Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000269831
Ethics application status
Approved
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
6/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the adherence to action plans in patients with chronic obstructive pulmonary disease
Scientific title
A 12-months parallel group randomised trial of patients with Chronic Obstructive Pulmonary Disease (COPD) comparing provision of a COPD action plan with dispensed antibiotics and oral steroids, against an action plan without dispensed medications, on action plan adherence and quality of life
Secondary ID [1] 280000 0
Nil.
Universal Trial Number (UTN)
Trial acronym
A-TAPAS
(Adherance to Action Plan Antibiotics and Steroids.)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 285908 0
Condition category
Condition code
Respiratory 286098 286098 0 0
Chronic obstructive pulmonary disease
Public Health 286181 286181 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A written COPD action plan provided with dispensed antibiotics and steriods.

The COPD action plan is that recommended by the Thoracic Society of Australia and New Zealand and the Australian Lung Foundation.
This plan outlines (in one A4 sheet) a patients usual medication regime, the symptoms of and medications to be taken with a moderate exacerbation, as well as instructions on seeking emergency assistance with symptoms of a severe attack/ exacerbation. This is signed by the patients physicain and or GP. The patient keeps a copy with them in case of exacerbation.
The provision and level of education provided with this Action Plan is at the descretion of the Doctor writing it.
Within the Respiratory Chronic Care program patients are visited regularly by case managers with Action Plan education and reminders provided on case management home visits, these visits usually last approximately 20 to 30 minutes.
These visit are attended based on clients coping ability and community support need. Therefore it varies between patients as to frequency. Within the Respiratory Chronic Care program the minimum frequency at which visit are attended is monthly.

There is no recommendation as to how often these plans are to be reviewed yet RCC has a policy of updating these every 12 months unless otherwise indicated.
The medications on this action plan are also dispensed at the discretion of the treating doctor, at times no script or medication is provided , other times a script and medication is provided on the same day and some patients are provided with a script only.
Prednisolone and antibiotics specific to respiratory infections are the medications usually prescribed.
Intervention code [1] 284324 0
Treatment: Other
Comparator / control treatment
A written COPD action plan, provided with prescriptions for the required medications. The action plan remains the same for the intervention group in that the standard prctice of physician descretion determines what is prescribed for the patients action plan.
Control group
Active

Outcomes
Primary outcome [1] 286574 0
Adherence to written COPD action plan, defined as occurring if the patient initiates both the prescribed prednisolone and antibiotics within 3 days of a change for at least 24 hours in at least two of the following three major symptoms: dyspnea, sputum volume and sputum colour (Bischoff et al. Thorax 2011; 66:26-31). Symptoms and medication use will be determined by interview at study related visits at 3, 6, 9, 12 months or by clinically-indicated telephone calls or visits initiated by the patient or respiratory chronic care team
Timepoint [1] 286574 0
At first exacerbation and adherence rate at 12 months
Primary outcome [2] 286575 0
COPD Assessment Test (CAT)
This is a quality of life assessement -(Jones et al 2009)
Timepoint [2] 286575 0
At three, six, nine and twelve month intervals throughout study. As well as for patients experiencing an exacerbation.
Secondary outcome [1] 296204 0
Exaccerbation recovery, Time to first exaccerbation, Annual exacerbation rate - weighted mean
Timepoint [1] 296204 0
At first exaccerbation and over 12 months
Secondary outcome [2] 296205 0
Health Care Utilisation, emergency presentations , hospitalisation, Unscheduled hospitall visits. This will be assessed by data linkage to patient medical records and by interview, as above.
Timepoint [2] 296205 0
Over 12 months

Eligibility
Key inclusion criteria
Physician Diagnosis of COPD
Post bronchodilator FEV1/FVC <0.7
Patient is enrolled in the respiratory chronic care program- a program based at Royal Prince Alfred Hospital Sydney Australia that provides regular planned home vists for patients with COPD, within Royal Prince Alfred hospitals catchment area.The program offers continuing health support through education and assistance to patients and their carers. This program augments existing respiratory services by enhancing communication and coordination of care between hospital, community services and general practitioners.
This care is provided by specialist nurses and physiotherapists.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treating clinician or respiratory chronic care team believes that the patient is unsuitable eg poor comprehension, inability to follow an action plan
Severe uncontroled other diseases that would likely interfere with study outcomes.
Active malignancy other than skin cancer.

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)
Eligible patients who consent to participate will be randomised and stratefied by 'new ' and 'existing' stratefied . Allocation concealment will be maintained by the use of two sets of sequentially-numbered, opaque sealed envelopes that are to be opened only at the time of randomisation, after baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two randomised sequences will be generated by a computer program in randomly permuted blocks for each of the two strata (new Respiratory Chronic Care patients or existing Respiratory Chronic care Patients).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Neither the patients nor the Respiratory Chronic Care staff will be blinded. Primary outcome measures will be concealed for Respiratory Chronic Care staff.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284762 0
Self funded/Unfunded
Name [1] 284762 0
Country [1] 284762 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 283715 0
None
Name [1] 283715 0
Address [1] 283715 0
Country [1] 283715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286787 0
Sydney Local Health District Ethics Review Comittee
Ethics committee address [1] 286787 0
Research and Develeopment Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 286787 0
Australia
Date submitted for ethics approval [1] 286787 0
30/11/2011
Approval date [1] 286787 0
02/02/2012
Ethics approval number [1] 286787 0
hrec/11/rpah/640

Summary
Brief summary
Background
There is debate about the effectiveness of written COPD action plans. A recent study by Bischoff et al (Thorax 2011) showed that adherence to a COPD action plan was associated with reduced time for exacerbation recovery.

There are several barriers to adherence with a COPD action plan, such as:
*The practicalities of the patient obtaining the relevant prescribed medications from the pharmacy at a time when the patient is unwell.
*The indiscriminate us of relevant prescribed medication

This study will test the effect of removing one of these barriers.

For this pragmatic pilot study the COPD action plan, from the Australian Lung Foundation (ALF) will be utilised
The Respiratory Chronic Care Program provides, regular planned home visits, offering continuing health support through education and assistance to patients, carers and their families. The program augments existing respiratory services by enhancing communicating and coordination of care between hospital, community and general partitioners.


Primary Aim
Is to provide a written action plan to COPD patients to assess whether dispensing antibiotic and prednisone leads to:

*Better adherence with a written action plan
*Better health outcomes

Over 9 months compared with prescription “only” without dispensing these medications


Secondary Aims
*For the RCC team to gain an appreciation and understanding for research
*Providing pragmatic data for future research and funding


Reference:
Effects of written action plan adherence on COPD exacerbation recovery.
Bischoff E, Hamd D, Sedeno M et al. Thorax 2011;66:26-31
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33816 0
Address 33816 0
Country 33816 0
Phone 33816 0
Fax 33816 0
Email 33816 0
Contact person for public queries
Name 17063 0
Nicole Taylor
Address 17063 0
Respiratory Chronic Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 17063 0
Australia
Phone 17063 0
+61295156656
Fax 17063 0
+6195158607
Email 17063 0
[email protected]
Contact person for scientific queries
Name 7991 0
Nicole Taylor
Address 7991 0
Respiratory Chronic Care
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 7991 0
Australia
Phone 7991 0
+61295156656
Fax 7991 0
+6195158607
Email 7991 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.