A SCHIZOPHRENIA OR BIPOLAR TYPE I DISORDER REGISTRY- LESSONS LEARNED FROM CONDUCTING A REGISTRY STUDY WITH SAFETY NET PROVIDERS

Author(s)

Panish J1, Dirani R2, Mark T3, Montejano LB4, Starr HL1, Mao L11Johnson & Johnson, Titusville, NJ, USA, 2Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA, 3Thomson Reuters, Washington, DC, USA, 4Thomson Reuters, Cambridge, MA, USA

OBJECTIVES: Registries are increasingly used to collect information on effectiveness of new medications in real-world practice settings. Conducting a registry study focused on providers who treat vulnerable populations and have limited research experience can present unique challenges. The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations OUTcomes (REACH OUT) Registry is a naturalistic, longitudinal study of patients receiving primary treatment at community behavioral health organizations (CBHOs) to provide information on paliperidone palmitate, risperidone long-acting therapy, and other antipsychotics. This presentation discusses lessons learned thus far from the REACH OUT study. METHODS: REACH OUT recruits patients with schizophrenia or bipolar type I disorder from multiple CBHOs in the United States. Patients are identified by treating clinicians and screened by research coordinators to determine eligibility. A Web-based data collection tool is used to enter data obtained from patient self-reports, interviewer/clinician assessments, and medical records abstraction. Patients will be followed for 1 year with assessments at baseline, 6 months, and 12 months. RESULTS: Lessons learned thus far are 1) the value of collaborating with the provider member organization to recruit sites; 2) the need for buy-in from site management; 3) the importance of identifying dedicated staff committed to research endeavors; 4) the importance of selection of instruments that balance data collection burden and the desire for a variety of outcome measures; 5) benefits of vetting the draft protocol with potential sites to assess feasibility; and 6) the importance of working with sites to address individual needs (e.g., local internal review board approval). CONCLUSIONS: Registry studies focusing on patients treated by safety net providers, often with limited research experience, require unique considerations. Working closely with sites up-front and obtaining buy-in from site management and research staff have been crucial to REACH OUT thus far.

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PMH85

Topic

Methodological & Statistical Research

Topic Subcategory

Modeling and simulation

Disease

Mental Health

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