Chronic Obstructive Pulmonary DiseaseNCT02433223
Retrospective Evaluation of COPD Patient Care
An observational study of Chronic Obstructive Pulmonary Disease, run by The Queen Elizabeth Hospital.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New patients to the Respiratory Nursing Service in 2006, 2011, 2013 \& 2015 with a diagnosis of Chronic Obstructive Pulmonary Disease
Who may be able to join
- 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
Who cannot join
- not a pre- existing client of the Respiratory Nursing Service
- not having a diagnosis of Chronic Obstructive Pulmonary Disease
About this study
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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- outreach nursing, respiratory nursing guidelines
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)'
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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?
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Carson, The Queen Elizabeth Hospital
- Investigators
- Brian J Smith, PhD, Study director, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433223
- Sponsor's protocol ID
- QElizabethH COPD
- Status last verified
- May 2018
- First submitted
- 29 Apr 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of COPD Patient Care
- ClinicalTrials.gov ID
- NCT02433223
- Acronym / sponsor ID
- QElizabethH COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- outreach nursing, respiratory nursing guidelines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New patients to the Respiratory Nursing Service in 2006, 2011, 2013 \& 2015 with a diagnosis of Chronic Obstructive Pulmonary Disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- not a pre- existing client of the Respiratory Nursing Service
- not having a diagnosis of Chronic Obstructive Pulmonary Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)'
2 secondary outcomes
Impact of respiratory nursing outreach on hospital, patient and service outcomes
Time frame: 12 months
Comorbidity in respiratory nursing
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Smith, PhD study director
The Queen Elizabeth Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by The Queen Elizabeth Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of care provided by the Respiratory Nursing Service (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.