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Reduction in medical error rates when implementing a 48h EWTD-compliant rota for junior doctors in the UK: a single-blind intervention study FP Cappuccio 1,3 , A Bakewell 1 , FM Taggart 1 , G Ward 1 , C Ji 1 , JP Sullivan 2 , - PowerPoint PPT Presentation
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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