CLINICAL GUIDANCE FRAMEWORKS Protracted investigation of patients - PDF document

21/07/2017 IMPROVING CARE PROCESSES FOR PATIENTS WITH POSSIBLE SUSPECTED ACUTE CORONARY S Aldous; on behalf of the SYNDROME (ICARE-ACS): A NATIONAL IcareACS team IMPLEMENTATION TRIAL OF A CLINICAL GUIDANCE FRAMEWORK CLINICAL GUIDANCE FRAMEWORKS Protracted investigation of patients presenting to emergency departments with symptoms suggesting acute coronary syndromes (ACS) is a major hospital burden. Clinical Guidance Frameworks, which assist medical decision making, can improve the accuracy of diagnosis and facilitate more timely definitive care, or discharge from hospital if significant pathology is excluded 1

21/07/2017 ACCELERATED DIAGNOSTIC PROTOCOLS A component of the guidance framework, an Accelerated Diagnostic Protocol (ADP), can provide direction regarding clinical risk stratification and interpretation of early biochemical markers so that an earlier, safe discharge from hospital can be achieved. An ADP can combine variables usually including cardiac troponin (cTn) results, ECG results and objective scoring of clinical variables. ADPs allow blood sampling for cTn measurement at early time-points in patients who are low risk by the other variables. This allows clinicians to rapidly proceed to the same ‘next step’ in clinical management (such as cardiac stress test, imaging and/or discharge) as would have occurred using a more prolonged time course for serial troponin testing to exclude AMI. ADP RESULTS FROM CHRISTCHURCH - 2011 The ASia Pacific Evaluation of Chest pain Trial (ASPECT) was an observational study of 3582 patients presenting with to the ED with acute chest pain. Christchurch Hospital contributed 1000 patients. 421 (11·8%) patients had 30 day MACE. 9.8% were classified low risk by the ASPECT ADP  Modified TIMI=0  No new ischaemic ECG changes  No elevation of any 0/2h biomarkers in a POC multimarker panel. MACE occurred in 0·9% of low risk patients  Sensitivity 99·3% (95% CI 97·9 – 99·8)  NPV 99·1% (97·3 – 99·8) 2

21/07/2017 ADP RESULTS FROM CHRISTCHURCH - 2012 2h Accelerated Diagnostic protocol to Assess Patients with chest pain symptoms using contemporary Troponins as the Only biomarker (ADAPT) was a sub-study of ASPECT including 1975 patients. 302 (15.3%) had a 30 day MACE. 19.8% were classified as low risk by the ADAPT ADP  Modified TIMI=0  No new ischaemic ECG changes  No elevation of 0/2h laboratory cTn MACE occurred in 1 (0.25%) of low risk patients  Sensitivity 99.7% (98.1% to 99.9%)  NPV 99.7% (98.6% to 100.0%) ADP RESULTS FROM CHRISTCHURCH – 2014-15 Development of new risk stratification ADP (EDACS) ADAPT cohort (1974 patients, 30 day MACE rate 15.5%) 37 potential candidate variables including age, gender, symptoms, PMH/risk factors, medication, observations and using boot strapping to aim for sensitivity of 99% for 30 day MACE whilst maintaining the highest specificity possible.  Sensitivity 99.0% (96.9-99.7); Low risk 42.4% (ASPECT 9.8%, ADAPT 19.8%) . Validated: Combined TIMI RCT and Australian cohort (608 patients, 30 day MACE rate 13.0%)  Sensitivity 100% (94.2-100); Low risk population of 51.3% Vancouver cohort (763 patients, 10% AMI)  Sensitivity 100% (94.2-100); Low risk population of 41.6% 3

21/07/2017 MINISTRY OF HEALTH This successful transition at Christchurch Hospital prompted the New Zealand Ministry of Health to mandate all hospitals to implement Clinical Guidance Frameworks for possible ACS. The actual Clinical Guidance Framework or ADP to be used is not specified by the Ministry as minimal data exists of head-to-head comparisons (even observationally) between strategies. AIM To evaluate the safety and effectiveness of adopting Clinical Guidance Frameworks for possible ACS across the New Zealand National Health system by evaluating their adoption in 7 diverse hospitals. The hypothesis was that introducing the guidance frameworks would increase the proportion of patients safely discharged home within six hours of presentation to ED. 4

21/07/2017 METHODS - DESIGN The study design was a pragmatic stepped-wedge implementation trial of guidance frameworks with 6 months control (or pre-implementation) and at least 4 months intervention (or post implementation). A stepped-wedge design involves sites beginning the study one after another. This means that later sites could benefit from lessons learnt from earlier sites on how to best manage the change of practice. METHODS - SETTING Sites (acute hospitals) were included if they were willing to participate and intended to implement a guidance framework incorporating an ADP by 1 September 2015. This allowed at least four months post-implementation data to be collected from all sites by the end of the study. Sites were not eligible if they had a pre-existing clinical pathway or ADP for suspected ACS. There were no restrictions regarding cTn assay/ADP or clinical guidance framework. 5

