Advancing Best Care for Patients with Diabetes Mellitus through Action Research in Family Medicine

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1 Advancing Best Care for Patients with Diabetes Mellitus through Action Research in Family Medicine Cindy L K Lam, Danny D. B. Ho Professor in Family Medicine Department of Family Medicine & Primary Care The University of Hong Kong clklam@hku.hk

2 Acknowledgement Funding support from Health & Medical Research Fund, Food & Health Bureau, Government of HKSAR (EPC-HKU-1A & EPC-HKU-2 ) The Hospital Authority of Hong Kong Dr. S.V. Lo, Dr. Christina Maw, Cluster COS in FM, RAMP-DM programme coordinators & teams, and Statistics & Workforce Planning Department Co-Investigators Dr. William CW Wong, Dr. Weng-Yee Chin, Dr. Julie Y Chen, Dr. Colman SC Fung, Dr. Esther YT Yu & Dr. Daniel YT Fong, HKU; Ms. Ruby Kwok & Ms Eva Tsui, HA Research team Dr. Carlos Wong, Dr. Wendy Wong, Dr. Eric Wan, Dr. Frances Jiao, Ms. June Chow, Mr. Jason So, Mr. Anca Chan, Ms. Karina Chan, Mr. Ryan Pak, Ms. Soki Ho

3 Presentation Outline Risk Assessment & Management Programme for Patients with DM (RAMP-DM) Action Research on this Complex Intervention Results on Quality of Care, Effectiveness & Coseffectiveness of RAMP-DM Reflection

4 Challenges of DM Management in Primary Care Prevent complications & mortality A to E A1c Blood pressure Cholesterol Diet Exercise Living with DM for decades A to E Adaptation & coping Behavioural changes Co-morbidities Daily living & quality of life Enablement & empowerment

for complications Receive appropriate counselling & interventions

6 Multi-disciplinary Risk Assessment & Management for DM- RAMP-DM Patients with DM Undergo comprehensive risk assessment & screening for complications Receive appropriate counselling & interventions Achieve optimal control of the disease, Cx & risk factors, enablement & QoL

7 Source: Manual for RAMP (Diabetes Mellitus) in Primary Care Setting, Working Group of RAMP (GOPC) DM Manual, HA, 2011

8 Source: Manual for RAMP (Diabetes Mellitus) in Primary Care Setting, Working Group of RAMP (GOPC) DM Manual, HA, 2011

9 Can this complex intervention be implemented in real world practice? lead to significant health benefit? be affordable?

10 Research Aims & Objectives To evaluate the QOC of RAMP-DM A framework of quality criteria with target standards Measure the standard of care against target for each QOC criterion Identify gaps & quality enhancement strategies To evaluate the long-term (5-y) effectiveness (Vs usual care) Disease control Complications Mortality To evaluate the cost-effectiveness Translate the effectiveness to health benefit (NNT) Measure the costs of RAMP-DM & usual care Estimate the cost of RAMP-DM per complication or death reduction

Action Research on a Complex Intervention Feedback to Programme Team; recommendation 3 rd Evaluation on QOC & Effectiveness 2 nd Evaluation on QOC 1 st Evaluation on QOC Audit Spiral Feedback

11 Action Research on a Complex Intervention Feedback to Programme Team; recommendation 3 rd Evaluation on QOC & Effectiveness 2 nd Evaluation on QOC 1 st Evaluation on QOC Audit Spiral Feedback to Programme Team; Action Plan for Improvement; Update Criteria & Standards Feedback to Programme Team; Action Plan for Improvement; Update Criteria & Standards Set Criteria & Standards of Care

12 Development of QoC Framework- Partnership with HA Programme Team Step 1: HKU team drafted generic QoC Indicator framework Step 3: HKU team refined indicators & criteria & proposed standards Step 5: programme WG and HKU team reconciliation on indictors, criteria, standards and operational definitions Step 2: Programme WG defined indicators and criteria Step 4: Programme WG reviewed & gave feedback on indicators, criteria & standards Step 6: Programme WG endorsement of framework that is evidence-based and practical

