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Diabetes Care: So clear yet so hard

Diabetes Care: So clear yet so hard. Tom A. Elasy, M.D., M.P.H. Vanderbilt University February, 2012. So Clear. Yet so hard. Scalability People Intervention Context Sustainability Theories Interventions: induction vs. maintenance Monitoring Goal setting. So hard.

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Diabetes Care: So clear yet so hard

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  1. Diabetes Care: So clear yet so hard Tom A. Elasy, M.D., M.P.H. Vanderbilt University February, 2012

  2. So Clear

  3. Yet so hard • Scalability • People • Intervention • Context • Sustainability • Theories • Interventions: induction vs. maintenance • Monitoring • Goal setting

  4. So hard Yarnall KS, et al. Am J Public Health 2003;93:635-641

  5. Outline • A line of inquiry • “Relapse” in glucose control • Causes of Relapse • A Taxonomy of Interventions • Results of a RCT to prevent Relapse • Implications

  6. Case Presentation 64 y.o. woman presents to establish primary care – referred by NP in endocrine clinic. “I’m not doin’ so good. My life has been chaotic lately.” PMHx: DM dx’d 1992 – started insulin 2yrs prior to presentation HTN Depression –pharmacotherapy for 3yrs OA – primarily of Left Knee

  7. Case Presentation Medication: Lisinopril, HCTZ, Metformin, Glipizide, Basal/Bolus(fixed) insulin, ASA, Citalopram, Simvastatin, occasional Tylenol #3 SHx: Married – lives with husband. 3 grown children. AA at Vanderbilt for 1 yr. No substance abuse. ROS: One yeast infection in last 6 months. Weight stable. No hypoglycemia.

  8. Case Study

  9. Case Presentation Assessment: “Her diet has been erratic and she has missed several doses of her insulin. She’s lost her motivation.” Plan: “I emphasized the importance of keeping her glucose under good control and encouraged her to resume her previous successful management. I scheduled her to come back in 4 weeks.”

  10. Outline • A Line of Inquiry • “Relapse” in glucose control • Causes of Relapse • A Taxonomy of Interventions • Results of a RCT to prevent Relapse • Implications

  11. Relapse in Glucose Control Step 1 Objective: Quantify the occurrence of glycemic deterioration AFTER achieving acceptable glucose control had been achieved. Hypothesis: In individuals who have achieved adequate glucose control, deterioration (“Relapse”) will occur at a rate greater than expected based on previous longitudinal studies.

  12. Study Design and Methods • Retrospective Cohort: N=396 • Inclusion: • Initial A1c > 8% and had improved by at least 1% AND final A1c less than 8% • Received f/u primary care at Vanderbilt • Primary Outcome (time to event) • A1c > 1% of nadir and exceeds 8%

  13. Natural History of Relapse (n=396) 1.0 0.8 0.6 Probability without Relapse 0.4 0.2 0.0 0 6 12 18 24 30 36 Months after Nadir

  14. Relapse: Insulin Start Median time to relapse: 1.0 34.1 months 23.8 months 0.8 p=0.045 (Log Rank test) 0.6 Probability of Relapse Free 0.4 Insulin Started No 0.2 Yes 0.0 0 6 12 18 24 30 36 Months after Nadir

  15. Step 1 Findings • Cumulative incidence of relapse at 1yr: 25% • Initiation of insulin therapy is the only independent predictor identified: HR 1.96 • 50% relapse by 30 months • Median time to relapse in those who relapsed is 9 months.

  16. Outline • A Line of Inquiry • “Relapse” in glucose control • Causes of Relapse • A Taxonomy of Interventions • Results of a RCT to prevent Relapse • Implications for Primary Care

  17. “She’s lost her motivation” Movere: To move

  18. Behavioral Variance is due to . . . Intent Ability/Skill Norms Environmental constraints Anticipated outcomes Self-standards Emotion Self-efficacy Fishbein 1991

  19. Causes of Relapse Step 2 Objective: Determine the dispositional and situational variables that contribute to deterioration of glycemic control Hypothesis : Individuals who successfully complete a diabetes improvement program will be more likely to experience glycemic deterioration if exposed to a life stressor compared to those who are not exposed to a life stressor.

