Translating The GOLD COPD Guidelines Into Primary Care Practice (LungAge)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Donna R. Parker, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01237561
First received: November 8, 2010
Last updated: May 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Other: provider support tools plus spirometer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Translating The GOLD COPD Guidelines Into Primary Care Practice

Resource links provided by NLM:


Further study details as provided by Memorial Hospital of Rhode Island:

Primary Outcome Measures:
  • Adherence to COPD guidelines [ Time Frame: Twelve months post intervention ] [ Designated as safety issue: No ]
    An 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 Outcome Measures:
  • patient activation [ Time Frame: Baseline and 12 months post intervention ] [ Designated as safety issue: No ]
    A 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.


Enrollment: 3593
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: provider support tools plus spirometer
Patient Activation Tool, Provider Web-based decision support tool, academic detailing
Other Name: Determine the effectiveness of tools developed in improving guideline implementation and adherence.
No Intervention: Usual Care
Spirometer and spirometry training of staff

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237561

Locations
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Investigators
Principal Investigator: Donna R Parker, Sc.D. MHRhode Island
  More Information

No publications provided by Memorial Hospital of Rhode Island

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donna R. Parker, Associate Professor of Family Med & Epidemiology, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01237561     History of Changes
Other Study ID Numbers: 08-19, R01HL093090
Study First Received: November 8, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Hospital of Rhode Island:
Chronic Obstructive Pulmonary Disease
COPD Guidelines
Patient Activation
Lung Age

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014