Background
Methods
Study design
Eligibility of participants
Intervention
Feedback reports
Goal setting and action planning
Educational outreach visits
Outcome measures
Patient involvement
Data collection and validation
Sample size
Cluster randomization and allocation
Statistical analysis
Results
Participants
Characteristics | Group A (feedback on psychosocial rehabilitation) | Group B (feedback on physical rehabilitation) |
---|---|---|
Centres | ||
Number participating | 12 (66.6) | 6 (33.3) |
Median (min-max) number of patients per year | 431 (183–1156) | 370 (256–988) |
Large centre (>30 patients per month) | 6 (50.0) | 3 (50.0) |
Centre type | ||
Non-teaching hospital | 7 (58.3) | 3 (50.0) |
Teaching hospital | 2 (16.7) | 3 (50.0) |
University hospital or specialized rehabilitation centre | 3 (25.0) | 0 (0.0) |
Patients | ||
Number included in analyses | 9353 | 5494 |
Mean (SD) age in years | 65.0 (11.5) | 65.9 (11.8) |
Male gender | 6650 (71.1) | 3900 (71.0) |
Indications for CR | ||
ACS with revascularization | 4689 (50.1) | 2620 (47.7) |
ACS without revascularization | 469 (5.0) | 401 (7.3) |
Elective CABG or valvular surgery | 1346 (14.4) | 637 (11.6) |
Elective PCI | 536 (5.7) | 341 (6.2) |
Other elective interventions | 360 (3.8) | 119 (2.2) |
CHF or stable AP, no intervention | 262 (2.8) | 194 (3.5) |
Other diagnosis, no intervention | 456 (4.9) | 163 (3.0) |
Unknown | 1235 (13.2) | 1019 (18.5) |
Implementation of the intervention
Implementation of the A&F intervention | Group A (feedback on psychosocial rehabilitation) | Group B (feedback on physical rehabilitation) | ||
---|---|---|---|---|
Range | Range | |||
Multidisciplinary teams | ||||
Length of study period per centre in months | 19.8 (6.0) | 12–30 | 22.5 (4.1) | 14–27 |
Number of A&F iterations | 4.6 (1.0) | 3–6 | 5.7 (0.7) | 4–6 |
Size of local multidisciplinary team | 7.5 (2.8) | 3–13 | 6.3 (1.3) | 4–8 |
Number of team members attending outreach visits | 5.4 (1.9) | 1–11 | 4.7 (1.8) | 2–8 |
Number (%) of teams receiving first telephone follow-up | 5 (41.7) | N.A. | 5 (83.3) | N.A. |
Number (%) of teams receiving second telephone follow-up | 3 (25.0) | N.A. | 5 (83.3) | N.A. |
Quality improvement plans | ||||
Number of goals set (number of areas for improvement included in plan) | 6.9 (3.1) | 1–14 | 6.3 (2.5) | 0–10 |
Mean number of planned actions per goal | 1.9 (0.5) | 1.0–3.3 | 1.6 (0.4) | 1.0–2.6 |
Number of goals achieved per A&F iteration | 1.7 (1.5) | 0–5 | 1.9 (1.5) | 0–6 |
Number of goals unachieved at study end | 5.9 (3.5) | 1–13 | 3.5 (2.2) | 0–7 |
Effects on clinical performance
Care processes and patient outcomes | Type | Control group | Intervention group | P value | ||||
---|---|---|---|---|---|---|---|---|
Crude baseline performance | Crude follow-up performance | Adjusted performance trend [OR (95% CI)] | Crude baseline performance | Crude follow-up performance | Adjusted performance trend [OR (95% CI)] | |||
Psychosocial rehabilitation (study group A) | ||||||||
1. Complete data on psychological functioning | Process | 69.0% (623/903) | 68.3% (3134/4591) | 0.64 (0.32 to 1.28) | 86.1% (1733/2012) | 84.7% (6217/7341) | 0.69 (0.42 to 1.11) | 0.872 |
2. Complete data on social functioning | Process | 16.1% (145/903) | 15.5% (712/4591) | 0.17 (0.01 to 2.06) | 53.2% (1071/2012) | 56.4% (4142/7341) | 1.36 (0.05 to 3.71) | 0.130 |
3. Complete data on lifestyle factors | Process | 82.8% (748/903) | 84.6% (3885/4591) | 0.92 (0.46 to 1.85) | 86.1% (1733/2012) | 80.2% (5884/7341) | 1.03 (0.57 to 1.86) | 0.815 |
4. Disease specific education completeda | Process | 51.3% (424/827) | 44.1% (1796/4071) | 0.76 (0.48 to 1.20) | 62.7% (842/1342) | 61.7% (3046/4934) | 0.44 (0.29 to 0.67) | 0.091 |
5. Lifestyle modification programme completeda | Process | 41.3% (373/903) | 40.8% (1874/4591) | 1.08 (0.63 to 1.85) | 55.7% (877/1575) | 58.3% (3255/5580) | 1.34 (0.78 to 2.31) | 0.385 |
