HIMSS ASIAPAC 11 CONFERENCE & LEADERSHIP SUMMIT SEPTEMBER 2011 MELBOURNE, AUSTRALIA

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1 HIMSS ASIAPAC 11 CONFERENCE & LEADERSHIP SUMMIT SEPTEMBER 2011 MELBOURNE, AUSTRALIA

2 THE IMPACT OF A DECISION SUPPORT TOOL LINKED TO AN ELECTRONIC MEDICAL RECORD, ON GLYCAEMIC BURDEN IN PEOPLE WITH TYPE 2 DIABETES PROFESOR DEVAKA FERNANDO CONSULTANT ENDOCRINOLOGIST AND HONORARY PROFESSOR ASSOCIATE MEDICAL DIRECTOR SHERWOOD FOREST HOSPITALS NHS FOUNDATION TRUST 9/22/ Healthcare Information and Management Systems Society 2

3 The Clinical Problem Clinical Decision Support Systems The Evaluation 9/22/ Healthcare Information and Management Systems Society 3

4 High Cholesterol Excess food Genetics DM type 2 Heart Attacks Stroke Kidney failure Blindness Gout Lack of excercise Sociocultural factors High Blood Pressure Obesity The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1997; 20 (7):

5 7-year incidence of cardiovascular events (%) High Risk of Cardiovascular Events in Type 2 Diabetes Myocardial infarction Stroke Cardiovascular deaths No diabetes Type 2 diabetes Prior myocardial infarction Haffner, NEJM 1998,

6 Rrisk of cardiovascular complications CVD risk based on diabetes duration 1,4 1,2 1 0,8 High risk 0,6 0, Diabetes Duration (years) VADT: ADA (2008) San Francisco and N Engl J Med (2009) 360:

7 Visceral adiposity is the basis of the metabolic syndrome The hidden effect of abdominal obesity

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9 All other drugs 16% Oral antidiabetic agents 2% Primary care 11% In-patient care 41% NHS costs in Type 2 diabetes are mainly due to in-patient care Insulin 16% Outpatient care 14% Hospital costs: 55% 1. T 2 ARDIS. A satellite symposium at the BDA Annual Professional Conference, 2000.

10 World Health Organization, 2002 Non-modifiable Risk Factors Age Sex Genes BEHAVIOURAL RISK FACTORS Tobacco Diet Alcohol Physical Activity CVD, Risk Factors INTERMEDIATE RISK FACTORS Hypertension Diabetes Obesity ENDPOINTS Coronary heart disease Stroke Peripheral vascular disease Socio-economic, cultural & environmental factors

11 Tertiary care Industrial Age Secondary care Primary care Self care family/friends Information Age Self help networks Professional as teacher Professional as partner Professional as authority

12 Factors Influencing HbA1c GLYCATION 3 2 HEMOGLOBIN 4 1 ERYTHROPOIESIS ERYTHROCYTE DESTRUCTION 5 ASSAY Gallagher EJ, et al. J Diabetes. 2009;1:9-17.

13 Incidence per 1000 person-years (%) The relationship between glycaemia and the risk of complications in Type 2 diabetes MI Microvascular complications Mean HbA 1c concentration (%) Stratton IM et al. BMJ 2000; 321:

14 UKPDS: Tight Glycaemic Control Reduces Complications Epidemiological extrapolation showing benefit of a 1% reduction in mean HbA 1c HbA 1c 1% 21% 37% 14% Deaths related to diabetes * Microvascular complications e.g. kidney disease and blindness * Heart attack * * p< ** p=0.035 Stratton IM et al. UKPDS 35. BMJ 2000; 321: % 12% Amputation or fatal peripheral blood vessel disease * Stroke **

15 The Benefits of Early Tight Control- UKPDS 10 year Post-Trial Follow-Up Randomisation Intensive vs Conventional Treatment 10 yr Post Trial Follow Up (Non Interventional) 1997 (20 yrs) 2007 Trial End 1 (30 yrs) 2 Any diabetes related endpoint Microvascular disease Myocardial Infarction 12%* 9%* 16%*** 15%* 25%* 24%* *P<0.05 ***P= Unnikrishnan AG et al. UKPDS 33. Lancet, 1998: 352; Holman RR et al. UKPDS 80. NEJM (15):

