Mark S. Bauer

Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact

Objectives:This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a “hybrid effectiveness-implementation” typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results:An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant outcomes. Conclusions:The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD)

The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) was conceived in response to a National Institute of Mental Health initiative seeking a public health intervention model that could generate externally valid answers to treatment effectiveness questions related to bipolar disorder. STEP-BD, like all effectiveness research, faces many design challenges, including how to do the following: recruit a representative sample of patients for studies of readily available treatments; implement a common intervention strategy across diverse settings; determine outcomes for patients in multiple phases of illness; make provisions for testing as yet undetermined new treatments; integrate adjunctive psychosocial interventions; and avoid biases due to subject drop-out and last-observation-carried-forward data analyses. To meet these challenges, STEP-BD uses a hybrid design to collect longitudinal data as patients make transitions between naturalistic studies and randomized clinical trials. Bipolar patients of every subtype with age >/= 15 years are accessioned into a study registry. All patients receive a systematic assessment battery at entry and are treated by a psychiatrist (trained to deliver care and measure outcomes in patients with bipolar disorder) using a series of model practice procedures consistent with expert recommendations. At every follow-up visit, the treating psychiatrist completes a standardized assessment and assigns an operationalized clinical status based on DSM-IV criteria. Patients have independent evaluations at regular intervals throughout the study and remain under the care of the same treating psychiatrist while making transitions between randomized care studies and the standard care treatment pathways. This article reviews the methodology used for the selection and certification of the clinical treatment centers, training study personnel, the general approach to clinical management, and the sequential treatment strategies offered in the STEP-BD standard and randomized care pathways for bipolar depression and relapse prevention.

Comparative Effectiveness of Collaborative Chronic Care Models for Mental Health Conditions Across Primary, Specialty, and Behavioral Health Care Settings: Systematic Review and Meta-Analysis

OBJECTIVE Collaborative chronic care models (CCMs) improve outcome in chronic medical illnesses and depression treated in primary care settings. The effect of such models across other treatment settings and mental health conditions has not been comprehensively assessed. The authors performed a systematic review and meta-analysis to assess the comparative effectiveness of CCMs for mental health conditions across disorders and treatment settings. METHOD Randomized controlled trials comparing CCMs with other care conditions, published or in press by August 15, 2011, were identified in a literature search and through contact with investigators. CCMs were defined a priori as interventions with at least three of the six components of the Improving Chronic Illness Care initiative (patient self-management support, clinical information systems, delivery system redesign, decision support, organizational support, and community resource linkages). Articles were included if the CCM effect on mental health symptoms or mental quality of life was reported. Data extraction included analyses of these outcomes plus social role function, physical and overall quality of life, and costs. Meta-analyses included comparisons using unadjusted continuous measures. RESULTS Seventy-eight articles yielded 161 analyses from 57 trials (depression, N=40; bipolar disorder, N=4; anxiety disorders, N=3; multiple/other disorders, N=10). The meta-analysis indicated significant effects across disorders and care settings for depression as well as for mental and physical quality of life and social role function (Cohens d values, 0.20-0.33). Total health care costs did not differ between CCMs and comparison models. A systematic review largely confirmed and extended these findings across conditions and outcome domains. CONCLUSIONS CCMs can improve mental and physical outcomes for individuals with mental disorders across a wide variety of care settings, and they provide a robust clinical and policy framework for care integration.

Implementing evidence-based interventions in health care: application of the replicating effective programs framework

BackgroundWe describe the use of a conceptual framework and implementation protocol to prepare effective health services interventions for implementation in community-based (i.e., non-academic-affiliated) settings.MethodsThe framework is based on the experiences of the U.S. Centers for Disease Control and Prevention (CDC) Replicating Effective Programs (REP) project, which has been at the forefront of developing systematic and effective strategies to prepare HIV interventions for dissemination. This article describes the REP framework, and how it can be applied to implement clinical and health services interventions in community-based organizations.ResultsREP consists of four phases: pre-conditions (e.g., identifying need, target population, and suitable intervention), pre-implementation (e.g., intervention packaging and community input), implementation (e.g., package dissemination, training, technical assistance, and evaluation), and maintenance and evolution (e.g., preparing the intervention for sustainability). Key components of REP, including intervention packaging, training, technical assistance, and fidelity assessment are crucial to the implementation of effective interventions in health care.ConclusionREP is a well-suited framework for implementing health care interventions, as it specifies steps needed to maximize fidelity while allowing opportunities for flexibility (i.e., local customizing) to maximize transferability. Strategies that foster the sustainability of REP as a tool to implement effective health care interventions need to be developed and tested.

