Geoffrey M. Curran

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.

Role of "external facilitation" in implementation of research findings: a qualitative evaluation of facilitation experiences in the Veterans Health Administration

BackgroundFacilitation has been identified in the literature as a potentially key component of successful implementation. It has not, however, either been well-defined or well-studied. Significant questions remain about the operational definition of facilitation and about the relationship of facilitation to other interventions, especially to other change agent roles when used in multi-faceted implementation projects.Researchers who are part of the Quality Enhancement Research Initiative (QUERI) are actively exploring various approaches and processes, including facilitation, to enable implementation of best practices in the Veterans Health Administration health care system – the largest integrated healthcare system in the United States. This paper describes a systematic, retrospective evaluation of implementation-related facilitation experiences within QUERI, a quality improvement program developed by the US Department of Veterans Affairs.MethodsA post-hoc evaluation was conducted through a series of semi-structured interviews to examine the concept of facilitation across several multi-site QUERI implementation studies. The interview process is based on a technique developed in the field of education, which systematically enhances learning through experience by stimulating recall and reflection regarding past complex activities. An iterative content analysis approach relative to a set of conceptually-based interview questions was used for data analysis.FindingsFindings suggest that facilitation, within an implementation study initiated by a central change agency, is a deliberate and valued process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship. Facilitation was described primarily as a distinct role with a number of potentially crucial behaviors and activities. Data further suggest that external facilitators were likely to use or integrate other implementation interventions, while performing this problem-solving and supportive role.Preliminary ConclusionsThis evaluation provides evidence to suggest that facilitation could be considered a distinct implementation intervention, just as audit and feedback, educational outreach, or similar methods are considered to be discrete interventions. As such, facilitation should be well-defined and explicitly evaluated for its perceived usefulness within multi-intervention implementation projects. Additionally, researchers should better define the specific contribution of facilitation to the success of implementation in different types of projects, different types of sites, and with evidence and innovations of varying levels of strength and complexity.

Depression after alcohol treatment as a risk factor for relapse among male veterans

We examined the association between relapse-to-drinking and depressive symptomatology measured during inpatient treatment for alcohol disorder and 3 months posttreatment. Data were obtained from 298 veterans who completed 21-day inpatient treatment. Follow-up interviews were conducted at 3, 6, 9, and 12 months posttreatment. We used multiple logistic regression to assess the association between relapse and baseline/3-month posttreatment measures of depression (Beck Depression Inventory; BDI), controlling for important covariates. Our results showed that (a) the mild-to-moderately symptomatic participants (BDI = 14-19) at 3 months posttreatment were on average 2.9 times more likely than the nondepressed to have relapsed across follow-ups, and (b) the severely symptomatic participants (BDI = 20+) at 3 months posttreatment were on average 4.9 times more likely to have relapsed across follow-ups. Other analyses revealed that those with persistent depressive symptomatology reported at both baseline and 3 months posttreatment did not experience worse outcomes that those who reported symptomatology at 3 months posttreatment alone.

Referral patterns, cancer diagnoses, and waiting times after introduction of two week wait rule for breast cancer: prospective cohort study.

Objective To investigate the long term impact of the two week wait rule for breast cancer on referral patterns, cancer diagnoses, and waiting times. Design Prospective cohort study. Setting A specialist breast clinic in a teaching hospital in Bristol. Participants All patients referred to breast clinic from primary care between 1999 and 2005. Main outcome measures Number, route, and outcome of referrals from primary care and waiting times for urgent and routine appointments. Results The annual number of referrals increased by 9% over the seven years from 3499 in 1999 to 3821 in 2005. Routine referrals decreased by 24% (from 1748 to 1331), but two week wait referrals increased by 42% (from 1751 to 2490) during this time. The percentage of patients diagnosed with cancer in the two week wait group decreased from 12.8% (224/1751) in 1999 to 7.7% (191/2490) in 2005 (P<0.001), while the number of cancers detected in the “routine” group increased from 2.5% (43/1748) to 5.3% (70/1331) (P<0.001) over the same period. About 27% (70/261) of people with cancer are currently referred in the non-urgent group. Waiting times for routine referrals have increased with time. Conclusion The two week wait rule for breast cancer is failing patients. The number of cancers detected in the two week wait population is decreasing, and an unacceptable proportion is now being referred via the routine route. If breast cancer services are to be improved, the two week wait rule should be reviewed urgently.

Perceived need for alcohol, drug, and mental health treatment

BackgroundTo investigate determinants of perceived need for alcohol, drug, and mental (ADM) health treatment and differences in ADM treatment patterns between individuals with perceived need and those without.MethodsWe used data from a nationally representative telephone survey of 9585 adults conducted in 1997–1998. Logistic regression was used to study the determinants of perceived need and the correlation between perceived need and any ADM treatment, specialty ADM treatment, appropriate care, and medication adherence.ResultsJust fewer than 37% of individuals with an ADM disorder perceived a need for treatment, while 4.6% of those without an ADM disorder perceived a need for treatment. Women, the young and middle aged, the better educated, those with greater emotional support, and those with greater psychiatric morbidity were more likely to perceive need for ADM services. Perceived need was strongly correlated with receiving ADM treatment, although almost 44% of individuals in ADM treatment did not perceive a need for treatment. Among individuals in ADM treatment, those with perceived need were significantly more likely to receive specialty ADM treatment, but not more likely to be treatment adherent, or to receive appropriate care.ConclusionSubstantial levels of unmet need are likely to persist as long as perceived levels of need remain low. Interventions targeting perceived need may hold promise for decreasing unmet need.

The association of psychiatric comorbidity and use of the emergency department among persons with substance use disorders: an observational cohort study

BackgroundPsychiatric and substance use problems are commonly found to be contributing factors to frequent Emergency Department (ED) use, yet little research has focused on the association between substance use and psychiatric comorbidity. This study assesses the association of a psychiatric comorbidity on (ED) use among patients with substance use disorders (SUDs).MethodsThe study focuses on 6,865 patients who were diagnosed with SUDs in the ED of a large urban hospital in the southern United States from January 1994 – June 1998. Patients were grouped by type of substance use disorder. After examining frequency of visits by diagnosis, the sample was assigned to the following groups–alcohol dependence (ICD9 = 303), alcohol abuse (ICD9 = 305.0), cocaine dependence/abuse (ICD9 = 304.2, 305.6), and polysubstance/mixed use (ICD9 = 305.9). A patient was classified with psychiatric comorbidity if a psychiatric diagnosis appeared during any of the patients visits. The following psychiatric diagnoses were included–schizophrenia/psychoses, bipolar disorder, depression, anxiety, and dementia (ICD-9 codes available upon request).ResultsPatients with SUDs and psychiatric comorbidity had significantly higher mean number of ER visits (mean = 5.2 SD = 8.7) than SUD patients without psychiatric comorbidity (mean = 2.5, SD = 3.7). In logistic regressions predicting several categorizations of heavier use of the ED (either 4+, 8+, 12+, 16+, or 20+ visits over the span of the study) SUD patients with psychiatric comorbidity had adjusted odds ratios of 3.0 to 5.6 (reference group = patients with SUDs but no psychiatric comorbidity). This association was found across all substance use diagnostic categories studied, with the strongest relationship observed among patients with cocaine disorders or alcohol dependence.ConclusionThe results provide further support for the notion that the ED could and should serve as an important identification site for cost-effective intervention.

Depressive symptomatology and early attrition from intensive outpatient substance use treatment.

This study examines the relationship between depressive symptoms and attrition from outpatient treatment in a Veterans Affairs facility that had recently moved to intensive outpatient-only treatment for substance abuse. This article focuses on 126 consecutively admitted patients who were enrolled on their last day of a 3- to 4-day outpatient detoxification. Results indicate that severe depressive symptomatology presenting at treatment entry is a significant risk factor for early attrition from intensive outpatient substance use treatment but not later attrition. These data indicate that retention efforts should be directed toward the assessment and management of depressive symptoms early in the treatment process, with interventions targeted to those who report severe symptomatology. The results also indicate that future research should focus on potential distinguishing characteristics between early and later attrition.

A process for developing an implementation intervention: QUERI Series

BackgroundThis article describes the process used by the authors in developing an implementation intervention to assist VA substance use disorder clinics in adopting guideline-based practices for treating depression. This article is one in a Series of articles documenting implementation science frameworks and tools developed by the U.S. Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI).MethodsThe process involves two steps: 1) diagnosis of site-specific implementation needs, barriers, and facilitators (i.e., formative evaluation); and 2) the use of multi-disciplinary teams of local staff, implementation experts, and clinical experts to interpret diagnostic data and develop site-specific interventions. In the current project, data were collected via observations of program activities and key informant interviews with clinic staff and patients. The assessment investigated a wide range of macro- and micro-level determinants of organizational and provider behavior.ConclusionThe implementation development process described here is presented as an optional method (or series of steps) to consider when designing a small scale, multi-site implementation study. The process grew from an evidence-based quality improvement strategy developed for – and proven efficacious in – primary care settings. The authors are currently studying the efficacy of the process across a spectrum of specialty care treatment settings.

Predictors of attrition from a national sample of methadone maintenance patients.

Background: Methadone substitution therapy is an effective harm reduction treatment method for opioid dependent persons. Ability to retain patients in methadone treatment is an accepted predictor of treatment outcomes. Objectives: The current study evaluates the roles of psychiatric comorbidity, medical comorbidity, and sociodemographic characteristics as predictors of retention in methadone treatment utilizing retrospective analysis of data from a nationwide sample of patients in methadone treatment in the VA. Methods: Data were gathered using the VAs national health services use database. A cohort of veterans with a new episode of “opiate substitution” in fiscal year 1999 was identified, and their continuous service use was tracked through fiscal year 2002. The sample included a total of 2,363 patients in 23 VA medical centers. Survival analysis was used to explore factors associated with retention in methadone treatment. Results: Younger age, having a serious mental illness, being African American, or having race recorded as unknown were associated with lower rates of retention in methadone treatment programs in this population of veterans (controlling for site). Conclusion: Given that extended methadone treatment is associated with improved outcomes while patients remain in treatment, more longitudinal studies using primary data collection are needed to fully explore factors related to retention. For the VA population specifically, further research is necessary to fully understand the relationship between race/ethnicity and treatment retention. Scientific Significance: This is the first retention study the authors are aware of that utilizes data from a nationwide, multisite, population of participants in methadone treatment.

Implementation of evidence-based substance use disorder continuing care interventions.

Continuing care following initial substance use disorder treatment often is associated with improved treatment outcomes and evidence-based interventions (EBIs) have been developed in this area. However, rates of patient participation in continuing care treatment and mutual help groups (MHGs) are low and a large gap exists between the existing EBIs and actual clinical care. This paper uses the Consolidated Framework for Implementation Research (CFIR; Damschroder et al., 2009) to review the literature on continuing care treatment and monitoring, and mutual help-group promotion. Although existing research provides implications for implementing EBIs in continuing care, few direct implementation trials have been conducted. This literature indicates that EBIs in continuing care have been successfully modified for different settings, that they can be delivered using different modalities (e.g., individual, group, and telephone-based care), and that low cost options are available. Additionally, much is known about the differential effectiveness of continuing care with different populations that may guide treatment programs and providers in selecting the most effective interventions for their clients. One significant barrier to successful implementation of EBIs for continuing care is the lack of information about incentives for providing continuing care across what in the CFIR terminology is a programs outer setting (i.e., external economic, political, and social setting), and its inner setting (i.e., internal political, structural, and cultural contexts). Implications for implementation of EBIs in substance use disorder continuing care are discussed.