Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000296639
Ethics application status
Approved
Date submitted
16/03/2014
Date registered
20/03/2014
Date last updated
2/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic Snapshot for Outpatient Management of Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
In patients with chronic obstructive pulmonary disease, does an electronic personalised COPD Snapshot improve GP uptake of clinical care recommendations?
Secondary ID [1] 284273 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ESO-COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 291404 0
Condition category
Condition code
Respiratory 291767 291767 0 0
Chronic obstructive pulmonary disease
Public Health 291795 291795 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will receive a COPD Snapshot for the duration of the study. The COPD Snapshot is a communication tool that is a checklist-format adaptation of the Lung Foundation Stepwise Management of Stable COPD Guidelines. This Snapshot will be developed and piloted in-house in the initial phase of this project, and will contain key management points that have been identified by each patient’s thoracic physician as requiring ongoing review by the patient’s GP. It will also contain relevant recent investigation results, current medication list, and allergies. In addition, the Snapshot will be accessible if patients attend the ED. Utilisation of the Snapshot by ED will be monitored as a guide to feasibility for potential future expansion of the Snapshot scope based on initial results.

The Intervention Group (n=100 participants) will receive an electronic personalised COPD Snapshot in the form of a credit card sized USB stick, in addition to usual care from their thoracic physician (consultation, and clinic letter to GP). The electronic Snapshot will be given to participants during their consultation at the respiratory outpatient clinics. They will be asked to provide it to their GP to review when they next attend for ongoing care, within the next 2 months. After reviewing the Snapshot, GPs will return it to their patient and complete a brief, 3-question satisfaction survey. After attending follow up with their GP, participants will return the COPD Snapshot to the investigators by mail in a pre-addressed envelope. In addition, participants will complete a brief follow up survey (free text comments from patient and/or telephone interview) regarding their experience with the Snapshot and the clinical care they received.
Intervention code [1] 288983 0
Treatment: Other
Comparator / control treatment
The Control Group (n=100 participants) will receive usual care from their thoracic physician (consultation, and clinic letter to GP), without the addition of any COPD Snapshot. In addition, participants will complete a brief follow up survey (free text comments from patient and/or telephone interview) regarding their experience and the clinical care they received. For comparison with the intervention group, the GP will be requested to complete a brief, 3-question satisfaction survey regarding the usefulness of the clinic letter they have received.

Participants in both groups will be provided with a paper copy of the Lung Foundation Stepwise Management of Stable COPD Guidelines to give to their GP when they attend for follow up, to provide all GPs with this up-to-date guideline information.
Control group
Active

Outcomes
Primary outcome [1] 291698 0
GP uptake of clinical care recommendations from the thoracic specialist, as measured by survey (survey specifically designed for this trial).
Timepoint [1] 291698 0
At time of first GP follow-up consultation.
Secondary outcome [1] 307313 0
Disease impact on quality of life as measured by COPD Assessment Test.
Timepoint [1] 307313 0
Baseline and at 4 month follow-up survey.
Secondary outcome [2] 307314 0
Time to first exacerbation as measured by survey (survey specifically designed for this trial).
Timepoint [2] 307314 0
At 6 month follow-up survey (included in survey specifically designed for this trial)
Secondary outcome [3] 307315 0
Patient satisfaction and experience as measured by survey (survey specifically designed for this trial).
Timepoint [3] 307315 0
2 months after enrolment.
Secondary outcome [4] 307316 0
GP satisfaction as measured by survey (survey specifically designed for this trial).
Timepoint [4] 307316 0
Immediately after follow-up consultation with participant.
Secondary outcome [5] 307317 0
Thoracic physician satisfaction as measured by survey (survey specifically designed for this trial).
Timepoint [5] 307317 0
At conclusion of study.
Secondary outcome [6] 307318 0
Mortality as measured by hospital and other records.
Timepoint [6] 307318 0
6 month follow-up after enrolment.
Secondary outcome [7] 307319 0
Number of recommendations made by thoracic physicians per patient.
Timepoint [7] 307319 0
6 months after enrolment.
Secondary outcome [8] 307320 0
Number of patients who take the COPD Snapshot to their GP follow-up appointment as measured by participant survey.
Timepoint [8] 307320 0
6 month follow-up.
Secondary outcome [9] 307321 0
Number of GPs who open and access COPD Snapshot as measured by GP survey (survey specifically designed for this trial).
Timepoint [9] 307321 0
Immediately after GP follow-up appointment.
Secondary outcome [10] 307322 0
Number of GPs who confirm electronically that they have reviewed the COPD Snapshot as measured by observation of editing COPD Snapshot tool.
Timepoint [10] 307322 0
Immediately after GP follow-up appointment.

