Secondary objectives: satisfaction, adherence, and patient and doctor behaviours (ITT analysis)
| (A) Satisfaction | Control group without PILs (n=156) | Intervention group with PILs (n=168) | OR (95% CI) | P value |
| 1. Satisfaction with infrastructure (reception, food, waiting time) | 92/156 (59%) | 91/168 (54.2%) | 0.82 (0.53 to 1.28) | 0.38 |
| 2. Satisfaction with nurses and care assistants | 112/156 (71.8%) | 137/168 (81.6%) | 1.74 (1.03 to 2.93) | 0.04 |
| 3. Satisfaction with the doctor | 103/156 (66%) | 131/168 (78%) | 1.82 (1.11 to 2.98) | 0.016 |
| 4. Satisfaction with the medical consultation | 93/156 (59.6%) | 129/168 (76.8%) | 2.24 (1.39 to 3.62) | <0.0.01 |
| 5. Would you recommend the ED to friends or family? | 119/156 (76.3%) | 135/168 (80.4%) | 1.27 (0.75 to 2.16) | 0.37 |
| Total satisfaction score | 19 (16–20) | 19 (17–20) | 0.20 |
| (B) Adherence* (according to doctors’ behaviours) | Control group without PILs | Intervention group with PILs | OR (95% CI) | P value |
| 1. Have you taken the whole course of the prescribed treatment? | 108/134 (80.6%) | 107/130 (82%) | 1.12 (0.60 to 2.09) | 0.72 |
| 2. Did you respect the prescribed doses? | 127/134 (94.8%) | 122/124 (98.4%) | 3.36 (0.68 to 16.5) | 0.18 |
| 3. Did you comply with the regimen and conditions (time at which you should take the medication, if you were fasted or not, during meals and so on)? | 113/134 (84.3%) | 116/124 (93.5%) | 2.69 (1.15 to 6.33) | 0.02 |
| 4. Did you have additional examinations or a specialised consultation prescribed by your doctor (imagery, laboratory analyses, an appointment with a specialist)? | 87/98 (88.8%) | 119/141 (84.4%) | 0.68 (0.32 to 1.48) | 0.34 |
| 5. Did you follow the recommendations and the advice given (have you changed any habits as a result of the consultation)? | 82/89 (92.1%) | 104/123 (84.6%) | 0.47 (0.19 to 1.17) | 0.10 |
| 6. Did you follow health monitoring instructions and advice given by your doctor on if and when to reconsult a healthcare professional? | 75/78 (96.2%) | 81/83 (97.6%) | 1.62 (0.26 to 9.96) | 0.67 |
| Total adherence score | 0.93 (0.80–1) (n=154) | 0.89 (0.76–0.97) (n=165) | 0.21 |
| (C) Patient behaviours | Control group without PILs | Intervention group with PILs | OR (95% CI) | P value |
| 1. Did you need a new medical consultation for the same condition? | 50/156 (32.1%) | 30/168 (17.9%) | 0.46 (0.27 to 0.77) | <0.01 |
| 2.1. Did you consult an ED physician? | 42/156 (26.9%) | 14/168 (8.3%) | 0.25 (0.13 to 0.47) | <0.01 |
| 2.2. Did you consult your primary care physician? | 11/156 (7.1%) | 17/168 (10.1%) | 1.48 (0.67 to 2.28) | 0.32 |
| (D) Doctor behaviours | ||||
| 1. Drug prescriptions? | 134/156 (85.9%) | 130/168 (77.4%) | 0.56 (0.32 to 1.00) | 0.049 |
| 2. Prescriptions of further tests (laboratory analysis, imaging, appointment with specialists)? | 98/156 (62.8%) | 141/168 (83.9%) | 3.09 (1.83 to 5.22) | <0.01 |
| 3. Given advice to follow? | 89/155 (57.4%) | 123/168 (73.2%) | 2.03 (1.27 to 3.23) | <0.01 |
| 4. Information on if and when to consult a doctor again? | 79/155 (51.0%) | 84/165 (50.9%) | 1.00 (0.64 to 1.55) | 0.99 |
*Two patients in phase 1 (control) and three patients in phase 2 (with PILs) did not receive any prescription and were not included in the adherence analysis.
P values in bold were considered statistically significant (p<0.05).
There were no significant differences in overall satisfaction and adherence scores across the entire population (intention-to-treat). All three satisfaction items related to healthcare professionals and for adherence, the item related to timing of medication intake, were significantly improved. The overall satisfaction score significantly improved on per-protocol analysis. Table 4 shows the answers to questions concerning the PIL in the intervention group.
ED, emergency department; ITT, intention-to-treat; PILs, patient information leaflets.