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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02433223
Other study ID # QElizabethH COPD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2018

Study information

Verified date May 2018
Source The Queen Elizabeth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to evaluate hospital utilisation, patient and service outcomes of a Respiratory Nursing Service to examine current clinical care of COPD. This evaluation aims to identify the important gaps in current clinical care of respiratory chronic disease nursing management. The primary outcomes of this evaluation is to determine the efficacy of clinical care in 2006, 2011, 2013 and 2015 and compare data to current Nursing Best practice guidelines for COPD through the quantification of hospital utilisation for hospital admission, average length of stay, readmission within 28 days, emergency service attendance, outpatient review, use of Hospital and Home (H@H), frequency of exacerbations, disease severity and progression (FEV1: GOLD Classification), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 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 Efficacy of care provided by the Respiratory Nursing Service 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 Impact of respiratory nursing outreach on hospital, patient and service outcomes 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
Secondary Comorbidity in respiratory nursing 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
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