Study protocol for evaluating Six Building Blocks for opioid management implementation in primary care practices.

BACKGROUND: The Six Building Blocks for improving opioid management (6BBs) is a program for improving the management of patients in primary care practices who are on long-term opioid therapy for chronic pain. The 6BBs include building leadership and consensus; aligning policies, patient agreements, and workflows; tracking and monitoring patient care; conducting planned, patient-centered visits; tailoring care for complex patients; and measuring success. The Agency for Healthcare Research and Quality funded the development of a 6BBs implementation guide: a step-by-step approach for independently implementing the 6BBs in a practice. This mixed-method study seeks to assess practices' use of the implementation guide to implement the 6BBs and the effectiveness of 6BBs implementation on opioid management processes of care among practices using the implementation guide. METHODS: Data collection is guided by the Consolidated Framework for Implementation Research, Proctor's taxonomy of implementation outcomes, and the Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain. A diverse group of health care organizations with primary care clinics across the USA will participate in the study over 15 months. Qualitative data collection will include semi-structured interviews with stakeholders at each organization at two time points, notes from routine check-in calls, and document review. These data will be used to understand practices' motivation for participation, history with opioid management efforts, barriers and facilitators to implementation, and implementation progress. Quantitative data collection will consist of a provider and staff survey, an implementation milestones assessment, and quarterly opioid prescribing quality measures. These data will supplement our understanding of implementation progress and will allow us to assess changes over time in providers' opioid prescribing practices, prescribing self-efficacy, challenges to providing guideline-driven care, and practices' opioid prescribing quality measures. Qualitative data will be coded and analyzed for emergent themes. Quantitative data will be analyzed using descriptive statistics and clustered multivariate regression. DISCUSSION: This study contributes to the knowledge of the implementation and effectiveness of a team-based approach to opioid management in primary care practices. Information gleaned from this study can be used to inform efforts to curtail opioid prescribing and assist primary care practices considering implementing the 6BBs.

The relationship between gastrointestinal symptom attribution, bothersomeness, and antiretroviral adherence among adults with HIV.

Patients who attribute their symptoms to HIV medications, rather than disease, may be prone to switching antiretrovirals (ARVs) and experience poor retention/adherence to care. Gastrointestinal (GI) symptoms (e.g., nausea/vomiting) are often experienced as a side effect of ARVs, but little is known about the relationship of symptom attribution and bothersomeness to adherence. We hypothesized that attribution of a GI symptom to ARVs is associated with a reduction in adherence, and that this relationship is moderated by the bothersomeness of the symptom. Data for our analysis come from the pre-randomization enrollment period of a larger study testing an adherence improvement intervention. Analyses revealed that patients with diarrhea who attributed the symptom to ARVs (compared to those who did not) had significantly worse adherence. We did not find a significant moderating effect of bothersomeness on this relationship. Incorporating patient beliefs about causes of symptoms into clinical care may contribute to improved symptom and medication management, and better adherence.

Preparing for analysis: a practical guide for a critical step for procedural rigor in large-scale multisite qualitative research studies.

Despite attention to technical aspects of conducting qualitative research, few studies describe procedures for managing pre-analysis activities in large-scale multisite qualitative projects. As part of the data collection for the Criminal Justice Drug Abuse Treatment Studies, a national multisite research cooperative with nine research centers (RCs) conducted 700 semi-structured interviews to evaluate interorganizational strategies in three protocols focused on improving addiction- and health related service delivery in criminal justice settings. Guided by the research cooperative, RCs collaborated on many aspects of the qualitative data activities (e.g., codebook development and coding activities), however, pre-analysis procedures, such as organizing and managing resources, were primarily managed at the RC level. The present study examines these various practices and describes two exemplary approaches to pre-analysis, with emphasis on lessons learned and recommendations for coordinating resources, managing data, and maintaining fidelity to the study procedures for large-scale qualitative projects.

Evaluating Fidelity to a Modified NIATx Process Improvement Strategy for Improving HIV Services in Correctional Facilities.

