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Evaluation of Medical and Nursing Management for Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 6, 2017
First Posted Date June 8, 2018
Last Update Posted Date September 17, 2019
Study Start Date June 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03550417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 6, 2018)
  • Number of admissions [ Time Frame: 12 months ]
    Service outcome includes number of emergency department attendance and admissions
  • 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
  • Number of outpatient (OPD) attendances [ Time Frame: 12 months ]
    Service outcome includes respiratory and all cause OPD attendances
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Medical and Nursing Management for Bronchiectasis
Official Title Evaluation of Medical and Nursing Management for 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Bronchiectasis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 6, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03550417
Other Study ID Numbers QElizabethH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Available upon request
Responsible Party Kathryn Lawton, The Queen Elizabeth Hospital
Study Sponsor The Queen Elizabeth Hospital
Collaborators Not Provided
Investigators
Study Director: Antony Veale, PhD The Queen Elizabeth Hospital
PRS Account The Queen Elizabeth Hospital
Verification Date September 2019