ANZCTR - Registration

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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]

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)

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

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]

Early detection / Screening

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Health status and symptom score as measured by the COPD Assessment Test (CAT)

Timepoint [1]

Baseline and three months

Secondary outcome [1]

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]

Baseline, one month and three months

Secondary outcome [2]

Smoking status assessed via a study specific case record form

Timepoint [2]

Baseline and if applicable at one month and three months

Secondary outcome [3]

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]

Baseline, one month and three months

Secondary outcome [4]

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]

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]

Number (%) with accurate spirometry completed (FEV1 and FVC data) assessed by an independent assessor against ATS/ERS quality criteria

Timepoint [5]

Spirometry recordings will be reviewed at end of study

Secondary outcome [6]

Number of known COPD/smokers/ex smokers patients over 40 years in the general practice drawn from the practice database/records

Timepoint [6]

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]

Number (%) confirmed COPD diagnosis and severity assessed via spirometry testing

Timepoint [7]

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]

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]

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]

Number (%) invited to attend appointment with physiotherapist as drawn from practice data and recorded by physiotherapist/research assistant

Timepoint [9]

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]

Number (%) attended first appointment with physiotherapist as drawn from practice data and recorded by physiotherapist

Timepoint [10]

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]

Number (%) attended pulmonary rehabilitation as assessed by self report from patient in study specific case report form

Timepoint [11]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Chronic and Complex Care, Primary and Community Health, Northern Sydney Local Health District

Address [1]

The Lodge, Building 37, Macquarie Hospital,
Cnr Twin and Badajoz Roads,
North Ryde, NSW 2113

Country [1]

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]

University

Name [1]

University of Sydney

Address [1]

Faculty of Health Sciences
75 East Street,
Lidcombe NSW 2141

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics committee

Ethics committee address [1]

Research Office Kolling Building, Level 13 Royal North Shore Hospital St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2016

Approval date [1]

13/03/2017

Ethics approval number [1]

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

A/Prof Sarah Dennis

Address

Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141

Country

Australia

Phone

+61293519265

Fax

sarah.dennis@sydney.edu.au

Contact person for public queries

Name

Sarah Dennis

Address

Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141

Country

Australia

Phone

+61293519265

Fax

sarah.dennis@sydney.edu.au

Contact person for scientific queries

Name

Sarah Dennis

Address

Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe NSW 2141

Country

Australia

Phone

+61293519265

Fax

sarah.dennis@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3229	Study protocol					377979-(Uploaded-18-07-2019-11-32-26)-Study-related document.docx
3230	Ethical 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

Source	Title	Year of Publication	DOI
Embase	The feasibility of an innovative GP-physiotherapist partnership to identify and manage chronic obstructive pulmonary disease (INTEGRATED): Study protocol.	2020	https://dx.doi.org/10.1186/s40814-020-00680-4
Embase	Accuracy of the COPD diagnostic questionnaire as a screening tool in primary care.	2022	https://dx.doi.org/10.1186/s12875-022-01685-z
Embase	Identifying airway obstruction in primary care: is there a role for physiotherapists?.	2022	https://dx.doi.org/10.1186/s12875-022-01944-z
Embase	The effects of an innovative GP-physiotherapist partnership in improving COPD management in primary care.	2023	https://dx.doi.org/10.1186/s12875-023-02097-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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