1. TIME MANAGEMENT FOR PATIENT SAFETY Rene Amalberti & Jean Brami HAS, Haute Autorité de Santé France

2. I. Patient safety in Primary care 2 IHI-BMJ Forum

3. Outline of the session  The need for a dedicated approach of patient safety in Primary care  Adverse event analysis : taxonomy versus guiding protocol  The importance of time control in human activities : The Tempo framework 3 IHI-BMJ Forum

4. The Paradox of Primary Care  Primary care associated with:  (1) apparently poorer quality care for individual diseases,  yet (2) similar functional health status at lower cost for people with chronic disease,  and (3) better quality, better health, greater equity, and lower cost for whole people and populations. 4 IHI-BMJ Forum

5. How big is the problem of Safety in Primary care?  We just don’t really know…  We spent 10 intensive years to develop Quality and Safety into Hospitals, via accreditation programs and numerous incentives  Most Quality Improvements priorities have been put on the reduction of highly publicized ‘never events’ : infections, wrong site, wrong patients, blood products, etc.,  Efforts has been especially made on team work, care organization, and procedures  EBM elaborated by the colleges of medical and surgery specialties have became the standard approach to improve Quality and Safety  Little was made until recent time to design specific priorities for Quality and Safety programs in Primary care 5 IHI-BMJ Forum

6. We know figures of risk in primary care here and there  About 4 to 7 % of hospital admissions are due to errors made in primary care (National Adverse Events studies)  Estimates of patient safety incidents in primary care were 0.004- 240.0 per 1000 primary care consultations and 45%-76% of all “errors” were preventable [Makeham, WHO, 2009].  Within 4 weeks of receiving a primary care prescription, 25% of patients experience an adverse drug event (Royal, 2006, QSHC)  Missed and Delayed Diagnoses in the Ambulatory Setting represent a significant part of errors (Ghandi, Annals, 2006)  GPs’ and specialists’ compliance to recommendations remains extremely low, ranging from 20 to 60%  But many exceptions seem appropriate to individual cases (Persell, Annals, 2010) 6 IHI-BMJ Forum

7. Claims, Errors, and Compensation Payments in Medical Malpractice Litigation (Sou médical-groupe MACSF, 2003-04-05, 1046 files) Nature of ADVERSE EVENTS Raw numberPourcentage Missed or delayed diagnostis 38937.2 Treatment, inappropriate, delayed, omitted, absence of coordination among specialists and GPs, or with hospital, procedural complication 28327.1 Medications, incorrect drug or dose, delayed administration, omitted administration 11010.5 Invasive and risky medical acts (infiltrations…) 807.6 Falls in the medical setting (from the table, in the access to the office) 313.0 Visits on call at patients’ home : refused, delayed; risky telephone call management, 757.2 Ethics, writing of certificates 918.5 Expertise, patient disagree with results 151.4 1074100% Amalberti, Responsabilité, 2009, IHI-BMJ Forum 7

8. 8 Limited transferability of Hospital Quality and Safety models  High pressure of work, short consultations  Many topics to address in the same consultation  Early manifestations of illness, or routine consultations (for chronic patients), often against backgrounds of existing psychosocial problems, commonplace pathologies, and physical co- morbidities  A strategic role on the long term in the control of diseases  A considerable time spent on coordination (medical networking) (and administration), especially with chronic diseases, but little teamwork  Patient’s non compliance much greater IHI-BMJ Forum

9. In-hospital Vs Out-hospital general conditions of care Primary careHospital Readibility and availability of the patient LimitedPermanent Working condition Isolated, networkTeam work Pathologies Large variety Commonplace pathologies Specific and Severe pathologies Patient health Average to good for most Pathologies under control Chronic diseases Evolutive pathologies Usual impact on general health Most frequent Adverse events Missed or delayed diagnosis Medication errors Missed or maladjusted response to telephone call Poor chronic disease management Wrong emergency care Medication errors Team errors IHI-BMJ Forum 9

10. Consequences  We need an approach dedicated to Primary care  Although safety theories and concepts are similar, little is concretely transferable from the Hospital tool kit to primary care  This is true for Adverse event definition and perimeter  This is true for safety policies  This is true for indicators  And this is true for analytical methods for Adverse Event analysis 10 IHI-BMJ Forum

