical profession phased over 5 years

(junior doctors’ six-monthly average weekly working hours reduced from 72 to 54)

• The New Deal: BMA negotiations with DoH to improve lives of junior doctors – key feature to reduce extended working hours and ensure adequate rest was built in rotas

• Aug 2009: EWTD-compliant rotas must be in place

Background (2)

2004: UK Multidisciplinary Working Group of the Royal College of Physicians established to:

– develop practical advice for junior doctors working night shifts– guide those designing rotas for junior doctors

2006 Recommendations of the UK EWTD WP of the RCPi. Rotas involving seven consecutive 13h night shifts may increase risks to patients and

staff, and should be avoidedii. Number of night shifts in succession should be limited to a maximum of four, and their

length reducediii. Encouraged to testing of three 9h shifts to cover 24h to achieve improved health, safety,

teaching and supervision, and efficiency.iv. Using an evidence-based approach, hospitals should implement optimal 48h rotas by

2009v. A ‘cell’ of 10 junior doctors is necessary for any post that provides 24h cover, plus

specialty work and training

Need to implement EWTD competes with demands to– maintain medical cover at all times– provide safe and effective healthcare to patients – ensure doctors access educational and training opportunities– ensure safety and quality of life of doctors

Background (3)

• Considerable controversy– Concerns raised about

• Doctors’ and patients’ lives at risk (BMJ 2005;330:1404)• Reduced time available for training, with negative impact on clinical experience

and quality of care (BMJ 2007;334:777. BMJ 2008;336:345. Clin Med 2008;8:126-7)

– Without exceptions, assertions based on opinions, anecdotes or non validated questionnaires

(Occup Environ Med 2007;64:733-8. Ann R Coll Surg Engl 2008;90:60-3 and 68-70. BMA 2008)

• Evidence– Studies in the US show that a reduction in total hours worked in a week and

in the duration of each shift results in• More sleep (i.e. less fatigue)• Fewer attentional failure• Fewer serious medical errors• Fewer car crashes when doctors’ driving home after a shift• Fewer sharp injuries

(NEJM 2004;351:1829-37 and 1838-48. NEJM 2005;352:125-34. JAMA 2006;296:1055-62. PLoS Med 2006;3:e487)

• To study the effects of implementing an EWTD-compliant 48h week rota on– Patients’ safety– Doctors’ work-sleep patterns– Quality of life and well-being– Quality of handover

• Comparing the effects of an EWTD compliant 9h shift system versus a traditional rota for junior doctors at UHCW

Aims of our study

No objective evidence in the UK and Europe

Methods (1) - Study period and design

• 7th May – 31st July 2007 (12 weeks)– MTAS time!!!

• 12-week single-blind intervention trial– Intervention group (9h shift system=48h/wk)– Traditional Group (traditional shift system=56h/wk)

• Intervention group (n=9) – CDU and Endocrinology

• Traditional group (n=10) – Respiratory and Care of the Elderly

• Rota adjustment after 6 weeks (to increase day-time cover and extend night shift from 9h to a max of 11h)

Self-reported sleep times () and work hours () are shown for four junior doctors while working on either a 56-hour schedule (Subjects 1 and 2, left panels) or a 48-hour schedule (Subjects 3 and 4, right panels).

Methods (2): examples of junior doctor work and sleep patterns

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

6:00 12:00 18:00

6:00 12:00 18:006:00 12:00 18:00

6:00 12:00 18:00

Clock time (h) Clock time (h)D

ay

of

we

ek

Da

y o

f w

eek

Subject #1

Subject #2

Subject #3

Subject #4

Traditional 56-h rota Intervention 48-h rota

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

MTWTFSSMTWTFSS

6:00 12:00 18:00

6:00 12:00 18:006:00 12:00 18:00

6:00 12:00 18:00

Clock time (h) Clock time (h)D

ay

of

we

ek

Da

y o

f w

eek

Subject #1

Subject #2

Subject #3

Subject #4

Traditional 56-h rota Intervention 48-h rota

Methods (3)

• Retrospective manual case note review Random selection

916 case notes out of 1677 admissions (55%) Episode of care >24 hours Institute for Healthcare Improvement Global Trigger Tool

Trigger words e.g. confusion, warfarin, hypotension Clinical Adverse Event forms Incident identified - descriptive information collected Incidents submitted to physician review (2 or 3)

Reviewers blind to allocated rota Error classification Error type

• Statistical analysis Error rate per 1,000 patient-days Intervention effect by intention-to-treat analysis Hazard ratios

Methods (4) - Incidents detected

Preventable Adverse EventOn warfarin, INR not monitored bled

Intercepted Potential Adverse Event Prescribed contraindicated drugs (pharmacy note)

Non-intercepted Potential Adverse Event Drug allergy not recorded on prescription chart (but not prescribed during stay)

Minor errorBlood tests not repeated as planned (but improved)

Results (2) - Distribution of scheduled weekly work hours across 12 weeks by group

