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Evaluation of Medical and Nursing Management for Bronchiectasis

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ClinicalTrials.gov Identifier: NCT03550417
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Kathryn Lawton, The Queen Elizabeth Hospital

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.

Condition or disease
Bronchiectasis

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of Medical and Nursing Management for Bronchiectasis
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of admissions [ Time Frame: 12 months ]
    Service outcome includes number of emergency department attendance and admissions

  2. Impact of bronchiectasis outpatient management on patient outcomes [ Time Frame: 12 months ]
    Frequency of exacerbation reported in patient case notes (electronic and hard copy) extracted by two respiratory nurses

  3. Number of outpatient (OPD) attendances [ Time Frame: 12 months ]
    Service outcome includes respiratory and all cause OPD attendances

  4. Patient mortality [ Time Frame: 0 years up to 4 to 7 years dependent on qualifying year ]
    Mortality of patients from qualifying admission to present day



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550417


Sponsors and Collaborators
The Queen Elizabeth Hospital
Investigators
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Study Director: Antony Veale, PhD The Queen Elizabeth Hospital

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Responsible Party: Kathryn Lawton, Principle Investigator, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier: NCT03550417     History of Changes
Other Study ID Numbers: QElizabethH
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available upon request
Keywords provided by Kathryn Lawton, The Queen Elizabeth Hospital:
disease management
best practice guidelines
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases