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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03550417
Other study ID # QElizabethH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2015
Est. completion date March 28, 2023

Study information

Verified date March 2023
Source The Queen Elizabeth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date March 28, 2023
Est. primary completion date March 28, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Queen Elizabeth Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary Number of admissions Service outcome includes number of emergency department attendance and admissions 12 months
Secondary 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 12 months
Secondary Number of outpatient (OPD) attendances Service outcome includes respiratory and all cause OPD attendances 12 months
Secondary Patient mortality Mortality of patients from qualifying admission to present day 0 years up to 4 to 7 years dependent on qualifying year
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