13 Process of Care Criteria (Total 14) DM patients should be enrolled into the RAMP. 70% Target Std Patients must be stratified into a RAMP risk group. 100% Medium / high risk groups with HbA1c 8.5% and BP >140/90 mmhg or LDL-C >3.4 mmol/l should be referred to additional RAMP nurse intervention. Very high risk group with HbA1c 8.5% should be referred to additional Associate Consultant (AC) / RAMP doctor consultation. Patients who smoke could be referred to smoking counseling and cessation centres (SCCC). 30% Patients with foot problems should be referred to the podiatrist or P&O or wound clinic or surgical SOPC. 50% Patients with diabetic retinopathy (R2,R3 or Maculopathy) should be referred to ophthalmologist within 6 m 70% Patients with LDL-C > 2.6mmol/L should be prescribed lipid lowering drugs if target not achieved after life style modification. 50% Patients with microalbuminuria should be prescribed ACEI or ARB. 50% Patients with very high/ high risk and HbA1c > 8.5% should have repeat RAMP within 2 years 70% 65% 70%

14 Longitudinal Cohort Study Apr 2010 Jul 2011 Food and Health Bureau HHSRF commissioned extended evaluation study (5 years) Jun 2016 HA commissioned study Subject inclusion 1EC Collect Data Subject inclusion 3EC Collect Data Subject inclusion Collect Data 2EC Aug 2009 Mar 2011 Dec 2011 Mar 2012 Jun 2013 Aug 2013 Nov 2014 Nov 2015 Jun 2016 Effectiveness study data collection up to 30 Nov EC 1 st Evaluation Cycle; 2EC 2 nd evaluation cycle; 3EC 3 rd evaluation cycle

15 All DM patients consulted HA GOPC 1 Aug Nov 2015 (N=316,869) Patients had no RAMP-DM till 30 Nov 2015 (N=87,514, 27.6%) RAMP-DM patients (N=229,355, 72.4%) (1EC=48,823;2EC=66,693;3EC=29,587) Non RAMP-DM patients under GOPC care on or before 30 Jun 2011 (N=29,478) RAMP-DM patients enrolled on or before 30 Jun 2011 (N=62,940) Long-term effectiveness of RAMP-DM study on propensity score matched cohort* (RAMP-DM=8,570; Usual care without RAMP-DM=8,570) 1EC 1 st evaluation cycle: 1 Aug Mar 2011; 2EC 2 nd evaluation : 1 Apr Mar 2012 ; 3EC 3 rd evaluation cycle : 1 Aug Sep 2014; Attended at least one RAMP-DM nurse intake assessment; Without any DM-complication * Propensity scores matched for socio-demographics, disease factors and co-morbidities.

16 Outcome Measures Quality of Care % achieving criterion care Effectiveness of RAMP-DM (RAMP-DM & usual care patients) % achieving target HbA1c, BP, LDL-C after 5 y Complication (CVD, STDMR, ESRD) incidence & mortality rates up to 5 y RAMP-DM Costs over 5 years Central administration: HA Finance Office Set up costs including staff training & equipment On-going cost per subject per RAMP-DM service attendance Unit cost = staff & consumables / No. of patients served per session number of attendance x unit cost Costs of public healthcare in 5 y (RAMP-DM & usual care patients)

17 Data collection Structure of care & costs Structured questionnaires completed by programme coordinators Qualitative evaluation by site visits Process of care and clinical outcomes Extraction of anonymized individually linked routine clinical data from the CMS system by HA Statistics Department Patient Reported Outcomes (baseline, 12 & 24 m) Telephone survey of convenient samples by the HKU SSRC

18 Data Analysis Quality of Care % patients achieving criterion care (standard) Differences between audit cycles by ANOVA for continuous outcomes & Chi-squared test for categorical outcomes Effectiveness Within-subject changes by paired t -test for continuous outcomes & McNemar test for binary outcomes. Differences between RAMP-DM and usual care patients by independent t- test for continuous outcomes and Chi-squared test for categorical outcomes Multiple variate (linear, logistic or Cox) regressions to determine the effectiveness of RAMP-DM, adjusting for confounders

19 Results Courtesy of

20 Quality of Care Quality of Care Criteria Total number of criteria Number achieving target standards 5% discrepancy from target Achieving Target Standard Structure Process Outcomes 1EC 2EC 3EC 1EC 2EC 3EC 1EC 2EC 3EC

21 Quality Enhancements Structure Standardized templates in CMS for recording clinical data Regular training and audit of Nurses & Patient Care Assistants Alert to usual care doctor of RAMP-DM assessment results Process Clearer criteria for additional interventions or referrals Annual tests for HbA1c, lipid profile, RFT and urine protein as quality criteria Prescription of drugs as indicated (e.g. statin for LDL, ACEI for ACR ) Outcomes HbA1c 7%: 55.8% 60.9% 71.9% BP 130/80mmHg: 38.4% 45.4% 52.8% LDL-C 2.6 mmol/l: 45.6% 57.6% 67.4%

