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Implementation of Treat to Target in RA Through a Learning Collaborative Daniel H. Solomon, MD, MPH Chief, Section of Clinical Sciences Professor of Medicine Matthew H. Liang Distinguished Chair Division of Rheumatology Division of Pharmacoepidemiology Brigham and Women’s Hospital Harvard Medical School NIH-P60-AR047782 Disclosures • • • • NIH: NIAMS, NIA, NHLBI PCORI A&R Deputy Editor Research grants: Amgen, Lilly, Pfizer, BMS, Genentech, Astra Zeneca, CORRONA • Pfizer, Executive Committee PRECISION trial (unpaid) • UpToDate royalties • No personal financial relationship with any pharmaceutical company Unsuspecting rheumatologists feeling confused when considering TTT What is TTT? • Brigham Fellows: – “The new paradigm in RA treatment is for early diagnosis and treatment with goals of remission and prevention of long-term sequelae.” – “TTT for RA to me means to have the patient with no significant morning stiffness, joint pain or swelling.” What is TTT? • Brigham Attendings: – “Using DAS < 2.6 as target for DMARD therapy.” – “Treating with medications in order to meet a prespecified, quantitative target for disease activity.” – “Change or add therapy to get to low disease activity or remission.” EULAR Recommendations for TTT Overarching Principles: A. The treatment of RA must be based on a shared decision between patient and rheumatologist. A.The treatment of RA based B. The primary goal of treating the must patientbe with RA is toon a maximize long-term health-related quality of life through shared decision between patient and control of symptoms, prevention of structural damage, and rheumatologist. normalization of function and social participation. C. Abrogation of inflammation is the most important way to achieve these goals. D. Treatment to target by measuring disease activity and adjusting therapy accordingly optimizes outcomes in RA. Ref: Smolen et al, ARD, 2010 EULAR Recommendations for TTT 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. (III) 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity.(IV) 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable 1.The primary target goal, for treatment rheumatoid alternative therapeutic particularlyof in established longstanding should disease.(Ib) arthritis be a state of clinical remission. 4. Until the desired treatment target is reached, drug therapy should be least every 3months.(Ib) 2.Until theadjusted desiredattreatment target is reached, drug 5.therapy Measuresshould of disease activity must obtained be adjusted at be least everyand 3months. documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3–6months) for patients in sustained low disease activity or remission.(IV) Ref: Smolen et al, ARD, 2010 6. The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions.(IV) 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of 3. The use of validated composite measures of disease activity.(IV) 8. Thedisease desired treatment should be maintained activity,target which include jointthroughout the remaining course of the disease.(III) is needed in routine clinical 9. Theassessments, choice of the (composite) measure of disease activity and the level of thepractice target value may be influenced by consideration of co-morbidities, to guide treatment decisions. patient factors and drug-related risks.(IV) 10.The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the 4. The patient has to be appropriately rheumatologist.(IV) informed about the treatment target and the Ref: Smolen et al, ARD, 2010 strategy planned to reach this target under the supervision of the rheumatologist. Do you practice TTT? • Brigham Fellows: – “YES” – “YES” – “YES” Do you practice TTT? • Brigham Attendings: – “Mostly” – “No” – “No, I don’t find that the concept provides for an individualized balanced discussion about tradeoffs between toxicity and disease control.” – “Yes” – “TTT is not viable in patients who have failed a biologic-- lucky to see any response; TTT is most helpful in new onset disease.” Structured RA Disease Activity • Which one? We cannot even agree how to measure RA disease activity! – With an APR or not? – How