Practice-Based Research is for the Clinician

1. Practice-Based Research is for the Clinician James W. Mold, M.D., M.P.H. Department of Family and Preventive Medicine University of Oklahoma Health Sciences Center

2. Objectives Increase your understanding of practice-based research Importance Feasibility Increase your enthusiasm for participating Added value for you Added value for your practice

3. Definitions Practice-based research: Research that is grounded in, informed by, and intended to improve practice. Practice-based research network (PBRN): A group of separate practices that collaborate with each other and often with outside experts to conduct multiple research projects over an extended period of time while continuing to deliver care to patients

5. The Ecology of Medical CareGreen LA. Fryer GE Jr. Yawn BP. Lanier D. Dovey SM. The ecology of medical care revisited. New England Journal of Medicine. 344(26):2021-5, 2001 Jun 28.

6. So Many Questions Which headache patients should have a CT or MRI? What causes LE edema in most primary care patients without heart failure? Does it make sense to ask patients for their e-mail address? What should you do when a non-perimenopausal patient complains of night sweats? How important are asymptomatic loss of ankle reflex and vibratory sense in older patients?

7. So Many Questions Does a CBC help in the diagnosis of influenza? What’s the best way to manage laboratory test results, and how much does it cost? What do the practices that score highest on diabetes quality indicators do differently from other practices? What is the best way to assure that all patients are offered the preventive services indicated for them? Is systematic delivery of preventive services economically feasible?

9. “While working at a community health center, I conducted a study with assistance from my colleagues [at the PBRN] to look at the causes of leg edema. In the vast majority of cases, the bedside diagnosis was venous insufficiency. However, it turned out that only a fraction of patients actually had venous insufficiency. The big surprise was that 40% had pulmonary hypertension. I subsequently was able to show that lower extremity edema in women, but not men is a marker for obstructive sleep apnea independent of obesity.” Bob Blankenfield, M.D. Ohio

10. “I practice in a small town…It is hard to be on time…most days…The thought of doing research in this environment was overwhelming. I thought my staff… would surely mutiny.” “…This wasn’t the case…research gives us the opportunity to … avoid burnout while expanding our horizons and helping patients.”

11. The Shoebox Studies In 1997 and again in 2007, OKPRN practices asked their patient to consider completing a 5-question survey about their use of computers, e-mail, and the internet. They were asked to put the surveys (completed or not) into a sealed shoebox through a slot cut in the top. Results were reported back to each practice and aggregated by type of location (rural, medium-sized town, urban).

12. Results Urban 1997 2007 Computer (H) 55% (54-56) 57% (45-76) Computer (W) 57% (57-59) 38% (22-54) E-Mail 48% (48-50) 57% (45-72) Mid-Sized City Computer (H) 36% (35-37) 62% (52-75) Computer (W) 43% (42-44) 41% (31-54) E-Mail 30% (29-31) 63% (52-73) Rural Computer (H) 28% (28-29) 66% (58-76) Computer (W) 38% (37-39) 43% (24-59) E-Mail 21% (21-22) 62% (50-74)

13. Results Solo practice in a small rural town on a lake where people vacation. Eufaula 1997 2007 p Computer (H) 18% 73% 0.0003 Computer (W) 50% 59% E-Mail 14% 71% 0.0001

14. Results Proportions who would like to use e-mail to communicate with their primary care clinician. 1997 2007 Eufaula 32% 65%

15. “As family physicians we see patients on a daily basis with problems for which there is inadequate information. It is gratifying to work with others to help find answers to questions regarding these problems, even if this adds to our work load and the benefits are not immediate.”

16. Night Sweats Card Study – consecutive adult patients for one week in summer, one week in winter (31 clinicians; 2267 patients) PDA Study – consecutive patients on 3 consecutive days (10 clinicians; 363 patients) Longitudinal Study – nurses enrolled patients >65; patients completed questionnaires (23 clinicians; 795 patients) Sleep Lab Study – Retrospective (282 patients)

17. Neither we nor our patients know what causes this symptom or how to evaluate someone who has it. Less than 20% of physicians and patients, when asked, were able to even venture a guess as to the cause of the patients’ night sweats Most frequent guesses were: Menopause (48% of patients; 44% of their PCPs) Stress (12% of patients; 8% of their PCPs) Medications (9% of patients; 10% of their PCPs) Diabetes (4% of patients; 11% of their PCPs)

