Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001127190
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Innovative GP-Physiotherapist Partnership on Outcomes for Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The effects of an innovative GP-Physiotherapist Partnership on health status for people with COPD (INTEGRATED): A Pilot Study
Secondary ID [1] 298745 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
INTEGRATED (InNovaTivE Gp-physiotheRapist pArTnErship for copD)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 313707 0
Condition category
Condition code
Respiratory 312120 312120 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 312202 312202 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will attend an initial one hour face-to-face appointment within the GP practice with the respiratory physiotherapist. In this appointment, all patients will undergo pre and post bronchodilator spirometry testing based on the American Thoracic Society/European Respiratory Society (ATS/ERS) lung function guidelines. The physiotherapist will then determine the level of obstruction for those with existing COPD or determine whether the patient has a diagnosis of COPD which will be based on post-bronchodilator results of a forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) of <0.7. All patients (new cases and existing COPD) will also be required to complete a number of disease-specific and activity related questionnaires. Patients will be included for follow up testing in the study based on a COPD diagnosis from spirometry testing determined by the physiotherapist. If obstruction is confirmed, participants will be required to attend two further face-to-face appointments with the physiotherapist at one month and at three months which will go for approximately 45 minutes duration each. If spirometry appears abnormal for other reasons, the results will be discussed with the GP and where appropriate, patients will be referred for further testing with respiratory specialists.

Intervention will include;
Arm 1: Newly diagnosed COPD (administered by the physiotherapist):
a) referral to GP for review and medications as well as commencement of GP management plan/team care arrangement at the baseline assessment for participant to attend within one month of referral. The physiotherapist will determine if the participant has attended this appointment by either patient self-report at the one month assessment or by audit of GP records
b) physical activity advice, exercise prescription and provision of a pedometer to monitor physical activity goals. The physiotherapist will provide physical activity advice using the 5As approach. The 5As (Ask, Advise, Agree, Assist, Arrange) are a clinical tool recommended for health behaviour counselling in primary care which will enable the physiotherapist to determine where the participant is currently at, identify barriers to engaging in regular physical activity as well as strategies to overcome these barriers and tailor physical activity goals towards the participant.
Examples of exercise prescription that the physiotherapist may encourage include forms of aerobic exercise such as walking, cycling and swimming and upper and lower limb resistance exercises such as squats, step ups and light dumbbell exercises. Participants will be given a handout of the exercises as well as a pedometer diary to monitor daily step count.
c) referral to pulmonary rehabilitation (PR) if meets the COPD-X Guidelines criteria for referral which state that all patients with COPD (of all dyspnoea grades) will benefit from PR and recommend that all patients with exertional dyspnoea, those at risk of exacerbation and following an exacerbation should be referred to PR
d) patient education and booklet from the Lung Foundation Australia
e) a written Lung Foundation Australia COPD action plan
f) smoking cessation advice and referral if necessary. A brief discussion and intervention will be provided to all smokers at the time of initial assessment and if necessary, at follow-up appointments informed by the The Royal Australian College of General Practitioners (RACGP) guidelines including readiness to change, identification of barriers to quitting, referral to quitline and referral to GP for pharmacological support

Arm 2: Patients with existing COPD (administered by the physiotherapist):
a) referral to GP for review/commencement of GP management plan/team care arrangement at the baseline assessment for participant to attend within one month of referral
b) physical activity advice using the 5 A’s approach, exercise prescription and pedometer to monitor physical activity goals
c) referral to PR if meets requirement
d) patient education and booklet from the Lung Foundation Australia
e) a written Lung Foundation Australia COPD action plan
f) smoking cessation advice and referral if necessary

Arm 3: Those without COPD on spirometry (administered by the physiotherapist):
a) physical activity advice using the 5 A’s approach and exercise prescription
b) smoking cessation advice and referral to the GP if necessary
Intervention code [1] 315031 0
Early detection / Screening
Intervention code [2] 315032 0
Rehabilitation
Intervention code [3] 315035 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320759 0
Health status and symptom score as measured by the COPD Assessment Test (CAT)
Timepoint [1] 320759 0
Baseline and three months
Secondary outcome [1] 372750 0
Physical activity levels will be assessed in two ways; self reported activity levels as measured by the Active Australia Questionnaire and daily pedometer step count
Timepoint [1] 372750 0
Baseline, one month and three months
Secondary outcome [2] 372751 0
Smoking status assessed via a study specific case record form
Timepoint [2] 372751 0
Baseline and if applicable at one month and three months
Secondary outcome [3] 372752 0
Hospital utilisation as assessed by self report from patient in study specific case record form. Example questions include self-report of exacerbations, hospital admissions and emergency department attendance
Timepoint [3] 372752 0
Baseline, one month and three months
Secondary outcome [4] 372753 0
Acceptibilty of this health service model on the effective identification and management of COPD as assessed by semi-structured interviews with the physiotherapists, GPs and a sample of participants
Timepoint [4] 372753 0
Sample of participants will be determined and interviews conducted within three months of that site's conclusion of involvement in the study i.e. completion of the final participant assessment
Secondary outcome [5] 372977 0
Number (%) with accurate spirometry completed (FEV1 and FVC data) assessed by an independent assessor against ATS/ERS quality criteria
Timepoint [5] 372977 0
Spirometry recordings will be reviewed at end of study
Secondary outcome [6] 372978 0
Number of known COPD/smokers/ex smokers patients over 40 years in the general practice drawn from the practice database/records
Timepoint [6] 372978 0
This information will be collected when research assistant will search the practice database at the identification of participants stage i.e. prior to recruitment and will be collated at the end of the study.
Secondary outcome [7] 372980 0
Number (%) confirmed COPD diagnosis and severity assessed via spirometry testing
Timepoint [7] 372980 0
This is a process outcome that will be collated from data collected at the baseline assessments. We will collate this data at the end of the study.
Secondary outcome [8] 372981 0
Number (%) eligible for pulmonary rehabilitation and number (%) referred as determined by the physiotherapist if they meet the COPD-X guideline criteria for referral as identified from the study specific case record form
Timepoint [8] 372981 0
This is a process outcome that will be collated from data collected at the baseline assessments. We will collate this data at the end of the study.
Secondary outcome [9] 372982 0
Number (%) invited to attend appointment with physiotherapist as drawn from practice data and recorded by physiotherapist/research assistant
Timepoint [9] 372982 0
This is a process outcome that will be collated from data collected when research assistant will search the practice database at the identification of participants stage i.e. prior to baseline assessments
Secondary outcome [10] 372988 0
Number (%) attended first appointment with physiotherapist as drawn from practice data and recorded by physiotherapist
Timepoint [10] 372988 0
This is a process outcome that will be collated from data collected at the baseline assessments. We will collate this data at the end of the study.
Secondary outcome [11] 373663 0
Number (%) attended pulmonary rehabilitation as assessed by self report from patient in study specific case report form
Timepoint [11] 373663 0
One month or three month assessments

