Clinical Decision Support to Improve Diabetes Care: A Search for Unintended Consequences

1. www.chrp.org Clinical Decision Support to Improve Diabetes Care:A Search for Unintended Consequences Randall D. Cebul, M.D. Center for Health Care Research & Policy Case Western Reserve University MetroHealth Medical Center Cleveland Supported by grant R01-HS015123, AHRQ

2. Purpose/Overview • Describe aspects of a trial of real-time clinical decision support (CDS) to improve care and outcomes of patients with diabetes. • Describe analyses/preliminary results of Secondary Aim #4: “to examine general and intervention-specific unintended consequences of our intervention.”

3. The Search for Unintended Consequences • Has our focused attention on diabetes and glycemic control been associated with: • Higher rates of clinically important hypoglycemia? • Inattention to/reduced quality for other conditions? • Has the CDS been associated with “Alert Fatigue”*? - do clinicians want to keep or eliminate the CDS at the end of the trial? * Chronic Alert Fatigue Syndrome (CAFS) “is an insidious disorder, characterized by mental exhaustion and exasperation secondary to frequent, involuntary exposure to displays of alerts and reminders in computerized clinical information systems.” Greengold NL. P & T. 2005; 30: 506-511.

4. Diabetes Improvement Group – Intervention Trial (DIG-IT*): Overview • Commercial EMR-facilitated: • study design (cluster randomized trial, or CRT) • real-time clinical decision support • performance measurement • Nurse Case Management • Two health care systems 24 sites, 200 PCPs • Cleveland Clinic, MetroHealth *Funded, in part, by grant R01-HS015123 Agency for Healthcare Research and Quality

5. White Black Hispanic Other ~8,000 Diabetics, by Race ~100 PCPs 10 Group Practices MetroHealth System (MHS)

6. DM2 Epic Only 5 Groups 5 Groups 10 Practices, ~100 PCPs, ~8000 Patients Primary Aims: Quality & Utilization (including sub-groups by insurance etc) Secondary Aims: Adoption/Correlates; Unintended Consequences Design: Random Assignment of Practices to CDS - Disease Management (DM2) - MHS

7. “Table 1”. Pre-trial Practice Characteristics

8. Clinical Decision Support – DM2 • Alerts and Linked Order Sets • Patient Lists/Registry • Practice panel performance feedback • Nurse Case Management Practice Panel Tools

9. Illustrative encounter-based Alerts What do we know about this patient? She has diabetes and is visiting her PCP Her kidneys are leaking protein, she has an elevated LDL, she is not on an ACE inhibitor or ARB, nor a statin, and has no documented allergies to them, and she has no other contraindications. There are several alternative drugs/doses {Links to Automated Order Sets}

10. Re-cap of indications Choice of Rxs/doses Follow-up testing SmartSet Linked to ACE/ARB Alert Patient name Patient name

11. “My panel” vs. Comparator Practice Performance Feedback

12. Click on tab to sort Individual Practice Registry Physician name Patient name, hosp number and phone #

13. Alert:“HbA1c is over 9 and increasing” Real-time Access to Nurse Case Management Encounter-based Alerts “Staff Msg” Solicitations Priority Patient: “Here’s how I can help” SmartSet: Refer PCP Refers Nurse Case Management Appt, Referral Social Svcs Order a Test Order Rx, Imm

14. Unintended consequences • Has our focused attention on diabetes and glycemic control been associated with: • Higher rates of clinically important hypoglycemia? • Outpatient visits with documented hypoglycemia? • ED Visits or hospitalizations for hypoglycemia? • Inattention to other conditions? • Preventive services: mammograms and pap smears? • Diagnosis or management: asthma and CHF?

15. Were there more clinically important episodes of hypoglycemia in the CDS group? (P=0.01) (P=0.96) (Documented glucose<60mg/dl) (DM-related hypoglycemia)

16. Were there fewer indicated mammograms, Pap smears, or evaluations for CHF in the CDS group? (All pts with dx CHF) (Women 50-75) (Women 18-75) (P=0.21) (P=0.55) (P=0.78)

17. Were there more ED visits or hospitalizations for asthma (“unrelated”) or CHF? (P=0.70) (P=0.03)

18. Planned Safety Comparisons Related to Alerts and Order sets • Differences in proportions of patients: • Prescribed ACE inhibitors or ARBs in face of relative contraindications (K+, renal function) or documented allergy • Prescribed statins with relative C/I or allergy • Obtaining appropriate follow-up testing for Rx side effects (kidney, liver function)

19. Alert Fatigue?PCP Satisfaction with CDS (n=51) Re: 1) Alerts; 2) Practice Panel tools; and 3) Nurse Case Management: • “How often do you use”…? • “How useful do you find”…? • “Should “X” remain in Epic after the trial?”

20. Early Returns (71% response):“Should “X” remain after the trial?” % Yes

21. Summary: Work-in-Progress • CDS intervention appears to be associated with: • Significant although small increases: • ED visits for hypoglycemia - unintended but not unexpected. • ED visits for CHF - ?related to use of TZDs • No significant differences: • Preventive services (mammograms, pap smears) • Appropriate testing among patients with CHF • ED visits for unrelated condition (asthma) • CDS-related alert fatigue did not occur, at least as measured by PCPs’ desires to retain the Alerts as the trial period ends.

22. Unintended Consequences: Closing Thoughts • Don’t assume that well-intentioned and well-designed CDS is without unintended adverse consequences. • Unintended consequences may relate: • directly from the activity that we are trying to improve (e.g., hypoglycemia; ? CHF from TZDs?) • to seemingly unrelated conditions (e.g., screening) • Controlled trials are the best way to test for these “side effects”, and can be facilitated by using EMR-facilitated balancing of sites before assignment.

24. Illustrative Performance Measures:“ADA Scores” Measured Every Week Clinical Outcome: Change in Scores Ace/ARB* 1 Pnvx* 1 Eye Exam* 1 LDL<100* 1 A1C<7% 1 BMI<30 1 Non-Smker 1 SBP<130 1 0-8 points “MD-centric” Measures

25. Changes in ADA Scores for MHS Experimental Group Patients (n=5288) % of 4 MD-Centric Measures Met % of All ADA Measures Met