Clarke 2000.

Methods	RCT Setting: Community‐based mental health services in Portland (OR), USA in conjunction with consumer run drop in centre and subsequently case management services Mind Empowered Inc. (MEI), an assertive case management/supported housing program. MEI was entirely consumer operated and over 80% of the Board of Directors were consumers. MEI was the site for both the consumer‐provider and non‐consumer teams. Funding: Center for Mental Health Services. Recruitment (Clients): Clients being discharged from state and local hospitals or transferring to new service providers in the community were recruited by county mental health workers. Direct referrals from mental health agencies were also accepted. Research staff screened clients for eligibility. 180/189 met the inclusion criteria, two participants declined (no reasons reported). Recruitment (Consumer‐provider): Recruitment details not provided. Training/support: Intensive training on the assertive community treatment (ACT) model provided to staff from both teams at the beginning of the study, and throughout the next several years. Inclusion criteria: Adults in the Portland metropolitan area who met the Oregon definition of chronically mentally ill and priority 1 criteria. All had to be 18 years with a severe mental disorder as identified by a psychiatrist, a licensed clinical psychologist or a certified non medical examiner, and having a documented history of persistent psychotic symptoms (not caused by substance abuse), as well as impaired role functioning in two of three areas (social role, daily living skills, and social acceptability). Exclusions: Mental retardation.
Participants	Clients: 178 participants (60.7% male). Mean age 36.5 (SD 10.3). Principal mental health problem/diagnosis: Schizophrenia (59.5%). Other characteristics: Substance abuse (33,1%), homeless in past six months (30.7%), hospitalised in the last six months (60.7%), and at least one prior arrest (63.2%). Treatment receiving: Not described. Description consumer‐providers: Self‐identified mental health consumers with a DSM‐III‐R axis I diagnosis. Main diagnosis was bipolar disorder (n = 4, 50%), other diagnoses included major depression, schizoaffective disorder, or cyclothymia. Most held a Bachelor's degree.
Interventions	Study aim: To examine time to first episode, and number of clients experiencing hospital use, incarceration, emergency room visits and homelessness in people randomised to ACT involving consumer‐providers compared to ACT with professional staff or usual care. Intervention aim: To decrease adverse outcomes such as episodes of hospital use, incarceration, ER visits and homelessness. Trial duration: 3 years. Role of consumer‐provider: Case managers in ACT teams. Both ACT teams shared a psychiatrist, nurse practitioner, and clinical director. Each team consisted of four full‐time and one part‐time case manager, including a team leader. Intervention:(n = 57) Consumer‐provider case managers in an ACT team. Average caseload was 4.6 clients per case manager. Non‐consumer ACT team: (n = 57) Professional case managers with no diagnosable mental illness. Most held a Masters degree. Average caseload was 5.4 clients per case manager. Usual care: (n = 49) Participants received mental health services from agencies in the Portland metropolitan area. Delivery: Clients in ACT groups frequently had three to five weekly contacts with their mental health providers. Fidelity: Assessed with the Dartmouth ACT Fidelity Scale. Both ACT groups scored lower on all three scales compared with other states (Illinois and East Coast). Poor effectiveness may have been due to poor implementation based on lower fidelity. Consumer involvement outside of the intervention: None. Changes in trial protocol: None stated.
Outcomes	Interviews conducted every 6 months up to 24 months post randomisation. Case manager activity logs Case manager time allocation Location of services provided Emergency room visits Psychiatric hospitalisation
Notes	Data analysis involved comparison of the two ACT teams (Comparison 1) and did not include the usual care group. Power calculation: Authors calculated sample sizes needed to detect significant effects for each major outcome. Sample size used was far too small to detect an effect for each outcome.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomly assigned to one of three conditions" Insufficient information provided to determine whether adequate sequence generation.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding (performance bias and detection bias) Self‐reported outcomes	High risk	Participants had to provide consent and were most likely aware of purpose of study.
Blinding (performance bias and detection bias) All other outcomes	High risk	Providers were aware of the different treatment being provided to participants.
Incomplete outcome data (attrition bias) up to 6 months	Unclear risk	Fifteen participants were excluded from the analysis (11 never began assigned treatment, 3 engaged with non‐study providers, and one subject had a developmental disability and was unable to complete the baseline interview). It is unclear whether missing data were balanced across treatment groups.
Incomplete outcome data (attrition bias) post 6 months	Unclear risk	Fifteen participants were excluded from the analysis (11 never began assigned treatment, 3 engaged with non‐study providers, and one subject had a developmental disability and was unable to complete the baseline interview). It is unclear whether missing data were balanced across treatment groups.
Selective reporting (reporting bias)	Low risk	Data reported for all quantitative outcomes.
Groups comparable at baseline?	Low risk	"No significant baseline differences were found between study conditions on demographic or clinical characteristics"
No contamination between treatment groups?	High risk	"While none of the usual care CMHC's initially operated assertive outreach case management teams, over the study period some agencies adopted aspects of the ACT program" Although located at separate locations, ACT teams involving consumer‐providers or professionals only shared staff that participated in treatment planning and consultation across both groups.