Background
Method
Sample
RCT design
Definition of intervention and standard care
Target patient group: | Refractory dyspnoea – chronic breathlessness which is medically optimally managed |
Referral: | Post, fax, electronic |
Assessment lead: | Clinical Specialist Physiotherapist |
BIS team: | ❑ Clinical Specialist Physiotherapist: expert in three different disease groups (cancer, heart failure, COPD), conducts highly specialised assessment, works off-site and on-site. |
❑ Palliative Medical Consultant | |
Medical assessment: | May be required |
Average no. of home visits: | 3 |
Average no. of telephone contacts: | 3 |
Ratio of face-to-face to telephone: | 1:1 |
Average length of service contact: | 6–8 weeks |
Outcome measures collected at first assessment: | ❑ modified Borg [19] at rest, self-reported, on exertion completion of exercise test |
❑ anxiety due to breathlessness at rest, self reported, on exertion & on completion of exercise test | |
❑ physiological measures e.g. oxygen saturation, heart rate & respiratory rate | |
Non-pharmacological interventions: | 1st stage of intervention |
Pharmacological interventions: | 2nd stage of intervention |
1st stage interventions (selection & application as clinically indicated, majority used): | ❑ explanation & reassurance |
❑ anxiety management | |
❑ psychological support | |
❑ hand-held fan | |
❑ information fact sheets | |
❑ emergency plan | |
❑ positioning to reduce work of breathing (rest, recovery & activity) | |
❑ breathing control | |
❑ education to patient, carer & health care generalists | |
❑ pacing & lifestyle adjustment | |
❑ individualised exercise plan | |
❑ relaxation & visualisation | |
❑ airway clearance techniques | |
❑ advice regarding nutrition & hydration | |
❑ support to family & patient to utilise education & self-support programmes | |
❑ sleep hygiene | |
❑ smoking cessation prompt | |
❑ brief cognitive therapy | |
❑ pharmacological review | |
2nd stage interventions (choice dependent on outcome of first stage interventions): | ❑ further pharmacological review e.g. low dose opioids, anti-depressants, anxiolytics |
❑ referral to specialist services (see below) | |
❑ referral for long term oxygen therapy (LTOT) or short burst oxygen therapy (SBOT) assessment | |
Other symptom management: | May be required |
Documentation: | ❑ individualised patient plan |
❑ discharge summary to referrer with copies to GP, specialist services the patient was already in contact with (e.g. respiratory physicians), other involved health care professionals (e.g. district nurses, nursing home care staff) | |
Referrals: | ❑ Pulmonary rehabilitation |
❑ Specialist dietetic | |
❑ OT advice | |
❑ Specialist psychological services | |
❑ Hospice day services | |
❑ other specialist assessment | |
❑ (n.b. these services usually have a wait time) |
Single-blinding
Measurement points
Sample size
Baseline and outcome measures
Baseline characteristic/outcome | Instrument/measure |
---|---|
PATIENT | |
Patient breathlessness | Modified Borg [19] at rest and on exertion & identification of activity that makes breathlessness worst |
Patient breathlessness at best/worst | Visual Analogue Scale (VAS) [7] |
Patient functional ability | WHO performance scale [16] |
Patient social functioning | No. of times patient goes out of the house (average for last month) |
Patient quality of life | SEIQoL-DW [17] |
Patient satisfaction with the service | Qualitative (t1 – expectations of the BIS; t3/t5 – useful aspects of the service) |
Patient critical incidents data | Qualitative (e.g. identification of examples of difficulty getting help/medication/advice needed) |
Patient anxiety | Hospital Anxiety and Depression Scale [20] |
Patient distress due to breathlessness | Visual Analogue Scale for distress caused by breathlessness [7] |
Patient mastery of breathlessness | Mastery items from Chronic Respiratory Questionnaire [18]1
|
Patient use of other services | Service use questions |
CARER
| |
Carer quality of life | SEIQoL-DW [17] |
Carer satisfaction with the service | Qualitative (t1 – expectations of the BIS; t3/t5 – useful aspects of the service) |
Carer critical incidents data | Qualitative (e.g. identification of examples of difficulty getting help/medication/advice needed) |
Carer anxiety | Hospital Anxiety and Depression Scale [20] |
