Treat-to-target in RA: Collaboration To Improve adOption and adhereNce

NCT02260778 | Completed

• 2 other identifiers: 2012P000664P60AR047782
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if a Learning Collaborative is an effective tool to improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S. rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has been embraced by the American College of Rheumatology through the RA Treatment Guidelines and by EULAR,however several lines of evidence suggest that TTT is not practiced consistently across rheumatology settings.Participating practices will be randomized to receive the Learning Collaborative intervention in one of two phases. Coaching consistent with Learning Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be used to determine if the Learning Collaborative was an effective tool to increase TTT adherence.

Conditions

Arthritis, Rheumatoid

Keywords

Learning Collaborative; Treat-to-Target; Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Evidence of adherence to TTT by provider

  Chart abstraction will determine how strongly providers adhered to treat-to-target principles before and following the Learning Collaborative.

  9 months

Secondary Outcomes (2)

• Patient disease activity and adverse events

  9 months

• Patient/provider satisfaction

  within 1 month following intervention

Other Outcomes (1)

• Resource Utilization

  9 months

Study Arms (2)

Phase I Intervention

EXPERIMENTAL

The learning collaborative as designed will be delivered to this arm during phase I, which will last a period of approximately 9 months. After the 9 months, there will be passive follow-up of this arm to see if outcomes following the first 9 months are sustained.

Behavioral: Learning Collaborative

Phase II Intervention

NO INTERVENTION

This arm will serve as a control for the Phase I intervention arm during the first 9 months of the study for primary analysis. After the first 9 months, the Phase II intervention arm will receive the learning collaborative during the following 9 months.

Interventions

Learning Collaborative BEHAVIORAL

A learning collaborative is an established technique that uses the model for improvement to bridge the gap between what we know and what we do. Structured learning sessions and collaborative coaching are used to guide small cycles of change called Plan-Do-Study-Act (PDSA) cycles. This quality improvement intervention will help providers adopt treat-to-target practices through the structured learning collaborative.

Phase I Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• rheumatology practices with at least 50 RA patients for the practice
• rheumatology practices with at least 2 rheumatologists
• rheumatology practices utilizing an electronic medical record or typed notes

You may not qualify if:

• rheumatology practices already explicitly employing Treat-to-target principles

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Related Publications (24)

• Doran MF, Pond GR, Crowson CS, O'Fallon WM, Gabriel SE. Trends in incidence and mortality in rheumatoid arthritis in Rochester, Minnesota, over a forty-year period. Arthritis Rheum. 2002 Mar;46(3):625-31. doi: 10.1002/art.509.

  PMID: 11920397 BACKGROUND

• Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum Dis Clin North Am. 2001 May;27(2):269-81. doi: 10.1016/s0889-857x(05)70201-5.

  PMID: 11396092 BACKGROUND

• Scott DL, Wolfe F, Huizinga TW. Rheumatoid arthritis. Lancet. 2010 Sep 25;376(9746):1094-108. doi: 10.1016/S0140-6736(10)60826-4.

  PMID: 20870100 BACKGROUND

• Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, Moreland LW, O'Dell J, Winthrop KL, Beukelman T, Bridges SL Jr, Chatham WW, Paulus HE, Suarez-Almazor M, Bombardier C, Dougados M, Khanna D, King CM, Leong AL, Matteson EL, Schousboe JT, Moynihan E, Kolba KS, Jain A, Volkmann ER, Agrawal H, Bae S, Mudano AS, Patkar NM, Saag KG. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012 May;64(5):625-39. doi: 10.1002/acr.21641. No abstract available.

  PMID: 22473917 BACKGROUND

• Prince FH, Bykerk VP, Shadick NA, Lu B, Cui J, Frits M, Iannaccone CK, Weinblatt ME, Solomon DH. Sustained rheumatoid arthritis remission is uncommon in clinical practice. Arthritis Res Ther. 2012 Mar 19;14(2):R68. doi: 10.1186/ar3785.

  PMID: 22429277 BACKGROUND

• Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, Combe B, Cutolo M, de Wit M, Dougados M, Emery P, Gibofsky A, Gomez-Reino JJ, Haraoui B, Kalden J, Keystone EC, Kvien TK, McInnes I, Martin-Mola E, Montecucco C, Schoels M, van der Heijde D; T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Apr;69(4):631-7. doi: 10.1136/ard.2009.123919. Epub 2010 Mar 9.

  PMID: 20215140 BACKGROUND

• Smolen JS. Treat-to-target: rationale and strategies. Clin Exp Rheumatol. 2012 Jul-Aug;30(4 Suppl 73):S2-6. Epub 2012 Oct 18.

  PMID: 23073266 BACKGROUND

• Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Kerstens PJ, Nielen MM, Vos K, van Schaardenburg D, Speyer I, Seys PE, Breedveld FC, Allaart CF, Dijkmans BA. DAS-driven therapy versus routine care in patients with recent-onset active rheumatoid arthritis. Ann Rheum Dis. 2010 Jan;69(1):65-9. doi: 10.1136/ard.2008.097683.

  PMID: 19155234 BACKGROUND

• Schipper LG, van Hulst LT, Grol R, van Riel PL, Hulscher ME, Fransen J. Meta-analysis of tight control strategies in rheumatoid arthritis: protocolized treatment has additional value with respect to the clinical outcome. Rheumatology (Oxford). 2010 Nov;49(11):2154-64. doi: 10.1093/rheumatology/keq195. Epub 2010 Jul 29.

