Intention-to-treat analysis of primary and secondary outcomes and sensitivity analyses
| Control group | Intervention group | Adjusted difference (95% CI) | ICC/ICCadj | P | |||
| nc | Mean (SD) | ni | Mean (SD) | ||||
| Medication Appropriateness Index (MAI) | |||||||
| MAI, baseline (T0) | 253 | 4.6 (5.8) | 252 | 4.8 (5.4) | – | – | – |
| Number of prescriptions rated with MAI, baseline* | 253 | 7.8 (2.3) | 252 | 8.0 (2.6) | |||
| Primary outcome | |||||||
| MAI, 6 months (T1) | 243 | 3.8 (4.3) | 241 | 4.6 (5.5) | MD: 0.7 (−0.2 to 1.6)† | 0.016/0.017 | 0.137 |
| Number of prescriptions rated with MAI, 6 months* | 243 | 7.6 (2.2) | 241 | 8.1 (2.8) | RR: 1.0 (1.0 to 1.1) | 0.067/- | 0.354 |
| Secondary outcome | |||||||
| MAI, 9 months (T2) | 228 | 3.9 (4.9) | 238 | 4.8 (5.2) | MD 0.6 (−0.5 to 1.7)† | 0.000/0.000 | 0.272 |
| Number of prescriptions rated with MAI, 9 months* | 228 | 7.7 (2.3) | 238 | 8.1 (3.0) | RR: 1.0 (1.0 to 1.1) | 0.075/- | 0.497 |
| Sensitivity analysis | |||||||
| DMP non-participants | |||||||
| MAI, baseline | 114 | 4.1 (5.2) | 99 | 3.8 (3.8) | – | – | – |
| MAI, 6 months | 110 | 3.5 (4.2) | 92 | 4.2 (4.7) | MD: 0.7 (−0.4 to 1.9)† | 0.000/0.000 | 0.200 |
| MAI, 9 months | 103 | 4.5 (5.7) | 91 | 4.5 (5.1) | MD: 0.1 (−1.5 to 1.6)† | 0.000/0.000 | 0.939 |
| DMP participants | |||||||
| MAI, baseline | 139 | 5.1 (6.2) | 153 | 5.4 (6.1) | – | – | – |
| MAI, 6 months | 133 | 4.0 (4.5) | 149 | 4.8 (5.9) | MD: 0.7 (−0.6 to 1.9)† | 0.006/0.010 | 0.295 |
| MAI, 9 months | 125 | 3.5 (4.0) | 147 | 4.9 (5.3) | MD: 1.1 (0.0 to 2.2)† | 0.000/0.000 | 0.049 |
| Secondary outcomes on quality of life-related measures | |||||||
| EQ-5D index (percentage) | |||||||
| Baseline | 240 | 74.9 (23.0) | 241 | 73.9 (24.4) | – | – | – |
| 6 months | 225 | 73.2 (24.8) | 229 | 73.9 (23.8) | MD: 1.4 (−2.5 to 5.3) | 0.080/0.082 | 0.471 |
| 9 months | 214 | 72.8 (25.1) | 222 | 74.8 (23.4) | MD: 2.3 (−1.6 to 6.2) | 0.049/0.048 | 0.247 |
| Expected life duration (years) | |||||||
| Baseline | 200 | 11.6 (6.9) | 209 | 10.3 (6.9) | – | – | – |
| 6 months | 200 | 12.0 (7.1) | 202 | 11.0 (7.3) | MD: 0.0 (−1.1 to 1.1) | 0.000/0.000 | 0.987 |
| 9 months | 184 | 12.3 (7.0) | 195 | 11.7 (7.9) | MD: 0.5 (−1.3 to 2.4) | 0.185/0.192 | 0.588 |
| Desired life duration (years) | |||||||
| Baseline | 207 | 16.5 (9.1) | 218 | 15.2 (8.9) | – | – | – |
| 6 months | 196 | 16.6 (9.1) | 200 | 15.2 (8.7) | MD: −0.4 (−1.6 to 0.7)† | 0.000/0.000 | 0.423 |
| 9 months | 180 | 16.8 (9.2) | 195 | 16.4 (9.8) | MD: 0.5 (− 0.9 to 1.8) | 0.078/0.081 | 0.479 |
| Secondary outcomes on functional status, pain and hospitalisation | |||||||
| Functional status (VES-13) | |||||||
| Baseline | 228 | 3.0 (2.9) | 223 | 2.6 (2.7) | – | – | – |
