McDonel‐Indiana 1997.

Methods	Allocation: randomised. Design: multicentre (5 rural sites). Duration: 24 months. Country: Indiana, USA.
Participants	Diagnosis*: severe mental illness (DSM‐III‐R coded between 295 and 301.99). N = 200 (40 participants for each site). Setting: 5 rural CMHCs. Age: > 18 years, mean ˜ 38.1 years (SD 11.1). Sex: 43% M (86M, 114F). Ethnicity: 98% Caucasian (understood to be white). History**: i. poor utilisation of community mental health services and frequent use of psychiatric hospital or emergency room, ii. difficulties with the legal system or in maintaining stable housing, iii. more than 1 episode of intensive psychiatric care lasting > 2 months, iv. impaired role functioning on a continuing or intermittent basis for at least 2 years.
Interventions	1. ICM: Assertive Community Treatment (1 site had addition of Rhinelander model to ACT). Caseload: 1:10. N = 100. 2. Non‐ICM: provided by the mental health services: office‐based; subscribed to the tradition of individual Case Management (including day treatment, partial hospitalisation, outpatient therapy, residential services). Caseload: 1:30 to 1:60. N = 100.
Outcomes	Service use: average number of days in hospital per month (provided for 2 groups of centres, see below in McDonel‐Indiana 1997 A and McDonel‐Indiana 1997 B). Global state: leaving the study early. Unable to use ‐ Service use: admission (sample size not reported). Global functioning: Global Assessment of Functioning (GAF) (rated by the therapist), compliance with medication on 11‐item client‐rated checklist (not a peer‐reviewed scale). Social functioning: Indiana Level of Functioning (Indiana LOF) (rated by the therapist), accomodation quality and employment scale (not a peer‐reviewed scale). Social functioning: days in jail, number of police contacts (sample size not reported). Mental state: Brief Psychiatric Rating Scale (BPRS) (rated by the therapist). Quality of life: scale modified by the trialist (not a peer‐reviewed scale). Satisfaction with services: satisfaction with service scale (not peer‐reviewed scale).
Notes	*Schizophrenia 48%, affective disorder 32%. N = 153. **Mean lifetime hospitalisation: 8.4 (SD 7.5), mean hospitalisation in the previous years: 1.3 (SD 1.1). N = 153.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised. No further details.
Allocation concealment (selection bias)	Unclear risk	No details
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Primary outcome: clinician/participant mediated ‐ rating ‐ Unclear. Secondary outcome: clinician/participant mediated ‐ rating ‐ Unclear.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Service use (hospitalisation) was obtained from agency records and the state Department of Mental Health database. Blinding not reported. Accomodation, legal involvement, and education outcomes were self reported and verified by case managers. Blinding not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Insufficient reporting of attrition/exclusion (number of missing data is reported, but no reasons provided). Number of participants randomised to each group not clearly reported (some participants refused to participate and they were not clearly accounted for in each group).
Selective reporting (reporting bias)	High risk	Some listed outcomes of interest are reported incompletely (sample size not reported for social functioning and admission).
Other bias	Low risk	Publicly funded (NIMH grant). No details. No evidence of the presence of other bias.