ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001330932

Ethics application status

Approved

Date submitted

12/09/2020

Date registered

9/12/2020

Date last updated

9/12/2020

Date data sharing statement initially provided

9/12/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Breathless Clinic - working together to defeat breathlessness in chronic obstructive pulmonary disease (COPD)

Scientific title

Breathless Clinic - working together to defeat breathlessness in chronic obstructive pulmonary disease (COPD)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1246-9645

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breathlessness

chronic obstructive pulmonary disease (COPD)

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is the implementation of the Breathless Clinic (BC), a nine weeks’ programme to manage refractory breathlessness. The intervention duration is planned for a period of 12 months, so as to minimise the impact of seasonal variation on our results. The follow up duration comprises 12 months (from initial enrolment in clinic).
Following assessment, review and optimisation of pharmacotherapies, non-pharmacologic treatment interventions will commence and further investigations and referrals will be undertaken as required. The most crucial aspect of BC, is to provide coaching for dyspnoea self-management and daily coping strategies for survival in the domestic setting or community; for example, breathing techniques, posture, fans and self-talk (offered through senior specialist respiratory nursing colleagues) and the strategies provided to improve efficiency and therefore manage breathlessness during day-to-day activities, tailored for individual patients in the home setting, by our physiotherapy and occupational therapy clinicians. These aspects may allow for greater independence and participation in community activities. "Home visits" and standard clinic visits will usually occur face to face but may also utilise telephone or videoconference depending on the patient circumstances and preferences.

Non-pharmacologic breathlessness interventions (examples):
Beliefs
• Validation of breathlessness
• Clarifying mistaken beliefs (breathlessness is not always due low oxygen levels, breathlessness itself is not dangerous)
• Motivational interviewing

Strategies
• Hand-held, battery-operated fan
• “Breathing around the rectangle”, “flickering the candle” (single breath)
• Other breathing techniques (breathing pattern) – paced or diaphragmatic breathing, “blow as you go”
• Positions to relieve breathlessness

Training
• Walking program (supported by use of a pedometer)

Aids/efficiency
• four-wheel walker/ shower chair
• Energy conservation (save energy on what you must do, so that you have some spare to participate in activities that you enjoy).
• Home modifications
• Referral to dietitian if underweight/ malnourished

Education and Self-management
• Written breathlessness action plans* (3 Fs - lean Forward, Focus on breath out, Fan; 3Ps - Pause, Purse lips, Position)
• Written COPD exacerbation action plan** (guide of what to do in an exacerbation)
• Breathlessness DVD*** – reinforces key interventions to relieve breathlessness
• Relaxation CD***

Miscellaneous
• Sputum clearance techniques
• Carer support
• Management of incontinence

BC schedule
The clinic itself comprises eight to nine healthcare interactions over nine weeks, with most interactions occurring within the patient’s home;

Week 1 (patient’s home) – Initial assessment, Respiratory Nurse, research assistant
Week 2 (outpatient clinic) – Formulate Management Plan, Multidisciplinary Team
Week 3 (patient’s home) – Physiotherapist
Week 4 (patient’s home) – Occupational Therapist (as required)
Week 5 (patient’s home) – Respiratory Nurse
Week 6 (patient’s home) – Physiotherapist
Week 7 (patient’s home) – Respiratory Nurse
Week 8 (patient’s home) – Final assessments, research assistant
Week 9 (outpatient clinic) – Closure and follow up arrangements, Multidisciplinary Team

Clinical items to be reviewed/assessed at BC visits 1 and 2
1) Heart rate, blood pressure, respiratory rate and oxygen saturation
2) Electrocardiogram (ECG)
3) Height and weight
4) Most recent measures:
a) spirometry or complex lung function within previous 12 months
b) inflammation (white cell count and differential, C-reactive protein) within previous 12 months
c) cardiac biomarkers (high sensitivity Troponin T, NT-proB-type Natriuretic Peptide) within previous 12 months
d) microbiology (any positive gram stains, cultures and available antibiotic sensitivities, any positive respiratory viral screens within previous 12 months)
e) 6 minute walk test (6MWT), if available, within 12 months
5) Comorbidities and current medications
6) Mini Nutritional Assessment (MNA)
7) Eating Assessment Tool (EAT-10)
8) Exacerbation history
9) Healthcare visit data
10) COPD action plan

