Open Access Highly Accessed Study protocol

The study design and rationale of the randomized controlled trial: translating COPD guidelines into primary care practice

Donna R Parker12*, Charles B Eaton12, David K Ahern34, Mary B Roberts2, Caitlin Rafferty2, Roberta E Goldman25, F Dennis McCool67 and Joseph Wroblewski3

Author affiliations

1 Family Medicine and Epidemiology, Alpert Medical School of Brown University, Providence, RI, 02912, USA

2 Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, 111 Brewster Street, Pawtucket, RI, 02860, USA

3 Abacus Health Solutions, 1210 Pontiac Avenue, Cranston, RI, 02920, USA

4 Program in Behavioral Informatics and eHealth, Brigham & Women's Hospital/Harvard Medical School, Boston, MA, 02115, USA

5 Department of Family Medicine, Alpert Medical School of Brown University, Providence, RI, 02912, USA

6 Department of Medicine, Alpert Medical School of Brown University, Providence, RI, 02912, USA

7 Memorial Hospital of Rhode Island, 111 Brewster Street, Pawtucket, RI, 02860, USA

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Citation and License

BMC Family Practice 2013, 14:56  doi:10.1186/1471-2296-14-56

Published: 6 May 2013

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.

Method/Design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov, NCT01237561

Keywords:
COPD; Guidelines; Randomized Clinical Trial; Primary care