  20. Study Design and Methods • Cross-Sectional Structured Interviews • ~ 90 minutes each • Population: N= 89 (convenience sample) • 42 who had relapsed and 47 who had not • Timing: within 3 months of relapse • Exposure (new life stressor) definition: any change in financial, relational, health or new responsibility

  21. Baseline Characteristics

  22. New Life Stressors

  23. Step 2 Findings • Life stressors, high in both groups, appear to be higher (OR =1.5) in individuals who experience glycemic deterioration • New responsibilities (or competing priorities) appear to be driving the difference

  24. Outline • A Line of Inquiry • “Relapse” in glucose control • Causes of Relapse • A Taxonomy of Interventions • Results of a RCT to prevent Relapse • Implications

  25. Classic Dose Response Curve

  26. A Taxonomy of DM Educational Interventions Step 3 Objective: Identify the domains of variation within DM educational interventions. Exploratory Hypothesis: High intensity (“dose”) of DM educational interventions will be predictive of better glucose control.

  27. Study Design and Methods • Design: • Literature review and expert input “In what meaningful ways can DM educational interventions vary?” • Standard meta-analytical and meta-regression techinique • Population: RCTs with glycemic control as an outcome (1990-2000)

  28. Domains of Variation • Setting: One-on-one, group, family • Delivery: Face-to-face, telecommunication, written material • Teaching method: didactic, goal-setting, cognitive reframing, situational problem solving • Content: diet, exercise, medication adherence, knowledge • Provider: Nurse, RD, psychologist, exercise specialist • Intensity of the intervention: # of episodes, duration of episodes, duration of intervention

  29. “Dose” of the Intervention

  30. Meta-Analysis: DM Educational Interventions

  31. Step 3 Findings • Six domains characterize meaningful variation in DM educational interventions • Educational interventions have a modest net effect (0.32%) on HbA1c • No clear effect of educational “dose” on glycemic variation

  32. Outline • A Line of Inquiry • “Relapse” in glucose control • Causes of Relapse • A Taxonomy of Interventions • Results of a RCT to prevent Relapse • Implications

  33. A RCT to Prevent Relapse Step 4 Objective:To assess the relative effectiveness of 3 maintenance treatments, varying in intensity, for preventing glycemic relapse after acceptable glycemic control is achieved Hypothesis: A higher frequency of intervention will yield, in a dose-dependant fashion, a lower relapse rate

  34. Achieving Glycemic Control • 60% of primary care patients are not at A1C goal • Intensive diabetes improvement programs improve glycemic control • Many patients fail to sustain glycemic control after 1-2 years (i.e. relapse) • Biological • Behavioral

  35. Case Study

  36. HbA1c in the UKPDS Cross-sectional Median Values (7.0% vs 7.9%) 8.7% 9 Conventional Intensive 8.4% 8.1% 8 7.5% ADA action 7.4% suggested Median HbA1c (%) 7 ADA target 6.6% 6 6.2% upper limit of normal range 0 0 3 6 9 12 18 Years From Randomization Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-853. 6-3

  37. Case Study

  38. Glycemic Relapse • Relapse defined as an A1C≥1% • Approximately 45% of patients relapse within 1 year • 76% relapse by 3 years • Median time to relapse was 15.2 months

  39. Relapse Prevention: Lessons learned from other diseases • Routine contact with providers • Obesity, Perri et al, 1984 • Behavioral maintenance package • Identification of situations that are high risk for slips • Training in problem solving to deal with high-risk situations • Actual practice in coping with potential slips or high-risk situations • Development of cognitive coping techniques for negotiating lapses • Alcoholism, Marlatt et al, 1996 • Systematic but brief assessment & encouragement • Smoking, Baer et al, 1991

  40. Methods: Study Design • Un-blinded randomized controlled trial • Randomization: permuted block scheme • 3 arms • Least intensive – usual care, control • Moderate intensity – Quarterly telephonic contact • High intensity – Monthly telephonic contact

  41. Population • Patients with type 2 diabetes who recently completed a diabetes improvement program and achieved glycemic control (A1C decrease of ≥ 1%) • DIP is a 12 week intensive outpatient treatment consisting of education from a CDE NP and RD and medication titration

  42. Intervention • Phone contact by a nurse practitioner with a referral to a dietitian if nutrition self-care is perturbed • Identify and problem-solve issues arising in self-care behaviors, including diet, physical activity, self-monitoring of blood glucose and medication adherence

  43. Intervention • If no problem in self-care behaviors identified • Anticipatory planning • Positive reinforcement • Goal-setting

  44. Intervention • If problem in self-care behavior identified • Standard problem solving paradigm • If cannot identify source of problem • Goal setting was employed • Compensation with another self-care behavior

  45. Intervention Fidelity • Nurse practitioners were to adhere to a set of intervention protocols and guidelines • Intervention fidelity analysis performed to determine adherence to the protocol

  46. Outcome • Glycemic relapse • Defined as an increase in A1C of ≥ 1% from baseline • Proportion of relapse at each time point • Time to event

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