Table 2.
Outcomes and period | Intervention group | Control group | No of patients in multivariable analysis | Adjusted effect estimate* (intervention v control) (95% CI) | P value | ICC | |||
---|---|---|---|---|---|---|---|---|---|
No of patients | Mean (SD) | No of patients | Mean (SD) | ||||||
Primary outcome | |||||||||
Adherence level to depot treatment: | |||||||||
Baseline | 72 | 69% (16%) | 55 | 67% (16%) | 123 | 11.5% (3.9% to 19.0%)† | 0.0003 | 0.28 | |
One year study period | 75 | 85% (15%) | 56 | 71% (22%) | |||||
Secondary outcomes | |||||||||
Subjective quality of life (DIALOG mean score): | |||||||||
Baseline | 51 | 4.4 (0.9) | 34 | 4.9 (1.0) | 57 | 0.71 (0.26 to 1.15)‡ | 0.002 | <0.001 | |
End of study period | 56 | 5.2 (0.8) | 32 | 4.9 (1.0) | |||||
Satisfaction with medication (one item mean score): | |||||||||
Baseline | 51 | 4.9 (1.5) | 34 | 5.0 (1.5) | 57 | 0.26 (−0.74 to 1.27)† | 0.610 | 0.51 | |
End of study period | 56 | 5.6 (1.5) | 32 | 5.3 (1.3) | |||||
Outcomes in intervention group: | |||||||||
No of voluntary hospital admissions | 78 | 0.15 (0.49) | 60 | 0.13 (0.43) | |||||
No of involuntary hospital admissions | 78 | 0.31 (0.96) | 60 | 0.27 (0.63) | |||||
Adverse events | |||||||||
No of suicide attempts | 77 | 0.13 (0.41) | 58 | 0.10 (0.41) | |||||
No of violent incidents | 77 | 0.25 (0.78) | 58 | ||||||
No of police arrests | 77 | 0.18 (0.53) | 57 | ||||||
No of patients achieving at least 95% adherence: | |||||||||
Baseline | 72 | 5 (7%) | 55 | 1 (2%) | 123 | 8.21 (2.00 to 33.67)§ | 0.003 | 0.04 | |
One year study period | 75 | 21 (28%) | 56 | 3 (5%) | |||||
No of patients achieving clinical improvement on CGI: | |||||||||
End of study period | 57 | 33 (58%) | 44 | 18 (41%) | 96 | 2.73 (0.64 to 11.59)§ | 0.174 | 0.44 |
CGI=clinical global improvement; ICC=model based intracluster correlation coefficient.
*Each model adjusted for baseline measure of outcome (except when clinical global improvement was outcome), mental illness needs index score category (low v high), and average treatment cycle during baseline, and includes a random effect for team.
†Adjusted difference in means (95% CI) from linear mixed effects model.
‡Adjusted difference in means from random effects model fitted by generalised least squares.
§Adjusted odds ratio (95% CI) from logistic mixed effects model.