Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001075370
Ethics application status
Approved
Date submitted
18/07/2017
Date registered
25/07/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic Obstructive Pulmonary Disease (COPD) management at home to reduce emergency department presentations: a randomised controlled, feasibility trial
Scientific title
The use of respiratory outreach nursing and Extended Care Paramedic service for at home management of people with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) to reduce emergency department presentations and unnecessary hospital admissions: a randomised controlled, feasibility trial
Secondary ID [1] 292434 0
none
Universal Trial Number (UTN)
U1111-1199-3026
Trial acronym
COPD at home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 304029 0
Condition category
Condition code
Respiratory 303358 303358 0 0
Chronic obstructive pulmonary disease
Public Health 303422 303422 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of respiratory nursing service (RNS) and extended care paramedics (ECP's) to support home management of patients with a COPD (chronic obstructive pulmonary disease) exacerbation to reduce emergency department presentation and hospital admissions
Brief name: COPD at home
Participant education materials: All will be printed and given to the participant as an information package
*Respiratory nursing service information: RNS, The Queen Elizabeth Hospital (TQEH)
*COPD fact sheet: Central Adelaide Local Health Network (CALHN) intranet
*advance care directive, infection control-wash wipe cover, falls- medicines and balance, falls- making your home your haven: http://inside.sahealth.sa.gov.au/wps/wcm/connect/Non-public+content/sa+health+intranet/ SA Health website
*depression streess anxiety, breathing techniques, eating well with lung disease, continence and lung disease: pulmonary rehabilitation education series, Department of Health, Government of South Australia
*Quality of life through patient support: http://lungfoundation.com.au/

Folder for communication between services kept at patient home and includes:
* A4 poster COPD at home phone number
* Name and demographic page
* Only intervention group participants will be provided with a written COPD Action Plan and emergency pack if they do not have and receive education on how to use, and additional education on COPD management. Control group will not be given a written COPD action plan or emergency pack or receive additional education- they will receive their usual care from their health providers. Both groups will complete the questionnaires as previously identified. Where the intervention participant does not already have a COPD action plan or emergency pack both will be obtained from the Respiratory Registrar/Physician rostered to TQEH hospital consult service. The COPD Action Plan developed by Lung Foundation Australia will be used for the intervention participants that require one provided. Intervention participants only will receive education on the use of their inhalers in exacerbation management. Intervention participants will also be educated on when to commence their emergency pack of prednisolone or antibiotics as per their COPD Action Plan. Having a COPD Action plan and emergency pack is a pre-requisite for participants in this study as this is the tool to facilitate exacerbation management.
*Medical contact log
*Current medication list
*Observation Chart

General Practitioner letter advising of patient participation and summary of proposed research

Hospital switchboard instructions
South Australian Ambulance Service (SAAS), ECP: work instruction sheet-process to review participants and separation summary for RNS and GP describing review and recommendations made with participant

PROCEDURE
RNS: performs baseline assessment, reviews COPD optimisation and education. Can occur at participants residence or as an outpatient with a time period of 2 hours.
Planned contact: phone calls at 1 week and 3 months will be performed by a nurse from the RNS- to monitor healthcare utilisation, perform a respiratory phone assessment, provide phone coaching of symptom management, arrange reviews (rapid response) dependant on severity of respiratory symptoms
Final assessment at 6 months: same as baseline review with addition of semi-structured questionnaire. There will be one Respiratory Nurse who performs the assessments and phone calls at timed reviews. This respiratory nurse will not provide any of the clinical care during the trial period. Clinical care will be delivered by other members of the Respiratory Nursing Service.
Unplanned contact: participants identifying change in respiratory symptoms to contact COPD at home as per number provided (TQEH switchboard). During business hours weekdays will be directed to RNS, after hours, weekends and public holidays will be transferred to SAAS ECP's. If no answer within 15mins participant will be instructed to utilise GP, locum GP, emergency department or SAAS emergency '000'

If participant contacts RNS a respiratory phone assessment will occur including use of Modified Medical Research Council (MMRC) and COPD assessment test (CAT). RNS triage will occur and follow up actions will be based on the assessment
* early change in symptoms identified: use of action plan, GP, follow up phone review
* moderate to severe symptoms identified: rapid response review by RNS by outpatient or home visit, or may recommend contacting SAAS on '000'. If participant remains home will be supported to do so by RNS and in negotiation with GP.