Eligibility
Key inclusion criteria
Two groups of patients will be identified:
1) Adults aged 40 or over, and have a documented history of smoking (current or former smoker) but NO diagnosis of COPD and have visited the GP in the last 12 months.
2) Adults aged 40 or over, have a diagnosis of COPD recorded or are taking medications prescribed for COPD, and have visited the GP in the last 12 months.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Terminal cancer, cognitive impairment or require home oxygen, do not speak sufficient English or are pregnant

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/08/2018
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
20/03/2020
Actual
Sample size
Target
200
Accrual to date
94
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303303 0
Hospital
Name [1] 303303 0
Chronic and Complex Care, Primary and Community Health, Northern Sydney Local Health District
Country [1] 303303 0
Australia
Primary sponsor type
Hospital
Name
Chronic Disease Community Rehabilitation Service (CDCRS) Northern Sydney Local Health District
Address
The Lodge, Building 37, Macquarie Hospital,
Cnr Twin and Badajoz Roads,
North Ryde, NSW 2113
Country
Australia
Secondary sponsor category [1] 303323 0
University
Name [1] 303323 0
University of Sydney
Address [1] 303323 0
Faculty of Health Sciences
75 East Street,
Lidcombe NSW 2141
Country [1] 303323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303836 0
Northern Sydney Local Health District Human Research Ethics committee
Ethics committee address [1] 303836 0
Research Office Kolling Building, Level 13 Royal North Shore Hospital St Leonards NSW 2065
Ethics committee country [1] 303836 0
Australia
Date submitted for ethics approval [1] 303836 0
30/10/2016
Approval date [1] 303836 0
13/03/2017
Ethics approval number [1] 303836 0
HREC/16/HAWKE/434

Summary
Brief summary
COPD is commonly managed in general practice but there is growing evidence that diagnosis and management can be improved. This project aims to look at how a novel model of care in which physiotherapists and GP’s work in partnership can improve the identification and management of people with COPD. The physiotherapists will work in partnership with the general practice to case-find people with a new diagnosis of COPD, assess people with a known diagnosis of COPD and provide evidence based physiotherapy management and referral to appropriate services. The INTEGRATED study hypothesises that this GP-physiotherapist model of care will improve the diagnosis and management of people with COPD through more accurate spirometry interpretation, an increase in referrals to pulmonary rehabilitation in those who meet the guidelines criteria for referral, an increase in physical activity levels by people with COPD and an increase in smoking cessation in those who are smokers at baseline. It is also hypothesised that both GPs and physiotherapists will find this integrated partnership a feasible and acceptable way to work together to manage people with COPD within the primary care setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94974 0
A/Prof Sarah Dennis
Address 94974 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141
Country 94974 0
Australia
Phone 94974 0
+61293519265
Fax 94974 0
Email 94974 0
sarah.dennis@sydney.edu.au
Contact person for public queries
Name 94975 0
A/Prof Sarah Dennis
Address 94975 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141
Country 94975 0
Australia
Phone 94975 0
+61293519265
Fax 94975 0
Email 94975 0
sarah.dennis@sydney.edu.au
Contact person for scientific queries
Name 94976 0
A/Prof Sarah Dennis
Address 94976 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141
Country 94976 0
Australia
Phone 94976 0
+61293519265
Fax 94976 0
Email 94976 0
sarah.dennis@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is due to our ethics approval which stated that only study investigators and the research assistant coordinating the study will have access to de-identified research data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3229Study protocol    377979-(Uploaded-18-07-2019-11-32-26)-Study-related document.docx
3230Ethical approval    377979-(Uploaded-18-07-2019-11-31-53)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of an innovative GP-physiotherapist partnership to identify and manage chronic obstructive pulmonary disease (INTEGRATED): Study protocol.2020https://dx.doi.org/10.1186/s40814-020-00680-4
EmbaseThe effects of an innovative GP-physiotherapist partnership in improving COPD management in primary care.2023https://dx.doi.org/10.1186/s12875-023-02097-3
EmbaseAccuracy of the COPD diagnostic questionnaire as a screening tool in primary care.2022https://dx.doi.org/10.1186/s12875-022-01685-z
EmbaseIdentifying airway obstruction in primary care: is there a role for physiotherapists?.2022https://dx.doi.org/10.1186/s12875-022-01944-z
N.B. These documents automatically identified may not have been verified by the study sponsor.