18. Night sweats are common and under-reported. Night Sweats in past month: 30 – 40% of adults visiting a PCP 10-20% of older adults (age > 65) identified through PCP billing records Women only slightly more likely to be affected than men Only 12% of patients with night sweats have reported the symptom to their PCP Only 47% of patients with severe (soaking) night sweats have reported them to their PCP

19. They’re associated with lower quality of life. Patients with night sweats report lower health-related quality of life, general health, physical functioning, mental health, and social functioning, and more bodily pain than those without night sweats, after controlling for age, gender, education, income, and race The night sweats are bothersome to at least one other person in 10% of cases

20. They’re associated with many other symptoms. Fever Symptoms of anxiety and depression Symptoms of sensory impairment (e.g. impaired hearing, impaired vision, numbness of extremities) Pain (e.g. muscle cramps, waking up with pain) Sleep disturbances (e.g. daytime tiredness, waking up with a bitter taste in mouth, legs jerk during sleep)

21. And with use of some medications. SSRIs Tricyclic antidepressants Other antidepressants Antihistamines Alcohol

22. But not with objective evidence of disease Not association with actual sensory deficits Not associated with abnormalities on polysomnography other than time until first awaking during sleep Not associated with (stable/treated) diabetes, thyroid disease, depression, GERD, hypertension, osteoarthritis, osteoporosis, or autoimmune diseases Probably associated with chronic infections like TB (numbers were too small to be sure)

23. “I believe that active participation in a PBRN has improved my critical thinking skills and my patient care, kept me at the forefront of contemporary primary care practice, and serves as a source of (and stimulus to) continuing medical education. It also invigorates my office staff and encourages them to look for ways to improve the care we provide our patients.” Steven Dosh, M.D. Escanaba, Michigan

24. Idiopathic Peripheral Neuropathy in Older People Loss of Ankle DTR and vibratory sense is generally considered to be part of “normal aging” and of little consequence. That’s what they used to say about Alzheimer’s Disease (pre-senile vs. senile dementia), presbycusis (aging vs. cummulative noise exposure), osteoarthritis (wear and tear vs. a metabolic disease of cartilage)

25. Peripheral Neuropathy of Aging Prospective study of 795 primary care patients >65, enrolled and examined by a research nurse. Prevalence of bilateral peripheral sensory deficits (ankle DTR, vibration, fine touch, and/or position) Age Prevalence Prevalence (NPD)* 65-74 26% 19% 75-84 36% 31% 85+ 54% 58% * NPD = No predisposing disease (DM, RA, SLE, scleroderma, Crohn’s, B12 def, chronic hepatitis, sarcoidosis, renal failure, hereditary PN

26. Predictors in Patients with No Predisposing Disease Age OR: 1.1/yr (p<0.0001) BMI OR: 1.06/unit (p=0.007) Hx of Osteoarthritis OR: 1.54 (p=0.04) Hx of Hypertension OR: 0.60 (p=0.02) Not associated with current systolic BP, diastolic BP, pulse pressure, or orthostatic change in BP.

27. Associated with Use of Certain Medications Beta Blockers O.R. 3.56 (1.58-8.03) Primarily absent ankle reflexes NSAIDs O.R. 2.65 (1.37-5.10) Fine touch, vibration, and position sense Not other antihypertensive agents.

28. Importance Associated with: Restless legs (p=0.03) Trouble with balance (Subj.) (p<0.0001) Balance score (Obj.) (p<0.0001) Trouble walking (Subj.) (p<0.0001) After controlling for age

29. Importance Associated with lower health related quality of life (HRQoL) by two different measures (p=0.006), After controlling for: Age Gender ADL and IADL (functional status) Nutrition Risk Score (NSI) Diseases including arthritis and heart disease Symptoms

30. PN Consequences Associated with: Earlier Hospitalization H.R. 1.46 (1.04-2.05) Earlier Death H.R. 1.67 (1.06-2.63) After controlling for: age, gender, BMI, self-rated health, 50 ft walk time, physical function, bodily pain, and hx of a variety of medical diagnoses (HTN, heart disease, stroke, osteoporosis, etc.)

