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Case Management for Depression by Health Care Assistants in Small Primary Care Practices: A Cluster Randomized Trial

Jochen Gensichen, MD, MPH, MA; Michael von Korff, ScD; Monika Peitz, PhD; Christiane Muth, MD, MPH; Martin Beyer, MSc; Corina Güthlin, PhD; Marion Torge, MD; Juliana J. Petersen, MD, MPH; Thomas Rosemann, MD, PhD; Jochem König, ScD; Ferdinand M. Gerlach, MD, MPH, for PRoMPT (PRimary care Monitoring for depressive Patients Trial)
[+] Article and Author Information

International Standard Randomized Controlled Trial Number: ISRCTN66386086.


From Friedrich Schiller University, Jena, Germany; Goethe University Frankfurt am Main, Frankfurt am Main, Germany; Group Health Center for Health Studies, Seattle, Washington; University of Zürich, Zürich, Switzerland; and University Mainz, Mainz, Germany.


Acknowledgment: PRoMPT has received the German Research Award for Primary Care—Dr. Lothar–Beyer Award for 2008. The authors thank the jury and all contributing primary care practice teams.

Grant Support: By the German Ministry of Education and Research (grant 01GK0302).

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement:Study protocol: Available from Dr. Gensichen (e-mail, jochen.gensichen@med.uni-jena.de). Statistical code: Available from Dr. König (e-mail, koenig@imbei.uni-mainz.de). Data set: Not available.

Requests for Single Reprints: Jochen Gensichen, MD, MPH, MA, Institute for General Practice, Friedrich Schiller University/University Hospital Jena, Bachstrasse 18, D-07743 Jena, Germany; e-mail, jochen.gensichen@med.uni-jena.de.

Current Author Addresses: Dr. Gensichen: Institute for General Practice, Friedrich Schiller University/Hospital Jena University, Bachstrasse 18, D-07740 Jena, Germany.

Dr. von Korff: Group Health Center for Health Studies, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101-1448.

Drs. Peitz, Muth, Güthlin, Torge, Petersen, and Gerlach and Mr. Beyer: Institute for General Practice, Goethe University Hospital, Theodor-Stern-Kai 7, D-60590 Frankfurt am Main, Germany.

Dr. Rosemann: Institute for General Practice, University of Zürich, Rämistrasse 100, CH-8091 Zürich, Switzerland.

Dr. König: Institute of Medical Biostatistics, Epidemiology and Informatics, University Mainz, Obere Zahlbacherstrasse 69, D 55131 Mainz, Germany.

Author Contributions: Conception and design: Gensichen J, von Korff M, Muth C, Peitz M, Beyer M, Güthlin C, Torge M, Rosemann T, Gerlach FM.

Data collection: Gensichen J, Muth C, Peitz M, Torge M, Beyer M.

Analysis and interpretation: Gensichen J, von Korff M, Muth C, Peitz M, Beyer M, Güthlin C, Torge M, Petersen JJ, Rosemann T, Gerlach FM, König J.

Statistical analysis: König J, Gensichen J.

Drafting of the article: Gensichen J, Güthlin C, König J.

Critical revision of the article for important intellectual content: Gensichen J, von Korff M, Muth C, Peitz M, Beyer M, Güthlin C, Torge M, Petersen JJ, Rosemann T, König J, Gerlach FM.

Final approval of the article: Gensichen J, von Korff M, Muth C, Peitz M, Beyer M, Güthlin C, Torge M, Petersen JJ, Rosemann T, König J, Gerlach FM.

Obtaining of funding: Gensichen J, Gerlach FM.


Ann Intern Med. 2009;151(6):369-378. doi:10.7326/0003-4819-151-6-200909150-00001
Text Size: A A A

Background: Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms.

Objective: To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression.

Design: Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned.

Setting: 74 small primary care practices in Germany from April 2005 to September 2007.

Patients: 626 patients age 18 to 80 years with major depression.

Intervention: Structured telephone interview to monitor depression symptoms and support for adherence to medication, with feedback to the family physician.

Measurements: Depression symptoms at 12 months, as measured by the Patient Health Questionnaire-9 (PHQ-9); secondary outcomes were patient assessment of chronic illness care, adherence to medication, and quality of life.

Results: A total of 310 patients were randomly assigned to case management and 316 to usual care. At 12 months, 249 intervention recipients and 278 control patients were assessed; 555 patients were included in a modified intention-to-treat-analysis (267 intervention recipients vs. 288 control patients). Compared with control patients, intervention recipients had lower mean PHQ-9 values in depression symptoms (−1.41 [95% CI, −2.49 to −0.33]; P = 0.014), more favorable assessments of care (3.41 vs. 3.11; P = 0.011), and increased treatment adherence (2.70 vs. 2.53; P = 0.042). Quality-of-life scores did not differ between groups.

Limitation: Patients, health care assistants, family physicians, and researchers were not blinded to group assignment, and 12-month follow-up of patients was incomplete.

Conclusion: Case management provided by primary care practice–based health care assistants may reduce depression symptoms and improve process of care for patients with major depression more than usual care.

Primary Funding Source: German Ministry of Education and Research.

Figures

Grahic Jump Location
Figure.
Study flow diagram.

PHQ-9 = Patient Health Questionnaire-9.

* Modified intention-to-treat analysis included patients with the primary outcome (PHQ-9 score) available at baseline and at least 1 follow-up assessment (6-mo or 12-mo assessment).

Grahic Jump Location

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