SAAS: ECP’s will follow their ‘work instruction’ for participants. Phone calls will be triaged by the ECP coordinator who will determine the deployment of ECP or ambulance response (priority 2) based on severity of participant symptoms.
Phone assessment: not an emergency: ECP to review at participant residence for assessment and management of symptoms. If safe to stay home ECp will advise RNS and GP by email and/or facsimile of the visit, if safe to remain home and recommendations provided to participant , for follow up review by RNS and/or GP
If ECP assessment determines need to present to the emergency department SAAS ECP will coordinate. ECP will notify RNS only via email, GP will receive separation summary of presentation on discharge as per standard practice.

Participants will be enrolled for a 6 month period and may access COPD at home as often as required.

Feasibility outcomes will be collected via documentation from nursing and SAAS records following phone calls made to and from patients during the intervention period.


Intervention code [1] 298636 0
Prevention
Intervention code [2] 298637 0
Treatment: Other
Comparator / control treatment
Participants will not be provided a written COPD Action Plan or emergency pack if they do not have, nor will they be provided with any further education on COPD management. Control participants will undergo initial baseline assessment and complete questionnaires only. They will be advised to continue with normal management of their COPD as recommended by their health professionals
Control group
Active

Outcomes
Primary outcome [1] 302791 0
Feasibility of randomised controlled trial design
*success or failure of execution: success determined by >80% of the population using the intervention as intended
*degree of execution: evaluated by the number of subjects that are eligible to participate actually agreeing to take part in the study
* amount of resources needed to implement: number of phone calls made to the nursing service and ECP service
Timepoint [1] 302791 0
6 months after allocation to intervention or control
Primary outcome [2] 302792 0
Emergency department presentations: casemix/DRG data will be collected for 5 years prior to enrolment and 6 months post enrolment
Timepoint [2] 302792 0
6 months after allocation to intervention or control
Primary outcome [3] 302816 0
Demand: Actual use of the intervention as intended. Independant investigator not associated with intervention delivery will audit RNS and SAAS records to determine intervention consistently delivered by RNS nurses and SAAS.
Timepoint [3] 302816 0
6 months after allocation to intervention or control
Secondary outcome [1] 336999 0
Anxiety assessed using Depression, Anxiety, Stress Scale (DASS21)
Timepoint [1] 336999 0
At baseline assessment and final assessment at 6 months
Secondary outcome [2] 337000 0
Quality of life assessed using SF-36 Quality of Life Questionnaire
Timepoint [2] 337000 0
At initial assessment and final assessment at 6 months
Secondary outcome [3] 337001 0
Severity of dyspnoea using modified medical research council (MMRC) questionnaire
Timepoint [3] 337001 0
At baseline, 1 week, 3 months and final assessment of 6 months. Also used for any unplanned contact made by participant throughout trial period.
Secondary outcome [4] 337002 0
Assess impact of current symptoms on health status using COPD Assessment Test (CAT)
Timepoint [4] 337002 0
At initial assessment, 1 week, 3 month and final assessment at 6 month. Will also be used for any unplanned contact during trial period.
Secondary outcome [5] 337003 0
Confidence in managing breathing difficulties using the COPD Self-Efficacy Scale
Timepoint [5] 337003 0
At initial assessment and final assessment at 6 months
Secondary outcome [6] 337004 0
Participant self-assessment of their self management knowledge and behaviour using Partners in Health The Flinders Program for Chronic Condition Management
Timepoint [6] 337004 0
At initial assessment and final assessment at 6 months
Secondary outcome [7] 337005 0
Patient satisfaction of the intervention assessed using a semi-structured interview
Timepoint [7] 337005 0
Final assessment at 6 months
Secondary outcome [8] 337137 0