important is the patient global and tender joint count? – Biomarker panel? ACR Recommendations for RA Disease Activity Measures Measure Scale Remission Low Moderate High Patient driven PAS 0-10 0-0.25 0.26 – 3.7 3.71 – 7.9 8+ RAPID-3 0-10 0-1 1.1 - 2 2.1 - 4 >4 > 10 - 22 >22 Patient and provider CDAI 0-76 ≤ 2.8 > 2.8 – 10 Patient and provider with laboratory DAS28 0-9.4 < 2.6 2.6 – 3.1 3.2 – 5.1 > 5.1 SDAI 0-86 ≤ 3.3 > 3.3 - 11 > 11- 26 >26 Ref: Anderson et al, AC&R, 2012 Even if we can agree on which target…. • Which is the best “route” to achieve the target? TTT’s Attraction • Establishing a Target allows for measurement of a process associated with each visit. • Targets are possible when many treatments exist (many “routes”). • Other well recognized targets: – DM targets Hgba1c – LDL targets – BP targets Selected Prior Trials Demonstrating Benefits of TTT • At least 10 RCTs have found that TTT produces better outcomes than usual care in RA, including reduced pain, improved function, better DAS scores, and less radiographic progression. • The treatment algorithm used has varied and the exact schedule of visits has varied. • Most trials have occurred in Europe. Why Rheumatologists Do Not Change Treatment • Patients with RA in Australia with DAS28 • 584 were in MDA or HDA and had no change in DMARDs • Rheumatologists recorded barriers to treatment change Barriers to Treatment Change % Irreversible joint damage 20 Patient driven undertreatment 15 MD driven undertreatment 10 Non-inflammatory MSK pain 9 Waiting for DMARD response 9 Safety or contraindications 8 Comorbidities 7 DMARD resistant RA 6 Other* 16 *Logistics, reimbursement, pregnancy Tymms, AC&R, 2014 Implementation of TTT in RA Through a Learning Collaborative DH Solomon, E Losina, B Lu, A Zak, C Corrigan, SB Lee, J Agosti, A Bitton, LR Harrold, T Pincus, H Radner, Z Yu, JS Smolen, L Fraenkel, JN Katz Division of Rheumatology, Division of Pharmacoepidemiology, Department of Orthopaedics, Brigham and Women’s Hospital, Harvard Medical School, University of Massachusetts Medical School, Rush Medical School, Medical University of Vienna, Yale School of Medicine NIH-P60-AR047782 Acknowledgment Practice Sites Team Members Cedars Sinai (Venturapali) Venturapali, Gaggi, Uy, Bustos, Vasquez Loyola Tehrani, Ostrowski, Briones, Murphy North Shore Grober, Malik, Woodrick, Lynn, Sun, Drevlow, Zaacks, Bilbrey, Chavez, Casey, Gan, Myers Park Nicollet Paisansinsup, Shousboe, Glickstein, Steele University of Kansas Lindsley, Schmidt, Colbert, Springer, Bhadbhade, Parker, Estephan, McMillian, Heneghan University of Kentucky Lohr, Hanaoka, Lightfoot, Jenkins, Baker, Bisono, Wafford, Wiard, Lenert, Howard University of Houston Scholz, McCray, Barnes, Tan, Homann University of Vermont Hynes, Bethina, Kennedy, Lau, Edwards, Libman, Farely Univeristy of Virginia Kimpel, Lewis, D’Souza, Potter, Carlson, Mosteanu, Khalique, Khurana, Swamy UTMB -- Galveston Murthy, Musty, Rudrangi, Ganti, Gonzalez, McCullum Vanderbilt Annapureddy, Kroop, Hayden Design • Cluster randomized controlled trial • Wait list control (step wedge design) Intervention • Learning Collaborative (LC) – – – – Developed by Institute for Healthcare Improvement Team learning with frequent measurement Rapid cycle improvement (PDSA cycles) Central team coaches with each team contributing to the collaborative – Central website for sharing PDSA cycles, results, questions, resources – Face-to-face meeting to start with monthly webinars – Faculty developed a change package which guided LC Change Package Shared decision making Valid disease Activity measure Use a target and stick to it Site Recruitment • E-mail contact with smaller academic programs plus other practices • 25 rheumatology practices responded • Telephone contact to describe program, assess interest, and whether practice already implemented TTT • 12 sites expressed interest and were randomized • 1 site dropped out before start of first phase Total Providers Patient Insurance (%) Trainees MidLevels Total Patients Seen in 2014 Medicare Medicaid Commercial None Treatment Arm Site location Intervention Chicago IL 3 No No 1800-2000 31 16 49 4 Houston TX 5 Yes No 1000 20 20 55 5 Suburban Chicago, IL 10 No No 920 35 5 59 1 Louisville KY 9 Yes Yes 1850 23 33 38 3 Burlington VT 5 Yes Yes NA NA NA NA NA Minneapolis MN 6 No No 2300 13 12 72 3 Los Angeles CA 2 No Yes 350 60 1 35 4 Kansas City KS 10 Yes Yes 500 40 10 45 5 Galveston TX 6 Yes No 4000 40 15 40 5 UVA Rheumatology 5 No Yes 550 25 10 50 5 Nashville TN 2 No No 250 25 5 60 10 Control Measurement of TTT Adherence TTT Adherence: 4 components based on visit note 1. 