2003 — Ensuring Patient Safety and Confidentiality in Multi-Site Quality Improvement Research: A Proactive Partnership Approach to Risk Management

Chaney EF (University of Washington), Simon B (GLA VA HSR&D COE), Bonner L (PSHCS VA HSR&D COE), Simons C (PSHCS VA HSR&D COE), Ober S (Louis Stokes VAMC), Rubenstein LV (GLA VA HSR&D COE), Cody M (COACH VA R&D)

Workshop Objectives:
Researchers’ partnering with multiple clinical sites is one method to move toward optimal care by introducing and studying evidence-based care improvements. Such partnerships involve multiple ethical, regulatory, and logistical challenges. These challenges include: confidentiality protection for patients and clinicians; ethical and regulatory concerns in research on quality improvement; multiple roles of professional participants; training and supporting site investigators; coordinating risk management across multiple sites; and facilitating communication and adherence to standards and procedures. Multiple barriers may be encountered due to differing organizational, training, and regulatory issues across sites, changes in personnel over the course of partnerships, and competing demands on scarce resources. Workshop participants will learn to partner effectively with local sites to ensure patient safety, track and monitor protocol adherence, and educate local site leaders and clinicians using previously developed tools.

Activities:
The workshop is based on experience with the VA MH QUERI projects TIDES (Translating Initiatives for Depression Into Effective Solutions), WAVES (Well-being Among Veterans Enhancement Study) and ReTIDES (Regional TIDES). Researchers from three Centers of Excellence partnered with thirteen VA primary care practices. Presenters will discuss implementation evaluation points drawing on Stetler’s work and RE-Aim to conceptualize challenges and approaches. We will describe tools developed to assist sites in meeting risk management challenges in evidence-based quality improvement. Tools include a Site PI Orientation Checklist, sample Project Implementation Charter and Site Memorandum of Agreement, local IRB Contact Questionnaire, and risk management Relational Database. Tools are designed to facilitate appropriate and positive relationships among researchers, practice administrators, clinicians, patients, and regulatory personnel across sites. Use of tools will be illustrated through case examples. We will discuss the process aspects of recruiting and educating site PIs regarding their collaborative role and keeping PIs informed about progress of evaluation and maintaining compliance. We specifically address suicidality risk management issues raised by telephone assessment of depression symptomatology across multiple sites. Attendees will be encouraged to discuss risk management issues raised by their own partnering efforts.

Target Audience:
Investigators, administrators, and clinicians interested in risk management issues inherent in forming clinician-researcher partnerships across multiple practices.

Assumed Audience Familiarity with Topic:
None