Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial

Abstract

Importance: Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment.

Objective: To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing.

Design, setting, and participants: Randomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California.

Interventions: DEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control).

Main outcomes and measures: Among depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted.

Results: Of the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control, -0.2 (95% CI, -1.2 to 0.8); IMCP vs control, 0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point difference [PPD]: DEV vs control, -2.2 [90% CI, -8.0 to 3.49], P = .0499 for noninferiority; IMCP vs control, -3.3 [90% CI, -9.1 to 2.4], P = .02 for noninferiority); patient-reported antidepressant recommendation did not achieve noninferiority (mean PPD: DEV vs control, 0.9 [90% CI, -4.9 to 6.7], P = .23 for noninferiority; IMCP vs control, 0.3 [90% CI, -5.1 to 5.7], P = .16 for noninferiority).

Conclusions and relevance: A tailored IMCP increased clinician recommendations for antidepressant drugs, a mental health referral, or both among depressed patients but had no effect on mental health at the 12-week follow-up. The possibility that the IMCP and DEV increased patient-reported clinician recommendations for an antidepressant drug among nondepressed patients could not be excluded.

Trial registration: clinicaltrials.gov Identifier: NCT01144104.

Figures

Figure 1. Flow of subjects through study

Of 6191 patients successfully contacted, 1261 were ineligible due to age, lack of English proficiency, inability to operate a computer, psychosis, or currently taking antidepressants. An additional 1280 subjects (denoted in the Figure by an asterisk) were excluded at random by an automated sampling program designed to maintain a ratio of depressed:non-depressed participants of approximately 5:3 and, within the depressed sample, to slightly over-sample patients with PHQ-8 scores ≥10. Of the remaining 3620 patients, 2725 declined participation or did not keep their appointments, leaving 925 (25.5%) who underwent randomization at the index visit. A total of 58 patients (44 in the depressed sample and 14 in the non-depressed sample) were excluded post-randomization. For the effectiveness analysis, 559 patients were included in the primary analysis and 473 were available for follow-up at 12 weeks. For the harms analysis, 308 patients were included. PHQ-9 = Patient Health Questionnaire-9 DEV = Depression engagement video IMCP = Interactive multimedia computer program