16 Natural history of Type 2 diabetes: a progressive disease Insulin sensitive Normal Impaired glucose tolerance Type 2 diabetes Late Type 2 diabetes complications Normoglycaemia Hyperglycaemia Normal insulin secretion Insulin resistance β-cell exhaustion Insulin resistance Fasting plasma glucose Adapted from Bailey CJ et al. Int J Clin Pract 2004; 58: Insulin resistance

17 Pathophysiology of diabetes complications Activation of oxidative stress Glucose fluctuations (MAGE) Activation of oxidative stress Risk of complications PPG FPG HbA 1 c (glycation) L Monnier, C Colette. Diabetes Care 2008; 31: S

18 Problem Type 2 Diabetes Which Blood Glucose level Contributes most glucose PP-glucose Fasting glucose Blood glucose NGT Normal Glucosetolerance IFG IGT IFG IGT Diabetes modified from DeFronzo RA et al., Diabetes Care 1998

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20 HbA 1c (%) Initiation of diet and exercise Total glycaemic burden the need for improved intervention Initiation of monotherapy Additional intervention Time since diagnosis Glycaemic burden 6 Adapted from Brown JB et al. Diabetes Care 2004; 27:

21 HbA 1c (%) Diet A conservative target-based approach 8.5 OAD monotherapy OAD combination OAD combination up-titration OAD + insulin 8 Glycaemic burden Target HbA 1c 6 Time since diagnosis 6 Adapted from Campbell IW. Br J Cardiol 2000; 7:

22 What could an early, intensive, target-based approach achieve? 10 Diet 9 Monotherapy Combination therapy 8 7 Target HbA 1c 6 Time since diagnosis

23 Treatment summary Newly Newly diagnosed Type Type 2 2 diabetes Lifestyle modification Lifestyle modification Diet Diet Physical activity Physical activity Smoking cessation Smoking cessation Test HbA 1c 3 months after initial diagnosis STEP 1 Start Metformin Titrate to maximal tolerated dose or if: unable to tolerate metformin metformin contraindicated Use an insulin sensitiser ( (glitazone) or Use a sulphonylurea *** STEP 2 Add Add an an insulin sensitiser Particularly if BMI if BMI > 27 > 27 or add a sulphonylurea * or post - prandial glucose regulator* ** STEP 3 Add additional oral hypoglycaemic agents or convert to insulin therapy* +/ - oral agent Test HbA 1c 3 months after initial diagnosis Review Review patient patient every every months If HbA If HbA 1c 1c remains > 7% > 7% move move on on to the to the next next treatment step step Diet and exercise Blood pressure and lipid management * Clinicians should be alert to the risk of hypoglycaemia with ins ulin, sulphonylureasand post - prandialglucose regulators Post - prandialglucose regulators may be of particular use in patients with no n-routine daily patterns *Clinicians Acarbosemay should be be considered alert to the as an risk alternative of hypoglycaemia agent in patients with insulin, unable sulphonylurea to use and other post-prandial oral therapies. glucose regulators Insulin sensitisersare not licensed for triple therapy or in combination with insulin **Post-prandial glucose regulators may be of particular use in patients with non-routine daily patterns Acarbose may be considered as an alternative agent in patients unable to use other oral therapies. Insulin sensitisers are not licensed in combination with insulin

24 High risk approach Population approach Risk factor distribution Identify and treat those beyond a threshold for risk factor Resource intensive Screening necessary Provable in RCT Large effect in small number of people Risk factor distribution Shift the whole population distribution of risk factor lower Less resource intensive Less amenable to RCT No spec. need to identify high risk subjects Small effect in large number of people

25 Managing diabetes is neither an art nor a science but an interpretive practice with the patient at its core. It draws on science to inform reasoning but practice of medicine cannot be a universally replicable, invariant process.

26 The clinical Problem Complex Disorder Many contributing variables Treatment needs to be individualised and not one size fits all Increasing frequency Specialist care too expensive. Training Generalists to critical knowledge and skill base takes time. 9/22/ Healthcare Information and Management Systems Society 26

27 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? How can they be put to use? Do they work?

28 Decision Support Systems Decision support systems are a class of computer-based information systems including knowledge based systems that support decision making activities. -Wikipedia

29 Clinical Decision Support Systems Employing a knowledge base Used by a clinician Involved in patient care Direct aid to clinical decision making

30 Clinical Decision Support Systems Knowledge-based tools Fully integrated with both the clinician workflow components of a computerized patient record Repository of complete and accurate data

31 Clinical Decision Support Systems : Clinician and Patient-related information Presented at appropriate times

32 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? How can they be put to use? Do they work?

