Background
-
assess whether the PICANT intervention was effective in improving the TTR and cTTR
-
describe variations in cTTR between practices
-
determine practice- and patient-level factors that are associated with the TTR
Methods
Study design and population
Randomization and masking
Interventions
Data collection
Calculation of TTR and cTTR
Statistical analyses
Results
Baseline characteristics
Characteristics of practices | Intervention (n = 26) | Control (n = 26) | Total (n = 52) |
---|---|---|---|
Practice type | |||
Single-handed practice, no. (%) | 11 (42.3) | 11 (42.3) | 22 (42.3) |
Shared or group practice, no. (%) | 15 (57.7) | 15 (57.7) | 30 (57.7) |
Third-party certification in quality management for medical practices (e.g. QEP), no (%)b | 12 (46.2) | 17 (65.4) | 29 (56.9) |
Location of the practice, no. (%) | |||
Rural (< 20,000 inhabitants) | 12 (46.2) | 10 (38.5) | 22 (42.3) |
Provincial (20,000–100,000 inhabitants) | 9 (34.6%) | 9 (34.6%) | 18 (34.6%) |
Urban (> 100,000 inhabitants) | 5 (19.2%) | 7 (26.9%) | 12 (23.1%) |
Panel size, registered patients per quarter, no. (%)c | |||
500–999 | 7 (26.9) | 1 (3.8) | 8 (15.4) |
1000–1499 | 9 (34.6) | 11 (42.3) | 20 (38.5) |
1500–1999 | 7 (26.9) | 5 (19.2) | 12 (23.1) |
≥ 2000 | 3 (11.5) | 9 (34.6) | 12 (23.1) |
Main focus of the practice, no. (%)d | |||
Cardiology | 13 (50%) | 13 (50%) | 26 (50%) |
Diabetology | 13 (50%) | 13 (50%) | 26 (50%) |
Geriatrics | 9 (34.6%) | 7 (26.9%) | 16 (30.8%) |
Natural medicine | 3 (11.5%) | 4 (15.4%) | 7 (13.5%) |
Structured training courses for patients, no. (%) | 11 (42.3) | 16 (61.5) | 27 (51.9) |
Characteristics of GPs | |||
Male gender, no. (%) | 18 (69.2) | 16 (61.5) | 34 (65.4) |
Age, mean (SD) | 52.4 (7.7) | 49.3 (7.4) | 50.9 (7.7) |
Knowledge test on OAC for GPs, points, mean (SD)e | 9.9 (1.6) | 9.6 (1.5) | 9.7 (1.6) |
Years of job experience since medical school, mean (SD) | 23.1 (8.1) | 20.4 (7.9) | 21.8 (8.0) |
Participated in a study in the last 5 years, no. (%)f | 8 (30.8) | 11 (42.3) | 19 (36.5) |
Characteristics of healthcare assistants | |||
Age, mean (SD) | 40.4 (11.8) | 37.9 (12.4) | 39.2 (12.0) |
Years of job experience (including education), mean (SD) | 19.3 (10.1) | 18.6 (11.7) | 19.0 (10.8) |
Intervention (n = 365) | Control (n = 371) | Total (n = 736) | |
---|---|---|---|
Sociodemographic characteristics | |||
Age, mean (SD), yearsb | 74.4 (9.5) | 72.8 (9.3) | 73.6 (9.4) |
Male gender, no. (%) | 205 (56.2) | 200 (53.9) | 405 (55.0) |
Educational attainment, no. (%) | |||
No educational attainment | 54 (15.9%) | 38 (11.3%) | 92 (13.6%) |
Vocational training | 2 (0.6%) | 0 (0%) | 2 (0.3%) |
Vocational on-the-job training | 145 (42.8%) | 153 (45.4%) | 298 (44.1%) |