22 Effect on PRO & Service Utilization Absolute Difference in Change from Baseline 12M RAMP-DM Vs Usual Care 24M SF-12v2 PCS Absolute Difference in Public Service Utilization RAMP-DM Vs Usual Care Rate (per 100 person-y ) IRR SF-12v2 MCS PEI Score> %* 7.74%* GRS Score>0 6.15%* 9.11%* SF-12v2: 12 item Short-form Health Survey; PCS: Physical component summary score; greater score=better QOL MCS: Mental Component Summary Score; greater score=better QOL PEI: Patient Enablement Instrument; score>0=better enablement GRS: Change in Global Health Rating Scale, score>0=better hearth * Significant differences p<0.05 compared to usual care group Hospitalization * A&E * SOPC * GOPC * IRR< 1 indicates reduction in service utilizations compared to usual care group, adjusted for socio-demographic & clinical characteristics * Significant differences p<0.05 compared to usual care group

23 Long Term Effectiveness Disease Parameter Absolute Difference (RAMP-DM Vs Usual Care) after 5 y HbA1c (mean) -0.16%* HbA1c < 7% 6.25%* SBP (mean) DBP (mean) SBP/DBP < 130/80mmHg LDL-C (mean) -3.06mmHg* -1.49mmHg* 7.95%* -0.14mmol/L* LDL-C < 2.6mmol/L 8.24%* Observed Events in 5 y ARR (RAMP-DM Vs. Usual Care) NNT HR Any complications % * CVD % * CHD -7.78% * Heart Failure -4.69% * Stroke -3.29% * ESRD -0.77% * STDR -1.41% * All-cause mortality % * ARR: Absolute risk reduction; NNT: Number Needed to Treat; 8,570 RAMP-DM subjects and 8,570 usual care subjects were matched by propensity score HR Hazard ratio < 1 indicates risk reduction for events compared to usual care group, by Cox regression adjusted for socio-demographic and clinical characteristics * Significant differences p<0.05 compared to usual care group

24 Costs of RAMP-DM Central administrative cost in HKD 5 Cluster set-up cost in HKD 41 On-going cost in the first year Provider costs in HKD (cluster range) Average Unit cost per On-going cost attendance attendance per subject per subject* Risk assessment Nurse assessment ( ) 229 ( ) Allied Health (26-238) 21 (4-37) Nurse intervention ( ) 85 (48-168) AC intervention ( ) 77 (36-121) Subtotal cost 412 ( ) Total cost in first year in HKD 458 ( )

25 Cost-effectiveness of RAMP-DM Average Provider Costs (HKD) per Subject (cluster range) RAMP-DM administrative cost 5 RAMP-DM set-up cost 41(11-72) RAMP-DM on-going cost First year 458 ( ) Second year 249 ( ) Third year 191(95-310) Fourth year 183 (92-290) Fifth year 141 (70-226) Total costs over 5 years 1268 (512-1,631) 5-y Outcome All-cause mortality Any Cx CVD STDR ESRD HbA1c<7% NNT Cost (HKD) per benefit 8,876 10,144 11,412 90, ,840 20,288 Cost (USD) per benefit 1,138 1,300 1,463 11,542 21,133 2,601

26 Total Public Service Provider Costs Public Service Cost per subject (HKD) RAMP-DM (N=8570) Usual care (N=8570) Difference RAMP-DM set-up cost (mean) 41 N.A. 41 RAMP-DM administrative cost 5 N.A. 5 RAMP-DM ongoing cost over 5y 1,222 N.A. 1,222 Public healthcare cost over 5 y 94, ,573-58,112 Total costs over 5 years 95, ,573-56,848

27 Conclusions RAMP-DM can be implemented in real world practice QoC of RAMP-DM was assured, with standards reaching targets Trend of improving standards esp. in outcomes over 5 y RAMP-DM was effective in reducing Cx by 40% and total mortality by 56% in 5 years RAMP-DM is affordable, cost-effective & probably cost-saving RAMP-DM should be normalized in primary care Enhancement of supporting services (podiatry & ophthalmology)

28 Reflections on Action Research Impact on health services in the real world Stakeholder & service provider engagement Mutual respect and trust Be pragmatic & sensitive to clinical limitations Regular communication and constructive feedback Team work led by academic clinicians in practice with strong biostatistician input Perseverance & problem solving Big quality routine clinical data is a gold mine