| 6 months | 217 | 3.0 (2.9) | 222 | 2.6 (2.8) | MD: 0.1 (−0.3 to 0.5) | 0.000/0.000 | 0.681 |
| 9 months | 199 | 2.7 (2.8) | 204 | 2.8 (2.8) | MD: 0.4 (0.0 to 0.8) | 0.051/0.043 | 0.047 |
| Pain (von Korff Index) | |||||||
| Baseline | 197 | 1.7 (1.3) | 204 | 1.7 (1.2) | – | – | – |
| 6 months | 184 | 1.7 (1.4) | 198 | 1.8 (1.2) | MD: 0.2 (−0.1 to 0.4)† | 0.000/0.000 | 0.135 |
| 9 months | 168 | 1.6 (1.2) | 194 | 1.7 (1.2) | MD: 0.0 (−0.2 to 0.3) | 0.004/0.006 | 0.782 |
| Number of hospital stays | |||||||
| Baseline | 40 | 1.4 (0.7) | 42 | 1.7 (1.0) | – | – | |
| 6 months | 45 | 1.4 (0.7) | 34 | 1.4 (0.5) | RR: 1.2 (0.6 to 2.3) | 0.000/ - | 0.646 |
| 9 months | 25 | 1.2 (0.4) | 28 | 1.3 (0.6) | RR: 1.0 (0.3 to 3.1) | 0.000/ - | 0.949 |
| Number of days spent in hospital | |||||||
| Baseline | 40 | 14.9 (12.9) | 42 | 19.0 (12.2) | – | – | – |
| 6 months | 45 | 13.1 (11.5) | 34 | 9.8 (8.9) | RR: 1.1 (0.5 to 2.3) | 0.894/ - | 0.850 |
| 9 months | 25 | 9.7 (8.2) | 28 | 28 (11.6) | RR: 0.4 (0.1 to 2.8) | 0.859/ - | 0.336 |
| Secondary outcomes of adherence and related measures | |||||||
| Self-reported adherence | |||||||
| Baseline | 252 | 3.7 (0.8) | 250 | 3.7 (0.6) | – | – | – |
| 6 months | 238 | 3.8 (0.5) | 237 | 3.6 (0.8) | MD: −0.1 (−0.2 to 0.0) | 0.005/0.002 | 0.044 |
| 9 months | 225 | 3.7 (0.6) | 231 | 3.7 (0.7) | MD: 0.0 (−0.2 to 0.1) | 0.005/0.007 | 0.629 |
| Observed adherence: drug score (number and percentage of deviating patients) | |||||||
| Baseline | 251 | 101 (40.2%) | 250 | 87 (34.8%) | – | – | – |
| 6 months | 237 | 101 (42.6%) | 237 | 78 (32.9%) | OR: 0.7 (0.5 to 1.0) | 0.000/0.000 | 0.051 |
| 9 months | 224 | 88 (39.3%) | 231 | 85 (36.8%) | OR: 0.9 (0.6 to 1.4) | 0.010/0.009 | 0.736 |
| Observed adherence: dose score (number and percentage of deviating patients) | |||||||
| Baseline | 251 | 125 (49.8%) | 248 | 134 (54%) | – | – | – |
| 6 months | 235 | 128 (54.5%) | 236 | 136 (57.6%) | OR: 1.1 (0.7 to 1.6)† | 0.000/0.000 | 0.756 |
| 9 months | 222 | 121 (54.5%) | 229 | 145 (63.3%) | OR: 1.4 (0.9 to 2.0)† | 0.013/0.005 | 0.119 |
| Observed adherence: regimen score (number and percentage of deviating patients) | |||||||
| Baseline | 251 | 124 (49.4%) | 249 | 131 (52.6%) | – | – | – |
| 6 months | 235 | 117 (49.8%) | 236 | 134 (56.8%) | OR: 1.3 (0.8 to 2.0)† | 0.057/0.051 | 0.297 |
| 9 months | 222 | 114 (51.4%) | 229 | 137 (59.8%) | OR: 1.4 (0.9 to 2.1)† | 0.050/0.042 | 0.148 |
| Number of prescriptions | |||||||
| Baseline | 253 | 8.0 (2.4) | 252 | 8.1 (2.8) | – | – | – |
| 6 months | 242 | 7.8 (2.3) | 241 | 8.4 (3.0) | RR: 1.0 (1.0 to 1.1)† | 0.097/ - | 0.183 |
| 9 months | 227 | 7.8 (2.2) | 238 | 8.4 (3.2) | RR: 1.0 (1.0 to 1.1)† | 0.100/ - | 0.310 |
| Number of single doses | |||||||
| Baseline | 253 | 9.2 (3.5) | 252 | 9.4 (4.1) | – | – | – |