On-the-job training combined with school-based education | 38 (11.2%) | 46 (13.6%) | 84 (12.4%) |
Education in a technical college | 56 (16.5%) | 47 (13.9%) | 103 (15.2%) |
Polytechnic degree | 25 (7.4%) | 25 (7.4%) | 50 (7.4%) |
University degree | 19 (5.6%) | 28 (8.3%) | 47 (7%) |
BMI, mean (SD) | 28.8 (5.1) | 29.1 (4.8) | 28.9 (5.0) |
Smoking, no. (%) | |||
Non-smoker | 185 (51.5%) | 205 (56%) | 390 (53.8%) |
Former smoker | 151 (42.1%) | 136 (37.2%) | 287 (39.6%) |
Occasional smoker | 9 (2.5%) | 11 (3%) | 20 (2.8%) |
Regular smoker | 14 (3.9%) | 14 (3.8%) | 28 (3.9%) |
Migration background, no. (%) | 27 (7.4) | 24 (6.5) | 51 (6.9) |
Clinical characteristics | |||
Long-term indication for oral anticoagulation therapy, no. (%)c | |||
Atrial fibrillation/flutter | 302 (82.7) | 295 (79.5) | 597 (81.1) |
Recurrent venous thromboembolism | 32 (8.8) | 40 (10.8) | 72 (9.8) |
Recurrent pulmonary embolism | 31 (8.5) | 30 (8.1) | 61 (8.3) |
Mechanical heart prosthesis | 29 (7.9) | 28 (7.5) | 57 (7.7) |
Intracardiac thrombus | 3 (0.8) | 4 (1.1) | 7 (1.0) |
Other indication | 33 (9.0) | 34 (9.2) | 67 (9.1) |
Comorbidities, no. (%)c | |||
Ischemic heart disease | 133 (36.4%) | 106 (28.6%) | 239 (32.5%) |
Cerebral insult/bleeding | 72 (19.7%) | 56 (15.1%) | 128 (17.4%) |
Congestive heart failure | 120 (32.9%) | 103 (27.8%) | 223 (30.3%) |
Peripheral arterial occlusive disease (PAOD) | 39 (10.7%) | 26 (7%) | 65 (8.8%) |
Arterial hypertension | 317 (86.8%) | 307 (82.7%) | 624 (84.8%) |
Renal insufficiency | 62 (17%) | 63 (17%) | 125 (17%) |
Diabetes mellitus | 119 (32.6%) | 135 (36.4%) | 254 (34.5%) |
Chronic pulmonary diseases | 58 (15.9%) | 63 (17%) | 121 (16.4%) |
Diseases of the esophagus, stomach, duodenum | 68 (18.6%) | 63 (17%) | 131 (17.8%) |
Malignant tumor | 18 (4.9%) | 23 (6.2%) | 41 (5.6%) |
CHA2DS2-VASc-Score, no. (%)d | |||
> 1 | 292 (97.0) | 282 (95.9) | 574 (96.5) |
= 1 | 9 (3.0) | 12 (4.1) | 21 (3.5) |
Antithrombotic medication, no. (%)e | |||
Phenprocoumon | 341 (93.4) | 349 (94.1) | 690 (93.8) |
Dabigatran | 8 (2.2) | 4 (1.1) | 12 (1.6) |
Rivaroxaban | 7 (1.9) | 13 (3.5)) | 20 (2.7) |
Aspirin | 4 (1.1) | 6 (1.6) | 10 (1.4) |
Other | 9 (2.5) | 3 (0.8) | 12 (1.6) |
Last INR within therapeutic target range, no. (%)f | 240 (69.2) | 239 (68.7) | 479 (68.9) |
INR self-measurement, no. (%)g | 39 (11.3) | 46 (13.3) | 85 (12.3) |
Patient compliance, no. (%)h | |||
Highly compliant | 308 (84.4) | 266 (72.1) | 574 (78.2) |
Moderately compliant | 51 (14.0) | 86 (23.3) | 137 (18.7) |
Not compliant | 6 (1.6) | 17 (4.6) | 23 (3.1) |
TTR and cTTR
Range | Patients (n = 688) |
---|---|
1.5–1.8 | 1 |
1.8–2.3 | 1 |
1.8–2.9 | 1 |
1.8–3 | 1 |
2–3 | 657 |
