ABSTRACT
Despite the availability of efficacious treatments for bipolar disorder, their effectiveness in general clinical practice is greatly attenuated, resulting in what has been called an 'efficacy-effectiveness gap'. In designing VA Cooperative Studies Program (CSP) Study #430 to address this gap, nine principles for conducting an effectiveness (in contrast to an efficacy) study were identified. These principles are presented and discussed, with specific aspects of CSP #430 serving as illustrations of how they can be implemented in an actual study. CSP #430 hypothesizes that an integrated, clinic-based treatment delivery system that emphasizes (1) algorithm-driven somatotherapy, (2) standardized patient education, and (3) easy access to a single primary mental health care provider to maximize continuity-of-care, will address the efficacy-effectiveness gap and improve disease, functional, and economic outcome. It is an 11-site, randomized controlled clinical trial of this multi-modal, clinic-based intervention versus usual VA care running from 1997 to 2003. The trial has enrolled 191 subjects in each arm, using minimal exclusion criteria to maximize the external validity of the study. Subjects are followed for 3 years. The intervention is highly specified in a series of operations manuals for each of the three components. Several continuous quality improvement (CQI) interventions, process measures, and statistical techniques deal with drift of care in both the intervention and usual care arms to ensure the internal validity of the study. CSP #430 is designed to have impact well beyond the VA, since it evaluates a basic health care operational principle: that augmenting ambulatory access for major mental illness will improve outcome and reduce overall treatment costs. If results are positive, this study will provide a reason to reconsider the prevailing trend toward limitation of ambulatory services that is characteristic of many managed care systems today.
Subject(s)
Algorithms , Bipolar Disorder/drug therapy , Randomized Controlled Trials as Topic , Activities of Daily Living , Adult , Bipolar Disorder/psychology , Continuity of Patient Care , Endpoint Determination , Female , Humans , Male , Mental Health Services , Middle Aged , Patient Education as Topic , Patient Selection , Research Design , Treatment OutcomeABSTRACT
The article focuses on the large and increasing number of older widows who are available for human service work within the hospice movement caring for the dying and the bereaved. The need for preparation for widowhood is cited as one major reason why widows should assist potential widows to prepare more adequately for this eventuality. Widows are portrayed as effective lay counselors in hospice because they have experienced the reality of death and possess an empathetic readiness for work in this human service field. The hospice training program for widows is appealing because it presents learning experiences that are satisfying for the older learner. Numerous therapeutic and educational benefits are available to the older widows who participate in hospice work and training. Widows, therefore, become both the beneficiaries and the benefactors of their service efforts.
