Depression Decision Support in Primary Care: A Cluster Randomized Trial

Context Most successful disease management interventions for depression care have required intensive involvement of care managers or mental health specialists. Contribution The authors randomly assigned 41 primary care physicians from 5 clinics to receive either depression decision support or usual care. Depression decision support was provided by a team that included a psychiatrist and a nurse care manager and involved an initial telephone contact, patient education, monthly record review, and sending a progress report to primary care physicians every 3 months. Depression severity improved equally in both groups over 12 months, despite evidence that intervention clinicians delivered more depression-related services. Implications Decision support improved processes of depression care but not outcomes. The Editors Depression is a common problem worldwide. According to projections from the World Health Organization (WHO), depression will be the second leading cause of disability in the developed world by 2020 (1). One in 10 primary care patients meets criteria for major depression (2), yet underrecognition and undertreatment are common (3, 4). Untreated depression is associated with increased deaths, adverse medical outcomes, deficits in function and well-being, and increased use of health services (3, 59). Multifaceted, collaborative interventions have been shown to improve depression-related outcomes in primary care (1022). These interventions include decision support for clinicians, self-management support for patients, clinical information systems modifications, and care management. Care management typically consists of patient education and activation, symptom and treatment adherence monitoring, and self-management reinforcement (23). Most collaborative depression interventions have relied on intensive involvement of care managers and specialists, usually shifting responsibility and workload toward mental health or research teams. Clinical systems may not be capable of sustaining this level of intensity. We therefore developed a multifaceted depression decision support intervention, which was designed to optimize primary care clinicians' abilities to treat depression without adding substantial new resources. We aimed to determine the effect of depression decision support on clinical outcomes and processes of care among patients with depression in a Veterans Affairs (VA) primary care setting. Methods Design Overview Our clinician-level, cluster randomized, controlled trial studied depression decision support versus usual care. We randomly assigned clinicians to either group and nested patients within clinician group assignment. We recruited participants between July 2002 and October 2003 from 5 primary care clinics of a VA medical center and followed patients for 12 months. The local institutional review board approved the study, and all patients and clinicians gave written informed consent. Setting Approximately 25000 veterans were treated during the study period in the 5 primary care clinics (3 urban and 2 rural clinics). Mental health clinicians are available on site in all clinics to provide consultation and brief treatment. A separate, more traditional mental health clinic serves approximately 8000 patients with chronic mental illnesses. Participants Full- and part-time staff physicians, fellows, physician assistants, and nurse practitioners were eligible to participate, and 41 (95%) of 43 eligible clinicians agreed to participate. To decrease variability in baseline depression-related knowledge and skills, we invited all clinicians to participate in the MacArthur Foundation depression education program (2427) before randomization. In two 4-hour sessions, the program addresses communication skills and knowledge related to recognizing and managing depression. All patients of participating clinicians were eligible for the study. Research assistants reviewed medical records of patients with upcoming primary care appointments (within 4 to 6 weeks). They excluded patients who had received treatment from mental health specialists within the previous 6 months; who had received a diagnosis of psychotic disorder, dementia, or bipolar disorder; or who were considered to be terminally ill. They mailed study introduction letters to nonexcluded patients. The letters informed the patients that the research team would call them within 2 weeks unless they declined screening by notifying the study office. Telephone screening measures included the Patient Health Questionnaire (PHQ-9) (28) and the Short Blessed Test screening for dementia (29). We invited patients with PHQ-9 scores of 10 to 25 (moderate to severe depression) (30) to attend in-person enrollment interviews. We referred patients with PHQ-9 scores greater than 25 (very severe depression) or active dangerous ideation for urgent care, and we excluded them from participation. Enrollment interviews were scheduled within 2 