2–3.5 | 2 |
2–4 | 10 |
2.5–3.5 | 11 |
2.5–4 | 3 |
3–4 | 1 |
Associations between practice / patient characteristics and the level of TTR
Variables | Regression coefficient | 95% confidence interval | P valueb |
R
2
|
---|---|---|---|---|
Male gender of GP | −4.07 | −7.97; −0.18 |
0.041
| 0.08 |
Age of GP, years | 0.05 | −0.21; 0.32 | 0.687 | 0.09 |
Job experience since medical school, years | 0.06 | −0.19; 0.31 | 0.609 | 0.09 |
Practice type | ||||
Single-handed practice | Reference | |||
Shared or group practice | −0.66 | −4.56; 3.25 | 0.737 | 0.09 |
Panel size, registered patients per quarter, no. (%)c | 0.784 | 0.09 | ||
500–999 | Reference | |||
1000–1499 | −1.03 | −7.12; 5.06 | ||
1500–1999 | −3.34 | −9.81; 3.14 | ||
> 2000 | −2.37 | −9.24; 4.51 | ||
Main focus of the practiced | ||||
Cardiology | −0.79 | −4.65; 3.08 | 0.684 | 0.09 |
Diabetology | −0.43 | −4.30; 3.44 | 0.824 | 0.09 |
Geriatrics | −1.13 | −5.31; 3.05 | 0.590 | 0.09 |
Natural medicine | −4.02 | −9.58; 1.54 | 0.153 | 0.09 |
Third-party certification in quality management for medical practices (e.g. QEP)e | −5.12 | −8.79; − 1.46 |
0.007
| 0.09 |
Knowledge test on OAC for GPs, pointsf | −0.05 | −1.30; 1.20 | 0.933 | 0.09 |
Location of the practice | ||||
Rural (< 20,000 inhabitants) | Reference | |||
Provincial (20,000–100,000 inhabitants) | −3.82 | −8.15; 0.52 | 0.290 | 0.09 |
Urban (> 100,000 inhabitants) | −0.58 | −5.48; 4.31 |
Variables | Regression coefficient | 95% confidence interval | P valueb |
R
2
|
---|---|---|---|---|
Age, yearsc | − 0.12 | − 0.26; 0.02 | 0.083 | 0.09 |
Male gender | 2.99 | 0.38; 5.60 |
0.025
| 0.10 |
Educational attainment | 0.069 | 0.11 | ||
No educational attainment | Reference | |||
Vocational training | −47.66 | −81.63; −13.68 | ||
Vocational on-the-job training | 2.63 | −1.53; 6.80 | ||
On-the-job training combined with school-based education | −0.94 | −6.12; 4.24 | ||
Education in a technical college | 3.19 | −1.88; 8.27 | ||
Polytechnic degree | 1.78 | −4.56; 8.11 | ||
University degree | 3.84 | −2.58; 10.26 | ||
BMI, units | 0.14 | −0.13; 0.40 | 0.318 | 0.08 |
Smoking | 0.953 | 0.08 | ||
Non-smoker | Reference | |||
Former smoker | −0.30 | −3.04; 2.45 | ||
Occasional smoker | 0.96 | −7.38; 9.30 | ||
Regular smoker | −2.01 | −8.84; 4.82 | ||
CHA2DS2-VASc-Score > 1d | 3.42 | −5.14; 11.98 | 0.433 | 0.09 |
Long-term indication for oral anticoagulation therapye | ||||
Atrial fibrillation/flutter | 2.22 | −1.06; 5.50 | 0.185 | 0.08 |
Recurrent venous thromboembolism | −0.81 | −5.17; 3.55 | 0.716 | 0.08 |
Recurrent pulmonary embolism | −2.12 | −6.76; 2.53 | 0.371 | 0.08 |
Mechanical heart prosthesis | −3.27 | −8.00; 1.46 | 0.175 | 0.08 |