52.411.2 vs 43.27.7 h/week; p<0.001

Range: 26 to 60 h/weekRange: 30 to 77 h/week

25% >58h

2% >58h

Results (3) – Distribution of work shift duration

Scheduled work (n=19) Self-reported work (n=9)9.0 0.8 h [3.0 to 11.0; n=5] vs

9.91.8 h [4.5 to 12.5; n=4] p<0.001

25% >12h

Nil >12h

9.20.8 h [5.5 to 11.5] vs9.91.9 h [3.0 to 13.0]

p<0.001

Results (4) - Comparison of average duration of sleep after each shift type during the two rotas

Intervention rota Traditional rota

*p=0.095 vs traditional

7.260.36h* 6.750.40h

8.68h

6.28h6.93h

5.69h

Age

40

50

60

70

80

90

100

Elderly (C) Respiratory (C) Endocrine (I) Clinical DecisionsUnit (I)

Ward

Yea

rs

P<0.001

Results (5) - Wards’ characteristics

Hospital stay

0

5

10

15

20

25

30

35

Elderly (C) Respiratory (C) Endocrine (I) Clinical Decisions Unit(I)

Ward

Days

P<0.001

Length on Study

0

5

10

15

20

25

Elderly (C) Respiratory (C) Endocrine (I) Clinical Decisions Unit(I)

Ward

Days

P<0.001

Results (6) - Characteristics of patients and episodes

  TraditionalRespiratory

InterventionEndocrinolog

y

p-value

Admissions (n) 248 233

Patients (n) 244 230

Age (years) - median (IQR) 71 (27) 71 (31) 0.14

Patient-days in hospital - median (IQR)

10 (9) 9 (13) 0.37

Patient-days on study wardmedian (IQR)

7 (7) 7 (10) 0.61

Death Rate - n (%) 34 (13.7) 38 (16.3) 0.43

Death Rate (age adj.) - n (%) 34 (14.2) 38 (15.8) 0.62

Results (7) -Adverse events and error rates between Traditional and Intervention rotas

  TraditionalRespiratory

InterventionEndocrinology

Rate reduction % (95% C.I.)†

p

Patient-days 2,315 2,467

Preventable Adverse Events n (rate*) Intercepted Potential Adverse Events n (rate) Non-Intercepted Potential Adverse Events n (rate) Minor Errors n (rate) Overall n (rate)

5 (2.2)

16 (6.9)

56 (24.2)

18 (7.8)

95 (41.0)

4 (1.6)

3 (1.2)

41 (16.6)

20 (8.1)

68 (27.6)

-27.3 (-85.1 to 249)

-82.6 (-97.7 to -38.5)

-31.4 (-55.2 to 4.6)

3.8 (-52.2 to 91.0)

-32.7 (-52.9 to -10.4)

0.68

0.002

0.067

0.90

0.006

†: rate reduction = (rate of Endocrine – rate of Respiratory) * 100 / rate of Respiratory.*: rate is expressed as Number (per 1000 patient-days)

HR: 0.62 (0.45 to 0.84)

HR: 0.16 (0.05 to 0.57)

HR: 0.63 (0.42 to 0.94)

Results (8) – Qualitative analysis

• Workload issues and Perception of Patient Safety– Reduced day-time cover with potential for delay in investigations

and treatments– Lack of time for team interaction

• Learning opportunities– Drs in intervention felt educational opportunities were compromised

• Rest and Sleep– Pro: less tired and performing better– Con: felt performing worse due to higher workload, though less tired

• Quality of Life– Shifts at night and w/end impact negatively (irrespective of rotas)

• Handover– Few concerns about quality– Several comments about number and timing (potential for missing

things)

Summary• First intervention study in the UK and Europe on the effects of a 48h/wk

EWTD-compliant rota on patient care, as assessed objectively from medical error rates

• The results show that – 33% fewer medical errors occurred on the 48h/wk intervention rota– the new rota dramatically reduced the proportion of long work weeks– the experimental sequence facilitated sleep by providing opportunity

for a long recovery sleep after the evening shift prior to starting the first night shift

– implementation of a 48h work week can be accomplished without adverse effects of patients’ safety

• Limitations– Only tested in medical wards (generalisability > controlled studies

needed)– Comparability of wards (case-mix and likelihood of medical errors)– Not designed to assess the impact on educational opportunities (need

for validated educational outcomes)

Conclusions

• Patient care can be safely provided on a 2009 EWTD-compliant rota

• Although our findings may not be directly applicable to all specialties, they do not indicate that a reduction in work hours inevitably leads to a reduction in the quality of patient care

• There is a need for a wider re-engineering of shift systems and hospital processes to ensure that the safety gains for patients cared for by less tired doctors are not compromised by difficulties in managing the routine daytime workload

• Evidence-based policy decisions must be made for work hours in the same way as evidence-based medicine is used for clinical decisions

• Concerns remain regarding reduced educational opportunities. More objective research is needed around these areas