Positive emotion and health : Going beyond the negative

This study examined the relationships between positive emotions and health. Two positive emotions were considered, hope and curiosity, in conjunction with 3 physician-diagnosed disease outcomes: hypertension, diabetes mellitus, and respiratory tract infections. Medical data were abstracted over a 2-year period from 1,041 patient records from a multispecialty medical practice, and emotions were assessed through a mailed questionnaire. Across 3 disease outcomes, higher levels of hope were associated with a decreased likelihood of having or developing a disease. Higher levels of curiosity were also associated with decreased likelihood of hypertension and diabetes mellitus. Results suggest that positive emotion may play a protective role in the development of disease.

Determinants of functional outcome and healthcare costs in bipolar disorder: a high-intensity follow-up study

BACKGROUND Review of published studies reveals few data regarding determinants of the poor functional outcome and high healthcare costs that are characteristic of bipolar disorder. In order to identify potential mechanisms, critical to designing optimal treatment strategies, this longitudinal study investigated (a) the degree to which disease outcome is correlated with functional outcome and direct treatment costs, and (b) whether similar demographic or clinical characteristics predict disease and functional outcome and healthcare costs. METHODS Disease and functional outcome were assessed in bimonthly structured interviews over 48 weeks in 43 outpatient veterans with bipolar disorder. Direct mental health treatment costs from the VA perspective were determined from the VA database and patient interview. Regression analysis was used to determine association among the three outcome domains, and to identify clinical or demographic variables that predicted each of the three domains. RESULTS Functional outcome was correlated with depressive, but not manic, symptoms during follow-up. Costs were not correlated with any measure of disease or functional outcome. Several demographic, but not clinical, characteristics predicted functional outcome. In contrast, several clinical, but not demographic, characteristics predicted symptom status. No predictors were associated with direct treatment costs. LIMITATIONS Subjects were predominantly male veterans of relatively homogeneous social class, followed prospectively for approximately one year in a clinic designed specifically to minimize barriers to care. CONCLUSIONS Data from this and prior studies indicate that ongoing depressive symptoms are strongly associated with functional outcome, although substantial variance remains unexplained. Optimal models to explain functional outcome and healthcare costs will need to address factors besides simply disease severity and chronicity. The authors present a heuristic paradigm for understanding both the research and therapeutic aspects of these findings.

A review of quantitative studies of adherence to mental health clinical practice guidelines.

Mental health clinical practice guidelines have proliferated, but there is little evidence regarding the degree to which they are actually implemented in clinical practice. The goal of this study was to locate and review all peer-reviewed reports published through 2000 that provide quantitative information on rates of adherence to specific mental health guidelines. A literature search yielded 41 pertinent studies. These studies were of three types: 26 were cross-sectional investigations performed after the release of guidelines, six were conducted before and after release of guidelines without any specific intervention (pre/post), and nine involved a controlled trial of a specific intervention. Only 37% were conducted in the mental health specialty sector. Adequate adherence was found in 27% of the cross-sectional and pre/post studies but in 67% of the controlled trials. Successful interventions tended to be complex, involving system redesign or additional resources. Only six of 13 investigations (46%) that also measured patient outcome found that better outcome was associated with greater guideline adherence. Several studies showed that after cessation of interventions, adherence rates returned to preintervention levels. Thus, evidence indicates that guideline adherence is not high without specific intervention, but that certain interventions (typically multifaceted and resource-intensive ones) improve adherence. However, the public health challenge is to design and implement interventions that are sustainable in general clinical practice.

