Background
Methods
Study design
Participants
Ethics, consent and permissions
Participant-reported data and sample size
Data collection
Analysis
Results
Recruitment and baseline characteristics
Baseline characteristics - patients | Mean (SD) or % (n) | ||
---|---|---|---|
Intervention arm (fast track) | Control arm (waiting list) | Total | |
Age (years) | 72.3 (10.6) | 72.2 (9.4) | 72.2 (9.9) |
Sex (male) | 64 % (28) | 58 % (25) | 61 % (53) |
Lives alone | 21 % (9) | 37 % (16) | 29 % (25) |
Diagnosis: | |||
COPD Other non-malignant | 80 % (35) 20 % (9) | 88 % (38) 12 % (5) | 83 % (72) 17 % (14) |
GOLD COPD classification (if available): | |||
1 - mild 2 - moderate 3 - severe 4 - very severe | 9 % (2) 9 % (2) 48 % (11) 35 % (8) (23/35 with COPD) | 0 % (0) 32 % (7) 36 % (8) 32 % (7) (22/38 with COPD) | 5 % (2) 20 % (9) 42 % (19) 33 % (15) (45/72 with COPD) |
Charlson Co-Morbidity Index (0-9)a
| 4.4 (1.39) | 4.4 (1.46) | 4.4 (1.42) |
Australia-modified Karnofsky Performance Scale (0-100)b,c
| 66.8 (14.9) | 65.8 (14.9) | 66.3 (14.9) |
Modified Borg at rest (0-10)a
| 1.9 (1.27) | 1.9 (1.05) | 1.9 (1.16) |
Modified Borg on exertion (0-10)a
| 6.5 (2.28) | 6.0 (2.18) | 6.2 (2.23) |
NRS worst breathlessness 24 h (0-10)a
| 6.0 (2.14) | 5.6 (2.29) | 5.8 (2.21) |
NRS breathlessness now (0-10)a
| 2.8 (2.13) | 2.8 (1.91) | 2.8 (2.01) |
NRS average breathlessness 24 h (0-10)a
| 4.5 (1.99) | 4.7 (1.83) | 4.6 (1.91) |
NRS distress due to breathlessness (0-10)a
| 6.2 (2.50) | 5.9 (3.17) | 6.0 (2.84) |
Anxiety score (HADS; 0-21)a
| 7.84 (3.79) | 8.86 (4.75) | 8.35 (4.31) |
Depression score (HADS; 0-21)a
| 6.81 (3.27) | 7.84 (3.72) | 7.33 (3.52) |
Anxiety (HADS)a: | |||
Normal (0-7) Mild (8-10) = possible clinical disorder Moderate (11-14) = probable clinical disorder Severe (15-21) = probable clinical disorder | 42 % (18) 35 % (15) 18 % (8) 5 % (2) | 51 % (22) 9 % (4) 26 % (11) 14 % (6) | 47 % (40) 22 % (19) 22 % (19) 9 % (8) |
Depression (HADS)a: | |||
Normal (0-7) Mild (8-10) = possible clinical disorder Moderate (11-14) = probable clinical disorder Severe (15-21) = probable clinical disorder | 58 % (25) 28 % (12) 12 % (5) 2 % (1) | 51 % (22) 17 % (7) 30 % (13) 2 % (1) | 55 % (47) 22 % (19) 21 % (18) 2 % (2) |
CRQ dyspnoea score (1-7)b
| 3.12 (0.91) | 3.06 (0.92) | 3.09 (0.91) |
CRQ fatigue score (1-7)b
| 3.15 (0.96) | 2.76 (1.18) | 2.95 (1.09) |
CRQ emotional function score (1-7)b
| 3.95 (1.05) | 3.78 (1.18) | 3.86 (1.12) |
CRQ mastery score (1-7)b
| 3.87 (1.28) | 3.91 (1.34) | 3.89 (1.30) |
Number of respondents | 37-44 | 37-43 | 74-87 |
Baseline characteristics - carers | Mean (SD) or % (n) | ||
---|---|---|---|
Intervention arm (fast track) | Control arm (waiting list) | Total | |
Carer age (years) | 62.5 (14.82) | 62.0 (12.02) | 62.2 (13.39) |
Carer sex (female) | 79 % (23) | 79 % (22) | 79 % (45) |
Carer employment status: | |||
Employed – full time Employed – part time Voluntary work Retired Other (e.g., unemployed due to illness/student) | 22 % (6) 22 % (6) 0 % (0) 48 % (13) 8 % (2) | 8 % (2) 4 % (1) 4 % (1) 73 % (19) 11 % (3) | 15 % (8) 13 % (7) 2 % (1) 60 % (32) 10 % (5) |
NRS carer distress due to patient’s breathlessness (0-10)a
| 5.0 (2.80) | 4.5 (2.75) | 4.7 (2.76) |
Carer anxiety score (HADS; 0-21)a
| 7.64 (4.97) | 7.69 (4.36) | 7.67 (4.64) |