In a study aimed at improving the quality of HIV services for inmates, an organizational process improvement strategy using change teams was tested in 14 correctional facilities in 8 US states and Puerto Rico. Data to examine fidelity to the process improvement strategy consisted of quantitative ratings of the structural and process components of the strategy and qualitative notes that explicate challenges in maintaining fidelity to the strategy. Fidelity challenges included (1) lack of communication and leadership within change teams, (2) instability in team membership, and (3) issues with data utilization in decision-making to implement improvements to services delivery.

Application of the Consolidated Framework for Implementation Research to community pharmacy: A framework for implementation research on pharmacy services.

BACKGROUND: Community pharmacies are an increasingly important health care setting with opportunities for improving quality and safety, yet little is understood about determinants of implementation in this setting. OBJECTIVE: This paper presents an implementation framework for pharmacy based on the Consolidated Framework for Implementation Research (CFIR). METHODS: This study employed a critical review of 45 articles on professional services provided in community pharmacies, including medication therapy management (MTM), immunizations, and rapid HIV testing. RESULTS: The relevant domains and associated constructs for pharmacy services were as follows. Intervention Characteristics ultimately depend on the specific service; of particular note for pharmacy are relative advantage and complexity. The former because implementation of services can pose a cost-benefit challenge where dispensing is the primary role and the latter because of the greater challenge implementing multi-faceted services like MTM compared to a discrete service like immunizations. "In terms of Outer Setting, pharmacies are affected by patient needs and acceptance, and external policies and incentives such as reimbursement and regulations. For Inner Setting, structural characteristics like pharmacy type, size and staff were important as was pharmacists' perception of their role and available resources to provide the service. Key Characteristics of Individuals include training, preparedness, and self-efficacy of the pharmacist for providing a new service. Few studies revealed relevant Process constructs, but if they did it was primarily related to engaging (e.g., champions). CONCLUSIONS: As pharmacists' roles in health care are continuing to expand, a framework to inform implementation research in community pharmacy (and other) settings is crucially needed.

Efficacy of Structured Organizational Change Intervention on HIV Testing in Correctional Facilities.

This article presents findings from a multisite cluster randomized trial of a structured organizational change intervention for improving HIV testing services in jails and prisons. Matched pairs of prison and jail facilities were randomized to experimental and control conditions; all facilities received baseline training about best practices in HIV testing and other HIV services and selected an area of HIV services on which to focus improvement efforts. The experimental facilities formed local change teams and were provided external coaching based on the Network for the Improvement of Addiction Treatment (NIATx) process improvement model. Difference-indifference analyses indicate a significant relative increase in HIV testing in the experimental compared to the control condition. Meta-analyses across the matched pairs indicated a small to medium effect of increased testing overall. The results indicate that the local change team model can achieve significant increases in HIV testing in correctional facilities. Implications for HIV testing policies and challenges for expanding testing are discussed.

A Qualitative Examination of Stigma Among Formerly Incarcerated Adults Living With HIV.

The over-representation of people with stigmatized characteristics in the U.S. criminal justice population, including adults living with HIV, makes formerly incarcerated adults susceptible to multiple stigmas. Yet, the experience of HIV-related stigma, especially among individuals who have an additional compromising status in society (i.e., a criminal record) is understudied. This study used qualitative data from 30 interviews with formerly incarcerated adults living with HIV to explore the contexts within which one of these statuses becomes more salient than another for these individuals. Anticipated stigma was the primary barrier to disclosure of either status. The salience of anticipated stigma depended on the context within which disclosure may occur, including social interactions, employment, and engaging in HIV care. Communities with a high prevalence of HIV and incarceration, and health care providers within those communities should be targeted for stigma reduction efforts. Practitioners should work to empower individuals living with HIV, especially in the face of multiple potential stigmas.

HIV Stigma in Prisons and Jails: Results from a Staff Survey.

