BronchiectasisNCT03550417
Evaluation of Medical and Nursing Management for Bronchiectasis
An observational study of Bronchiectasis, run by The Queen Elizabeth Hospital.
Trial summary
The purpose of this research is to retrospectively evaluate current clinical care of Bronchiectasis (non-cystic fibrosis [CF]) in adults from a multidisciplinary management perspective. This evaluation aims to address the important gaps in current clinical care in 2011, 2013 and July 2016- Jun2017. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchiectasis
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2015to 28 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted or attending Emergency Department at The Queen Elizabeth Hospital in 2011, 2013 and July2016-June2017 with primary or secondary diagnosis of bronchiectasis.
Inclusion Criteria: Admission or attendance to emergency services at The Queen Elizabeth hospital with primary or secondary diagnosis of Bronchiectasis in 2011. Repeated using same criteria in 2013 and July2016-June2017
Exclusion Criteria: Patients who do not have bronchiectasis. Patients with traction bronchiectasis. Patients who do not have outpatient follow up. Patients who have follow up by private physicians or other hospitals and records are unavailable.
About this study
The purpose of this research is to retrospectively evaluate current clinical care of Bronchiectasis (non-cystic fibrosis [CF]) in adults from a multidisciplinary management perspective. This evaluation aims to address the important gaps in current clinical care in 2011, 2013 and July 2016- Jun2017. The primary outcome of this evaluation is to compare the efficacy of current multidisciplinary clinical practice to the British Thoracic Society (BTS) \& Thoracic Society of Australia and New Zealand (TSANZ) guidelines for bronchiectasis. Secondary outcomes of this evaluation will determine the impact of clinical care in 2011, 2013 and July2016-June2017 through quantification of:hospital utilization for using hospital admission data, average length of stay, readmission rates within 28 days, emergency service attendance, outpatient review, exacerbations use of antibiotics, use of Hospital and Home (H@H), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.
Read the detailed description
Project design: The study will be a 12 month retrospective observational cohort study conducted through a review of medical records, internal respiratory databases and electronic hospital patient record (OACIS, HOMER \& EPAS). Participants: Participants in the study will include all patients who have emergency service presentations or admissions to The Queen Elizabeth Hospital (TQEH) with new or existing bronchiectasis in 2011(Jan 1st to Dec 31st). This will be repeated using the same criteria in 2013. An additional year of July2016- Jun2017 has been added for recency of management and to assess if change occurred with introduction of electronic patient record. Data collection: Demographics, clinical data, hospital service utilization, and clinical outcomes such as exacerbation frequency and disease progression. All data will be extracted into a standardized data extraction form, which a random subset will be checked by a second researcher.Analysis of results:Demographic and descriptive data will be given in means + standard deviation and compared using a two-tailed and Student t-test. Categorical variables will be compared using chi-squared or Fisher exact tests, and when appropriate the Mann Whitney U test for non-parametric data. Statistical significance will be determined using an alpha of p <0.05. All analyses will be examined using SPSS software (version x). A subgroup analysis for primary and secondary admission diagnosis will also be performed.
- Conditions
- Bronchiectasis
- Keywords
- disease management, best practice guidelines
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2011 Patients | Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010. | |
| 2013 Patients | Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010. Comparison of 2011, 2013 cohorts \& July16/June17. | |
| July2016/Jun17 Patients | Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010 \& 2014. Comparison of 2011, 2013 cohorts \& July16/June17. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with bronchiectasis guideline compliant care
Percentage of patients who meet guideline compliant care for management of bronchiectasis based in TSANZ and BTS guideline recommendations for outpatient management
Measured: 12 months
Secondary outcomes (4)
Number of admissions
Service outcome includes number of emergency department attendance and admissions
Measured: 12 months
Impact of bronchiectasis outpatient management on patient outcomes
Frequency of exacerbation reported in patient case notes (electronic and hard copy) extracted by two respiratory nurses
Measured: 12 months
Number of outpatient (OPD) attendances
Service outcome includes respiratory and all cause OPD attendances
Measured: 12 months
Patient mortality
Mortality of patients from qualifying admission to present day
Measured: 0 years up to 4 to 7 years dependent on qualifying year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start22 Jun 2015
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Lawton, The Queen Elizabeth Hospital
- Investigators
- Antony Veale, PhD, Study director, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550417
- Sponsor's protocol ID
- QElizabethH
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2017
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical and Nursing Management for Bronchiectasis
- ClinicalTrials.gov ID
- NCT03550417
- Acronym / sponsor ID
- QElizabethH
- Conditions
- Bronchiectasis
- Keywords
- disease management, best practice guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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.
