Chronic Obstructive Pulmonary Disease (COPD)LungAgeNCT01237561
Translating The GOLD COPD Guidelines Into Primary Care Practice
A study testing provider support tools plus spirometer in people with Chronic Obstructive Pulmonary Disease (COPD), run by Memorial Hospital of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- provider support tools plus spirometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,593 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 25 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 40 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
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.
Read the 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.
- Being tested
- provider support tools plus spirometer
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD Guidelines, Patient Activation, Lung Age
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
provider support tools plus spirometerOther
Also called Determine the effectiveness of tools developed in improving guideline implementation and adherence.
Patient Activation Tool, Provider Web-based decision support tool, academic detailing
| Study group | Role | What they receive |
|---|---|---|
| spirometry, patient activation tool | 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 Receives: Other: provider support tools plus spirometer |
| Usual Care | No intervention | Spirometer and spirometry training of staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve months post intervention
Secondary outcomes (1)
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.
Measured: Baseline and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2010
- Primary completion25 Oct 2013
- Study completion25 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Donna R. Parker, Memorial Hospital of Rhode Island
- Investigators
- Donna R Parker, Sc.D., Principal investigator, MHRhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237561
- Sponsor's protocol ID
- 08-19
- Other IDs
- R01HL093090
- Acronym
- LungAge
- Status last verified
- Mar 2017
- First submitted
- 8 Nov 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23641803
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating The GOLD COPD Guidelines Into Primary Care Practice
- ClinicalTrials.gov ID
- NCT01237561
- Acronym / sponsor ID
- LungAge / 08-19
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD Guidelines, Patient Activation, Lung Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,593 participants (actual)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2010 (actual)
- Primary completion
- 25 Oct 2013 (actual)
- Study completion
- 25 Oct 2013 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spirometry, patient activation tool | Experimental | Other: provider support tools plus spirometer* 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 |
| Usual Care | No intervention | –Spirometer and spirometry training of staff |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- < 40 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| provider support tools plus spirometerAlso: Determine the effectiveness of tools developed in improving guideline implementation and adherence.Patient Activation Tool, Provider Web-based decision support tool, academic detailing | Other | spirometry, patient activation tool |
Primary outcome
Adherence to COPD guidelines
Time frame: Twelve months post intervention
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.
1 secondary outcome
patient activation
Time frame: Baseline and 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 23641803Parker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna R Parker, Sc.D. principal investigator
MHRhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing provider support tools plus spirometer in people with Chronic Obstructive Pulmonary Disease (COPD), run by Memorial Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to COPD guidelines (time frame: Twelve months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.