With numerous HIV service gaps in prisons and jails, there has been little research on HIV stigma attitudes among correctional staff. Such attitudes may undermine HIV services for inmates at risk of or infected with HIV. This HIV stigma attitudes survey among 218 correctional staff in 32 US facilities (1) provides an overview of staff's stigma attitudes, (2) reports psychometric analyses of domains in Earnshaw and Chaudoir's HIV Stigma Framework (HSF), and (3) explores differences in stigma attitudes among different staff types. Overall, correctional and medical staff expressed non stigmatizing attitudes toward people living with HIV/AIDS, but perceived that stigma and discrimination exist in others. Factor analyses revealed a three factor structure capturing two mechanisms of the HSF (prejudice, discrimination). Few factor score differences were found by staff type or setting. Implications for correctional HIV services and future research on HIV stigma attitudes are discussed.

Defining Success: Insights From a Random Assignment, Multisite Study of Implementing HIV Prevention, Testing, and Linkage to Care in U.S. Jails and Prisons.

In the emerging field of implementation science, measuring the extent to which a new or modified healthcare program or practice is successfully implemented following an intervention is a critical component in understanding how evidence-based treatments become part of regular practice. This paper is intended to expand our understanding of factors that influence the successful adoption of new or modified HIV services in correctional settings. The nine-site project developed and directed an organization-level intervention designed to implement improvements in preventing, detecting, and treating HIV for persons under correctional supervision. Using semi-structured interviews to elicit perceptions from Senior Researchers and Executive Sponsors at each of the nine sites, this paper presents their views and observations regarding the success of the experimental intervention in their criminal justice setting. Within the areas of focus for implementation (either HIV prevention, testing, or linkage to community treatment) the complexity of programmatic needs was very influential with regards to perceptions of success. An organization's pre-existing characteristics, staffing, funding, and interorganizational relationships contributed to either the ease or difficulty of programmatic implementation. Results are discussed pertaining to furthering our understanding of why new or modified healthcare interventions achieve success, including whether the intervention is a modification of existing practice or is a new intervention, and the choice of implementation strategy.

Efficacy of a Process Improvement Intervention on Inmate Awareness of HIV Services: A Multi-Site Trial.

The prevalence of HIV among U.S. inmates is much greater than in the general population, creating public health concerns and cost issues for the criminal justice system. The HIV Services and Treatment Implementation in Corrections protocol of the NIDA funded Criminal Justice Drug Abuse Treatment Studies cooperative tested the efficacy of an organizational process improvement strategy on improving HIV services in correctional facilities. For this paper, we analyzed efficacy of this strategy on improving inmate awareness and perceptions of HIV services. The study used a multi-site (n=28) clustered randomized trial approach. Facilities randomized to the experimental condition used a coach-driven local change team approach to improve HIV services at their facility. Facilities in the control condition were given a directive to improve HIV services on their own. Surveys about awareness and perceptions of HIV services were administered anonymously to inmates who were incarcerated in study facilities at baseline (n=1253) and follow-up (n=1048). A series of one-way ANOVAs were run to test whether there were differences between inmates in the experimental and control facilities at baseline and follow-up. Differences were observed at baseline, with the experimental group having significantly lower scores than the control group on key variables. But, at post-test, following the intervention, these differences were no longer significant. Taken in context of the findings from the main study, these results suggest that the change team approach to improving HIV services in correctional facilities is efficacious for improving inmates' awareness and perceptions of HIV services.

Different Patterns of Drug Use and Barriers to Continuous HIV Care Post-Incarceration.

Individuals with a drug use history often experience drug use relapse when they are released from incarceration. This article explores the processes by which a sample of adults experienced relapse post-incarceration and consequently experienced HIV treatment interruption. Data are from in-depth interviews with 25 formerly incarcerated HIV-positive adults who have a self-reported history of drug use. Findings reveal that each participant relapsed post-incarceration. Some participants relapsed immediately after release; others remained drug free until something "triggered" a relapse. Once a participant relapsed, factors that contributed to HIV treatment interruption included re-incarceration, a lack of concern for HIV care, and the overlap of symptoms between addiction and HIV infection. The relationship between drug use and HIV treatment interruption was exacerbated when the participant reported also having a mental health disorder. Cessation of drug use facilitated HIV treatment engagement for participants. The implications of these findings for policy and practice are discussed.

