Translating The GOLD COPD Guidelines Into Primary Care Practice

NCT ID: NCT01237561

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3593 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-10-25

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

spirometry, patient activation tool

• Receive Portable Spirometer
• Spirometry training of staff
• Provide clinician with web-based COPD interactive guideline tool
• Provide clinician with patient activation tool
• Train clinicians (tools, integration into workflow)
• Academic Detailing

Group Type: EXPERIMENTAL

provider support tools plus spirometer

Intervention Type: OTHER

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

Usual Care

Spirometer and spirometry training of staff

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

provider support tools plus spirometer

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

Intervention Type: OTHER

Other Intervention Names

Determine the effectiveness of tools developed in improving guideline implementation and adherence.

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Donna R. Parker

Associate Professor of Family Med & Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna R Parker, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

MHRhode Island

Locations

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23641803 (View on PubMed)

Other Identifiers

R01HL093090

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-19

Identifier Type: -

Identifier Source: org_study_id