BronchiectasisNCT01315626
Bronchiectasis: Evaluation of an Educational Intervention
An observational study of Bronchiectasis, run by Hill-Rom at 1 site in United States.
Trial summary
A study of an educational intervention of primary care practice physicians to assist in the identification of patients who have Bronchiectasis and to assess the effectiveness of the specific didactic educational intervention targeting primary care physicians in the recognition of Bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Primary Care Educational event
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present, or who have been seen in the above time periods, to the participating primary care physician with the following inclusion / exclusion criteria will be enrolled.
Who may be able to join
- Respiratory is the chief complaint
- Patient > 35 years of age
- Seen in practice for > 12 months
Who cannot join
- 1) Prior diagnosis with bronchiectasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard Rupard, MD Primary Care Practice
Shelbyville, Tennessee, 37160
About this study
Official title: Identification of Patients With a Diagnosis of Bronchiectasis: Evaluation of an Educational Intervention
A study of an educational intervention of primary care practice physicians to assist in the identification of patients who have Bronchiectasis and to assess the effectiveness of the specific didactic educational intervention targeting primary care physicians in the recognition of Bronchiectasis.
Read the detailed description
A pilot study will be conducted for the purpose of evaluating an educational intervention (Description in Appendix A). As part of the educational intervention, primary care physician(s) will be trained in the use of an algorithm to guide assessment of patients seen with a respiratory chief complaint, and who have not previously been identified as having a diagnosis of BE. We propose an evaluation of three primary care practice(s) to compare the number of patients identified in three three-month periods as having a diagnosis of BE.
The evaluation periods will be as follows: Period 1) the three-month period immediately following the intervention, Period 2) the three-month period immediately preceding the intervention, Period 3) the three month period starting one year prior to the intervention.
- Conditions
- Bronchiectasis
- Being tested
- Primary Care Educational event
- Keywords
- Bronchiectasis, pulmonary exacerbations, pulmonary infections
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Educational eventOther
The purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE. The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients. In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs.
| Study group | Role | What they receive |
|---|---|---|
| Immediately preceding intervention | 3 months immediately before the education event. Charts of patients with a primary respiratory complaint will be reviewed so evaluate if they 1) have experienced 3 or more suppurative respiratory infections and 2) have required 3 or more courses of antibiotic therapy for respiratory infection over the period of one year. 4) Whether or not they underwent a HRCT, and if so, and 5) Were the patients diagnosed with BE. | |
| 3 months after educational event | 3 months immediately after the education event. An active assessment will be preformed as per the proposed diagnostic algorithm (attachment B) Patients that meet all criteria in the algorithm are considered at risk for bronchiectasis and based on these criteria, physicians will be encouraged to order HRCT, and the number/ proportion of patients identified with BE will be noted and compared to the other time periods. Receives: Other: Primary Care Educational event | |
| Seasonal prior year | As respiratory illnesses are commonly seasonal, an assessment of rate of Bronchiectasis diagnosis during the months of Period 2 in the year prior to the educational intervention will also be assessed as described in Period 1 Receives: Other: Primary Care Educational event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number / Percent of BE patients
The primary outcome for this study will be the number/proportion of patients that meet entrance criteria that are subsequently diagnosed with bronchiectasis.
Measured: 18 months
Secondary outcomes (1)
HRCT patients
Secondary outcomes are the number/proportion of those subjects that undergo HRCT, and the number/proportion of subjects that are then identified as having Bronchiectasis.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: Sponsor did not move forward with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315626
- Sponsor's protocol ID
- CR-2010-04
- Status last verified
- Mar 2011
- First submitted
- 20 Dec 2010
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients With a Diagnosis of Bronchiectasis: Evaluation of an Educational Intervention
- ClinicalTrials.gov ID
- NCT01315626
- Acronym / sponsor ID
- CR-2010-04
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, pulmonary exacerbations, pulmonary infections
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor did not move forward with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 15 Mar 2011 (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.
A study of an educational intervention of primary care practice physicians to assist in the identification of patients who have Bronchiectasis and to assess the effectiveness of the specific didactic educational intervention targeting primary care physicians in the recognition of Bronchiectasis.
Detailed description
A pilot study will be conducted for the purpose of evaluating an educational intervention (Description in Appendix A). As part of the educational intervention, primary care physician(s) will be trained in the use of an algorithm to guide assessment of patients seen with a respiratory chief complaint, and who have not previously been identified as having a diagnosis of BE. We propose an evaluation of three primary care practice(s) to compare the number of patients identified in three three-month periods as having a diagnosis of BE.
The evaluation periods will be as follows: Period 1) the three-month period immediately following the intervention, Period 2) the three-month period immediately preceding the intervention, Period 3) the three month period starting one year prior to the intervention.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediately preceding intervention | – | –3 months immediately before the education event. Charts of patients with a primary respiratory complaint will be reviewed so evaluate if they 1) have experienced 3 or more suppurative respiratory infections and 2) have required 3 or more courses of antibiotic therapy for respiratory infection over the period of one year. 4) Whether or not they underwent a HRCT, and if so, and 5) Were the patients diagnosed with BE. |
| 3 months after educational event | – | Other: Primary Care Educational event3 months immediately after the education event. An active assessment will be preformed as per the proposed diagnostic algorithm (attachment B) Patients that meet all criteria in the algorithm are considered at risk for bronchiectasis and based on these criteria, physicians will be encouraged to order HRCT, and the number/ proportion of patients identified with BE will be noted and compared to the other time periods. |
| Seasonal prior year | – | Other: Primary Care Educational eventAs respiratory illnesses are commonly seasonal, an assessment of rate of Bronchiectasis diagnosis during the months of Period 2 in the year prior to the educational intervention will also be assessed as described in Period 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present, or who have been seen in the above time periods, to the participating primary care physician with the following inclusion / exclusion criteria will be enrolled.
Key inclusion criteria (3 listed)
- Respiratory is the chief complaint
- Patient > 35 years of age
- Seen in practice for > 12 months
Key exclusion criteria (1 listed)
- 1) Prior diagnosis with bronchiectasis
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 |
|---|---|---|
| Primary Care Educational eventThe purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE. The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients. In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs. | Other | 3 months after educational event, Seasonal prior year |
Primary outcome
Number / Percent of BE patients
Time frame: 18 months
The primary outcome for this study will be the number/proportion of patients that meet entrance criteria that are subsequently diagnosed with bronchiectasis.
1 secondary outcome
HRCT patients
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Hill-Rom 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: withdrawn, as of the sponsor's last update on 18 Mar 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number / Percent of BE patients (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2015.