33 Why do we need them? Increasing need to keep up to-date Millions of facts needed to practice. Covell DG, Annals of Intern Med Oct;103(4):596-9

34 Why do we need them? A single prescription requires adjustment for: Age Weight Height Kidney function Liver function Results of lab tests Concurrent use of other medicines Patient history of allergies Co existing health conditions

35 Case History: 48 year old Patient with a BMI of 37, type 2 diabetes who has had diabetes for 15 years and has impaired kidney function and nerve damage and has had a heart attack last year. Current tablets are not working and he has poor blood glucose control HBA1c 10%. Which medication?

36 Clinical Coding used to assess quality Data Entry The process Written Clinical Record Refer Clinical Guideline protocol Or Take History Examine Take History Examine Refer Clinical guideline or protocol Data Entry Electronic Health Records Ask expert by phone Decision Support Integration Better Practice

37

38 38 Clinical decision support Gives clinicians, patients, and others relevant information in context, that helps them make better decisions, prevent errors, and improve care quality and outcomes CDS interventions include guidelines, alerts, order sets, tools to interpret patient data

39

40 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? Do they work? How can they be put to use?

41 Do They work? Evidence? Facilitating use of Guidelines and Management Protocols? Prescribing Protocol based care Referral Diagnosis? 9/22/ Healthcare Information and Management Systems Society 41

42 Better care for diabetes in the VA system than for patients in commercial managed care. Annals of Internal Medicine, August 17, 2004

43 Benefits of integration with Electronic Medical Record Improve healthcare outcomes Real time decision support for clinicians at point of care reminders, alerts Avoid reliance on memory, clinician vigilance Reduce errors (omissions, transcriptions, etc) Facilitate documentation for performance measurement and improvement efforts

44 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? Do they work? How can they be put to use?

45 Types of Decision Support Systems Informative Guidelines Literature search Triggers and warnings Guidance and advice

46 Decision Support Systems: how do they interact with user? Passive decision support: make information available when specifically requested Active decision support: process information and interact with clinical data Co-operative: user interface

47 1. Trigger Components of active decision support 2. Output 3. Relevant Data available in the system

48 Active decision support: The medication list you generated is a repeat prescription Her current Glycaemic Burden is.. Glycaemic burden displayed graphically Please list reason for exclusion from treatment to target glycaemic control Dialogue box

49 Clinical Reminders 1. Direct Patient care Real time decision support Targeted to specific patient Targeted to specific clinician Patient recall if missed intervention 2. Clinical Governance Performance improvement feedback against benchmarks Reports for appraisal documentation Targeting outlier clinicians for educational intervention

50 Clinical Reminders 2 Administrative Reminder Reports related to Patient care: Future Appointments Which patients need an intervention (medication change, referral)? Past Visits Which patients missed an intervention? Action Lists - What results need review and action?

51 Clinical Reminder Reports Identify patients for case management People with Diabetes who have poor glycaemic, blood Pressure control Identify patients with incomplete task completion lists (especially non medic actions) Identify high risk patients needing frequent intervention Identify low risk patients for discharge to primary care Track annual review.

52 The setting

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54 Telemedicine The module permits a tele-medicine consultation through , video images and data, to enable specialist interpretation and expert advice from specialists based in the UK.

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56 E-education The Network enhances and supports the ongoing educational collaboration that exists between the University in Sri Lanka, Teaching Hospital Kandy, Teaching Hospital Peradeniya, Endocrine Metabolic Disease Trust, Sheffield Hallam University and the Sherwood Forest Hospitals NHS Trust.

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58 The Clinical Problem Clinical Decision Support Systems The Evaluation 9/22/ Healthcare Information and Management Systems Society 58

59 Safety Testing As to disease, make a habit of two things to help, or at least do no harm- Hippocrates, Epidemics (book I Chapter XI) c 400 BC Medicine used to be simple, ineffective and relatively safe. It is now complex, effective and potentially dangerous. 9/22/ Healthcare Information and Management Systems Society 59

60 Safety Testing Health Informatics Before disseminating any biomedical information resource designed to influence real-world practice decisions check that it is safe Friedman and Wyatt Evaluation Methods in Biomedical Informatics 2006

61 Meeting the Challenge A work in progress Design and re-designing the system after input from key stakeholders Pre tests offline Pilots tested with early physician adopters Later tested with typical users (early adopters at pilot stage excluded from analysis)

