1. Shared Decision Making in the Prediabetes Office Visit John G. King, MD, MPH Brain Flynn, DSc Lise Vance, Research Assistant University of Vermont Department of Family Medicine

2. This research project is supported by a grant from the AAFP Foundation

3. Learning Objectives 1.Describe the risk of diabetes in a pre-diabetic population and the benefit of lifestyle intervention and explore how these may change for patient and physician with a point of care decision making aid (DMA). 2.Describe the key components of a decision aid based on the International Patient Decision Aids Standards and how one can be incorporated into an electronic health record. 3.Describe how a decision aid performed for patient and physician in risk communication and self management goal setting in prediabetes.

4. Outline  Population and selected study subjects  Decision making aid development  Background  Focus groups  Study Design and Methods  Results  Discussion

5. Population: Milton, Vermont and Milton Family Practice Milton, VT  Population 10,000  12 miles from Burlington, Vermont population ~100,000  Rural and suburban  Low income  97% white Milton Family Practice  Family Medicine Residency training site for the University of Vermont  5-6 FTE equivalent, 27,000 annual visits  18 Residents and 8 faculty with no full time patient care physicians.  5462 active patients over 18

6. Patient selection for study Active (seen within 2 years) Milton Family Practice patients age 18-90 n = 5462 Patients with blood sugars >100 or hemoglobin A1C 5.6 -6.4 within the past year and without a diagnosis of diabetes n = 393 (7.2 % of all patients – population prevalence 35%*) Primary physician selected for a pre-diabetes office visit n = 229 (58 % of those with abnormal labs) Study participants n = 107 (47 % of those eligible by physician judgment) *National Diabetes Information Clearinghouse, 2010

7. Decision aid background  Patients and physicians are often unaware of the actual benefits and harms of lifestyle or medical interventions.  Decision aids can remedy this lack of information and provide patients and clinicians with relevant point of care data to inform their decisions.  Decision aids can help patients explore values.

8. The case for Prediabetes  35% of adults over age 20 have pre diabetes.  Progression to diabetes occurs at a rate of 10% annually, but can be cut in half with lifestyle interventions (Knowler et al, NEJM 2002).  The estimated annual direct medical care expenses for diabetics is $13,400. This is $9,700 per year more than those without diabetes.  For a population of 100,000 with 35,000 prediabetics, even a 5% change in the annual rate of progression could lead to over $17 million in savings over 5 years. $2.83 pmpm!

9. International Patient Decision Aids Standards Collaboration - Standards Content:  Provide information about options in sufficient detail for decision making.  Present probabilities of outcomes in an unbiased and understandable way.  Include methods for understanding and expressing patients’ values.  Include structured guidance in deliberation and communication. Elwyn et al, BJM 2006. 2012 update at ipdas.ohri.ca

10. IPDAS Standards Development process:  Present information in a balanced manner.  Have a systematic development process.  Use up to date scientific evidence.  Disclose conflicts of interest  Use plain language Effectiveness:  Ensures decision making is informed and values based Elwyn et al, BJM 2006. 2012 update at ipdas.ohri.ca

11. Our Prediabetes Decision Aid  Reviewed Risk communication and decision aid and motivational interviewing literature.  Started with several ideas and formats  Convened focus groups of patients, clinicians, and office staff to develop the aid and questions for evaluation.  Iterative process of refinement with each focus group.

12. The Prediabetes Decision Aid

13. Outline  Population and selected study subjects  Decision aid development  Background  Focus groups  Study Design and Methods  Results  Discussion

14. Study Design and Methods All patients chosen by their primary physician as eligible for an office visit to discuss prediabetes. Different patients pre and post, all asked questions about their experience after the visit.  Pre implementation of decision aid  57 patients in usual care group scheduled and seen by their primary physicians.  Visits often combined with upcoming already scheduled appointments.  Verbal consent over the phone and written on arrival.

15. Study Design and Methods  Implementation of Decision Making Aid  15-20 minute group or individual physician training in use of the aid.  50 patients (30 on paper and 20 in computer) in intervention group scheduled to see primary physician with use of the decision aid  Physicians asked about their knowledge of prediabetes risk and experience with the visits between the control and intervention patients and then again after the intervention patients.  Chart review for patient risk characteristics, documentation of self management plans.

