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Translating The GOLD COPD Guidelines Into Primary Care Practice

Translating The GOLD COPD Guidelines Into Primary Care Practice

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01237561
Acronym
LungAge
Enrollment
3593
Registered
2010-11-09
Start date
2010-10-31
Completion date
2013-10-25
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease, COPD Guidelines, Patient Activation, Lung Age

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.

Interventions

OTHERprovider support tools plus spirometer

Patient Activation Tool, Provider Web-based decision support tool, academic detailing

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Memorial Hospital of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to COPD guidelinesTwelve months post interventionAn adherence tool will be developed and reviewed by an expert panel. They will review the suggested criterion and make recommendations regarding an item's status on the tool. The panel may also suggest additional criteria for inclusion in the tool. The tool will be modified based on expert consensus. Once the tool is finalized, a detailed algorithm will be developed for scoring the primary care practice data which will include an adherence score for each visit and an overall adherence score and will be piloted the first 2 months of chart review.

Secondary

MeasureTime frameDescription
patient activationBaseline and 12 months post interventionA patient activation measure (PAM) developed by Hibbard et al. will be used to assess a patient's knowledge, skills and behaviors necessary to create an activated patient for managing their own health care. The patient activation tool will also measure other co-morbidities and will be assessed during a telephone survey at baseline and on a subsample 12 months post-intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026