Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatment provider support tools plus spirometer
Phase phase 2
Sponsor Memorial Hospital of Rhode Island
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date October 2010
End date September 2015
Trial size 3593 participants
Trial identifier NCT01237561, 08-19, R01HL093090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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
provider support tools plus spirometer Determine the effectiveness of tools developed in improving guideline implementation and adherence.
Patient Activation Tool, Provider Web-based decision support tool, academic detailing
(No Intervention)
Spirometer and spirometry training of staff

Primary Outcomes

Measure
Adherence to COPD guidelines
time frame: Twelve months post intervention

Secondary Outcomes

Measure
patient activation
time frame: Baseline and 12 months post intervention

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Translating The GOLD COPD Guidelines Into Primary Care Practice
Principal investigator Donna R Parker, Sc.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Memorial Hospital of Rhode Island.