Adverse Event Monitoring as a Quality Improvement Driver: The Free State Case Study Dr Sipho Kabane Contents • • • • • • • • Introduction South African context WHA Resolutions Free State Study: Aims and Objectives Design and Methodology Interventions Results Discussion Introduction • IOM report 44 000 to 98 000 die as a result of adverse events in the USA in 1999 • These cost between $17 and $29bn p.a. • Various international studies indicate that 10% of all hospital admissions associated with AE • Medicines, wound sepsis and technical complications • Between 35% and 50% preventable South African Context • • • • • • • • • • • Resource constrained environment Burden of disease driven by HIV, AIDS & TB Chronic Shortage of personnel High patient: nurse ; High patient: Dr ratios Long working hrs; Inappropriate skills mix “Moonlighting” and RWOPS Absence of clinical guidelines and protocols Faulty, out‐dated equipment Infrastructure that is falling apart Poor Leadership and Stewardship Poor waste management and Infection control TH WHO: [55 WHA‐2002] Identified the following as urgent priorities: • Development of common definitions and classification systems • Placing patient safety high in quality agenda • Development of a framework for measuring and reporting adverse events • Establish research networks • Establish partnerships between private and public sectors to address problem Location of the Free State province in South Africa Limpopo Mpumalanga North West Gauteng Free State Kwa-Zulu Natal Northern Cape Eastern Cape Western Cape Aim of Study The overall aim of the study is to determine if the development and implementation of a hospital clinical adverse events prevention programme will result in the improvement of the performance of hospitals in the Free State, South Africa. Objectives of study • To develop and implement a clinical adverse event management programme linked to an accreditation programme in public sector hospitals • To determine the impact of the programme on – the rate and severity of incidents – the overall quality of healthcare services • To identify information categories to monitor incidents and adverse events that impact on patient safety • Based on the findings, develop processes that will prevent and / or reduce the impact of incidents and adverse events on patient safety. Quasi experimental study : Randomly selected intervention and control hospitals in Free State MRR to compare the AE pick‐up capacity with the MRR approach MRR + patient and staff satisfaction surveys and staff safety culture surveys Jan 2008 to June 2010 MRR + patient and staff satisfaction survey and staff safety survey AIMS 12 Intervention hospitals 0 Months 9 30 12 Control hospitals AIMS MRR + patient and staff satisfaction and safety culture surveys (All hospitals were using COHSASA FAP programme at the start of the programme. The FAP measured performance in all services throughout the study) Research Design An interventional, quasi‐experimental study with intervention and control groups of hospitals. Hospital sampling Total number of Free State provincial hospitals: • 1 tertiary, 5 regional and 25 district hospitals. Assumptions influencing sampling: • Interventions involve entire hospitals so cluster randomisation will be used. • Free State Adverse Event rate > reported 10% rate for developed countries (expected rate = +/‐ 18% due to high burden of disease and shortages of personnel and other resources). • Interventions will – reduce severe incident rates per hospital. – will reduce the adverse events rate by a minimum of 6% over a period nine months. The resultant sample size: • 24 hospitals comprising 12 intervention and 12 control hospitals. Cluster randomisation of intervention and control hospitals Selected strata: 1. District hospitals: • Complex 1: six were chosen (from seven hospitals) • Complex 2: six were chosen (from nine hospitals) • Complex 3: six were chosen (from seven hospitals) • Complex 4: two were chosen (from 2 hospitals) 2. Regional and tertiary hospitals: • Four out of five hospitals were chosen Randomisation of strata: • The hospitals in each stratum were randomly selected into two groups of 12, the intervention and control groups and matched according to bed numbers and the levels of care provided. Location of research hospitals in five health districts of Free State Northern Free State Thabo Mofutsanyane Lejweleputswa Motheo Control Hospitals Intervention Hospitals Xhariep Free State Interventions • Implementation of AIMS • Development and implementation of Clinical Governance and Adverse Events Committees • Establishment of Incident investigating teams • Creation of a Event reporting and Just Culture • Evidence‐based Continuous quality interventions Advanced Incident Management System (AIMS) A computerised system for monitoring, analysing, reporting and managing problems ranging from near misses to sentinel events across the entire spectrum of health care. AIMS system (off site) Notifying incidents Hospital staff phone in to call centre: They are guided to provide detailed data specific to the incident by cascading questions AIMS system (off site) Data is entered Takes +/- 7 minutes to fully record an incident which is immediately emailed to hospital (or phoned through if serious) The computer system captures, classifies and grades clinical incidents, adverse events and near misses. Once alerted, hospital staff use the Internet to: • access call centre data • manage incidents. Adverse events and near misses Adverse event YES Adverse patient incident "Any event or circumstance that could have, or did lead to, unintended or unexpected harm, loss or damage" Did the incident result in harm, loss or damage? NO Near miss Free State Study: Results‐ All Incidents All Incidents reported to the AIMS call centre per month by 100 000 PDE Jan 2008 – March 2010 Comparison of Intervention & Control hospitals Intervention Control 200 178 180 171 170 163 162 169 167 162 160 137 140 124 115 112 120 100 80 119 114 110 113 75 66 67 61 60 40 20 0 109 98 95 132 129 122 41 38 29 62 126 112 107 103 92 95 86 77 70 73 64 46 53 54 68 Free State Study: Results: All Incidents Free State Study: Results(AE/NM/RF) Free State Study: Results –Control vs Intervention Free State Results: Near Misses Near Miss Incidents reported to the AIMS call centre per month by 100 000 PDE Jan 2008 – March 2010 Comparison of Intervention & Control hospitals Intervention Control 45 41 40 35 29 30 25 27 25 20 20 0 16 14 13 12 10 10 5 18 17 15 15 22 22 10 9 88 3 7 4 4 4 2 3 8 6 3 2 2 3 3 22 3 5 2 3 2 Free State Results: Near Misses Free State Study Results: Adverse Events by PIT Free State Study: Results‐ Clinical Management Free State Study: Result‐ MRR 14 12 10 8 6 4 2007 2008 2 0 Free State Results MRR: Adverse Event Classification MRR Adverse Events per 100 admissions by PIT 70 60 50 40 30 20 10 0 Free State Study FAP scores: Intervention and Control Free State Study Service Element Scores: Intervention Sites Free State Study Service Element Scores: Control Sites Mean Patient Satisfaction Rates: Intervention Sites Mean Patient Satisfaction Rate: Intervention Sites 90 80 70 60 50 40 MSR 1 30 MSR 2 20 10 0 Mean Patient Satisfaction Rates: Control Sites Mean Patient Satisfaction Rate: Control Sites 90 80 70 60 50 40 MSR 1 MSR 2 30 20 10 0 Free State Study: Discussion and Conclusions • Computerised Incident Management system increased incident and adverse event reporting • More incidents and adverse event reported through AIMS compared to paper based system • More incidents and adverse events reported through AIMS than captured through MRR • Classification of incident and adverse event types is better through a computerised system Free State Study: Discussion and Conclusion • Implementation of relevant structures, and the establishment of a “Just Culture”, improved incident and adverse event reporting • There was an overall increase in patient satisfaction and quality accreditation scores in all hospitals over the study period • The overall satisfaction and quality accreditation scores were more pronounced in the intervention compared to the control sites
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