Clinic team: Specialist Respiratory Physician, Specialist Respiratory Nurse, Senior Physiotherapist (with experience running pulmonary rehabilitation program), Senior Occupational Therapist.
The clinic team will deliver the intervention as per the clinic program above. The team may also include general practitioner, senior registrars in Cardiology and Respiratory Medicine

All clinic interactions will ideally involve a single participant and their partner/carer (if relevant). The sessions will last 30 - 120 minutes.

Since BC is part of the clinic services of our hospital, each clinic interaction will be recorded within each subject's electronic medical record (EMR). Compliance for some individualised BC components will be assessed (for example step counts measured by pedometer for patients receiving exercise recommendations to achieve a goal daily step count). However, for the most part, the assessment of adherence to clinic recommendations will be subjective (by patient report) and captured during the post-clinic interviews collecting qualitative data, along with the patients' perception of which clinic interventions were most and least helpful for managing their breathlessness.

* Written breathlessness action plans, resources originally developed by Cambridge Breathlessness Intervention Service and distributed via their education seminars, then adapted for use in Westmead Hospital's breathlessness clinic service (used with permission)
** COPD action plan, readily available free resource from Lung Foundation Australia, routinely used in clinical practice
*** Breathlessness DVD, developed for breathlessness clinics at Westmead Hospital and used with permission.
**** Relaxation CD, developed for breathlessness clinics at Westmead Hospital and used with permission.

Note: Westmead Hospital's Breathlessness Clinic service has provided collaboration and mentorship in developing/designing the clinic used in this intervention, which has been adapted to the Campbelltown Hospital setting. Associated Investigator TS is also a lead clinician within the Westmead Hospital breathlessness service.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control is "standard care" which may involve pulmonary rehabilitation, general practice review, outpatient specialist clinic review, community nursing involvement.
Participants will act as their own controls, with breathlessness impact data being compared with baseline and health outcome data (from the previous 12 months) being compared with the 12 months from commencement of protocol.
Benchmarking with similar or theoretically comparable populations will also be applied, where appropriate, for healthcare outcomes:
1. comparison of unplanned admission rates and unplanned hospital bed days within the year of the study with the corresponding figures for a population comprising all patients hospitalised within Campbelltown Hospital with diagnostic related group (DRG) code "COPD" during the 12 months prior to BC commencement (study participants excluded).
2. comparison of unplanned admission rates and unplanned hospital bed days within the year of the study with the corresponding figures for population comprising all patients presenting to Campbelltown Emergency Department with the triage category "SOB respiratory" (Shortness of breath, respiratory) during the 12 months prior to BC commencement
Study participants will be excluded from populations used for benchmarking.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mastery of breathlessness as measured by Chronic Respiratory disease Respiratory Questionnaire (CRQ) - mastery subscale

Timepoint [1]

Baseline, 9 weeks post-commencement of intervention (primary timepoint), 26 and 52 weeks post-commencement of intervention

Secondary outcome [1]

Breathlessness impact:
Total CRQ score and (other) subscale scores

Timepoint [1]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [2]

Breathlessness impact:
Breathlessness intensity and unpleasantness numerical rating scale (NRS)

Timepoint [2]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [3]

Breathlessness impact::
COPD Assessment Test (CAT) score

Timepoint [3]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [4]

Breathlessness impact::
Hospital Anxiety and Depression (HAD) Score

Timepoint [4]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [5]

Breathlessness impact::
EQ-5D-5L

Timepoint [5]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [6]

Breathlessness impact::
Average number of steps per day (as measured by pedometer) over the past 7 days.

Timepoint [6]

Baseline, 9, 26 and 52 weeks post-commencement of intervention

Secondary outcome [7]

Number of unplanned healthcare presentations in 12 months since BC enrolment (overall number)
Data will be sourced from EMR and corroborated/supplemented by patient report and general practice records. Analysis will compare with the 12 months prior to BC enrolment.

Timepoint [7]