| 6 months | 242 | 8.9 (3.3) | 241 | 9.4 (4.1) | RR: 1.0 (1.0 to 1.1)† | 0.183/- | 0.573 |
| 9 months | 227 | 9.0 (3.6) | 238 | 9.4 (4.4) | RR: 1.0 (0.9 to 1.1)† | 0.212/- | 0.761 |
| MRCI | |||||||
| Baseline | 253 | 26.9 (12.3) | 252 | 28.4 (14.3) | – | – | – |
| 6 months | 242 | 26.3 (12.2) | 241 | 28.6 (14.3) | MD: 0.7 (−0.7 to 2.1)† | 0.030/0.032 | 0.308 |
| 9 months | 227 | 26.3 (11.9) | 238 | 29.1 (15.6) | MD: 1.0 (−0.6 to 2.5)† | 0.042/0.042 | 0.212 |
| Man-Son-Hing Scale | |||||||
| Baseline | 241 | 8.4 (3.4) | 246 | 8.6 (3.4) | – | – | – |
| 6 months | 233 | 8.6 (3.2) | 233 | 8.4 (3.4) | MD: −0.1 (−0.7 to 0.5) | 0.047/0.050 | 0.789 |
| 9 months | 219 | 8.8 (3.5) | 231 | 8.7 (3.7) | MD: −0.2 (−1.0 to 0.5) | 0.041/0.041 | 0.519 |
| BMQ, specific necessities | |||||||
| Baseline | 233 | 22.1 (3.3) | 240 | 22.1 (3.1) | – | – | – |
| 6 months | 219 | 22.0 (2.9) | 230 | 21.8 (3.5) | MD: −0.2 (−0.8 to 0.4) | 0.043/0.046 | 0.557 |
| 9 months | 207 | 21.6 (3.6) | 226 | 21.9 (3.4) | MD: 0.3 (−0.4 to 1.0) | 0.000/0.000 | 0.349 |
| BMQ, specific concerns | |||||||
| Baseline | 229 | 13.4 (5.2) | 238 | 13.4 (5.2) | – | – | – |
| 6 months | 223 | 13.1 (4.8) | 227 | 12.8 (4.8) | MD: −0.2 (−1.0 to 0.7) | 0.021/0.023 | 0.714 |
| 9 months | 211 | 12.6 (5.0) | 226 | 12.5 (5.1) | MD: 0.1 (−0.8 to 1.0) | 0.044/0.047 | 0.838 |
| BMQ, general overuse | |||||||
| Baseline | 237 | 10.5 (3.5) | 241 | 10.5 (3.7) | – | – | – |
| 6 months | 229 | 10.4 (3.6) | 226 | 10.4 (3.4) | MD: −0.2 (−0.8 to 0.5) | 0.048/0.050 | 0.637 |
| 9 months | 213 | 10.5 (3.6) | 225 | 10.6 (3.6) | MD: 0.0 (−0.7 to 0.6) | 0.054/0.057 | 0.917 |
| BMQ, general harms | |||||||
| Baseline | 239 | 8.0 (3.0) | 245 | 7.9 (3.0) | – | – | – |
| 6 months | 229 | 7.9 (2.8) | 234 | 7.9 (3.2) | MD: 0.1 (−0.4 to 0.6) | 0.000/0.002 | 0.631 |
| 9 months | 214 | 8.2 (3.1) | 232 | 8.0 (3.2) | MD: −0.2 (−0.8 to 0.4) | 0.045/0.047 | 0.602 |
nc/ni (number of patients in control group/intervention group), SD, MD (mean differences), OR and RR (relative risk) are provided with 95% CIs, and adjusted for clustering effects and baseline. ICCs are provided as crude values using a mixed model without any adjustment (either group or baseline). The adjusted values use a mixed model that includes the group variable. P values are adjusted for cluster effects and baseline.
*Phytopharmaceutical, homeopathic and other complementary medicine products were excluded from rating.
†Control group tended to perform better.
BMQ, Beliefs about Medicine Questionnaire; CIRS, Cumulative Illness Rating Scale; DMP, disease management programme; EQ-5D, EuroQol five dimensions; ICC, intracluster correlation coefficient; MAI, medication appropriateness index; MRCI, Medication Regimen Complexity Index; VES-13, Vulnerable Elderly Survey-13 items.