Improving Medical and Psychiatric Outcomes Among Individuals With Bipolar Disorder: A Randomized Controlled Trial

OBJECTIVES Comorbid medical conditions, notably cardiovascular disease, occur disproportionately among persons with bipolar disorder; yet the quality and outcomes of medical care for these individuals are suboptimal. This pilot study examined a bipolar disorder medical care model (BCM) and determined whether, compared with usual care, individuals randomly assigned to receive BCM care had improved medical and psychiatric outcomes. METHODS Persons with bipolar disorder and cardiovascular disease-related risk factors were recruited from a large Department of Veterans Affairs mental health facility and randomly assigned to receive BCM or usual care. BCM care consisted of four self-management sessions on bipolar disorder symptom control strategies, education and behavioral change related to cardiovascular disease risk factors, and promotion of provider engagement. Primary outcomes were physical and mental health-related quality of life; secondary outcomes included functioning and bipolar symptoms. RESULTS Fifty-eight persons participated. Twenty-seven received BCM care, and 31 received usual care. The mean+/-SD age was 55+/-8 years, 9% were female, 90% were white, and 10% were African American. Repeated-measures analysis was used, and significant differences were observed between the two groups in change in scores from baseline to six months for the 12-Item Short-Form Health Survey (SF-12) subscale for physical health (t=2.01, df=173, p=.04), indicating that the usual care group experienced a decline in physical health over the study period. Change in SF-12 scores also indicated that compared with the usual care group, the BCM group showed improvements in mental health-related quality of life over the six-month study period; however, this finding was not significant. CONCLUSIONS Compared with usual care, BCM care may have slowed the decline in physical health-related quality of life. Further studies are needed to determine whether BCM care leads to long-term positive changes in physical and mental health-related quality of life and reduced risk of cardiovascular disease among persons with bipolar disorder.

Testing definitions of dysphoric mania and hypomania: prevalence, clinical characteristics and inter-episode stability

37 outpatients with at least one prospectively observed manic or hypomanic episode comprised a sample for comparison of five definitions of dysphoric (hypo)mania. Dysphoric symptoms were continuously rather than bimodally distributed. Prevalence of dysphoria varied from 5 to 73% depending on the definition used. Female gender was associated with dysphoria under two of the five definitions. Inter-episode stability in patients with at least two prospectively observed episodes (n = 15) was not significantly different from chance. These data do not indicate that (hypo)mania can be dichotomized on the basis of dysphoria. Advantages and disadvantages of dimensional and categorical approaches to specifying mood in mania or hypomania are discussed.

Randomized trial of a population-based care program for people with bipolar disorder.

BACKGROUND Despite the availability of efficacious medications and psychotherapies, care of bipolar disorder in everyday practice is often deficient. This trial evaluated the effectiveness of a multi-component care management program in a population-based sample of people with bipolar disorder. METHOD Four hundred and forty-one patients treated for bipolar disorder during the prior year were randomly assigned to continued usual care or usual care plus a systematic care management program including: initial assessment and care planning, monthly telephone monitoring including brief symptom assessment and medication monitoring, feedback to and coordination with the mental health treatment team, and a structured group psychoeducational program--all provided by a nurse care manager. Blinded quarterly assessments generated week-by-week ratings of severity of depression and mania symptoms using the Longitudinal Interval Follow-Up Evaluation. RESULTS Participants assigned to the intervention group had significantly lower mean mania ratings averaged across the 12-month follow-up period (Z= 2.44, p=0.015) and approximately one-third less time in hypomanic or manic episode (2.59 weeks v. 1.69 weeks). Mean depression ratings across the entire follow-up period did not differ significantly between the two groups, but the intervention group showed a greater decline in depression ratings over time (Z statistic for group-by-time interaction = 1.98, p = 0.048). CONCLUSIONS A systematic care program for bipolar disorder significantly reduces risk of mania over 12 months. Preliminary results suggest a growing effect on depression over time, but longer follow-up will be needed.