An Evaluation of a Universal Funding Program for Pediatric Insulin Pumps in Ontario McMaster Endocrinology Rounds September 16, 2016 Rayzel Shulman MD, PhD, FRCPC
German/Austrian Prospective Diabetes Follow-up Registry (DPV) (n=26,198) % on pump 41 T1D Exchange (n=13,755) 47 Patterns of pump use English/Welsh National Paediatric Diabetes Audit (NPDA) (n=14,457) 14 SWEET multicentre registry (n= 16 570) 44.4 Szypowska et al. Pediatric Diabetes 2016 Sherr et al. Diabetologia 2016
Sweden: n 5000 T1D DKA twice as high in pump vs. injections 77% within first year after pump start Pump Safety Australia: n=345 on pump DKA rate in pump vs. injection 2.3 vs. 4.7/100 person-years Newfoundland: n=90 DKA admissions 70% use pump DKA with established diabetes, 23.6% failed to recognize pump problem Hanas et al. Pediatric Diabetes 2009 Jackman et al. BMC Research Notes 2015 Johnson et al. Diabetic Medicine 2013
Glycemic control Systematic Review RCTs CSII vs. MDI HbA1c was reduced by 0.32 % in children (95 % CI, 0.13 0.51) P = 0.002 Benkhadra K et al. Endocrine 2016 Improvement during first year then back toward baseline beyond 1 yr- review Shulman R et al. Diabetes Management 2012
The Policy Problem Equivocal evidence about comparative long-term effectiveness Marginal benefits at increased costs ($2,000 USD annually) Ontario: universal funding since 2006 Lee et al. Journal of Pediatrics 2015; 167 (2): 449-54
Objectives Appreciate the Ontario context for pediatric insulin pump therapy Describe patterns of pediatric pump use in Ontario Examine factors associated with the safety profile of pump therapy in Ontario Understand how pumps are valued by physicians
Populationbased health administrative data Pediatric Diabetes Survey data about centres characteristics and resources Physician interviews about experience using pump therapy
Not-for-profit research institute Community of research, data and clinical experts Secure and accessible Ontario healthrelated data Admissions, ED visits, outpatient visits, lab data Population and Demographic data Links to PCMCH and MOH http://www.ices.on.ca/about-ices
Shulman et al. CMAJ Open 2016 Ontario Pediatric Diabetes Network Current State Survey 2013
Network description: Main Findings and Contribution Caseload of diabetes nurses varies across centres Differences in availability of 24 hour support Set the stage to examine relationship of local resources and pump use and safety
Methods Brought in ADP pump data to ICES Pump cohort Approved initial ADP application for pediatric pump November 1, 2006- March 31, 2013 Non-pump cohort (for baseline comparison) <19th birthday, prevalent in ODD on January 1, 2008, exclude pump users
Methods Association between uptake (centrelevel) and 24 hr support Negative binomial model Association between discontinuation (patient-level) and: Socioeconomic status Mean A1c before pump start Cox proportional hazards model with generalized estimating equations (GEE) to account for clustering at centres
3000 2500 Pump Use Following the Introduction of a Universal Funding Program in 2006 38.1% (5.3-67.8%) 2000 1500 1000 500 0 2007 2008 2009 2010 2011 2012 Number of individuals on pump therapy as of Jan 1 of each year Number of new applications in each calendar year (2007 includes Nov- Dec 2006 and 2012 includes Jan-Mar 2013)
Pump Uptake
Discontinuation 51 individuals discontinued pump therapy Discontinuation rate: 0.42 per 100 person-years
Pump use: Main Findings Pump cohort less deprived than nonpump cohort Universal funding: pump use is high and discontinuation very low Large variation in pump use not explained by the centre-level factors Discontinuation associated with small community centres and low SES
Pump Use: Limitations Pump uptake only measurable in 2012 We measured applications for pump funding, not actual pump use Date of discontinuation was estimated
Pump use: Discussion Disparity in pump use by SES Financial barriers Physician attitudes Need to further characterise population and practice patterns Design interventions aimed at improving appropriate access to and outcomes
Adverse Events in pump users
March 31, 2013 2 year baseline period Follow-up period Pump cohort n=3193 Initial application (Nov 1 2006-Mar 31, 2011) <19 th birthday
Outcomes and Exposures Primary Outcome: First admission for DKA or death Secondary Outcome: Diabetes-related admissions and ED visits Exposures: Socioeconomic status (SES) Low SES associated with increased risk of DKA 24 hour support DKA prevention programs including 24 hr support associated with decreased risk of DKA Keenan et al. Pediatrics (2002) 109(1) Hoffman WH et al. Diabetes Care (1978) 1
Results Rate of DKA was 5.28 per 100 personyears Baseline rate of DKA was 6.97 per 100 person-years Mean age at the time of first DKA admission or death was 12.8 years (SD 3.8) There were <6 deaths
Event free probability 1 0.98 0.96 0.94 0.92 0.9 0.88 0.86 0.84 0.82 0.8 Cumulative Probability of DKA or death according to time since pump start 0 10 20 30 40 50 60 70 Months since pump start