Carer depression score (HADS; 0-21)a
| 5.04 (3.89) | 5.04 (3.83) | 5.04 (3.82) |
Carer anxiety (HADS)a: | |||
Normal (0-7) Mild (8-10) = possible clinical disorder Moderate (11-14) = probable clinical disorder Severe (15-21) = probable clinical disorder | 52 % (13) 28 % (7) 8 % (2) 12 % (3) | 44 % (10) 30 % (7) 17 % (4) 9 % (2) | 48 % (23) 29 % (14) 13 % (6) 10 % (5) |
Carer depression (HADS)a: | |||
Normal (0-7) Mild (8-10) = possible clinical disorder Moderate (11-14) = probable clinical disorder Severe (15-21) = probable clinical disorder | 84 % (21) 4 % (1) 8 % (2) 4 % (1) | 74 % (17) 13 % (3) 13 % (3) 0 % (0) | 79 % (38) 8 % (4) 10 % (5) 2 % (1) |
Number of respondents | 24-29 | 21-28 | 45-57 |
No carer interview | 14 | 15 | 29 |
Change in patient and carer distress due to breathlessness
t1a
| t2 | t3 | t4 | t5 | Difference in mean t3 adjusted for baseline (I minus C) | With 95 % confidence interval |
p-value | |
---|---|---|---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||
Control arm (waiting list) | Baseline | Control | Completed control | Midway intervention | Completed intervention | |||
Intervention arm (fast-track) | Baseline | Midway intervention | Completed intervention | Post-intervention | Post-intervention | |||
Primary outcome: NRS distress due to breathlessness (0-10)b
| ||||||||
Control arm (waiting list) | 5.61 (3.23) | 5.03 (2.84) | 4.05 (2.57) | 3.73 (2.85) | 3.36 (2.63) | -0.24 | (-1.30,0.82) |
p = 0.65 |
Intervention arm (fast-track) | 6.24 (2.53) | 4.66 (2.85) | 4.02 (2.49) | n/a | 4.25 (2.92) | |||
Key secondary outcomes: | ||||||||
CRQc mastery (1-7) | ||||||||
Control arm (waiting list) | 4.13 (1.25) | 4.03 (1.25) | 4.24 (1.17) | 4.42 (1.30) | 4.74 (1.09) | 0.43 | (-0.02,0.89) |
p = 0.06 |
Intervention arm (fast-track) | 3.85 (1.33) | 4.44 (1.29) | 4.49 (1.35) | n/a | 4.72 (1.11) | |||
HADSb anxiety (0-21) | ||||||||
Control arm (waiting list) | 8.32 (4.30) | 9.05 (4.47) | 8.61 (4.25) | 8.00 (4.83) | 7.56 (4.16) | -0.76 | (-1.95,0.44) |
p = 0.21 |
Intervention arm (fast-track) | 7.80 (3.87) | 7.77 (3.49) | 7.45 (3.97) | n/a | 7.57 (3.82) | |||
HADSb depression (0-21) | ||||||||
Control arm (waiting list) | 7.71 (3.81) | 7.97 (4.11) | 7.71 (3.83) | 7.86 (4.67) | 7.47 (4.16) | -0.61 | (-1.76,0.54) |
p = 0.29 |
Intervention arm (fast-track) | 6.73 (3.32) | 6.62 (3.65) | 6.28 (3.97) | n/a | 6.80 (4.21) | |||
Number of respondents | 77-79 | 75-80 | 77-79 | 35-37 | 69-72 |
t1a
| t2 | t3 | t4 | t5 | Difference in mean t3 adjusted for baseline (I minus C) | With 95 % confidence interval |
p-value | |
---|---|---|---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||
Control arm (waiting list) | Baseline | Control | Completed control | Midway intervention | Completed intervention | |||
Intervention arm (fast-track) | Baseline | Midway intervention | Completed intervention | Post-intervention | Post-intervention | |||
Carer NRS distress due to patient’s breathlessness (0-10)b
| ||||||||
Control arm (waiting list) | 4.24 (2.72) | 4.48 (3.06) | 4.44 (3.14) | 3.67 (2.88) | 4.04 (3.21) | -0.42 | (-1.86,1.02) |
p = 0.56 |
Intervention arm (fast-track) | 5.30 (2.67) | 4.22 (2.92) | 4.27 (2.48) | n/a | 4.25 (2.99) | |||
Key secondary outcomes: | ||||||||
Carer HADSb anxiety (0-21) | ||||||||