31. “The benefits to my practice and patients have been improved well-child care and a sense of making a difference. The goal is to put research to use in the community and, if successful, continue to build on the knowledge obtained and make it sustainable. We want research that means something and works in rural America.”  Scott Graham, D.O. Rural Oregon

32. Influenza Diagnosis A 5 clinician practice collected symptoms, exam findings, and lab test results including rapid antigen tests and flu cultures on consecutive patients seen throughout 3 consecutive flu seasons Symptoms and signs were different for each epidemic Vaccination status not helpful for distinguishing flu cases WBC > 8,000 associated with negative flu culture Sensitivity: 92% Specificity: 31% Rapid antigen test also useful Sensitivity: 65% Specificity: 83%

33. “An investigator from another network proposed to study practitioner attitudes regarding the prescription of narcotics for non-malignant pain. He had done a literature search and had found a scarcity of research in the area. He told the meeting participants that he had found only one well-conducted study that could be used for comparison. He handed out copies of a study on which I had worked as a planner, participant, and writer several years earlier. I must admit, my heart was warmed.” Kenneth Gjeltema Albany, California

34. What’s the best way to do X? Okarche, Oklahoma 1998. It doesn’t help when the QIO comes in, audits my charts, and tells me what a poor job I am doing. If they would just tell me who is doing a good job, perhaps I could talk with or even visit their practices to see how to improve. Mark Gregory, M.D.

35. Lab Test Results Tracking tests to make sure results get back to chart and are reviewed Notification of patient about results (patients want their actual results and don’t want to have to call the office for them) Documentation in the chart that the patient was notified and what was recommended Tracking patients with abnormal results to be sure they follow through on recommendations

36. Identification of “Exemplars” Prioritize criteria for each piece Accuracy, cost, patient satisfaction, etc. Attach levels of acceptability Acceptable error rate, cost, etc. “Show of hands” then audit Audit everybody

37. Lab Test Results Tracking tests: Seems to require a dual tracking system Notification of patient: Note on actual test results report mailed to patient Documentation: Copy of report/note into chart (different for paper vs. EHR) Tracking patients with abnormal results: Couldn’t identify an exemplar Cost: $5 per test set (per patient)

38. “And honestly, participating made me feel a little smarter and maybe a bit virtuous. It seemed like I was giving back to the world in ways different and more far reaching than through my stethoscope or in my exam room.” Paul Hicks Fort Morgan, Colorado

39. Diabetes Care Exemplar principles: See all diabetics every 3 months Consider clustered or group visits Clearly mark charts of diabetic patients Use protocols for staff (teamwork) Keep and use a diabetic registry Use one eye consultant for all diabetics Use a flow sheet Assign responsibility

40. Diabetes Care All diabetic patients > 50 y.o. seen during that 3 month period (pre- or post-intervention) and followed for at least 1 year 25 physicians 595 pre-intervention patients 582 post-intervention patients

41. Quality of Care Indicators A1c: 87% ? 96% p=0.0003 Microalbumin: 53% ? 64% p=0.05 Lipid Panel: 69% ? 80% p=0.02 Foot Exam: 71% ? 82% p=0.004 Retinal Exam: 48% ? 59% p=0.04 Pneumovax: 42% ? 61% p=0.0006 ACEI for BP: 72% ? 86% p=0.03 ACEI for prot: 53% ? 64% p=0.05 Paired t-tests; physician as unit of analysis

42. “The beauty of being involved in a research network like this one is that a soldier in the field, trying to keep my head above water and take care of my patients, can get involved in research topics and quality improvement projects without having to think of them from scratch.” Kate Merrill Oregon

44. Implementation Research in OKPRN RCTs testing multi-component strategies designed to help practices improve performance in a particular area. Performance feedback Training Practice facilitation IT support Local learning collaboratives

46. Delivery of Preventive Services Things known to work Wellness visits Standing orders Recall/reminder systems Exemplars Focus on a few things Even with these methods, rates of delivery are too low.

47. Preventive Services Systematic vs. situational activities Must be separated Population-based vs. visit-based Should be individualized based upon risk factors and preferences In theory, could be accomplished as part of an annual wellness visit, though would still need to be tracked.

48. Preventive Services Reminder System (PSRS) Developed and tested with the help of network clinicians. Calculates eligibility for immunizations and other preventive services based upon: Age Gender Prior services Risk factors and contraindications Personal preferences

49. Prevention Nurse/Station Is it economically feasible to hire a nurse to run the registry and make sure patients get their preventive services? Appears to require ½ nurse per clinician Hard to separate completely; needs to be integrated to some degree Economic impact heavily dependent upon billable services offered One practice made an additional $28,000 in first 6 months

51. Objectives Increase your understanding of practice-based research Importance Feasibility Increase your enthusiasm for participating Added value for you Added value for your practice

52. Questions?