6. Improved quality of live after CR | Outcome | 44.6% (403/903) | 46.5% (2133/4591) | 0.99 (0.86 to 1.13) | 41.0% (826/2012) | 43.5% (3193/7341) | 1 (0.89 to 1.12) | 0.571 |
7. Successful smoking cessation | Outcome | 56.0% (506/903) | 54.2% (2489/4591) | 0.96 (0.84 to 1.09) | 49.5% (996/2012) | 51.1% (3752/7341) | 0.99 (0.89 to 1.11) | 0.553 |
8. Patients receive a discharge letter with remaining lifestyle goals | Process | 13.1% (118/903) | 19.9% (914/4591) | 5.39 (2.14 to 13.56) | 27.3% (549/2012) | 28.9% (2120/7341) | 4.61 (2.29 to 9.30) | 0.764 |
Physical rehabilitation (study group B) | ||||||||
9. Complete data on physical functioning | Process | 54.5% (1097/2012) | 61.8% (4534/7341) | 1.35 (0.72 to 2.54) | 52.6% (475/903) | 65.6% (3010/4591) | 1.78 (0.75 to 4.20) | 0.611 |
10. Complete data concerning cardiovascular risk factors | Process | 55.3% (1112/2012) | 49.8% (3656/7341) | 1.12 (0.76 to 1.65) | 54.4% (491/903) | 60.4% (2775/4591) | 1.34 (0.83 to 2.17) | 0.562 |
11. Exercise training completeda | Process | 53.4% (1074/2012) | 45.9% (3366/7341) | 0.44 (0.27 to 0.74) | 65.8% (421/640) | 60.9% (1780/2922) | 0.8 (0.29 to 2.21) | 0.374 |
12. Relaxation and stress management training completeda | Process | 43.6% (666/1528) | 48.3% (2367/4898) | 2.47 (1.25 to 4.88) | 44.7% (370/827) | 45.8% (1863/4071) | 1.04 (0.40 to 2.71) | 0.183 |
13. Cardiovascular risk factors evaluated at discharge | Process | 10.3% (208/2012) | 7.4% (541/7341) | 0.87 (0.41 to 1.83) | 32.7% (295/903) | 29.9% (1373/4591) | 1.01 (0.43 to 2.37) | 0.667 |
14. Improvement in exercise capacity | Outcome | 46.5% (936/2012) | 51.3% (3769/7341) | 1.28 (1.11 to 1.47) | 50.2% (453/903) | 49.7% (2280/4591) | 1.12 (0.91 to 1.38) | 0.248 |
15. Successful work resumption | Outcome | 53.3% (1072/2012) | 52.4% (3848/7341) | 0.93 (0.83 to 1.05) | 65.7% (593/903) | 68.5% (3146/4591) | 0.97 (0.84 to 1.12) | 0.448 |
16. Moderately active lifestyle norm met at discharge | Outcome | 37.1% (747/2012) | 35.7% (2621/7341) | 0.96 (0.83 to 1.11) | 71.8% (648/903) | 72.8% (3340/4591) | 1 (0.85 to 1.17) | 0.633 |
17. Vigorously active lifestyle norm met at discharge | Outcome | 22.1% (444/2012) | 30.8% (2263/7341) | 1.29 (1.15 to 1.45) | 26.8% (242/903) | 28.1% (1292/4591) | 1.13 (0.99 to 1.30) | 0.200 |
CR therapies | Control group | Intervention group | P value | ||||
---|---|---|---|---|---|---|---|
Crude baseline concordance | Crude follow-up concordance | Adjusted concordance trend [OR (95% CI)] | Crude baseline concordance | Crude follow-up concordance | Adjusted concordance trend [OR (95% CI)] | ||
Psychosocial rehabilitation (study group A) | |||||||
Education (prescribed) | 73.4% (663/903) | 66.0% (3031/4591) | 0.66 (0.43 to 1.01) | 85.8% (1727/2012) | 85.8% (6300/7341) | 0.62 (0.43 to 0.89) | 0.830 |
Lifestyle (prescribed) | 28.9% (261/903) | 24.9% (1145/4591) | 0.49 (0.14 to 1.80) | 62.5% (1258/2012) | 61.2% (4489/7341) | 0.37 (0.15 to 0.92) | 0.716 |
Education (attended)a | 74.6% (617/827) | 68.3% (2780/4071) | 0.98 (0.55 to 1.74) | 53.7% (720/1342) | 52.0% (2566/4934) | 0.51 (0.32 to 0.81) | 0.099 |
Lifestyle (attended)a | 26.3% (168/640) | 28.2% (824/2922) | 1.19 (0.74 to 1.91) | 43.5% (876/2012) | 51.5% (3777/7341) | 0.83 (0.64 to 1.08) | 0.187 |
Physical rehabilitation (study group B) | |||||||
Exercise (prescribed) | 72.1% (1450/2012) | 80.0% (5869/7341) | 2.52 (1.03 to 6.16) | 41.2% (372/903) | 49.4% (2269/4591) | 0.85 (0.24 to 3.07) | 0.176 |
Relaxation (prescribed) | 88.9% (1789/2012) | 92.8% (6811/7341) | 0.91 (0.70 to 1.17) | 78.5% (709/903) | 80.1% (3679/4591) | 1.03 (0.79 to 1.35) | 0.447 |
Exercise (attended)a | 61.2% (935/1528) | 61.3% (3003/4898) | 0.82 (0.61 to 1.09) | 46.8% (387/827) | 49.7% (2022/4071) | 0.92 (0.60 to 1.39) | 0.565 |
Relaxation (attended)a | 57.0% (898/1575) | 48.3% (2695/5580) | 0.44 (0.23 to 0.83) | 75.4% (681/903) | 74.4% (3416/4591) | 0.97 (0.47 to 2.01) | 0.147 |