  PMID: 20671022 BACKGROUND

• Schoels M, Knevel R, Aletaha D, Bijlsma JWJ, Breedveld FC, Boumpas DT, Burmester G, Combe B, Cutolo M, Dougados M, Emery P, van der Heijde D, Huizinga TWJ, Kalden J, Keystone EC, Kvien TK, Martin-Mola E, Montecucco C, de Wit M, Smolen JS. Evidence for treating rheumatoid arthritis to target: results of a systematic literature search. Ann Rheum Dis. 2010 Apr;69(4):638-643. doi: 10.1136/ard.2009.123976.

  PMID: 20237123 BACKGROUND

• Fransen J, Moens HB, Speyer I, van Riel PL. Effectiveness of systematic monitoring of rheumatoid arthritis disease activity in daily practice: a multicentre, cluster randomised controlled trial. Ann Rheum Dis. 2005 Sep;64(9):1294-8. doi: 10.1136/ard.2004.030924. Epub 2005 Apr 13.

  PMID: 15829574 BACKGROUND

• Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, Zwinderman AH, Peeters AJ, de Jonge-Bok JM, Mallee C, de Beus WM, de Sonnaville PB, Ewals JA, Breedveld FC, Dijkmans BA. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med. 2007 Mar 20;146(6):406-15. doi: 10.7326/0003-4819-146-6-200703200-00005.

  PMID: 17371885 BACKGROUND

• Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, Kincaid W, Porter D. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004 Jul 17-23;364(9430):263-9. doi: 10.1016/S0140-6736(04)16676-2.

  PMID: 15262104 BACKGROUND

• Mottonen T, Hannonen P, Leirisalo-Repo M, Nissila M, Kautiainen H, Korpela M, Laasonen L, Julkunen H, Luukkainen R, Vuori K, Paimela L, Blafield H, Hakala M, Ilva K, Yli-Kerttula U, Puolakka K, Jarvinen P, Hakola M, Piirainen H, Ahonen J, Palvimaki I, Forsberg S, Koota K, Friman C. Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. FIN-RACo trial group. Lancet. 1999 May 8;353(9164):1568-73. doi: 10.1016/s0140-6736(98)08513-4.

  PMID: 10334255 BACKGROUND

• Saunders SA, Capell HA, Stirling A, Vallance R, Kincaid W, McMahon AD, Porter DR. Triple therapy in early active rheumatoid arthritis: a randomized, single-blind, controlled trial comparing step-up and parallel treatment strategies. Arthritis Rheum. 2008 May;58(5):1310-7. doi: 10.1002/art.23449.

  PMID: 18438851 BACKGROUND

• Verstappen SM, Jacobs JW, van der Veen MJ, Heurkens AH, Schenk Y, ter Borg EJ, Blaauw AA, Bijlsma JW; Utrecht Rheumatoid Arthritis Cohort study group. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis. 2007 Nov;66(11):1443-9. doi: 10.1136/ard.2007.071092. Epub 2007 May 22.

  PMID: 17519278 BACKGROUND

• Lumley T, Diehr P, Emerson S, Chen L. The importance of the normality assumption in large public health data sets. Annu Rev Public Health. 2002;23:151-69. doi: 10.1146/annurev.publhealth.23.100901.140546. Epub 2001 Oct 25.

  PMID: 11910059 BACKGROUND

• McCullagh P, Nelder JA. Generalized Linear Models. 2nd Edition ed: CRC Press; 1989.

  BACKGROUND

• Mangione-Smith R, Schonlau M, Chan KS, Keesey J, Rosen M, Louis TA, Keeler E. Measuring the effectiveness of a collaborative for quality improvement in pediatric asthma care: does implementing the chronic care model improve processes and outcomes of care? Ambul Pediatr. 2005 Mar-Apr;5(2):75-82. doi: 10.1367/A04-106R.1.

  PMID: 15780018 BACKGROUND

• Knox SA, Chondros P. Observed intra-cluster correlation coefficients in a cluster survey sample of patient encounters in general practice in Australia. BMC Med Res Methodol. 2004 Dec 22;4(1):30. doi: 10.1186/1471-2288-4-30.

  PMID: 15613248 BACKGROUND

• Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004 Mar;94(3):416-22. doi: 10.2105/ajph.94.3.416.

  PMID: 14998805 BACKGROUND

• Solomon DH, Yu Z, Katz JN, Bitton A, Corrigan C, Fraenkel L, Harrold LR, Smolen JS, Losina E, Lu B. Adverse Events and Resource Use Before and After Treat-to-Target in Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1243-1248. doi: 10.1002/acr.23755. Epub 2019 Jul 19.

  PMID: 30221841 DERIVED

• Solomon DH, Lu B, Yu Z, Corrigan C, Harrold LR, Smolen JS, Fraenkel L, Katz JN, Losina E. Benefits and Sustainability of a Learning Collaborative for Implementation of Treat-to-Target in Rheumatoid Arthritis: Results of a Cluster-Randomized Controlled Phase II Clinical Trial. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1551-1556. doi: 10.1002/acr.23508.

  PMID: 29316341 DERIVED

• Solomon DH, Losina E, Lu B, Zak A, Corrigan C, Lee SB, Agosti J, Bitton A, Harrold LR, Pincus T, Radner H, Yu Z, Smolen JS, Fraenkel L, Katz JN. Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial. Arthritis Rheumatol. 2017 Jul;69(7):1374-1380. doi: 10.1002/art.40111. Epub 2017 May 31.

  PMID: 28512998 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Daniel H Solomon, MD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Clinical Sciences

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08