16. Methods – Hypothesis A natural frequency-based decision-making aid (DMA) presented by the physician during a planned office visit discussion of pre-diabetes may be useful in supporting shared decision-making about positive lifestyle changes. This pilot study will explore the effect of a DMA among patients and physicians. I. Among pre-diabetic adult patients ages 18 to 90 participating in a planned office visit with and without use of a DMA, the use of the DMA will:  increase knowledge of the risks of pre-diabetes and the benefits of lifestyle change;  increase perceived communication effectiveness, self efficacy, and intent to adopt healthier lifestyles and decrease decisional conflict.  Improve documentation of self management plans

17. Methods – Hypothesis II. Among attending and resident physicians providing usual care and then using the DMA shared decision-making process, the use of the DMA will:  increase knowledge of risks of pre-diabetes and benefits of lifestyle change;  increase the perceived value of a planned prediabetes visit.

18. Results - No significant differences between usual care and intervention patients VariableUsual care (n = 57) Intervention (n = 50) P value Age55 (range 31-78)58 (range 19-82)0.14 NS Sex51 % female42 % female0.36 NS Education58 % HS or less64 % HS or less0.56 NS Average BMI33.035.50.13 NS Avg. Hemoglobin A1C Blood Sugar (avg. of 3) 6.0 98 6.0 100 0.75 NS 0.64 NS Hypertension53 %62 %0.33 NS Hyperlipidemia42 %34 %0.39 NS Smokers23 %14 %0.23 NS Self reported Overall health 33 % Fair or Poor23 % Fair or Poor0.37 NS

19. Prediabetic patients and their physicians estimates of diabetes risk * NEJM, 2002 P < 0.08 p < 0.03

20. No difference between usual care and intervention in patients post visit perceptions of communication effectiveness. VariableUsual care (n = 57) DMA (n = 50) P value Time spent was right98 %95 %0.42 NS Satisfied with information given98 %100 %0.50 NS Information was easy to understand98 % 0.36 NS Doctor gave me enough explanation about choices98 %100%0.36 NS I can easily discuss with my doctor again98 %100%0.36 NS Doctor made me aware of what to do to reduce risk 98% 0.36 NS Overall satisfaction with the information98%100%0.36 NS Satisfied I am adequately informed96 % 0.50 NS Satisfied with the way the plan for change was made. 95 %96%0.81 NS Take Home: Patients who participated in this study were satisfied with their doctors communications about prediabetes.

21. No difference between usual care and intervention in patients post visit perceptions of self efficacy, intent to adopt healthier lifestyles and decreased decisional conflict. VariableUsual care (n = 57) DMA (n = 50) P value Doctor gave me a chance to ask questions96 %100 %0.43 NS Doctor gave me a chance to decide best for me 91 % 0.36 NS Doctor gave me a chance to express opinion 98 %100 %0.36 NS Doctor have me a chance to be involved96 %98 %0.24 NS Certainty I will carry out the plan (1-10 scale)* 7.85/10 0.99 NS Sure decision is the right one fro me93 %96 %0.53 NS Agreed on lifestyle change best for me.93 %94 %0.90 NS Made a plan for diabetes risk reduction95 %98 %0.41 NS

22. Chart review: Self Management Plan Usual care vs. DMA p < 0.0006 Paper vs. Computer p < 0.001 Usual care vs DMA p, 0.007 Usual care vs. DMA p = 0.03 Paper vs. Computer p = 0.43

23. Self Management Plan Specificity P < 0.0001

24. Record of motivational interviewing methods used P < 0.0001

25. Qualitative Physician Experience  “I prefer to use one form if able – all electronic”  “Engaged patient in computer with electronic”  “Paper form easier for sharing with patient”  “More valuable to have patients write their goals on paper and take it with them”  “Seemed faster and more seamless with electronic form”

26. Physician experience: Quantitative All NS

27. Conclusions  Patients and their physicians significantly over estimated the risk of developing diabetes over 3 years.  Use of a DMA in prediabetes improved accuracy of physicians perceptions of diabetes risk but not patients.  Use of a DMA did not significantly change patients high perceptions of their doctors communication, self efficacy or intent to change behavior.  Documentation of specific self management plans that incorporated motivational interviewing techniques significantly improved with use of the DMA.  Although not significant, Physicians tended to spend a few minutes longer and use more guiding and following styles while using the DMA.

28. Discussion  Your comments, questions, and ideas?