Clinical trial NCT01237561: Translating The GOLD COPD Guidelines Into Primary Care Practice
Official title: Translating The GOLD COPD Guidelines Into Primary Care Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
COPD Guidelines
Patient Activation
Lung Age
Lead sponsor: Memorial Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-11-09
Enrollment: 3593
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project will evaluate the translation of the Gold (the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD guidelines into primary care practice. During phase I, a needs assessment will evaluate 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 the focus groups, three tools will be developed, refined and pilot tested. The effectiveness of the materials developed in phase I will be tested in phase II (a randomized clinical trial conducted with one year of intervention within non-academic primary care practices) regarding physician performance of COPD guideline implementation and improvement in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD) compared to usual care.

Detailed description: This project will evaluate the translation of the GOLD (the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) COPD guidelines into primary care practice. This study is based upon the premise that an informed, activated patient will interact with a prepared, proactive team to improve appropriate COPD screening, diagnosis and management. During phase I, a needs assessment will evaluate 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 the focus groups, three tools will be developed, refined and pilot tested. These include: a computerized patient activation tool that will be used by the patient either in the waiting room or in the examination room; a web-based, interactive COPD guidelines tool to be used by primary care providers as a decision support tool at the point of care and a COPD patient education toolbox to be used by the practice team. During phase II, a block, randomized design cluster trial will be performed with one year of intervention within non-academic primary care practices (30 practices) throughout the state of Rhode Island and southeastern MA. The effectiveness of the materials developed in phase I will be tested in phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate screening, diagnosis and management of COPD) compared to usual care. The investigators will also examine the use of a patient activation tool -'MyLungAge' to prompt patients to talk with their health care provider regarding their lung health and risk for COPD. Products for dissemination from this grant will include the results of the focus groups barriers and facilitators to implementation and adherence to COPD guidelines, a computerized data collection module for quality of care assessment regarding COPD guidelines, a refined computerized patient activation tool, an enhanced web-based COPD interactive guideline tool, tailored academic detailing materials, and the results of the randomized clinical trial on the effectiveness of these tools to improve COPD guideline adherence in primary care practice.

Eligibility criteria: Inclusion Criteria:

* All patients 40 years or older
* Seen at least once in the past 2 years (active patients) by their PCP
* And/or 40 years of age and less than 81 years of age who smoke.

Exclusion Criteria:

* \< 40 years of age

Primary outcomes:
measure: Adherence to COPD guidelines
timeFrame: Twelve months post intervention
Secondary outcomes:
measure: patient activation
timeFrame: Baseline and 12 months post intervention
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: MHRhode Island
name: Donna R Parker, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker DR, Eaton CB, Ahern DK, Roberts MB, Rafferty C, Goldman RE, McCool FD, Wroblewski J. The study design and rationale of the randomized controlled trial: translating COPD guidelines into primary care practice. BMC Fam Pract. 2013 May 6;14:56. doi: 10.1186/1471-2296-14-56.