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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
provider support tools plus spirometer
Sponsored by
Memorial Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, COPD Guidelines, Patient Activation, Lung Age

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

spirometry, patient activation tool

Usual Care

Arm Description

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

Spirometer and spirometry training of staff

Outcomes

Primary Outcome Measures

Adherence to COPD guidelines
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
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.

Full Information

First Posted
November 8, 2010
Last Updated
March 31, 2017
Sponsor
Memorial Hospital of Rhode Island
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01237561
Brief Title
Translating The GOLD COPD Guidelines Into Primary Care Practice
Acronym
LungAge
Official Title
Translating The GOLD COPD Guidelines Into Primary Care Practice
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
October 25, 2013 (Actual)
Study Completion Date
October 25, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial Hospital of Rhode Island
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, COPD Guidelines, Patient Activation, Lung Age

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3593 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spirometry, patient activation tool
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Spirometer and spirometry training of staff
Intervention Type
Other
Intervention Name(s)
provider support tools plus spirometer
Other Intervention Name(s)
Determine the effectiveness of tools developed in improving guideline implementation and adherence.
Intervention Description
Patient Activation Tool, Provider Web-based decision support tool, academic detailing
Primary Outcome Measure Information:
Title
Adherence to COPD guidelines
Description
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.
Time Frame
Twelve months post intervention
Secondary Outcome Measure Information:
Title
patient activation
Description
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.
Time Frame
Baseline and 12 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna R Parker, Sc.D.
Organizational Affiliation
MHRhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23641803
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.
Results Reference
derived

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Translating The GOLD COPD Guidelines Into Primary Care Practice

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