Control arm (waiting list) | 7.55 (4.54) | 7.74 (5.22) | 7.40 (5.24) | 7.42 (6.34) | 7.08 (5.92) | -1.22 | (-2.84,0.40) |
p = 0.14 |
Intervention arm (fast-track) | 7.65 (5.19) | 7.00 (4.69) | 6.00 (4.29) | n/a | 6.90 (5.08) | |||
No. of respondents | 44 | 46 | 51 | 24 | 45 |
Change in patient mastery of breathlessness, and patient and carer anxiety and depression
Reported benefit of BIS
Results of categorisation of t3 (intervention arm: fast track) and t5 (control arm: waiting list) patient and carer qualitative interviews into levels of impact (Impact Categorisation Levels) | ||
---|---|---|
Level 1: Significant impact – clearly stated BIS made a difference | Level 2: Some impact – no major change recognised, but valued specific aspects of BIS | Level 3: No impact – BIS made no difference at all |
56 % (44/78) | 36 % (28/78) | 8 % (6/78) |
Change in NRS distress due to breathlessnessa (primary outcome measure) from t1 to t3 (and Impact Categorisation Level) | |
---|---|
Cell 1: Biggest Improvers (from high baseline scores) | Cell 2: Limited Improvers (high baseline score Cell 1 matches who improved the least) |
068: NRS distress reduced from 8-2 (Level 1) | 002: NRS distress unchanged at 8-8 (Level 2) |
012: NRS distress reduced from 9-3 (Level 1) | 038: NRS distress reduced from 8-6 (Level 1) |
137: NRS distress reduced from 10-3 (Level 1) | 059: NRS distress reduced from 10-7 (Level 2) |
140: NRS distress reduced from 10-2 (Level 1) | 103: NRS distress reduced from 10-9 (Level 1) |
100: NRS distress reduced from 8-0 (Level 1) | 109: NRS distress reduced from 9-7 (Level 3) |
Cell 3: Worseners (who turned out to have a low-middling baseline scores) | Cell 4: Moderate Improvers (closest baseline score Cell 3 matches who improved the most) |
072: NRS distress increased from 5-8 (Level 1) | 015: NRS distress reduced from 5-2 (Level 3) |
084: NRS distress increased from 6-9 (Level 2) | 036: NRS distress reduced from 5-0 (Level 2) |
126: NRS distress increased from 5-7 (Level 1) | 042: NRS distress reduced from 6-2 (Level 1) |
158: NRS distress increased from 1-3 (Level 1) | 161: NRS distress reduced from 5-0 (Level 2) |
027: NRS distress increased from 3-4 (Level 2) | 108: NRS distress reduced from 6-1 (Level 3) |
Mechanisms of impact |
Mechanism of impact - gaining knowledge: Patient: “Well I’ve gone back to my choir last Friday, first time in 6 months … and it was fantastic, I was so happy to be there, yeah, really pleased to be there. Couldn’t do the singing as much as I would like to, but it’s coming, it’s coming. And it was lovely because everybody was pleased to see me and lots of hugs and kisses, so … it was really nice […] I think it is the Breathlessness Service has done it […] talking it over with experts, having people come to the house giving me pointers of how I can improve my daily living” [137t3p; Impact Categorisation Level 1 – Significant impact; Cell 1 – Biggest Improvers on primary outcome] |
Mechanism of impact - feeling not alone: Carer: “the fact that there are things out there […] it is the reassurance and support really […] we have felt we’ve had support from everybody, and I’m always telling people […] what marvellous support we’ve had, and it does make a difference. You know the outcome’s not going to be really any different, but it does make a difference to have that support, definitely” [012t3pc; Impact Categorisation Level 1 – Significant impact; Cell 1 – Biggest Improvers on primary outcome] |
