Capoccia 2004b.

Methods	Design: RCT, parallel group Country: USA Setting: UWFMC, primary care clinic
Participants	Inclusion criteria: people diagnosed with a new episode of depression (DSM‐IV) and started on an AD medication. Exclusion criteria: aged < 18 years; terminal illness; psychosis; recent (within the past 3 months) alcohol (AUDIT score > 8) or substance abuse; > 2 suicide attempts; pregnancy or nursing; limited command of the English language; unwillingness to use UWFMC as a source of care for the next 12 months. Mean age (years): 39 (SD 13.5) Sex: 57 women; 17 men Severity of depression: not detailed AD use status: 32 participants had received prior AD medication for depression. Comorbidities: panic disorder: enhanced care group: 9 (22%); usual care group: 5 (15%); dysthymic disorder: enhanced care: 23 (56%); usual care: 16 (48%)
Interventions	Sample size (total): 74 Length of trial: 1 year Intervention: 'enhanced care' – a remotely delivered intervention consisting of a pharmacist collaborating with PCP and psychiatrist to facilitate patient education, initiation and adjustment of AD dosages, monitoring of patient adherence to the regimen, management of adverse reactions, and prevention of relapse. Follow‐up included weekly telephone calls for the first 4 weeks, followed by telephone contact every 2 weeks until week 12, after which point participants received a telephone call every other month. Support included addressing depression symptom and medication‐related concerns; support and education; medication dosage adjustment and management of adverse effects; change or discontinuation of ADs; additional pharmacotherapy for insomnia and sexual dysfunction; appointments with mental health providers were facilitated; included usual care, n = 41. Control: usual care (encouraged to use available resources such as PCPs, pharmacists, nurses, and mental health providers), n = 33.
Outcomes	Depression outcomes (20‐item Hopkins Symptom Checklist, SCL‐20 on an ITT basis); health‐related quality of life; medication adherence (measured by asking participants the number of days they took the AD medication in the past month on an ITT basis); patient satisfaction; use of depression‐related healthcare services (reported as median and range); cost‐effectiveness. Outcomes not used: patient satisfaction; cost‐effectiveness (not specified in our protocol); quality of life (not reported).
Notes	Sponsorship source: supported by Aetna Quality of Care Foundation Trial registration identifier: not detailed Date of recruitment: November 1999 to March 2001 Declarations of interest from primary researchers: none stated Correspondence: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Study subjects were randomly assigned to either enhanced care (EC) or usual care (UC) using simple computer randomization" (p. 586). Comment: no further details.
Allocation concealment (selection bias)	Unclear risk	Quote: "Due to the nature of the intervention, the clinical pharmacist, PharmD resident, and patients became aware of the randomization status once the EC or UC began" (p. 586).
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details provided.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "A research assistant who is blinded to the patients' randomization status conducts all baseline and follow‐up interviews over the telephone" (p. 587).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "all enhanced care patients were included in the analysis, regardless of whether they completed the interventions" (p. 367). Comment: ITT used.
Selective reporting (reporting bias)	Unclear risk	Quality of life outcome data not reported.
Other bias	Low risk	None detected.