Understanding the sustainability of implementing HIV services in criminal justice settings.

BACKGROUND: In the growing field of implementation science, sustainability is a critical component of the implementation process of moving evidence-based treatments to regular practice. This paper is intended to extend our understanding of factors that influence the sustainability of HIV services in correctional settings following an organization-level intervention designed to implement improvements in preventing, detecting, or treating HIV for persons under correctional supervision. METHODS: Using semi-structured interviews to elicit perceptions from the principal researcher and executive sponsor at each of nine participating sites, this study explores the variations in the sustainability of HIV services in these criminal justice settings following the experimental implementation intervention. RESULTS: In six of the nine sites, changes in HIV services implemented as a result of the organizational intervention were sustained six to nine months following the end of project implementation. Organizational endorsement at multiple levels is likely the principal factor that facilitates sustainability. CONCLUSIONS: The factors that result in the sustainability of changes to health services in correctional organizations include elements internal and external to the organization. Implementation strategies, such as the change team model strategy used in this study, are also sustainable and can be used to identify other changes that could be made, or improve other aspects of service delivery.

Improvements in Correctional HIV Services: A Case Study in Delaware.

This article describes the experience and outcomes of the National Institute on Drug Abuse-funded Criminal Justice Drug Abuse Treatment Studies HIV Services and Treatment Implementation in Corrections protocol in the state of Delaware. The protocol was designed to test the effectiveness of a change team model in improving HIV services in correctional settings. In Delaware, a team was created with representatives from correctional and community agencies to work on improving linkage to HIV care for individuals released from incarceration. The team made improvements in the entire HIV service continuum: linkage to HIV care, HIV education, and HIV testing. The experiences in Delaware and the findings from this study suggest that the use of a change team model is a viable method for making organizational change in correctional settings.

The effect of a local change team intervention on staff attitudes towards HIV service delivery in correctional settings: a randomized trial.

The National Criminal Justice Drug Abuse Treatment Studies research program conducted cluster randomized trials to test an organizational process improvement strategy for implementing evidence-based improvements in HIV services for preventing, detecting, and/or treating HIV for individuals under correctional supervision. Nine research centers conducted cluster randomized trials in which one correctional facility used a modified Network for Improvement of Addiction Treatment (NIATx) change team approach to implementing improved HIV services and the other facility used their own approach to implement the improved HIV services. This paper examines whether the intervention increased the perceived value of HIV services among staff of correctional and community HIV organizations. Baseline and follow-up measures of the perceived acceptability, feasibility, and organizational support for implementing HIV service improvements were collected from correctional, medical, and community HIV treatment staff. Results indicated that the perceived acceptability and feasibility of implementing HIV services improved among staff in the facilities using the modified NIATx change team approach as compared to staff in the comparison facilities.

The impact of intimate partner violence on women's condom negotiation efficacy.

HIV prevention efforts promote the use of condoms to prevent the spread of HIV and other STDs. Thus, a woman's agency to practice healthy sexual behaviors necessarily involves negotiation with another person. This poses unique challenges for women who have limited power in relationships. The current study explores how the experience of intimate partner violence (IPV) impacts a woman's confidence in her ability to negotiate condom use with a sexual partner (i.e., condom use self-efficacy), using data from incarcerated females in three states, who were interviewed just prior to release back into the community. The direct effect of experiencing IPV as an adult, controlling for other risk factors, on condom use self-efficacy has not previously been empirically tested. Results show that IPV experiences among women significantly decreases their confidence in negotiating condom use with a partner, putting them at a higher risk of HIV infection than women who do not report having recently experienced IPV.