Mechanism of impact - gaining confidence: Patient: “the next thing she said is cool air, you know, plenty of air, and gave me that fan, and that when you are sort of out of breath […] use that for about 10 minutes, and she showed me how to breathe in and went not ‘ha’ (harsh) like that but ‘ha’ (soft) like that, you know, and she explained all that to me, and then the next thing she said is relaxing, not tensed up, and how I should position myself, sitting, lying down, and so on, you know, everything that … even standing, how I should do it, and she gave me the notes on it […] it gave me a lot of confidence with myself, which I didn’t have before, with this breathing […] it gave me a lot of confidence in the sense that I’m more relaxed about breathing, and even smoke less” [158t3p; Impact Categorisation Level 1 – Significant impact; Cell 3 – Worsener on primary outcome] |
Valued interventions |
Valued intervention - handheld fan: Patient: “She said this [fan] might help instead of the oxygen. […] When I’m just a little bit out of breath or first thing in the morning… when I’m coughing and spluttering I start getting short of breath, I can lay in bed and use that, so I don’t have oxygen upstairs. […] I take it to work [and] I can get out of the lorry more […] because I know […] I’ll put my hand in my pocket, turn it on as I’m walking back to my cab (puts fan on) and by the time I get to the cab I’m OK. Before I had it I used to have to stand at the lorry door and catch my breath […] when I’ve got a chest infection, like now, I get to the back of the lorry [and] the weather’s wrong or I grab a bin wrong… ‘phew’ [but] I can put this on, walk back to the cab. Whereas before I had this like… if I had a chest infection I’d stay on my arse all day” [126t3p; Impact Categorisation Level 1 – Significant impact; Cell 3 – Worsener on primary outcome] |
Valued intervention - positioning: Patient: “well it was her who told me about my shoulders, which was very helpful I thought […] you get a pillow under each one […] and you relax your shoulders […] I found that very helpful actually, you know, I think ‘well, I’ve got to do my shoulders’ […] That’s entirely new to me that was. I’m surprised the exercise places I’ve been [didn’t mention] the shoulders. Amazing that is, absolutely amazing […] She said it puts a lot of strain on your shoulders by keeping them up all the time, you know, and she said do that […] and she showed me about the pillows, and […] that makes a difference” [036t3p; Impact Categorisation Level 2 – Significant impact; Cell 4 – Moderate Improver on primary outcome] |
Valued intervention – “breathlessness won’t kill you”: Carer: “when he’s breathless he panics naturally because he’s always felt that […] he was going to die, but [the BIS doctor] said ‘that will not happen, not in one of your breathless attacks, you will not die in an attack’, which helped me because you know, I then have to think ‘oh my gosh, what can I do to help him’…you know. So she did give me some leaders as to what I can do to help, knowing now that he won’t die in one of these sort of situations, so that certainly helped me, and it certainly helped me to realise that, you know, I can probably help him to calm down. So yes, as a carer I think it was a help.” [038t3c; Impact Categorisation Level 1 – Significant impact; Cell 2 – Limited Improvers on primary outcome] |
