An organizational readiness intervention and randomized controlled trial to test strategies for implementing substance use disorder treatment into primary care: SUMMIT study protocol

Ober et al. Implementation Science An organizational readiness intervention and randomized controlled trial to test strategies for implementing substance use disorder treatment into primary care: SUMMIT study protocol Allison J Ober Katherine E Watkins Sarah B Hunter Karen Lamp Mimi Lind Claude M Setodji Background: Millions of people who need treatment for substance use disorders (SUD) do not receive it. Evidence-based practices for treating SUD exist, and some are appropriate for delivery outside of specialty care settings. Primary care is an opportune setting in which to deliver SUD treatment because many individuals see their primary care providers at least once a year. Further, the Patient Protection and Affordable Care Act (PPACA) increases coverage for SUD treatment and is increasing the number of individuals seeking primary care services. In this article, we present the protocol for a study testing the effects of an organizational readiness and service delivery intervention on increasing the uptake of SUD treatment in primary care and on patient outcomes. Methods/design: In a randomized controlled trial, we test the combined effects of an organizational readiness intervention consisting of implementation tools and activities and an integrated collaborative care service delivery intervention based on the Chronic Care Model on service system (patient-centered care, utilization of substance use disorder treatment, utilization of health care services and adoption and sustainability of evidence-based practices) and patient (substance use, consequences of use, health and mental health, and satisfaction with care) outcomes. We also use a repeated measures design to test organizational changes throughout the study, such as acceptability, appropriateness and feasibility of the practices to providers, and provider intention to adopt the practices. We use provider focus groups, provider and patient surveys, and administrative data to measure outcomes. Discussion: The present study responds to critical gaps in health care services for people with substance use disorders, including the need for greater access to SUD treatment and greater uptake of evidence-based practices in primary care. We designed a multi-level study that combines implementation tools to increase organizational readiness to adopt and sustain evidence-based practices (EBPs) and tests the effectiveness of a service delivery intervention on service system and patient outcomes related to SUD services. Trial registration: Current controlled trials: NCT01810159 Implementation; Organizational readiness; Evidence-based substance use disorder treatment; Primary care; Collaborative care; Care coordination; Medication-assisted treatment; Extended-release injectable naltrexone; Vivitrol; Buprenorphine/naloxone; Suboxone; Motivational interviewing - Background Substance use disorders (SUD) continue to be underidentified and under-treated [1]. In 2013, 22.7 million people aged 12 or older needed treatment for an illicit drug or alcohol use problem; of these, 20.2 million did not receive it [1]. The consequences of untreated alcohol and drug abuse are great and include increased risk of disease, injury, disability, and death [2,3] as well as hundreds of billions of dollars in costs to the criminal justice, social welfare, and health care systems [4-6]. Historically, treatment of SUD has taken place in residential and outpatient specialty care settings. Although specialty care settings play an important role for individuals with severe dependence, long waiting lists, stigma, and the lack of public funding for patients without insurance coverage have contributed to the lack of access. Further, many people who need treatment are not aware that they need it, are not ready for treatment, or do not know how or where to seek treatment [7]. Primary care clinics are a feasible and opportune setting in which to identify and provide treatment to people with SUD. Studies suggest that the prevalence of alcohol use disorders and use of illicit drugs is higher among primary care and emergency room patients than it is in the general population [8,9]. Further, most individuals (82%) visit a health professional at least once a year, thus providing ample opportunity for providers to identify patients in need of treatment [10]. Research suggests that integrating SUD treatment and general health care can result in less utilization of inpatient care and fewer emergency room visits [11] and that integrated care is acceptable to patients with an SUD [12]. However, despite the potential benefits of providing SUD screening and treatment in primary care and the existence of evidence-based practices (EBP) suitable for delivery in these settings [13-21], uptake of evidencebased SUD treatments in primary care has been slow. Accordingly, patients are unlikely to receive treatment for their SUD in primary care [20-24]. Some of the organizational barriers to providing SUD treatment in primary care settings include lack of insurance reimbursement, perceived lack of time to fully assess and discuss substance use, and lack of administrative buy-in for integrating SUD care into medical practices [25,26]. At the physician level, perceived barriers to SUD treatment adoption include negative attitudes toward people with SUD, lack of confidence among physicians in their ability to treat SUDs, lack of adequate role models and access to decision support consultants, and deficiencies in training and expertise in addiction treatment [13,25-28]. Research on introducing new practices into health care and other organizations suggests that intervention at both the organizational level (i.e., to increase organizational readiness to adopt new practices) and service delivery system level (i.e., reorganizing how care is provided to support the new practice) may both be necessary to integrate and sustain EBP [29-31]. Organizational readiness refers to the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change [32]. Interventions that increase an organizations commitment to change and the ability of the members of the organization to visualize how the new practice could be adopted and incorporated into existing practices are both important to increasing organizational readiness and adoption of EBP [33]. However, even when an organization exhibits high organizational readiness, change may not be successful unless attention is paid to how the new practice is supported and integrated into existing care practices. Further, adapting new practices to fit the nuances of a setting is a key component of whether the practice is ultimately accepted and adopted. As Damschroder et al. note, without adaptation, interventions usually come to a setting as a poor fit, resisted by individuals who will be affected by the intervention, and requiring an active process to engage individuals in order to accomplish impleme (...truncated)