Safety Profile: Main Findings In the context of universal funding: positive safety profile that is not related to access to 24 hour support Lower income children had both a higher risk of DKA and diabetes-related admissions and ED visits. Identified other factor associated with increased risk of adverse events: Higher HbA1c Older age Prior DKA Higher nursing patient load
Safety Profile: Limitations Deprivation index is an ecologic measure but likely good proxy for individual SES Nursing patient ratio may be incomplete Could not measure A1c as an outcome
Safety Profile: Discussion Underlying causes of SES disparities requires further investigation High risk groups identified Need better understanding of nuances of centre-specific approaches to pump therapy
Physicians role Physicians beliefs about technology and the populations that they serve influence adoption processes Understanding how physicians, who play a critical role in adoption processes, value this technology is critical to understanding patterns of adoption
Objective and Importance To characterize physicians perceptions of how pumps are valued Understanding physicians valuation rationales is critical to: Inform policy and funding decisions that encourage more appropriate patterns of adoption Assist providers by encouraging more appropriate and successful use of technology in their practice
Methods Open-ended semi-structured interviews 16 physicians from Ontario PDN Qualitative descriptive approach Memos to group data by descriptive patterns based on pre-structured themes Iterative process Final themes based on different ways of valuing pump therapy
Results Theme 1: Falling Short Potential for good glycemic control, but most users do not do the hard work required Reliance on support from a broad network of care
Theme 1: Falling short people go on a pump thinking now they can eat whatever they want to eat; all they have to do is carbohydrate count and appropriately change their insulin doses and things will be fine. But, I think most people s abilities to actually carbohydrate count aren t that precise or accurate. They forget sometimes to give themselves extra boluses. And, so, that increased flexibility, if not fully accommodated, can actually result in worse control in the end or maybe a reason why some of these increased technologies haven t resulted in the improved outcomes we had hoped for (academic specialist-6)
Theme 2: Valuing Technology Valuing Technology Status as new technologies, with inherent appeal as the best way to manage diabetes Promise of future technology we need to be embracing the technology and encouraging them to be developing new and better tools. (academic specialist-16).
Theme 3: Building Therapeutic Relationships Building Therapeutic Relationships Enduring relationship with a child with a chronic illness and their family Tools to engage and motivate Respondents perceived that parents whose children they cared for want their child to have a more normal life and be more like their friends (academic specialist-5)
Limitations Unable to measure the value of pediatric insulin pump therapy, rather how it is valued by physicians Even if physicians perceptions about pumps are valued are inaccurate, they govern behaviour and help to explain the dynamics of adoption Did not study other key players
Conclusions Widespread use not a misunderstanding about effectiveness Technology is costly and excessive enthusiasm may eclipse a more thoughtful process of adoption Clinicians should consider how the therapeutic relationship, mediated by the role of pumps/other technology, may be influencing diabetes outcomes Policy makers and clinicians will have to consider how new tech is valued and decide whether and how to adopt them into practice and the healthcare system.
Need to better understand the dynamics of practice variation and the underlying causes of disparity and outcomes. Future Directions Evaluation of diabetes care using multiple methods to understand: practice patterns clinical outcomes practice goals and expectations of providers and patients and families
Acknowledgments CCHCSP Doctoral Award/Department of Pediatrics Creative Professional Activities grant from the Hospital for Sick Children and CIHR Applied Chair in Child Health Services and Policy Research (A Guttmann) Supervisors, mentors, committee members Astrid Guttmann Fiona Miller Denis Daneman Therese Stukel Alice Newman (data analyst) Division of Endocrinology, The Hospital for Sick Children
Questions
Only 66% of pump users assigned to their centre correctly using their postal code Validation of assignment to centre by postal code Not correctly assigned Correctly assigned Community 501 (52.0%) 1,349 (72.3%) Tertiary 462 (48.0%) 517 (27.7%)
SWEET: n= 16 570 Glycemic control When adjustment for age, gender, and diabetes duration: A1c in CSII remains lower than MDI