title: The study design and rationale of the randomized controlled trial: translating COPD guidelines into primary care practice.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease (COPD) is a progressive, debilitating disease associated with significant clinical burden and is estimated to affect 15 million individuals in the US. Although a large number of individuals are diagnosed with COPD, many individuals still remain undiagnosed due to the slow progression of the disorder and lack of recognition of early symptoms. Not only is there under-diagnosis but there is also evidence of sub-optimal evidence-based treatment of those who have COPD. Despite the development of international COPD guidelines, many primary care physicians who care for the majority of patients with COPD are not translating this evidence into effective clinical practice.
  
  
  METHODS
  This paper describes the design and rationale for a randomized, cluster design trial (RCT) aimed at translating the COPD evidence-based guidelines into clinical care in primary care practices. During Phase 1, a needs assessment evaluated barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from focus groups, three tools were developed. These include a computerized patient activation tool (an interactive iPad with wireless data transfer to the spirometer); a web-based COPD guideline tool to be used by primary care providers as a decision support tool; and a COPD patient education toolkit to be used by the practice team. During phase II, an RCT will be performed with one year of intervention within 30 primary care practices. The effectiveness of the materials developed in Phase I are being tested in Phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate diagnosis and management of COPD) compared to usual care. We will also examine the use of a patient activation tool - 'MyLungAge' - to prompt patients at risk for or who have COPD to request spirometry confirmation and to request support for smoking cessation if a smoker.
  
  
  CONCLUSIONS
  Using a multi-modal intervention of patient activation and a technology-supported health care provider team, we are testing the effectiveness of this intervention in activating patients and improving physician performance around COPD guideline implementation.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01237561.
authors: Family Medicine and Epidemiology, Alpert Medical School of Brown University, Providence, RI 02912, USA. Donna_Parker@Brown.edu
authors: Donna R
authors: DR
authors: Parker
authors: Charles B
authors: CB
authors: Eaton
authors: David K
authors: DK
authors: Ahern
authors: Mary B
authors: MB
authors: Roberts
authors: Caitlin
authors: C
authors: Rafferty
authors: Roberta E
authors: RE
authors: Goldman
authors: F Dennis
authors: FD
authors: McCool
authors: Joseph
authors: J
authors: Wroblewski
mesh_terms: D019317:Evidence-Based Medicine; D006801:Humans; D017410:Practice Guidelines as Topic; D029424:Pulmonary Disease, Chronic Obstructive; D012107:Research Design
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