Depression assessed using Depression, Anxiety, Stress Scale (DASS21)
Timepoint [8] 337137 0
At baseline assessment and final assessment at 6 months
Secondary outcome [9] 337138 0
Objective assessment of participants self management knowledge and behaviour using the Cue and Response questionnaire, The Flinders Program for Chronic Condition Management
Timepoint [9] 337138 0
At baseline assessment and final assessment at 6 months
Secondary outcome [10] 337139 0
Primary outcome: Acceptability
Safety of the intervention will be determined by nursing and SAAS records identifying adverse events likely caused by the intervention.
Timepoint [10] 337139 0
At planned contact reviews at 1 week or 3 month by phone call and final assessment at 6 months or if participant contacts RNS or SAAS at any time throughout the trial period.
Secondary outcome [11] 337140 0
Primary outcome :Hospital admissions
Use of casemix/DRG data will be collected for 5 years prior to enrolment and 6 months post enrolment
Timepoint [11] 337140 0
6 months after allocation to intervention or control
Secondary outcome [12] 337141 0
Primary outcome: Length of hospital stay
Use of casemix/DRG data will be collected for 5 years prior to enrolment and 6 months post enrolment
Timepoint [12] 337141 0
6 months after allocation to intervention or control
Secondary outcome [13] 337142 0
Primary outcome: Outpatient visits
Use of casemix/DRG data will be collected for 5 years prior to enrolment and 6 months post enrolment
Timepoint [13] 337142 0
6 months after allocation to intervention or control
Secondary outcome [14] 337143 0
Primary outcome: Cost effectiveness
The direct cost of the intervention (ambulance service use, nursing time and follow up) and the costs of associated health service use (inpatient frequency and duration, other health service use as captured by the casemix/DRG data sets).
Timepoint [14] 337143 0
6 months after allocation to intervention or control
Secondary outcome [15] 337146 0
Patient satisfaction: acceptability
A qualitative semi-structured one-on-one interview conducted during by an independant investigator not associated with intervention delivery
Timepoint [15] 337146 0
Final assessment at 6 months
Secondary outcome [16] 337147 0
Patient satisfaction: practicality
A qualitative semi-structured one-on-one interview conducted during by an independant investigator not associated with intervention delivery
Timepoint [16] 337147 0
final follow-up assessment at six months
Secondary outcome [17] 337148 0
General practitioner utilisation
Participants will be asked to complete a medical log of all appointments inclusive of date of attendance and reason for attendance
Timepoint [17] 337148 0
final follow-up assessment at six months

Eligibility
Key inclusion criteria
*Confirmed diagnosis of COPD (Pulmonary function test (PFT)/spirometry performed within last 12 months as per GOLD 2015; post bronchodilator FEV1/FVC<0.7)
*Two emergency department presentations and/or hospital admissions within the last 12 months related to COPD
*Have SA Ambulance Cover
*Phone Access
*English literacy (speaking and reading)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Unable to provide informed consent (cognitive impairment)
*COPD patients whom are active clients of a palliative care service
*Current case-managed patients of the Respiratory Nursing Service at TQEH
*Resident of an Aged Care Facility
*Assessed patients who are at risk of significant undertreated co-morbidities ie high levels of anxiety or depression requiring referral to specialist services

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)
Allocation will be performed by an independant researcher whom is not involved in outcome assessment who is located at an alternate administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant allocation will be performed using a pre-determined computer-generated block randomisation, with random variable block sizes ranging between 2 and 6
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As is a feasibility trial we have estimated that 20 subjects in each arm (40 in total) will be acceptable for recruitment, as per other similar published studies conducted in COPD cohorts.