11. II. ADVERSE EVENTS ANALYSIS Taxonomy versus Guiding Protocol 11 IHI-BMJ Forum

12. Analysing Adverse events  Total Consensus that AE analysis is required to progress in patient safety  However, this raises several questions  The generation of data does take place in a contextual vacuum  Adverse event definition critical (inclusion criteria)  Use of analysis critical (personal versus data base and policy making)  Lessons from analysis also critical (organization versus technique) 12 IHI-BMJ Forum

13. Example from the hospital: JCAHO taxonomy Five complementary root nodes, or primary classifications  Impact: the outcome or effects of medical error and systems failure, commonly referred to as harm to the patient.  Type: the implied or visible processes that were faulty or failed.  Domain: the characteristics of the setting in which an incident occurred and the type of individuals involved.  Cause: the factors and agents that led to an incident  Prevention and mitigation: the measures taken or proposed to reduce incidence and effects of adverse occurrences 13 IHI-BMJ Forum The root nodes then divided into 21 sub-classifications, which were in turn subdivided into more than 200 coded categories and an indefinite number of non-coded text fields to capture narrative information about specific incidents. Chang et al IJQHC, 17 2005

14. ALARM Protocol. London Protocol - Vincent et al, BMJ2000 14 IHI-BMJ Forum FACTOR TYPESCONTRIBUTORY INFLUENCING FACTOR Patient FactorsCondition (complexity & seriousness) Language and communication Personality and social factors Task and Technology FactorsTask design and clarity of structure Availability and use of protocols Availability and accuracy of test results Decision-making aids Individual (staff) FactorsKnowledge and skills Competence Physical and mental health Team FactorsVerbal communication Written communication Supervision and seeking help Team structure (congruence, consistency, leadership, etc) Work Environmental FactorsStaffing levels and skills mix Workload and shift patterns Design, availability and maintenance of equipment Administrative and managerial support Environment Physical Organisational & Management Factors Financial resources & constraints Organisational structure Policy, standards and goals Safety culture and priorities Institutional Context FactorsEconomic and regulatory context National health service executive Links with external organisations

15. A Preliminary taxonomy of medical error in general practice  Process errors  Office administration  Filing system  Chart completeness  Patient flow (through the HC system)  Message handling  Appointments  Errors in maintenance of a safe physical environment  Investigations  Laboratory  Diagnostis imaging  Other investigations  Treatments  Medications  Other treatments  Communation errors  With patients  With non-physician colleagues  With other doctors  Amongst the whole HC system  Payment errors  In processing insurance claims  In electronic payments  Wrongly charged for care not received  Health care workforce management IHI-BMJ Forum  Knowledge and skill errors  Execution of a colinical task  Mis-diagnosis  Wrong tratment decision All errors Principles Dovey 2002 “Safety is defined as freedom from accidental injury” Dovey 2002 “Error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim” Makeham 2002 “Errors are events in your practice that make you conclude: ‘that was a threat to patient well-being and should not happen. I don’t want it to happen again’ (Ac.Fam.Phys.2000) Assign a single error classification code to each error 15 Susan Dovey et al, QSHC, 11, 2002 Meredith Makeham, Dovey et al, MJA 177,2002

16. III. The importance of TIME CONTROL IN HUMAN ACTIviTiES The tempo Framework 16 IHI-BMJ Forum

17. Time in professionals activities  Time is what drives transformation in the world  Lessons from process control literature  Doctors manage parallel time scales, and use them as natural markers to distribute their activity throughout the day.  Situations are dynamic and, therefore, a problem encountered at one moment in time will not be the same as another encountered later.  Sometimes, not doing anything is the best way to solve difficulties.  Furthermore, time changes situations. As information stacks up over time; this can sometimes turn a complex problem into a much simpler one. Waiting sometimes becomes the best decision to make, including decisions in terms of workload management.  Error control usually follows this route.  Time is a precious error detection instrument and often helps to alleviate consequences of errors, but it is also the source of many errors in dynamic situation control. IHI-BMJ Forum 17