Interviewer: “[…] what did you find helpful?” Carer: “I think being able to talk to somebody other than… a total stranger shall we say… and like yourself, I mean I feel as if I’ve known you for years, it’s strange […] you know, you feel like part and parcel of the family” [Carer 108t3c] |
Patient: “[being] able to talk to somebody who understands. Because, with the best will in the world, people who don’t have breathing problems don’t understand what it’s like not to be able to breathe. All of them, my family, friends, everybody, because you all do it automatically, you don’t have to think about it, they’ve got no idea what it’s like, but talking to people who do understand like yourself, like [BIS team member], like the doctors, is helpful […] talking it over […] because you and [BIS team member] are approachable […] I feel as though I could talk to you, and I felt I could talk to her, I didn’t feel intimidated” [Patient 137t3p] |
Patient: “being able to talk to different people, yourself included, you realise that you can cope, and if you do what you’re told sort of thing… I suppose like a child! […] I’m glad that I’ve spoken to you, yourselves, and other people, and I don’t find any fault with any of you at all” [Patient 108t3p] |
Costs and cost effectiveness
Control arm (waiting list) (n = 43) | Intervention arm (fast-track) (n = 44) | |||||
---|---|---|---|---|---|---|
Service | N (%) using service | Mean (SD) contacts-users only | Mean (SD) cost in £s -all sample | N (%) using service | Mean (SD) contacts-users only | Mean (SD) cost in £s -all sample |
Inpatient | 19 (44) | 11.8 (11.5) | 2,993 (5,486) | 11 (25) | 9.7 (7.0) | 1,391 (3,112) |
Other hospital services | 37 (86) | 3.5 (4.7) | 357 (440) | 36 (82) | 2.1 (1.4) | 236 (204) |
GP | 36 (84) | 2.9 (2.2) | 114 (110) | 31 (71) | 2.4 (1.4) | 76 (86) |
Nurse | 30 (69) | 3.8 (2.9) | 73 (91) | 35 (80) | 3.7 (3.8) | 91 (134) |
Other health services | 20 (47) | 1.5 (1.0) | 27 (68) | 18 (41) | 1.8 (0.9) | 38 (70) |
Social and other care | 6 (14) | 20.0 (28.8) | 66 (280) | 11 (25) | 17.5 (21.1) | 119 (303) |
Total | 3,630 (5,588) | 1,952 (3,290) |
Control arm (waiting list) (n = 38) | Intervention arm (fast-track) (n = 41) | |||||
---|---|---|---|---|---|---|
Service | N (%) using service | Mean (SD) contacts-users only | Mean (SD) cost in £s -all sample | N (%) using service | Mean (SD) contacts-users only | Mean (SD) cost in £s -all sample |
BIS intervention | 2 (5) | 1.5 (0.7) | 4 (19) | 3 (95) | 2.1 (1.0) | 156 (80) |
Inpatienta
| 4 (11) | 6.0 (3.4) | 361 (1,200) | 6 (15) | 11.5 (8.3) | 963 (2,895) |
Other hospital services | 19 (50) | 2.5 (3.5) | 145 (262) | 20 (49) | 1.7 (1.0) | 108 (144) |
GP | 24 (63) | 1.6 (0.7) | 50 (63) | 25 (61) | 1.8 (1.2) | 49 (57) |
Nurse | 16 (42) | 2.5 (2.5) | 28 (62) | 21 (51) | 2.7 (3.3) | 41 (95) |
Other health services | 4 (11) | 1.0 (0.0) | 3 (11) | 14 (34) | 1.5 (1.1) | 25 (59) |
Social and other care | 9 (24) | 11.3 (22.8) | 68 (269) | 8 (20) | 5.4 (4.6) | 29 (75) |
Total | 659 (1253) | 1,371 (2,948) |