21/07/2017 METHODS - IMPLEMENTATION Participating sites were presented with evidence regarding published ADPs including ADAPT, EDACS, HEART, NACPR, TRAPID-AMI and the Vancouver Chest pain rule, and then chose which ADP they would use. Blood sampling for cTn was to be done on arrival and then at either 1, 2 or 3 hours after presentation Pre-implementation, there were meetings involving primary investigator MT and representatives from each stakeholder group Stakeholders then planned and facilitated implementation at each site. Clinical and management leaders were identified within the local health system. These people remained in contact throughout the process. In one hospital there was a local independent change management process. METHODS – DATA COLLECTION The data collection process was pre-planned and developed before study commencement. Participants were identified from electronic diagnostic laboratory records of all patients who had blood drawn in the ED for a troponin test. Each laboratory record is linked to a patient’s NHI. Using the NHI, each hopitals Decision Support department could pull basic demographic data including age, gender and ethnicity as well as follow-up data on all readmission ICD10 codes. The national mortality dataset (Ministry of Health) was used to capture deaths within the 30 day follow-up time frame. Additional data was collected on those discharged within 6 hours coded as having an adverse event by contacting the local hospital clinicians, GPs and/or patients. 6

21/07/2017 METHODS - OUTCOMES The primary outcome: Proportion “successfully” discharged home within 6h (no major adverse cardiac event (MACE) during the following 30 days). MACE included:  Death  Cardiac arrest, (ICD10 codes I46.0, 46.1, 46.9 )  Emergency revascularization procedure  Cardio-genic shock ( R57.0 )  Ventricular arrhythmia ( I47.2 ), ventricular fibrillation ( I49.0 )  High-degree atrioventricular block needing intervention ( I44.2 )  Acute myocardial infarction ( I21.0, 21.1, 21.2, 21.3, 21.4, 21.9, 22.0, 22.1, 22.8, 22.9 ). Secondary outcomes included:  Proportion of patients discharged within 6 hours who had a MACE within 30 days  Lengths of stay in hospital in patients without ACS RESULTS - SITES 7

21/07/2017 RESULTS – SITE DEMOGRAPHICS Site ED attendance Total people in DHB Waikato 68,383 359,310 Hutt 44,470 138,378 North Shore 49,600 525,555 Wellington 52,146 283,704 Wairarapa 15,841 41,112 Waitakere 41,482 525,555 Middlemore 96,764 469,293 RESULTS – PATIENT DEMOGRAPHICS Pre-Implementation Post-implementation Site Number % % Mean Number % % Mean female Maori age female Maori age Waikato 1495 45.3 15.1 66.8 5039 44.5 15.9 66.8 Hutt 844 44.8 12.2 67.2 1738 44.6 12.0 65.4 North Shore 2820 48.4 4.9 66.8 2514 47.9 4.7 66.2 Wellington 1266 43.8 7.4 67.6 2320 45.3 7.5 66.2 Wairarapa 284 42.3 3.2 70.2 395 41.8 1.5 69.6 Waitakere 1355 49.2 9.9 63.4 1409 47.7 11.8 63.8 Middlemore 3465 46.1 14.2 61.9 3135 43.6 13.4 63.1 8

21/07/2017 RESULTS – CHOSEN ADP Site cTn Assay ECG criteria Risk stratification Waikato hs-cTnT at 0/2h Ischaemic (not known to be old) EDACS Hutt hs-cTnT at 0/2h Ischaemic (not known to be old) EDACS North Shore cTnI at 0/2h Ischaemic TIMI Wellington hs-cTnT a t 0/2h Ischaemic (not known to be old) EDACS Wairarapa hs-cTnT a t 0/2h Ischaemic (not known to be old) EDACS Waitakere cTnI a t 0/2h Ischaemic TIMI Middlemore hs-cTnI a t 0/3h Dynamic ST changes EDACS The proportion of study patients discharged within 6 hours increased in RESULTS – PRIMARY OUTCOME every hospital with an overall change from 8.3% to 18.4%. Pre-Implementation Post-implementation Site % MACE % Successful discharge % MACE % Successful discharge within 6h within 6h Waikato 11.8 5.9 15.2 15.0 Hutt 11.4 37.2 10.9 43.6 North Shore 14.8 2.8 12.1 11.8 Wellington 14.1 9.9 12.5 38.2 Wairarapa 13.7 36.3 13.7 38.7 Waitakere 10.6 5.4 9.2 12.7 Middlemore 14.7 5.1 14.3 6.8 9

21/07/2017 RESULTS – ADVERSE EVENTS In the control cohort, 5 out of 962 patients (0.52%) discharged within 6 hours had a MACE within 30 days (1 NSTEMI, 4 Deaths). In the intervention cohort, 16 out of 3632 patients (0.44%) discharged within 6 hours had a MACE within 30 days (8 NSTEMI, 1 STEMI, 1 Ventricular Tachycardia, 1 Cardiac Arrest and 5 Deaths). The sensitivity for 30-day MACE or mortality did not change with guidance framework implementation; p=0.28. RESULTS – EVENTS PRE-IMPLEMENTATION Hospital Age/ Days after Coding Notes Review Gender index Waikato 87F 16 Death During bronchoscopy Hutt 75F 25 Death Lung cancer Hutt 78F 15 Death Cardiac - non ACS Hutt 69F 26 Death Non-cardiac Hutt 79M 23 NSTEMI NSTEMI 10