Academic journal article Journal of Drug Issues

Multi-Level Assessment Protocol (Map) for Adoption in Multisite Clinical Trials

Academic journal article Journal of Drug Issues

Multi-Level Assessment Protocol (Map) for Adoption in Multisite Clinical Trials

Article excerpt

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multisite clinical trials and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked the following question: how might the technology of multisite clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing eight organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. Analysis of interview data revealed four conceptual themes likely to affect adoption and may be informative in future multisite clinical trials. Planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice.

INTRODUCTION

Historically, much of the research supporting effectiveness of drug abuse treatment relied on uncontrolled studies (Institute of Medicine, 1990). In the past 10 years, the paradigm has shifted toward randomized clinical trials and, most recently through the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN), toward multisite clinical trials. The NIDA CTN aims to improve drug abuse treatment by conducting multisite trials of promising interventions and by developing models for integrating new interventions into clinical practice (National Institute on Drug Abuse [NIDA], n.d.). We view the latter aim, integrating new interventions into practice, in terms of adoption. In this study, we ask the broad question of whether multisite clinical trials can support adoption of research-based interventions. Treatment programs decide whether or not to continue research-based interventions using their own resources when study protocols near completion. Because the CTN did not yet have study protocols at the completion stage when the present study began, we instead studied adoption in the context of the Methamphetamine Treatment Project (MTP), funded by the Center for Substance Abuse Treatment (CSAT). The work reported in this paper explores adoption in the context of multisite clinical trials research in drug abuse treatment and may be informative to clinical trials both within and outside of the NIDA CTN.

The process of adopting a research-based intervention can be conceptualized as organizational change. The organizational change perspective, developed within management studies and the social sciences, is helpful for studying adoption as it treats the organization (i.e., the substance abuse clinic) as the unit of analysis, rather than the individual. This perspective acknowledges clinics' resistance to innovation as a common occurrence and identifies internal organizational factors and external environmental factors that may nonetheless facilitate change and intervention adoption.

Rogers (1995a) describes the potential for adoption of an innovation as the relationship of diffusion (the process by which an innovation is communicated) and rate of adoption (the decision to use the innovation). Intervention characteristics that support adoption are that it is advantageous in relation to current practice, compatible with existing values, not too complex, amenable to a trial period, and has observable effects. Second, an innovation is more likely to be adopted if innovator/adoptee communication occurs between people of similar social location (e.g., similar education and social status). Time can influence diffusion because it affects innovativeness and level of familiarity. Last, characteristics of the social system, such as its structure, norms, and decision-making processes, can affect diffusion (Rogers, 1995a). Focusing on adoption of innovations in drug treatment, Backer (1991) also identifies four influential factors. …

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