Bartels 2004.

Methods	Study design: Randomised controlled trial
Participants	Setting: Speciality settings and primary care Diagnosis: Significant psychological distress on the General Health Questionnaire, a positive response to suicidal ideation questions modified from the PRIME‐MD, or at‐risk alcohol consumption based on quantity/frequency criteria of more than seven drinks/week or more than two binge episodes in the past 3 months consisting of more than three drinks on a single occasion. Assessed by using the Mini‐International Neuropsychiatric Interview, CES‐D scale, Beck Anxiety Inventory, an alcohol quantity/frequency scale, and a detailed medication review Inclusion criteria: Met criteria for target conditions (depression, anxiety, and at‐risk drinking) assessed by using the Mini International Neuropsychiatric Interview, CES‐D scale, Beck Anxiety Inventory, an alcohol quantity/frequency scale, and a detailed medication review Exclusion criteria: Patients who had received mental health/substance abuse treatment in the preceding 3 months and patients with severe cognitive impairment (≥ 16 on the Brief Orientation Memory Concentration Test). Primary care providers were given the opportunity to withdraw patients with positive screens for medical reasons; patients with a positive assessment on the Mini International Neuropsychiatric Interview for psychosis, mania, or hypomania, patients with incomplete data Age: Mean 73.5 (SD 6.2) years Gender: 26% female Ethnicity: 52% white Country: United States Sample size (randomised): Total participants 2022, intervention 999, control 1023
Interventions	Intervention: Integrated care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: PCP, social workers, psychologists, psychiatric nurses, psychiatrists, and counsellors (CM) 2) a structured management plan: Integrated models included: 1) mental health and substance abuse services co‐located in the primary care setting (including counselling, case management, psychotherapy, and pharmacological treatment); 2) services provided by licensed mental health/substance abuse providers (including social workers, psychologists, psychiatric nurses, psychiatrists, and counsellors); 3) verbal or written communication between the MH specialist and PCP; and 4) an appointment within 2 to 4 weeks following the PCP visit. Specific clinical interventions were not required. Patients with at‐risk drinking were offered a manualised Brief Alcohol Intervention 3) scheduled patient follow‐ups: Alcohol = 3 counselling sessions, depression = the intervention varied across sites 4) enhanced inter‐professional communication: Verbal or written communication about the clinical evaluation and treatment plan between the CMs and PCP. PCPs were required to remain involved in the patients’ care and document their role in the medical record, and communicate with the CMs. PCPs were notified in the event that a patient failed to attend the initial clinical visit Control: Enhanced referral model which provided mental health/substance abuse services in a specialty setting that was physically separate and designated as a mental health/substance abuse clinic. The minimum criteria for the enhanced referral model included 1) referral within 2‐4 weeks of the PCP appointment; 2) comply with model requirements, including time to first appointment and coordinated follow‐up contacts if the patient failed to make the first scheduled visit; 3) assistance with transportation; and 4) assistance in meeting the costs of treatment
Outcomes	Depression (CES‐D): 3, 6 months Quality of Life (mental and mental health): 3, 6 months Satisfaction: 3 months
Notes	CES‐D: Centre for Epidemiological Studies Depression; CM: case manager; MH: mental health; PCP: primary care provider; SD: standard deviation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Computer generated blocks, the computer system malfunctioned for 2 weeks and 44 patients did not conform to randomisation procedure. Some patients assigned using social security number (even or odd)
Allocation concealment (selection bias)	Low risk	Researchers telephoned an independent person to receive patient allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (CES‐D) was: overall 311/1531 (20%), 159/758 (21%) intervention and 152/773 (20%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	Protocol available and all prespecified outcomes reported
Other bias	Unclear risk	Insufficient information available to assess
Implementation Integrity	Unclear risk	Insufficient information available to assess
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessor was potentially aware of treatment allocation