Subject enrollment and retention is presented in , and baseline variables are presented in . Slightly fewer than half of participants were male, while slightly more than half of the participants were white. Diagnostically, most participants were given the diagnosis of “adjustment disorder,” suggesting to us that thresholds were not met for other DSM-IV Axis I disorders. The second most frequent diagnosis was “depression, not otherwise specified,” a common rubric used in our ED when depressive symptoms are prominently present in the context of one of several co-occurring substance use disorders. The remaining participants were diagnosed with a major mood or substance abuse disorder or an assortment of other diagnoses. A majority of subjects presented with suicidal ideation (with or without plans) or a noninjurious attempt. However, of note, almost one in 10 presented with a more serious attempt regarded as having a higher degree of potential lethality. A substantial proportion of participants had been brought to the ED involuntarily, and several participants received medications while in the ED. Three subjects had undergone physical restraint during the index episode of care. Urine toxicology screens were obtained for participants based both on clinical assessment that raised concerns about intoxication or substance use and on patient willingness to provide a sample. Over half of those tested were positive for cocaine, amphetamines, or tetrahydrocannabinol.
Demographic and Clinical Characteristics of Participants by Treatment Group*
Most participants had significant previous mental health burden and involvement with mental health treatment of some type. A majority endorsed previous suicide attempts, past psychiatric outpatient treatment, current use of alcohol, the presence of at least one chronic medical condition, and past receipt of psychotropic medications. Forty percent had been admitted previously to a psychiatric inpatient service, while a similar number acknowledged current drug abuse, and almost 10% of female participants were pregnant when enrolled. There were no significant differences between groups in any of these variables at enrollment, and no adjustment was necessary for nominated baseline variables. Likewise, no significant differences in baseline clinical ratings were observed.
Retention in Research Follow-up
Of the 120 participants enrolled in the ED, 94 (78.3%) were successfully reevaluated in person by research staff 2 weeks postdischarge, and 76 (63.3%) were evaluated at 3 months (±2 weeks). Research retention rates did not vary by treatment group. Successful contact with the OPC group for research follow-up was 48/64 (75%) at the 2-week point and 37/64 (57.8%) at 12 weeks. For the MCT group, contact was successful in 46/56 (82.1%) at 2 weeks and 39/56 (69.6%) at 12 weeks.
Shortly after enrollment, a clinical staff member erroneously gave an OPC appointment to one subject who had been randomized to MCT. Another subject deteriorated clinically while still in the ED, requiring inpatient admission after randomization but before final ED discharge. Both subject’s initial results were carried forth in the study by assigned group in accord with our intent-to-treat analytic approach. No adverse events were reported in either treatment group.
Health Service Usage Outcomes
Significantly more MCT participants fulfilled the clinical follow-up appointment (initial “linkage”) following ED discharge (39 of 56, or 69.6%) versus participants randomized to OPC (19 of 64, or 29.6%; relative risk = 2.35, 95% CI = 1.55–3.56, p < 0.001). None of the comparisons between linked and unlinked participants shown in were significant.
Characteristics of Linked Versus Unlinked Participants
Postenrollment Health Service Use
Over the 6 months postenrollment, 38/58 (65.5%) of MCT subjects and 39/64 (60.1%) OPC subjects had at least one repeat ED presentation for a psychiatric complaint. Of subjects who subsequently presented at all to the ED, OPC subjects had a mean of 1.62 visits (SD = ±1.58), whereas OPC subjects had a mean of 1.68 visits (SD = ±1.38, p = 0.84). The mean number of outpatient mental health contacts in the 6 months after enrollment also did not differ significantly between OPC (5.45, SD = ±4.37) and MCT subjects (4.61, SD = ±5.48, p = 0.55).
As shown in , regardless of study group allocation, participants improved significantly on all measures between enrollment and 2 weeks (±1 week) and 12 weeks (±2 weeks) after ED discharge. There were no differences noted in magnitude of improvement between the MCT and OPC groups in terms of suicidal ideation, overall psychopathology, or functional status across this time period. While these represented statistically robust, clinically relevant improvements, it is important to note that many of the participants remained significantly symptomatic at the 3-month evaluation. For all measures, a statistically significant improvement in scores (p < 0.0001) was demonstrated from baseline to 3 months of follow-up; however, no difference between treatment groups was observed.
Comparing Participants by Treatment Group
To examine the impact of successful first contact by any means, data were reexamined to compare differences in outcomes for participants who successfully linked into first contact versus those who did not, regardless of initial randomization group. As shown in , there were no statistically significant differences in rates of improvement between the linked and unlinked groups in terms of suicidal ideation, overall psychopathology, or functional status. The differences on the Hamilton Depression Rating Scale between linked and unlinked approached statistical significance (p < 0.06), but apparent differences had little clinical meaning, given the magnitude of the scores. As noted with the comparison of treatment modalities, on average both participants who were linked and who did not link tended to improve over time, although many remained notably symptomatic at the 3-month point.
Clinical Improvement: Linked Versus Unlinked Groups