18. Five Tempos  Disease’s Tempo  Misleading pathology moving faster or slower than standard pathology of same category  Misleading therapeutic action, too slow, not efficient. Unfounded reassurance given to the patient on the basis of standard evolution  Poor explanations/instructions given to the patient and relatives on what should occur, when, what makes an alerting pattern, and what to do.  Doctor’s Tempo  Experiencing difficulties in accessing the right knowledge at the right time, due to misleading symptoms, fatigue, pressure, interruptions and more.  Technique required for medical act not timely applied, not with all usual rigor, due to poor practice, interruptions, fatigue, and more  Medical case not detected as going beyond doctor’s competencies  Office’s Tempo  Excessive busy diaries, time pressure  Interruptions management, telephone, patients, secretary, and more  Rushed medical history, bungled investigations, hasty traces of medical data, writing style limited to minimum  Patient’s Tempo  Failing to reveal symptoms, minimizing, or postponing the expression  Poor doctor-patient relationship, specific contexts, trouble telling the right think in a given time  System’s Tempo  Delay in getting appointments for examinations (imagery) or with specialists  Unexpected attitude of hospital emergency sending back the patient to home  Lost information among carers, lost mail, lost message IHI-BMJ Forum 18

19. Preliminary training: say the Tempo  A doctor forgetting to prescribe a medication after an interruption by a phone call.  A 18-month-old child seen in the morning with symptoms evoking a rhinopharyngitis; a reassuring routine information is given to parents mentioning to come back only if the situation not improving within two or three days ; the child is hospitalized in intensive care at the end of the day for pneumococcal infection.  Congested agenda at the office; a febrile patient asking for coming, not accepted, appointment given three days later; was an acute pyelonephritis.  Longer delay than expected to get an MRI  Urgent lab tests prescribed; the patient goes to the lab only three days later 19 IHI-BMJ Forum

20. Saturday, May, 7 : a difficult day …  Dr D.’s office, town of 15,000 inhabitants, Full waiting room. Dr D. is the only dentist opening on Saturday morning with no other office within 20 kms  9:30 : Peter S., a patient of another dentist of the town, calls Dr D. for getting an immediate appointment for a very painful tooth. Dr D. says sorry and explains that he is totally overbooked, but finally, since Peter insists, gives appointment for 11:00  11:00 : The medical examination of Peter shows a pulpitis of the 27 (left upper molar). Despite time pressure, Dr D. intends a pulpectomy.  11:15 : The pulpectomy is extremely fast, done within 10 minutes instead of the 20 to 30 usual minutes needed. Dr D. ends the works with a classic root canal filling.  Unfortunately, he mistakes in considering the correct length of the root, and pushes the pasta for the root canal filling much to far, invading the proximal sinus. He sees the problem on the control Xray, too late.  Samuel will suffer from a chronic sinusitis following the error, and will need a corrective surgery. He will decides suing the dentist. IHI-BMJ Forum 20

21. IV RESULTS FROM THREE STUDIES 21 IHI-BMJ Forum

22. The first study applied the framework to 623 insurance claims IHI-BMJ Forum Amalberti & Brami, BMJQS 2012 22 Contribution of each tempo ( in percentage) to the different types of immediate causes.

23. The second study compared the Tempos framework with the Makeham classification in an analysis of 326 insurance claims. IHI-BMJ Forum Brami, Amalberti, Wensing, submitted 23  Two GPs (blinded to the other) were asked to double code with the Makeham’s and the Tempo’s taxonomies 326 malpractice claims occurred in 2010 in general practice in the same insurance company than the previous study. The concordance among coders (kappa test), and the pros and cons of using each classification were considered.  Initial agreement between coders of adverse events was moderate for the Makeham classification of adverse events (Kappa 0,39), while it was slighly better for the Tempo framework (Kappa: 0.54).  Makeham classification was judged complex for untrained persons  The absence of the physician to who the problem occurred was problematic with the Tempo classification compared to Makeham.

24. The Third Study: Natl Adverse Event study in Primary care : ESPRIT STUDY  120 GPs included,  All Aes observed during one week  13 438 consultations, 475 Aes (1 on 30), 144 preventable  Use of the Tempo framework  42% Office tempo  21% System tempo  20% Physician tempo  10% Patient tempo  3% Disease tempo 24 IHI-BMJ Forum Kret M., Michel P., Esprit Study, Report CCECQA, 2014

