BACKGROUND: The treat-to-target (T2T) approach to the care of @entity1 with @entity309 involves using validated metrics to measure disease activity, frequent follow-up visits for @entity1 with moderate to high disease activity, and escalation of therapy when @entity1 have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify @entity1 and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights. METHODS/DESIGN: This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than @entity1 within sites or individual investigators to provide either T2T or usual care (UC) for qualified @entity1 who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of @entity309 and have moderate to high disease activity. Specific medication choices are left to the investigator and @entity1 , rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 @entity1 . During the 12-month follow-up, visits are mandated as frequently as monthly in @entity1 with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of @entity1 achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups. DISCUSSION: This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States. TRIAL REGISTRATION: NCT01407419.

The XXXX treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity309 :: ('MESH:D001172', 'Disease') :: ['rheumatoid arthritis']
@entity309 :: (MESH:D001172,Disease) :: ['rheumatoid arthritis']
