Case Management for Depression by Health Care Assistants in Small Primary Care Practices

Context Few studies have evaluated whether health care assistants can improve care for depressed patients. Contribution Patients who were randomly assigned to receive telephone case management by health care assistants reported slightly greater improvements in depression symptoms, better adherence to antidepressant therapies, and more favorable assessments of the quality of their care than did patients randomly assigned to receive usual care. Implication Telephone case management facilitated by health care assistants may be a feasible mechanism for small primary care practices to improve care of their patients with depression. The Editors Depression causes a substantial disease burden (1) and is responsible for annual health care costs of about $83.1 billion in the United States (2, 3). Most patients with depression are treated in primary care (46). Collaborative care can improve depression outcomes by providing decision support and clinical information for family physicians, as well as self-management support and follow-up for patients. However, evidence regarding collaborative depression care stems mostly from academic or managed care settings in the United States (711). In these trials, family physicians generally relied on mental health case managers and decision support from mental health specialists (12). Case management is a patient-centered element of collaborative care that may be effective in primary care (13). It comprises systematic tracking of patients, support for continuing the treatment, and taking action in the case of nonadherence or lack of improvement (14). Collaborative depression care has generally yielded positive results in diverse primary care settings (7). The IMPACT (Improving MoodPromoting Access to Collaborative Treatment) trial found that care managers who were supervised by psychiatrists and who provided education and support for medication adherence reduced depression symptoms in older patients (15). Dietrich and colleagues (16) found that telephone support, provided by a trained, centrally based mental health care manager who was supervised by a psychiatrist, improved depression symptoms. Dobscha and colleagues (17) evaluated a primary care decision-support team for depression (comprising a psychiatrist and a mental health nurse) and found improved care processes but no differences in depression symptoms (17), possibly because of less intensive follow-up of patients. Small, isolated primary care settings often have limited resources (18). In the United States, 26% of primary care practices are solo practices or 2-person partnerships, in which extensive collaborative models would be difficult to implement, and 22% are located in rural areas with limited access to mental health specialists (19). Health care assistants are established professionals in primary care settings. They have less training than U.S. physician assistants or nurse practitioners, who provide first-contact care, and need not be college graduates (20). In Germany, health care assistants have 3 years of on-the-job training. They are mainly responsible for administrative tasks in general practice but provide basic clinical procedures (21). Health care assistants are a potentially important resource for enhancing patient care in primary care settings (20). Our aim was to evaluate whether case management by a practice-based health care assistant can reduce depression symptoms and improve the process of care for patients with major depression in small primary care practices. Methods We designed a pragmatic, cluster randomized, controlled trial that used practice as the unit of randomization to avoid contamination (22). The institutional review board of Goethe University Frankfurt am Main, Frankfurt am Main, Germany, approved the study protocol on 25 April 2005 (23). We used written consent procedures for family physicians and patients. We recruited practices between February 2005 and May 2005 and patients between May 2005 and July 2006. We carried out the intervention between June 2005 and August 2007. We completed the last follow-up for study patients in September 2007. Setting and Participants After calculating the sample size (24), we informed all 1600 family physicians registered with the medical association of the state of Hesse, Germany (mandatory registration), about the trial and invited them by mail to participate in information meetings. As the registration list presents only names and addresses, we checked inclusion criteria only for those who participated in the meetings. We stopped recruiting when 74 practices had enrolled, even though more practices were interested in participating. Inclusion criteria for the practices were acceptance of all major health plans (90% of patients are covered by this type of insurance) (25); provision of a primary care service, according to the definition of Starfield and colleagues (26); and management by a family physician. Patients were screened on special dates and referred to the trial by the family physician in the primary care practice. Inclusion criteria for patients were diagnosis of major depression with indication for any antidepressive treatment, age 18 to 80 years, access to a private telephone, ability to give informed consent, and ability to communicate in German. The diagnosis of major depression was based on a score of more than 9 points and a categorical diagnosis in the Patient Health Questionnaire-9 (PHQ-9) (27), and was confirmed by the family physician by using the checklists in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and International Classification of Diseases, Tenth Edition. New patients were double-screened with the same procedure within 2 weeks. Exclusion criteria were confirmed pregnancy, severe alcohol or illicit drug consumption, or acute suicidal ideation assessed by the family physician. Randomization and Interventions The data safety and monitoring board stratified the practices according to the size of the city and performed computer-based randomization. Patient random assignment status was nested within the practice status. The data safety and monitoring board was responsible for allocation concealment by keeping the randomization results in a secure database. Because of the practice staff training required for the behavioral intervention, patients, health care assistants, family physicians, and researchers were not blinded to assignment once the trial was started. We designed our case management intervention in accordance with the Chronic Care Model (28, 29), which emphasizes proactive support for the patient by the entire practice team. We trained 1 health care assistant from each practice assigned to the intervention group in 2 workshops (an 11-hour and a 6-hour workshop). This interactive training included information on depression, communication skills, telephone monitoring, and behavioral activation for the patient (3032). The health care assistants contacted their patients by telephone twice a week in the first month and than once a month for the following 11 months. They monitored depression symptoms and adherence to medication by using the Depression Monitoring List (33). Health care assistants also encouraged patients to follow self-management activities, such as medication adherence and activation for pleasant or social activities. The assistants provided this information to the family physician in a structured report that stratified the urgency of the contact by a robot scheme. Family physicians in both the intervention and control groups received training on evidence-based depression treatment guidelines (34). During the trial, other forms of disease or case management programs were uncommon in Germany (35). No study practice carried out case management for any other diseases. Outcomes and Follow-up Self-rating questionnaires were handed out to the patients at baseline and at 6 and 12 months after baseline. Patients filled in the questionnaires at home and sent them back to the practice. We collected the questionnaires in the practices and collected data from patient records (number of family physician and specialist contacts, hospitalization, and prescribed medication). Research staff carried out data input and management (36). Serious adverse events were reported to the data safety and monitoring board. Clinical Outcomes The primary outcome was depression symptoms, which we assessed by using the primary carevalidated PHQ-9 (37). Each item is scored from 0 (not at all) to 3 (nearly every day), for a total score that ranges from 0 to 27 (high scores indicate more severe depression). We assessed response (50% improvement in PHQ-9 score) and remission status (PHQ-9 score<5) as secondary outcomes. We also report data for the following secondary outcomes: quality of life, patient assessment of chronic illness care, and medication adherence. We measured health-related quality of life by using the Medical Outcomes Study Short Form 36 (SF-36) (38, 39) and the EuroQol-5D (40). The SF-36 allows the calculation of scores for physical health and mental health (range, 0 to 100; higher scores indicate better status). The EuroQol-5D is a generic instrument that measures health-related quality of life with a visual analogue scale (range, 0 to 100; higher ratings indicate higher quality of life). We determined the number of physical comorbid conditions by counting the documented diagnoses from different diagnostic groups listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and International Classification of Diseases, Tenth Edition, excluding all psychiatric diagnoses in the patient record. We assessed severity of chronic physical diseases by using the Chronic Disease Score, on the basis of prescription data from the patient record (41). Process-of-Care Outcomes We assessed the number of family physician and mental health specialist contacts, as well as prescriptions for ant