weeks of primary care visits and usually took place the same day. The primary inclusion criterion was a repeated PHQ-9 score of 10 to 25 or a Hopkins Symptom Checklist-20 (SCL-20) (31) score of 1.0 or greater at the enrollment interview. Of the 5434 patients who were mailed study introduction letters, 3500 (64%) were reached by telephone and were offered screening (Figure 1), and 3103 (89%) of those patients completed telephone screening. Of these patients, 560 (18%) had PHQ-9 scores between 10 and 25 and were eligible for in-person enrollment interviews. Of the 402 patients who completed the enrollment interviews, 375 had repeated PHQ-9 scores between 10 and 25 or SCL-20 scores of 1.0 or greater and were enrolled in the study. Figure 1. Study flow chart. PHQ-9 = Patient Health Questionnaire. Randomization After clinicians participated in the MacArthur Foundation depression education program, we randomly assigned clinicians to receive depression decision support or to usual care. Patients were nested within clinician assignment group. A stratified technique used a random-number generator to produce equivalent distributions across clinician type (physician vs. physician's assistant or nurse practitioner) and clinic site. Clinicians in one clinic with substantial variation in caseload size were ranked by caseload and underwent block randomization. Intervention The depression decision support team consisted of 1 psychiatrist who was assigned up to 4 hours per week and 1 nurse care manager who was assigned up to 8 hours per week. Within 1 to 2 weeks after enrollment, the depression decision support care manager attempted to call each intervention patient to provide education, explore barriers, emphasize adherence to treatment, and encourage communication with clinicians about depression (Table 1). Supplemental educational materials were mailed to all intervention patients. During the telephone call, patients were invited to attend a 2-hour group depression education program led by the care manager or a depression education class offered by the mental health team in 1 of the urban clinics. Aside from this single early telephone contact, only rare additional contact between the depression decision support care manager and patients was expected. Table 1. Summary of Depression Decision Support Intervention and Usual Care Components The depression decision support team met weekly and reviewed PHQ-9 scores (collected by the research team at baseline and at 1, 3, 6, 9, and 12 months) and medication and appointment data from the medical records. The team reviewed each intervention patient record at least monthly. Using a database, the depression decision support care manager compiled symptom severity and adherence data, posttraumatic stress disorder and alcohol screening results (obtained from routine clinic screening), and treatment recommendations into a treatment progress report. The report was mailed to each intervention clinician for all of their enrolled patients quarterly. If primary care clinicians did not respond to initial PHQ-9 scores greater than 15 or when patients' depression did not adequately improve (PHQ-9 score>10 at 3 months or PHQ-9 score>5 at 6, 9, or 12 months), the depression decision support team reviewed records again and then contacted clinicians or their nurses to discuss treatment strategies or to offer consultation. When the depression decision support team and primary care clinician agreed that psychiatric consultation might be helpful, the psychiatrist arranged a visit. When ongoing mental health specialty care was indicated, the depression decision support team facilitated a referral. Usual Care Clinicians received notifications when their patients enrolled in the study and were provided baseline PHQ-9 scores (Table 1). Usual care clinicians had access to all initial and follow-up PHQ-9 scores (available in the medical record), but usual care clinicians did not receive notifications, reminders, or recommendations about scores from the depression decision support team. Usual care clinicians and their patients also had access to mental health services, including on-site mental health teams. Outcomes and Measurements Blinded research assistants collected baseline patient data in person and PHQ-9 scores (at 1, 3, 6, 9, and 12 months) and outcome data (at 6 and 12 months) by telephone. When patients could not be reached by telephone, research assistants mailed questionnaires to them. Baseline measures included demographic information, Medical Outcomes Study 36-item Short Form for Veterans (SF-36V) scores for health-related quality of life (32), SCL-20 score for depression severity (31), Alcohol Use Disorders Identification Test score (33, 34), PHQ scores for anxiety and panic disorders (35), Posttraumatic Stress Disorder Checklist score (36), Medical Outcomes Study pain effects score (37), and the dysthymia stem from the WHO Composite International Diagnostic Interview (38). The PHQ-9 from the enrollment interview was used to dia