29 Publications 1. Fung CSC et al. Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) diabetic patients. BMC Family Practice 2012, 13:116 doi: / Jiao FF et al. Effects of the Multidisciplinary Risk Assessment and Management Program for patients with diabetes mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study. Cardiovascular Diabetology 2014, 13:127 doi: /s Jiao FF et al. Comparison of four cardiovascular risk prediction functions among Chinese subjects with diabetes mellitus in the primary care setting. Journal of Diabetes Investigation. 2014; doi: /jdi Jiao FF et al. Long-term effects of the Multidisciplinary Risk Assessment and Management Program for patients with diabetes mellitus (RAMP- DM): a population-based cohort study. Cardiovascular Diabetology (1):105. doi: /s Fung CSC et al. Five-year change of clinical and complications profile of diabetic patients under primary care - A Population-based longitudinal Study on 127,977 Diabetic Patients. Diabetology & Metabolic Syndrome 2015; DOI: /s x 6. Wong CKH et al. Quality of care and volume for patients with diabetes mellitus in the primary care setting: a population based retrospective cohort study. Diab Ees Clin Pract 2016;120: DOI: /j.diabres Wan EYF et al. Effectiveness of a multidisciplinary Risk Assessment and Management Programme - Diabetes Mellitus (RAMP-DM) on Patient Reported outcomes. Endocrine 2016, 55(2), DOI: /s Jiao F. et al. Effectiveness of the Multidisciplinary Risk Assessment and Management Programme for patients with diabetes mellitus (RAMP- DM) on diabetic microvascular complications: a population-based cohort study. Diabetes and Metabolism 2017; DOI: /dom Jiao F et al. Annual direct medical costs associated with diabetes-related complications in the event year and in subsequent years in Hong Kong. Diabetic Medicine 2017; DOI: /dme (in press)

30 Publications 1. Fung CSC et al. Effect of metformin monotherapy on cardiovascular diseases and mortality: a retrospective cohort study on Chinese type 2 DM patients. Cardiovascular diabetology 2015; 137 doi: /s Wan EYF et al.. Prediction of all-cause mortality in Chinese Patients with Type 2 DM A Population-based retrospective cohort study. Journal of Diabetes and Its Complications. 2016, 30(7), DOI: /j.jdiacomp Wan EYF et al. Incidence and predictors for cardiovascular diseases in Chinese patients with Type 2 diabetes mellitus A population-based retrospective cohort study. Journal of Diabetes and its Complications. 2016, 30(3), DOI: /j.jdiacomp Wan EYF et al. Association of variability in Haemoglobin A1c with CVD and mortality in Chinese patients with type 2 DM - A Retrospective population-based cohort study. J Diabetes and Its Complications 2016; 30(7), DOI: 5. Fung CSC et al. Statin use reduces cardiovascular events and all-cause mortality amongst Chinese patients with type 2 DM : a 5-year cohort study. BMC Cardiovascular Disorders Jun 24;17(1): Fung CSC et al. Association of estimated glomerular filtration rate and urine albumin-to-creatinine ratio with incidence of cardiovascular diseases and mortality in Chinese patients with Type 2 DM - A population-based retrospective cohort study. BMC Nephrology 2017, 18(1), 47. DOI: 7. Wan EYF et al. Association of visit-to-visit variability of systolic blood pressure with cardiovascular diseases and mortality in Chinese patients with Type 2 DM A retrospective population-based cohort study. Diabetes Care 2017;40 (2): doi: /dc Wan EYF et al. Effect of multifactorial treatment targets and relative importance of haemoglobin A1c, blood pressure, low-density lipoproteincholesterol on cardiovascular diseases in Chinese primary care patients with Type 2 DM - A Population-based retrospective cohort study. Journal of the American Heart Association 2017 DOI: /JAHA Wan EYF et al. Prediction of end stage renal disease in Chinese patients with type 2 DM A population-based retrospective cohort study. BMC Nephrology (1), 257. doi: 10.Wan EYF et al. Development of a CVD risk prediction model and tools for Chinese patients with type 2 DM A population-based retrospective cohort study. Diabetes, Obesity and Metabolism 2017; DOI: /dom

Five-year cost-effectiveness of Patient Empowerment Programme (PEP) for type 2 diabetes mellitus in primary care

Title Five-year cost-effectiveness of Patient Empowerment Programme (PEP) for type 2 diabetes mellitus in primary care Author(s) Lian, JX; McGhee, SM; So, JC; Chau, J; Wong, CKH; Wong, WCW; Lam, CLK Citation