- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433223
Retrospective Evaluation of COPD Patient Care
Study Overview
Status
Conditions
Detailed Description
Study design: This study is a retrospective observational crosssectional study conducted through review of medical records, internal respiratory databases and electronic hospital patient record (OACIS & HOMER) over 3x12 blocks.
Participants: COPD patients from The Queen Elizabeth Hospital(TQEH) Respiratory Nursing Service who were new patients in 2006, 2011, 2013 and 2015 (Jan 1st to Dec 31st ). Data collection: Demographics, clinical data, hospital service utilisation, and clinical outcomes such as exacerbation frequency and disease progression. All data will be extracted into a standardised data extraction form, which a random subset will be checked by a second researcher.
Demographic data will include comparison of % without comorbidities, impact of comorbid conditions using Charleston Comorbidity index isolating diabetes, heart failure, anxiety and depression. Demographic and descriptive data will be given in means + SD and compared using a two-tailed Student t-test. Categorical variables will be compared using chisquared or Fisher exact tests, and when appropriate the MannWhitney Utest for nonparametric data. Statistical significance will be determined using an alpha of p <0.05. All analyses will be examined using SPSS software (version x).
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
- any new client or new referral to the Respiratory Nursing Service in the years 2006, 2011, 2013 or 2015 only
- have a diagnosis of Chronic Obstructive Pulmonary Disease
Exclusion Criteria
- not a pre- existing client of the Respiratory Nursing Service
- not having a diagnosis of Chronic Obstructive Pulmonary Disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
2006 Patients
Comparison of Respiratory Chronic Disease Management provided against recommendations in 2005 Respiratory Nursing Guidelines through documentation
|
2011 Patients
Comparison of Respiratory Chronic Disease Management provided against recommendations in 2005 Respiratory Nursing Guidelines through documentation.
With comparison of data against 2006 results.
|
2013 Patients
Comparison of Respiratory Chronic Disease Management provided against recommendations in 2005 Respiratory Nursing Guidelines through documentation.
With comparison of data against 2006 & 2011 results.
|
2015 Patients
Group added to reflect recency of practice.
Comparison of Respiratory Chronic Disease Management provided against recommendations in 2005 Respiratory Nursing Guidelines through documentation.
With comparison of data against 2006 & 2011 results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of care provided by the Respiratory Nursing Service
Time Frame: 12 months
|
Compare documentation against the components of 'Nursing Best Practice Guideline, Nursing Care of Dyspnea: The 6th Vital Sign in Individuals with Chronic Obstructive Pulmonary Disease (COPD)'
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of respiratory nursing outreach on hospital, patient and service outcomes
Time Frame: 12 months
|
Hospital utilisation is determined by hospital admissions, emergency department presentations, length of stay, readmission within 28 days, number of Respiratory Outpatient reviews and use of Hospital at Home.
Patient outcomes are frequency of exacerbations, disease severity and progression (FEV1: GOLD Classification), Quality of Life, lung function and exercise tolerance.
Respiratory Nurse outcomes are the number and type of contacts performed
|
12 months
|
Comorbidity in respiratory nursing
Time Frame: 12 months
|
Identify the percentage of patients involved in the Respiratory Nursing Service with COPD who do and do not have a co-morbidity?
Identify those with a comorbidity are they Aboriginal and Torres Strait Islander, of Cultural and Linguistic descent or of a low socioeconomic group?
Identify the impact of co-morbid conditions using Charlson Comorbidity index isolating diabetes, heart failure, anxiety and depression?
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Brian J Smith, PhD, The Queen Elizabeth Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QElizabethH COPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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