The purpose of this research is to retrospectively evaluate current clinical care of Bronchiectasis (non-cystic fibrosis [CF]) in adults from a multidisciplinary management perspective. This evaluation aims to address the important gaps in current clinical care in 2011, 2013 and July 2016- Jun2017. The primary outcome of this evaluation is to compare the efficacy of current multidisciplinary clinical practice to the British Thoracic Society (BTS) \& Thoracic Society of Australia and New Zealand (TSANZ) guidelines for bronchiectasis. Secondary outcomes of this evaluation will determine the impact of clinical care in 2011, 2013 and July2016-June2017 through quantification of:hospital utilization for using hospital admission data, average length of stay, readmission rates within 28 days, emergency service attendance, outpatient review, exacerbations use of antibiotics, use of Hospital and Home (H@H), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.
Detailed description
Project design: The study will be a 12 month retrospective observational cohort study conducted through a review of medical records, internal respiratory databases and electronic hospital patient record (OACIS, HOMER \& EPAS). Participants: Participants in the study will include all patients who have emergency service presentations or admissions to The Queen Elizabeth Hospital (TQEH) with new or existing bronchiectasis in 2011(Jan 1st to Dec 31st). This will be repeated using the same criteria in 2013. An additional year of July2016- Jun2017 has been added for recency of management and to assess if change occurred with introduction of electronic patient record. Data collection: Demographics, clinical data, hospital service utilization, and clinical outcomes such as exacerbation frequency and disease progression. All data will be extracted into a standardized data extraction form, which a random subset will be checked by a second researcher.Analysis of results:Demographic and descriptive data will be given in means + standard deviation and compared using a two-tailed and Student t-test. Categorical variables will be compared using chi-squared or Fisher exact tests, and when appropriate the Mann Whitney U test for non-parametric data. Statistical significance will be determined using an alpha of p <0.05. All analyses will be examined using SPSS software (version x). A subgroup analysis for primary and secondary admission diagnosis will also be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2011 Patients | – | –Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010. |
| 2013 Patients | – | –Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010. Comparison of 2011, 2013 cohorts \& July16/June17. |
| July2016/Jun17 Patients | – | –Evaluation of multidisciplinary management of bronchiectasis compared to the British Thoracic Society Guidelines 2010 \& 2014. Comparison of 2011, 2013 cohorts \& July16/June17. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted or attending Emergency Department at The Queen Elizabeth Hospital in 2011, 2013 and July2016-June2017 with primary or secondary diagnosis of bronchiectasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with bronchiectasis guideline compliant care
Time frame: 12 months
Percentage of patients who meet guideline compliant care for management of bronchiectasis based in TSANZ and BTS guideline recommendations for outpatient management
4 secondary outcomes
Number of admissions
Time frame: 12 months
Impact of bronchiectasis outpatient management on patient outcomes
Time frame: 12 months
Number of outpatient (OPD) attendances
Time frame: 12 months
Patient mortality
Time frame: 0 years up to 4 to 7 years dependent on qualifying year
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 29 Mar 2023.
- Individual participant dataSharing planned: Yes. Available upon request
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Bronchiectasis
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.
Antony Veale, PhD study director
The Queen Elizabeth Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by The Queen Elizabeth Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients with bronchiectasis guideline compliant care (time frame: 12 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 29 Mar 2023.