25. Examples from the Esprit Study, 2013 Office tempo: While consulting at the office, a physician is interrupted by a call from the lab telling that the INR of a patient is at 5 (international Normalized ratio, Prothrombine ratio). Patient should jump a dose. Unfortunately, the physician recalls too late, 3 hours later. The patient already took the medication. Physician tempo : A physician decides doubling the dose of Losartan to lower blood tension of an hypertensive patient. The patient falls at home the day after with a mild concussion. Desease tempo: a 70-year-old patient is under AVK with INR between 2 and 3. He recovers from an armless fall at home, but surprisingly develops afterwards an epidural hematoma needing surgery. Patient tempo : A patient named Gerard comes to visit her physician. Last biological testing are bizarre, totally unexpected. It finally reveals being that of Gerard’s brother. Gerard mistaken at home when taking medical papers. System tempo : A dermatologist consulted for a skin problem and having spoke with the patient, suggest to to make a rapid test (Gujak test). The test returns positive, and the is instructed by the dermatologist to consult her GP. The GP discovers the result with the patient. No mail, no letter, no prior contact between doctors. 25 IHI-BMJ Forum

26. TEMPO TRAINING YOUR TURN 26 IHI-BMJ Forum

27.  Dr B.’s Office, 14:30 Full waiting room, Holidays period. Dr ZH.on duty, locum of Doctor B.  Mrs Simone P., 56Yrs, usual patient of the office, very talkative, hard to control, asking for prescription replacement for non severe angina pectoris, type 2 diabetes, and hypercholesterolemia.  Simone says that she had multiple events from the last visit, some diarrhea (her husband also), she felt tired many times, with back pain, now going better… She just put on the table a package of old x-rays and biological results…and start discussing for the past  The patient’s file is quite laconic. The three last visits are traced only with mention to treatment replacements  The locum hesitates, records the patient queries in her file, and tries to regain control and conclude the visit…  Simone continues speaking and taking the lead: she said that usually doctor B takes the blood pressure …she lifted her right sleeve and waited, usually she has about 10/8,.. Dr B. says that aspirin 150mg is the most important in the list of drugs. “Don’t forget it”, she said…and also she needed something for the diarrhea if it returned…  Entries in the patient file mention the blood pressure and the renewal of prescriptions. The patient was prescribed yeast powder (not mentioned in the file)  2 months later, Diagnosis of a sigmoid cancer. Simone confirms having had black stools for three months with episodes of diarrhea and constipation Case 1 IHI-BMJ Forum 27

28. 2006: discovery of a diabetes in a 61-year-Old patient already presenting complications with a peripheral neuropathy and arterial disease (absence of palpable pulse on feet). The patient is instructed to follow dietary rules and take metformin. October 13, 2007, the patient consults for a small scars on the left foot due to new shoes. The physician judge the scars not worrisome and prescribes local care (betadine and paraffin tulles). October 20 : the left foot disperses nauseous odours, with a lower extremity oedema. Prescription of Phenoxymethylpenicillin (10 millions/j) local continuation of betadine and potassium permanganate October 24: the foot has changed of colour turning to purple. The physician reassures the patient that the colour is due to local cares. Prescription of Tinzaparin (0,8 ml/j. October 25, by telephone, the spouse tells the doctor that blood capillary sugar tests have moved from de 1,10 /1,20 g/l to 2,00 then 2,60 g/l. Repaglidine is added to metformine. October 27, 6am : temperature 39°C. Call to doctor on duty. Diagnosis of gangrene, decision for an emergency hospitalization October 27 9:20 am : It is noted in the report during the admission at the hospital : “admission : Patient 62-year-old, diabetes type II, faulty foot hygiene, deep and bad cut of third toe poorly treated. No palpable pulses, Temperature 39 despite antibiotics. Presctiption of tri-therapy (3 antibiotics)” October 28 : The surgeon makes diagnosis of a festering wound of forefoot typical of the bad evolution of a diabetic foot ulcer Case 2

29. Case 3  Mr Roger A. Building contractor, 55 years old, usual patient of Dr C., GPs’ office  Medical history: Recurrent episodes of chest and back pain in the past three years. Already referred twice to a cardiologist: full check-up, including stress testing, angiography and scintigraphy, all negative, monitoring and lifestyle changes  December 16, consultation for more or less chronic atypical chest and back pain. Prescription of biological exams including troponine.  December 20, the patient goes to the lab  December 21 Roger given his result at the lab....nothing apparently wrong; however, the measure of Troponine indicates 0.2 ng/ml (with indication of “normal 1.5ng)  December 24, Roger come backs and consults Dr C. at 5:00 pm, full waiting room, no appointment.  Dr C. accepts to see Roger between two patients. He quickly reads the results and comments that exams sound good. The symptomatology is still ambiguous. The nitroglycerine test is negative. Dr C. notes an hyperleucocytosis attributed to a possibly inflammatory rise in arthrosis. He prescribes paracetamol (acetaminophen) and asks for a chest ray to eliminate a pulmonary infection.  December 25 : Roger dies at 9:00 pm, massive myocardial infraction IHI-BMJ Forum 29