Eligibility
Key inclusion criteria
- Adult patients of any age with thoracic-physician diagnosed COPD.
- COPD diagnosis will be based on Global Initiative in Obstructive Lung Disease (GOLD) spirometric criteria of post-bronchodilator FEV1<80% predicted and FEV1/FVC <70%.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to give written informed consent.
- Presence of other respiratory conditions which are more predominant than the COPD (e.g. asthma; bronchiectasis; interstitial lung disease; current lung cancer). Patients with previously treated lung cancer, without known current active lung cancer, will be able to be included.
- No current regular general practitioner.
- High care level in a residential care facility.
- Women who are pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the respiratory outpatient clinics at The Prince Charles Hospital (TPCH), Brisbane, Australia. Both newly referred and current patients with COPD will be invited to join this study while attending their clinic appointment with their thoracic physician at the hospital.
Randomisation will take place at time of enrollment in the study. Participants will be randomised into one of two groups, using a random sequence generator, with 1:1 ratio in permuted blocks, and using balanced stratification based on new or review patient status. Allocations will be concealed in opaque envelopes, which are randomly assigned to participants, and not revealed until after informed consent. Allocation concealment will be implemented, so that investigators and participants are not aware of the treatment allocation prior to randomisation. Once randomised, both investigators and participants will be fully aware of the treatment allocation in an unblinded manner, and there will not be a sham intervention for the usual care, control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into one of two groups, using a random sequence generator, with 1:1 ratio in permuted blocks, and using balanced stratification based on new or review patients status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to compare between control and intervention groups, we will test differences between the primary and secondary outcomes using t-test for continuous variables, and chi squared test for categorical variables. Multivariate analysis using relevant clinical and demographic covariates will be performed. All analysis will be performed using SPSS Version 20. A p value (two-tailed) <0.05 will be considered statistically significant.
The power of the study was estimated using the PS Power Calculation Software. Assuming a baseline uptake of 50% of recommendations by GPs in the usual care group, 100 patients in the intervention group and 100 patients in the control group would give 80% power (alpha 0.05) to find an increase in uptake by 20% to 70% with use of the COPD Snapshot.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
17/02/2015
Date of last participant enrolment
Anticipated
17/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2193 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7870 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 288898 0
Charities/Societies/Foundations
Name [1] 288898 0
The Prince Charles Hospital Foundation
(funding sought)
Country [1] 288898 0
Australia
Funding source category [2] 288899 0
University
Name [2] 288899 0
The University of Queensland
Country [2] 288899 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital Rode Rd
Chermside
QLD 4032
Country
Australia
Secondary sponsor category [1] 287593 0
University
Name [1] 287593 0
The University of Queensland
Address [1] 287593 0
The University of Queensland
St Lucia
QLD 4072
Country [1] 287593 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290729 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 290729 0
Ethics committee country [1] 290729 0
Australia
Date submitted for ethics approval [1] 290729 0
13/11/2013
Approval date [1] 290729 0
13/01/2014
Ethics approval number [1] 290729 0
HREC/13/QPCH/324

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46986 0
Mr Jeffrey Overington
Address 46986 0
Thoracic Department
The Prince Charles Hospital, 627 Rode Rd
Chermside QLD 4032
Country 46986 0
Australia
Phone 46986 0
+61 478 049 078
Fax 46986 0
Email 46986 0
[email protected]
Contact person for public queries
Name 46987 0
Jeffrey Overington
Address 46987 0
Thoracic Department
The Prince Charles Hospital
627 Rode Rd
Chermside QLD 4032
Country 46987 0
Australia
Phone 46987 0
+61 478 049 078
Fax 46987 0
Email 46987 0
[email protected]
Contact person for scientific queries
Name 46988 0
Ian Yang
Address 46988 0
The Prince Charles Hospital
627 Rode Rd
Chermside QLD 4032
Country 46988 0
Australia
Phone 46988 0
+61 (0)7 3139 5050
Fax 46988 0
Email 46988 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.