62 Stages in Evaluating Clinical Decision Support Systems (CDSS) Eval Type Explore Feasibility, Reliability, safety informally More Formal Test of components Tests in Actual use; External reviewers Large Clinical trial,? RCT Postimplementation surveillance Stage Early Design And development Intermed Development More Mature System Wider Implementation

63 Benefits of the Offline Testing Offline testing successful in identifying errors Knowledge base Updates made before deployment

64 Comparison Method Comparing CDSS vs Clinician decision: Comparison for discrepancies in instructions / advice Manual review of all cases Reviewing discrepancies Review by specialist clinician panel

65 Stages in Evaluating Clinical Decision Support Systems Eval Type Explore Feasibility, Reliability, safety informally More Formal Test of components Tests in Actual use; External reviewers Large Clinical trial,? RCT Post- Implementation surveillance Stage Early Design And develop Intermed Development More Mature System Wider Implementation

66 Evaluator General Physician with experience in treating diabetes in primary care setting No previous involvement with EMR or CDSS project Guidelines available during evaluation of test cases

67 CDSS Methods Clinician EMR Electronic patient data: Test cases Clinician + Rules System recommendations Comparison Clinician recommendations

68 Stages in Evaluating Clinical Decision Support Systems Eval Type Explore Feasibility, Reliability, Safety informally More Formal Test of Components Tests in Actual use; External reviewers Large Clinical trial,? RCT Post- Implementation surveillance Stage Early Design And Develop Intermed Development More Mature System Wider Implementation

69 HbA 1c (%) Initiation of diet and exercise Total glycaemic burden the need for improved intervention Initiation of monotherapy Additional intervention Time since diagnosis Glycaemic burden 6 Adapted from Brown JB et al. Diabetes Care 2004; 27:

70 HbA 1c (%) Diet A conservative target-based approach 8.5 OAD monotherapy OAD combination OAD combination up-titration OAD + insulin 8 Glycaemic burden Target HbA 1c 6 Time since diagnosis 6 Adapted from Campbell IW. Br J Cardiol 2000; 7:

71 What could an early, intensive, target-based approach achieve? 10 Diet 9 Monotherapy Combination therapy 8 7 Target HbA 1c 6 Time since diagnosis

72 Glycaemic burden before and after specialist supported Observed HBa1c -7.5 intermediate care Without Consultant Support Community Based Consultant and DSN 0-0.5

73 Observed HBa1c -7.5 Impact on Glycaemic Burden using a clinical decision support system in patients discharged from specialist care With Decision support Without Decision support Time (months)

74 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? How can they be put to use? Do they work? What can de done to make this one work in a wider environment?

75 What is needed to successfully implement CDSS in a health community? Best knowledge made available when needed at clinician patient encounter. High adoption rate in health care community. Effective use by clinicians and patients Continuous Improvement through a governance mechanism (Industry may regard this as regulatory) 9/22/ Healthcare Information and Management Systems Society 75

76 Implementing an integrated CDSS Management team Informatics department Awareness Acceptance Adoption Adherence Present research data and Baseline audits of performance against benchmarks Clinician education and training Ensuring concordance with clinic workflow Audit, Evaluation Governance Improving access to clinical and research resources Present evidence relevant to patient care and facilitate clinicians access to knowledge base Integration with EMR Point-of-care patient-specific guidance in convenient clinician friendly format.

77 Next Stage Eval Type Explore Feasibility, Reliability, safety informally More Formal Test of components Tests in Actual use; External reviewers Large Clinical trial,? RCT Post- Implementation surveillance Stage Early Design And develop Intermed Development More Mature System Wider Implementation

78 Clinical Decision Support Systems What are Clinical decision support systems? Why do we need them? How can they be put to use? Do they work? What can de done to make this one work in a wider environment? Is there a role for National and International Organisations?

79 79 Is there a role for National and International Organisations? Ensure availability of standard clinically acceptable formats for representing CDS knowledge and interventions Ensure availability of communitywide approaches to procuring and distributing CDS Ensure availability of methods to remove or mitigate against policy, legal and financial barriers to implementation. Ensure availability of best practice guidance for implementation Ensure availability of standards and a process to collect data on, learn from, and share national CDS experience Ensure availability of a system to use EHR data systematically to advance knowledge through validated health service research methods

80 Georges Clemenceau French journalist, physician and statesman. He served as Prime Minister from 1906 to 1909 and from 1917 to War is too serious a matter to entrust to military men. Health Informatics?

81 THANK YOU DEVAKA FERNANDO 9/22/ Healthcare Information and Management Systems Society 81

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