Intracardiac thrombus | −0.23 | −13.22; 12.75 | 0.972 | 0.08 |
Comorbiditiese | ||||
Ischemic heart disease | −3.42 | −6.24; −0.59 |
0.018
| 0.09 |
Cerebral insult/bleeding | −2.17 | −5.68; 1.35 | 0.227 | 0.09 |
Congestive heart failure | −3.41 | −6.31; − 0.51 |
0.021
| 0.09 |
Peripheral arterial occlusive disease (PAOD) | −1.83 | −6.43; 2.78 | 0.436 | 0.08 |
Arterial hypertension | 0.00 | −3.64; 3.64 | 1.000 | 0.08 |
Renal insufficiency | −5.76 | −9.22; −2.30 |
0.001
| 0.10 |
Diabetes mellitus | −1.67 | −4.38; 1.05 | 0.228 | 0.09 |
Chronic pulmonary diseases | −5.91 | −9.33; −2.49 |
0.001
| 0.10 |
Diseases of the esophagus, stomach, duodenum | −0.41 | −3.89; 3.07 | 0.818 | 0.08 |
Malignant tumor | −4.31 | −9.84; 1.22 | 0.126 | 0.09 |
Compliancef | ||||
Not compliant | Reference | |||
Moderately compliant | 6.41 | −2.22; 15.04 |
0.008
| 0.10 |
Highly compliant | 10.87 | 2.67; 19.06 | ||
Self-measurement (n = 648)g | ||||
No | Reference | |||
Yes | 5.21 | 1.74; 8.67 |
0.003
| 0.10 |
Hospitalization | ||||
No | Reference | |||
Yes | −4.51 | −7.09; −1.93 |
0.001
| 0.10 |
Number of days of hospitalizationh | ||||
Per day | −0.09 | −0.14; −0.04 |
0.001
| 0.10 |
Occurrence of primary endpointi | −4.78 | −8.85; − 0.71 |
0.021
| 0.09 |
Variables | Regression coefficient | 95% confidence interval | P valueb |
R
2
|
---|---|---|---|---|
Male gender | −3.51 | −7.54; 0.52 | 0.086 | 0.09 |
Age of GP, years | 0.07 | − 0.20; 0.34 | 0.621 | 0.09 |
Job experience since medical school, years | 0.08 | −0.18; 0.33 | 0.551 | 0.09 |
Practice type | ||||
Single-handed practice | Reference | |||
Shared or group practice | −1.08 | −5.06; 2.90 | 0.588 | 0.09 |
Panel size, registered patients per quarter, no. (%)c | 0.598 | 0.10 | ||
500–999 | Reference | |||
1009–1499 | −2.72 | −8.87; 3.43 | ||
1500–1999 | −4.83 | −11.37; 1.71 | ||
> 2000 | − 4.19 | −11.13; 2.76 | ||
Main focus of the practiced | ||||
Cardiology | −0.41 | −4.36; 3.54 | 0.836 | 0.09 |
Diabetology | −0.06 | −4.01; 3.89 | 0.977 | 0.09 |
Geriatrics | −0.33 | −4.61; 3.95 | 0.878 | 0.09 |
Natural medicine | −4.26 | −9.93; 1.40 | 0.137 | 0.09 |
Third-party certification in quality management for medical practices (e.g. QEP)e | −5.74 | −9.47; − 2.01 |
0.003
| 0.10 |
Knowledge test on OAC for GPs, pointsf | 0.00 | −1.27; 1.28 | 0.996 | 0.09 |
Location of the practice | ||||
Rural (< 20.000 inhabitants) | Reference | |||
Provincial (20.000–100.000 inhabitants) | −4.14 | −8.55; 0.27 | 0.266 | 0.10 |
Urban (> 100.000 inhabitants) | −0.97 | −5.96; 4.02 |
Variables | Regression coefficient | 95% confidence interval | P valueb |
R
2
|
---|---|---|---|---|
Age, yearsc | −0.13 | − 0.27; 0.01 | 0.060 | 0.10 |
Male gender | 3.14 | 0.56; 5.72 |
0.017
