Table 4.
Primary and secondary outcomes at baseline, end of intervention and 6-month and 24-month follow-ups
| Incentives |
Control |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Period | n* 74†/75‡ | Number (%) or means (SD) | n* 58†/56‡ | Number (%) or means (SD) | Type of effect estimate | Adjusted effect estimate (intervention vs control) | p Value | ICC | |
| Primary outcome | |||||||||
| Adherence (percentage) to depot medication | Baseline | 72 | 69% (16%) | 55 | 67% (16%) | ||||
| 12-month intervention | 75 | 85% (15%) | 56 | 71% (22%) | Difference in means¶ | 11.5% (3.9% to 19.0%)** | 0.0003 | 0.28 | |
| 1–6-month follow-up | 58 | 70% (24%) | 41 | 77% (19%) | Difference in means¶ | −7.4% (−17.0% to 2.1%) | 0.127 | 0.175 | |
| 7–24-month follow-up | 66 | 68% (21%) | 50 | 74% (19%) | Difference in means | −5.7% (−13.1% to 1.7%) | 0.130 | n/a | |
| Secondary outcomes | |||||||||
| Achieving at least 95% adherence vs not | Baseline | 72 | 5 (7%) | 55 | 1 (2%) | ||||
| 12-month intervention | 75 | 21 (28%) | 56 | 3 (5%) | OR¶ | 8.21 (2.00 to 33.67) | 0.003 | 0.04 | |
| 1–6-month follow-up | 66 | 5 (8%) | 54 | 9 (17%) | OR¶ | 0.42 (0.11 to 1.61) | 0.205 | <0.001 | |
| 7–24-month follow-up | 66 | 4 (6%) | 50 | 5 (10%) | OR | 0.42 (0.06 to 3.02) | 0.392 | 0.42 | |
| At least one psychiatric hospital admission | Baseline | 78 | 14 (19%) | 60 | 10 (17%) | ||||
| 12-month intervention | 78 | 15 (19%) | 59 | 14 (24%) | |||||
| 1–6-month follow-up | 74 | 15 (20%) | 58 | 8 (14%) | |||||
| 7–24-month follow-up | 77 | 24 (31%) | 60 | 10 (17%) | |||||
| At least one suicide attempt vs none | Baseline | 78 | 9 (12%) | 59 | 7 (12%) | ||||
| 12-month intervention | 77 | 8 (10%) | 58 | 4 (7%) | |||||
| 1–6-month follow-up | 73 | 3 (4%) | 58 | 3 (5%) | |||||
| 7–24-month follow-up | 75 | 5 (7%) | 58 | 3 (5%) | |||||
| At least one violent incident vs none | Baseline | 77 | 15 (20%) | 60 | 10 (17%) | ||||
| 12-month intervention | 77 | 10 (13%) | 58 | 7 (12%) | |||||
| 1–6-month follow-up | 73 | 4 (6%) | 58 | 3 (5%) | |||||
| 7–24-month follow-up | 75 | 11 (15%) | 58 | 7 (12%) | |||||
| At least one police arrest vs none | Baseline | 77 | 13 (18%) | 60 | 9 (16%) | ||||
| 12-month intervention | 77 | 10 (13%) | 60 | 10 (17%) | |||||
| 1–6-month follow-up | 73 | 6 (8%) | 58 | 3 (5%) | |||||
| 7–24-month follow-up | 75 | 14 (19%) | 58 | 10 (17%) | |||||
*n is the number of patients in either group with both a baseline and follow-up period for the specified outcome.
†Number of patients during 6-month follow-up. Excludes 9 patients on whom no data were collected during the 6-month follow-up period: 2 who withdrew immediately after randomisation and 1 who was withdrawn as was not being prescribed depot medication, 1 who died during the intervention period, 2 who were discharged during the intervention period, 1 who was discharged during the 6-month follow-up period, 1 who moved abroad during follow-up and 1 who was out of the community for all of the follow-up period.
‡Number of patients during 24-month follow-up. Excludes 4 patients who were lost to follow-up before the start of the 6-month follow-up period. Of the remaining 137 patients, 5 were lost during the 6-month follow-up and a further 5 were lost to follow-up during the final phase of the study. Four patients lost during the 6-month follow-up returned to the study.
¶Each model was adjusted for baseline measure of outcome, MINI International Neuropsychiatric Interview score category (low vs high) and average treatment cycle during baseline, and includes a random effect for team. ICC, Intraclass Correlation Coefficient.