Carer's assessment of patient's breathlessness | Modified Borg [19] at rest and on exertion & identification of activity that makes breathlessness worst |
Carer's assessment of patient's breathlessness at best/worst | VAS adapted for carer |
Carer distress due to patient's breathlessness | VAS adapted for carer – distress caused to carer by patient's breathlessness |
Carer's assessment of patient's use of services | Service use questions |
Carer's social functioning | No. of times carer goes out of the house (average for last month) |
Caregiver burden | Burden Interview [21] Caregiver Appraisal Scale [22] |
Inclusion and exclusion criteria
Inclusion criteria | |
---|---|
Patients | i) Appropriate referral to the BIS |
ii) Diagnosis of COPD/COAD | |
iii) Aged 18 years or over | |
iv) Any patient who does not meet any of the exclusion criteria | |
Carers | i) The informal carers of patients specified above, who can be significant others, relatives, friends or neighbours |
ii) Aged 18 years or over | |
iii) Any carer who does not meet the exclusion criteria | |
Exclusion criteria
| |
Patients/carers | i) Any patient/carer unable to give informed consent |
ii) Any patient living outside of Cambridgeshire PCT, West Essex PCT, East & North Hertfordshire PCT, or Suffolk PCT | |
iii) Any patient who has previously had access to BIS | |
iv) Any patient/carer who is demented or confused | |
v) Any patient/carer with learning difficulties | |
vi) Any patient/carer from other vulnerable groups (e.g. head injury, severe trauma, and mental illness) |
Data collection
Data management
Approvals and trial registration
Data analysis
Results
ID No. | Agreed to recruitment/baseline visit? | Recruitment visit completed? | Reason for non-response |
---|---|---|---|
001 | Yes | Yes | |
002 | No | n/a | Moving house |
003 | Yes | Yes | |
004 | Yes | Yes | |
005 | Yes | Yes | |
006 | Yes | Yes | |
007 | Yes | No – withdrawn by researcher & referred straight to BIS | Significant deterioration between agreeing & baseline interview (t1) |
008 | No | n/a | Admitted to ITU – too ill on discharge |
009 | Yes | Yes | |
010 | No | n/a | None given |
011 | Yes | Yes | |
012 | No | n/a | Too ill (nursing home resident) |
013 | Yes | Yes | |
014 | Yes | Yes (but carer unobtainable) | |
015 | Yes (but died on waiting list; carer refused) | Yes (but died on waiting list; carer refused) | |
016 | Yes | Yes | |
017 | Yes | Yes | |
018 | Yes | No – withdrawn by researcher & referred straight to BIS | Admission & significant deterioration between agreeing & baseline interview (t1) |
019 | Yes | Yes | |
020 | Yes | Yes |
Recruitment/randomisation order | Recruitment/ID no. | Fast-Track group | Waiting List group | Unblinded early? |
---|---|---|---|---|
1 | 01 | 1 | By patient at t2 | |
2 | 03 | 1 | No | |
3 | 05 | 2 | No | |
4 | 04 | 2 | By patient | |
5 | 06 | 3 | By patient at t3 (early) | |
6 | 09 | 3 | No | |
7 | 11 | 4 | No | |
8 | 13 | 4 | No | |
9 | 15 (died pre t3) | (X) | No | |
10 | 14 | 5 | By patient on phone pre t3 | |
11 | 16 | 6 | By patient at t2 | |
12 | 17 | 5 | By carer at t1 (conducted post-patient's t1 and randomisation) * | |
13 | 19 | 6 | No | |
14 | 20 | 7 | No | |
Total | 7 | 6 | 6/13 |
Sample characteristics
Patient and carer missing data
ID No. | Interview no. | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
t1 | t2 | t3 | t4 | t5 | ||||||
Pt | Carer | Pt | Carer | Pt | Carer | Pt | Carer | Pt | Carer | |
001 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
003 | D | D | D | D | D | D | D | D | D | D |
004 | D | D | D | D | D | D | DI | DI | D | D |
005 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
006 | D | D | D | D | D | D | D | DP | D | D |
009 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
011 | D | D | D | D | D | D | D | D | D | D |
013 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
014 | D | U | D | U | D | U | n/a | n/a | n/a | n/a |
016 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
017 | D | D | D | D | D | D | DP | DP | D | D |
019 | D | D | D | X | D | DP | DP | DP | D | D |
020 | D | D | D | D | D | D | n/a | n/a | n/a | n/a |
No. taped | 13 | 12 | 13 | 11 | 13 | 11 | 3 | 2 | 6 | 6 |
No. of interviews/total sought | 13/13 | 12/13 | 13/13 | 11/13 | 13/13 | 12/13 | 6/6 | 6/6 | 6/6 | 6/6 |