30. Case 4  Mrs Marie C., 39 yrs, moderately obese, no other comorbidity  Wednesday, November 6 th, 11:30am, consultation at GP’s office for dry cough, sore throat, aching muscles, fever 38 6. Symptoms lasting for one day. Pandemic context of Flu. Nothing special at the examination, good general health, no alarming symptoms. The patient is prescribed a symptom relief medication, no antibiotics.  Same day, Wednesday, 6pm, patient called the office, feeling worse, increased fever, asking for advice. The doctor queries when the cure has been started (she says two hours before), and suggests waiting for effect, proposing to visit the patient at home the next day if the situation remains bad.  Thursday morning: patient feeling better, less aching, temperature 37 9. The doctor visits the patient at 11am and confirms treatment.  Thursday late afternoon: extreme fatigue, temperature 38° 8 reactive to aspirin. Doctor on call telling the patient that she should rest..  Friday morning, 6am, increased breathing difficulty, emergency service called on telephone, resulting in visit and hospitalization at 9am, immediate transfer to ICU, diagnosis of acute respiratory distress syndrome, Death at 9pm, same day. IHI-BMJ Forum 30

31. Case 5 IHI-BMJ Forum 31 Dr Julie D., on duty, Saturday night, 11:30pm, received a call about a teenager in who had a fall in a private house, upper class part of the town. Context of a party with about 40 teenagers without adults/parents at home. The patient is not the person who called the doctor (another teenager did) The doctor finds a 16yrs old girl, who did not wish to see the doctor, and was not cooperative. She was lying on her back, fully conscious describing a fall from a platform 1 foot high with immediate back pain. The girl moved herself from the location of fall to a quiet room on the first floor. She received 1 g aspirin. The neurological examination is normal. The doctor proposes to call the parents for immediate x-ray at the nearest clinic on duty. She faces an immediate and strong protest from the patient and the teenagers. The patient explains that she can move and she will wait until the next day. No teenagers want the parents to come. The doctor changes her mind, says that she must stop aspirin and use paracetamol. She leaves a prescription for x-ray. The day after, on Sunday, the parents come back, and drive the teenager to the hospital. They discover a undisplaced spinal-fracture of L4. They decide to sue the doctor the month after.

32. PART 3  Conclusion  New avenues 32 IHI-BMJ Forum

33. Control the adverse tempos and the ‘egg timer’ of the disease Complications, Lost of control Disease and treatment’s tempos : expected window of time during which medical actions should take place to remain in control of the disease Patient’s tempo : time lost by patient to make decision to consult the doctor, and clearly tell the symptom during the consultation ( at the right moment, with the right priority), symptoms and expectations Office and doctor’s tempos : time spent by doctors to see the patient ( access, visit) listen to symptoms, negotiate with and educate the patient in a short time of consultation, that must deal with various personal and patient’s competitive priorities and demands System’s tempo : time lost to get a rendez vous and results back from biology, radiology or specialists, Patient’s tempo : delayed decision to follow prescriptions, and make examination Time (hours, days, months) Margins Reduction of symptoms Control of the disease Patient’s tempo : time lost with poor compliance, nomadism, etc. IHI-BMJ Forum 33

34. Towards improvement  Managing your time at the office  Scheduling emergencies  Managing interruptions, telephone…  Managing your cognition (fatigue, burn out)  Managing the patient’s time  Proactive listening,  Comprehensive explanations and instructions  Managing the time of the disease  Anticipating non standard evolutions  Preparing to the unexpected  Managing the time of the medical system  Anticipating time for examinations IHI-BMJ Forum 34

35. Take home messages  Time management is important in primary care, but existing frameworks and classification systems pay little attention to the role of time in patient safety.  The newly developed Tempos framework specifies five time scales tempos (patient, doctor, office, disease, and system) for analysis of errors and adverse events.  The results show the intuitiveness and immediate payback on practices of the method, but further research is required.  Please, join, use and test 35 IHI-BMJ Forum