Data analysis plan: all statistical analysis will be done via IBM SPSS 20 or STATA14 unless otherwise indicated.
1. Hospital utilisation and limited efficacy: The potential influence of the intervention on ED presentation and hospital admission rate will be explored using Poisson Regression. The potential effect of the intervention on continuous outcome data (e.g. MMRC, BAI & BDI scores) will be assessed via independent samples t-tests or their non-parametric counterparts (e.g. Mann-Whitney U) and categorical data by using Chi² or Fishers Exact test.
2. Cost effectiveness: Costs and outcomes will be discounted at 5% per annum according to current PBAC guidelines (Commonwealth Department of Health and Ageing 2002). Analyses will report the discounted cost per life year gained ($/LY) and the discounted cost per quality adjusted life year gained ($/QALY) at trial end and extrapolated over a 15 year time horizon. One-way sensitivity analysis will be performed for key parameters and probabilistic sensitivity analyses will be conducted modelling (10,000 simulations) the distribution of individual parameters based on the patient level data leading to cost effectiveness acceptability curves, which report the probability that a particular intervention is cost-effective given a particular willingness to pay.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
31/07/2022
Actual
Sample size
Target
40
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8552 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 8553 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 16655 0
5011 - Woodville
Recruitment postcode(s) [2] 16656 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296992 0
Hospital
Name [1] 296992 0
The Queen Elizabeth Hospital
Country [1] 296992 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Central Adelaide Local Health Network
Citi Centre Building
11 Hindmarsh Square
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 295993 0
Government body
Name [1] 295993 0
South Australian Ambulance Service
Address [1] 295993 0
South Australian Ambulance Service
216 Greenhill Road
Eastwood
South Australia 5063
Country [1] 295993 0
Australia
Secondary sponsor category [2] 296056 0
Government body
Name [2] 296056 0
Respiratory Medicine Unit
Address [2] 296056 0
The Queen Elizabeth Hospital
Respiratory Medicine Unit
c/o Ward 4A
28 Woodville Road
Woodville, 5011
South Australia
Country [2] 296056 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298190 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 298190 0
Ethics committee country [1] 298190 0
Australia
Date submitted for ethics approval [1] 298190 0
05/12/2016
Approval date [1] 298190 0
06/03/2017
Ethics approval number [1] 298190 0
HREC Reference number: HREC/16/TQEH/268,

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2620 2620 0 0
/AnzctrAttachments/373304-SAAS protocol v8 clean docx.docx (Protocol)
Attachments [2] 2621 2621 0 0
/AnzctrAttachments/373304-attachment 3 PISv12 amendment clean (3).docx (Participant information/consent)
Attachments [3] 2622 2622 0 0
/AnzctrAttachments/373304-SAAS ethics amendment 121217.docx (Supplementary information)
Attachments [4] 2865 2865 0 0
/AnzctrAttachments/373304-SAAS protocol v9 clean docx.docx (Protocol)
Attachments [5] 2866 2866 0 0
/AnzctrAttachments/373304-HREC amendment SAAS 04072018.docx (Supplementary information)

Contacts
Principal investigator
Name 76274 0
Mrs Karen Royals
Address 76274 0
Respiratory Nursing Service
C/o Ward 4A , Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia, 5011
Country 76274 0
Australia
Phone 76274 0
+61 8 8222 6674
Fax 76274 0
+61 8 8222 6041
Email 76274 0
[email protected]
Contact person for public queries
Name 76275 0
Karen Royals
Address 76275 0
Respiratory Nursing Service
C/o Ward 4A , Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia, 5011
Country 76275 0
Australia
Phone 76275 0
+61 8 8222 6674
Fax 76275 0
+61 8 8222 6041
Email 76275 0
[email protected]
Contact person for scientific queries
Name 76276 0
Zoe Kopsaftis
Address 76276 0
C/o Ward 4A , Respiratory Medicine Unit
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia, 5011
Country 76276 0
Australia
Phone 76276 0
+61 8 82226670
Fax 76276 0
+61 8 82226041
Email 76276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan at this time as is a feasibility trial. We will consider in future if a need exists to share as de-identified participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2346Ethical approval    373304-(Uploaded-13-06-2019-14-37-23)-Study-related document.pdf



Results publications and other study-related documents

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