| 0.11 |
Educational attainment | 0.161 | 0.12 | ||
No educational attainment | Reference | |||
Vocational training | −32.54 | −66.17; 1.09 | ||
Vocational on-the-job training | 3.19 | −0.93; 7.31 | ||
On-the-job training combined with school-based education | −0.32 | −5.45; 4.80 | ||
Education in a technical college | 3.84 | −1.19; 8.86 | ||
Polytechnic degree | 1.90 | −4.37; 8.17 | ||
University degree | 5.34 | −1.02; 11.69 | ||
BMI, units | 0.15 | −0.11; 0.42 | 0.252 | 0.09 |
Smoking | 0.962 | 0.09 | ||
Non-smoker | Reference | |||
Former smoker | −0.25 | −2.96; 2.47 | ||
Occasional smoker | 0.74 | −7.51; 8.99 | ||
Regular smoker | − 2.24 | −9.00; 4.51 | ||
CHA2DS2-VASc-Score > 1d | 3.90 | −4.61; 12.40 | 0.368 | 0.10 |
Long-term indication for oral anticoagulation therapye | ||||
Atrial fibrillation /flutter | 1.90 | −1.34; 5.15 | 0.250 | 0.09 |
Recurrent venous thromboembolism | −0.85 | −5.17; 3.47 | 0.699 | 0.09 |
Recurrent pulmonary embolism | −2.55 | −7.14; 2.04 | 0.275 | 0.09 |
Mechanical heart prosthesis | −2.36 | −7.05; 2.32 | 0.322 | 0.09 |
Intracardiac thrombus | −0.93 | −13.77; 11.90 | 0.886 | 0.09 |
Comorbiditiese | ||||
Ischemic heart disease | −3.28 | −6.08; −0.49 |
0.022
| 0.10 |
Cerebral insult / bleeding | −2.24 | −5.72; 1.24 | 0.206 | 0.09 |
Congestive heart failure | −3.77 | −6.64; −0.90 |
0.010
| 0.10 |
Peripheral arterial occlusive disease (PAOD) | −2.19 | −6.75; 2.37 | 0.346 | 0.09 |
Arterial hypertension | −0.25 | −3.85; 3.35 | 0.893 | 0.09 |
Renal insufficiency | −5.26 | −8.69; −1.84 |
0.003
| 0.11 |
Diabetes mellitus | −2.01 | −4.70; 0.67 | 0.141 | 0.10 |
Chronic pulmonary diseases | −5.49 | −8.88; −2.11 |
0.002
| 0.11 |
Diseases of the esophagus, stomach, duodenum | −0.73 | −4.17; 2.72 | 0.679 | 0.09 |
Malignant tumor | −3.66 | −9.13; 1.81 | 0.190 | 0.09 |
Compliancef | ||||
Not compliant | Reference | |||
Moderately compliant | 6.89 | −1.64; 15.42 |
0.007
| 0.12 |
Highly compliant | 11.22 | 3.11; 19.32 | ||
Self-measurement (n = 648)g | ||||
No | Reference | |||
Yes | 6.17 | 2.76; 9.59 |
< 0.001
| 0.12 |
Hospitalization | ||||
No | Reference | |||
Yes | −4.58 | −7.13; −2.03 |
< 0.001
| 0.11 |
Number of days of hospitalizationh | ||||
Per day | −0.09 | −0.14; −0.03 |
0.001
| 0.11 |
Occurrence of primary endpointi | −4.42 | −8.44; − 0.39 |
0.032
| 0.10 |
Intervention (n = 365) | Control (n = 371) | Total (n = 736) | |
---|---|---|---|
Occurrence of primary endpoint: patients suffering a thromboembolic or major bleeding event, no. (%)b | 40 (11.0) | 48 (12.9) | 88 (12%) |
Hospitalized patients, no. (%) | 184 (50.4) | 209 (56.5) | 393 (53.5%) |
Days of hospitalization per patient, mean (SD)c | 12.7 (24.9) | 14.5 (24.1) | 13.6 (24.5) |