Clinical trial NCT03550417: Evaluation of Medical and Nursing Management for Bronchiectasis
Official title: Evaluation of Medical and Nursing Management for Bronchiectasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: disease management
best practice guidelines
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with bronchiectasis guideline compliant care
timeFrame: 12 months
Secondary outcomes:
measure: Number of admissions
timeFrame: 12 months
measure: Impact of bronchiectasis outpatient management on patient outcomes
timeFrame: 12 months
measure: Number of outpatient (OPD) attendances
timeFrame: 12 months
measure: Patient mortality
timeFrame: 0 years up to 4 to 7 years dependent on qualifying year
Other outcomes:
Locations:
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Antony Veale, PhD
role: STUDY_DIRECTOR
References: