Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial.

BACKGROUND: Chronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice's degree of behavioral health integration. METHODS: Forty-five primary care practices, with existing onsite behavioral health care, will be recruited for this study. Forty-three practices will be randomized to the intervention or usual care arm, while 2 practices will be considered "Vanguard" (pilot) practices for developing the intervention. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice's degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration. DISCUSSION: As primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT02868983 . Registered on August 16, 2016.

Pragmatic Cluster Randomized Trials Using Covariate Constrained Randomization: A Method for Practice-based Research Networks (PBRNs).

BACKGROUND: Cluster randomized trials (CRTs) are useful in practice-based research network translational research. However, simple or stratified randomization often yields study groups that differ on key baseline variables when the number of clusters is small. Unbalanced study arms constitute a potentially serious methodological problem for CRTs. METHODS: Covariate constrained randomization with data on relevant variables before randomization was used to achieve balanced study arms in 2 pragmatic CRTs. In study 1, 16 counties in Colorado were randomized to practice-based or population-based reminder recall for vaccinating children ages 19 to 35 months. In study 2, 18 primary care practices were randomized to computer decision support plus practice facilitation versus computer decision support alone to improve care for patients with stage 3 and 4 chronic kidney disease. For each study, a set of optimal randomizations, which minimized differences of key variables between study arms, was identified from the set of all possible randomizations. RESULTS: Differences between study arms were smaller in the optimal versus remaining randomizations. Even for the randomization in the optimal set with the largest difference between groups, study arms did not differ significantly on any variable for either study (P > .05). CONCLUSIONS: Covariate constrained randomization, which restricts the full randomization set to a subset in which differences between study arms are minimized, is a useful tool for achieving balanced study arms in CRTs. Because of the increasing recognition of the risk of imbalance in CRTs and implications for interpreting study findings, procedures of this type should be considered in designing practice-based or community-based trials.

Inaccuracy of ICD-9 Codes for Chronic Kidney Disease: A Study from Two Practice-based Research Networks (PBRNs).

BACKGROUND: Inaccurate use of International Classification of Diseases, Ninth Revision (ICD-9), codes obfuscates registries used for research, resulting in unreliable data and inaccurate measurement of outcomes, and it may contribute to mismanagement of patients. Thus it is important to understand the prevalence of ICD-9 code misuse. We chose chronic kidney disease (CKD) as a condition of interest after several patients recruited for a previous study indicated they did not have the disease, despite the presence of the ICD-9 code (585.x) in their electronic medical record (EMR). METHODS: Retrospective chart review of patients with the ICD-9 code for CKD stage 3 (585.3; n = 325). Data were collected from EMRs at 3 primary care practices Buffalo, New York (n = 2), and Kansas City, Kansas (n = 1). RESULTS: Across all practices, 47% of patients with the CKD ICD-9 code did not have clinical indicators for the disease, based on Kidney Disease Outcomes Quality Initiative guidelines. CONCLUSIONS: The CKD stage 3 ICD-9 code usage did not accurately reflect the prevalence of disease among this population. This has clinical implications because patients may be treated or receive tests for a disease they do not have. This also presents an important issue for research projects that rely on accurate data from EMRs to identify and recruit patients.

Effects of self-empowered teams on rates of adverse drug events in primary care.

Background. Most safety issues in primary care arise from adverse drug events. Team Resource Management intervention was developed to identify systemic safety issues to design and implement interventions to address prioritized issues. Objectives. Evaluate impact of intervention on rates of events and preventable events in a vulnerable population. Design. Cluster randomized trial. 12 practices randomly assigned to either: (1) Intervention; (2) Intervention with Practice Enhancement Assistants; (3) No intervention. The intervention took 12 months. Main Outcome Measure. Rate and severity of events and preventable events measured using a Trigger Tool chart review method for the 12-month periods before and after the start of the intervention. Results. In the ''intervention with Assistants" group there was a statistically significant decrease in the overall rate of events and in the rate of moderate/severe events. Analysis of Variance with study arm and time as the factors and moderate/severe events as the outcome showed a significant interaction between arm and time supporting the notion that the ''Intervention with Assistants" practices had a greater reduction in moderate/severe preventable events. Conclusions. The intervention had a significant effect on medication safety as estimated using a trigger tool. Further exploration of role of Assistants and trigger tool is warranted.

Estimating impacts on safety caused by the introduction of electronic medical records in primary care.

CONTEXT: Primary care is a highly complex environment in which multiple safety problems have been identified. Each primary care practice can be viewed as a complex adaptive system with its own unique characteristics. The introduction of an electronic medical record (EMR) into such a system represents a significant perturbation that can have multiple unpredictable effects. From a safety standpoint this can mean reduction in some vulnerabilities and increase in others, as well as the introduction of new vulnerabilities that did not exist under the old system. OBJECTIVE: To estimate the impacts of a new EMR on various aspects of practice function using a Failure Modes and Effects Analysis (FMEA) approach based on the concept of hazard adapted from safety engineering. SETTING/PARTICIPANTS: Academic rural primary care practice with 32 staff. DESIGN: At baseline, a survey instrument (Perceived Hazard Questionnaire) was used to elicit staff (physicians, nurses and administrative) perceptions of frequency and severity of multiple different primary care errors in 12 different domains in the practice. For each error, a Hazard score was calculated based on the product of frequency and severity. The Hazard scores thus derived were used to prioritise the safety problems within the practice. One year later, after partial implementation of an EMR, the survey was repeated. MAIN OUTCOME MEASURES: Comparison is made between priorities identified by physicians, nursing and administrative staff before and after EMR implementation. RESULTS: At baseline, a high concordance between priorities identified by physicians, nursing and administrative staff was recorded. This concordance halved after partial implementation of the EMR. The staff perceived decreased hazard in nurse-physician and physician-chart interactions but hazard increased in the already high-hazard domains of physician-patient interaction in the assessment stage and nurse-chart interactions, apart from three other domains. CONCLUSIONS: This FMEA-like approach identified changes in practice hazards apparently related to EMR implementation. This in turn can help in targeting pre-existing and new vulnerabilities in primary care practices.