2. 3. 4. Treatment target Disease activity measure Follow TTT paradigm (or if not, document why not) Shared-decision making if change in target or change in treatment Implementation Score 1. 2. Ordinal score using above 4 components Converted into a percentage Patient sampling 1. 2. 3. Providers participating in at least one learning session >40 patients/site with RA with a visit during periods of interest Sampled visits in 3-months prior to intervention and last 3-months of intervention period Table 1: Baseline subject characteristics Control (n = 321) Learning Collaborative (n = 320) N (%) unless noted Age*, years, mean BMI*, kg/m2, mean Female sex RA duration*, years ≤2 2-5 6-10 >10 Serologic status* Positive Use of synthetic DMARDs Use of biologic DMARDs Comorbidity index, mean ( SD) Joint erosion Yes Total medications 0 1-5 6-10 10+ 60 30.1 78 60. 29.4 79 16 29 22 34 26 25 24 25 P-value 0.75 0.24 0.72 0.12 0.15 76 77 41 1.33 82 81 46 1.28 53 60 0.25 0.16 0.24 0.19 0.16 0 13 32 55 0.3 17 37 47 Figure 1: TTT Implementation Control sites 70 Intervention sites p <.0001 60 p =0.004 Percent adherence 50 40 30 20 p = 0.93 10 0 Baseline Follow-up Change in implementation score Table 2: TTT Implementation Components 100 100 Target 80 80 60 P = 0.065 40 20 20 0 0 Baseline Follow-up Change Shared Decision Making 80 P < 0.001 40 20 20 0 0 Follow-up Change Follow-up Change Treatment Decision 60 40 Baseline Baseline 100 80 60 P = 0.002 60 40 100 Disease Activity Measure P = 0.064 Baseline Follow-up Change Percentage of visits fully adherent with TTT Figure 2: Full Adherence with TTT 100 Control 80 Learning collaborative 60 P = 0.045 40 25.9% 20 P = 0.25 0.0% 0.6% Baseline 5.6% Follow-up Table 3: Resource use and adverse events Control (n = 321) Learning Collaborative (n = 320) P-value* Number of tests or adverse events (mean number per patient) Monitoring laboratory tests (CBC, CMP) 2614 (8.14) 2591 (8.10) 0.67 CRP or ESR 788 (2.45) 607 (1.90) 0.66 Plain x-ray of musculoskeletal system 308 (0.96) 247 (0.77) 0.96 CT of musculoskeletal system 6 (0.019) 12 (0.038) 0.50 MRI of musculoskeletal system 14 (0.044) 16 (0.050) 0.77 Adverse events (GI, renal, liver, infxn, etc) 138 (0.43) 83 (0.26) 0.04 Table 4: Supplementary findings Control (n = 69) Disease activity measure Intervention (n = 284) N (%) Remission 18 (26.1%) 115 (40.5%) Low 19 (27.5%) 73 (25.7%) Moderate 16 (23.2%) 59 (20.8%) High 19 (23.2%) 37 (13.0%) Visits w/ DMARD changes Control Intervention (n = 321) (n = 320) N (%) 0- 30% 198 (62%) 201 (63%) >30 – 79% 101 (31%) 64 (20%) 22 (7%) 55 (17%) 80-100% P-value 0.07 P-value 0.0001 Strengths/Limitations • RCT across the US, but relatively small and participants unblinded to treatment. • Objective assessment tool to determine TTT adherence with high reliability, but assessors unblinded to treatment assignment. • Complex intervention (Learning Collaborative) but likely required for behavior change. Conclusions 1. Baseline TTT implementation was very low. – Even in these mostly academic programs. 2. A Learning Collaborative was an effective intervention to improve implementation of TTT. – But, few visits (25%) were fully adherent. 3. Explicit treatment target and following paradigm were most common deficiencies. 4. No excess in resource use or adverse events observed. Implications regarding TTT • More should be done to enhance adoption of TTT in the US as baseline rates are low. • A Learning Collaborative is a proven intervention to enhance adoption of TTT, but it requires investment of time by practices. – Should professional societies promote TTT Learning Collaboratives? – How can practices be incentivized to participate in Learning Collaboratives or other QI efforts? Thanks ([email protected])