Volume 3, Issue 2

"What Patients Want" and the Pharmacotherapy Implementation Gap
By Hannah K. Knudsen, Jamie L. Studts, and William W. Stoops, University of Kentucky

The "research to practice gap," or the limited implementation of evidence-based practices (EBPs) in specialty SUD treatment (Lamb, Greenlick and McCarty, 1998), has been the focus of considerable research attention in the past 15 years. This body of research and large-scale demonstration projects of EBP implementation has been supported by federal agencies, state governments, and private foundations; we have conducted research with this support. Our work and that of others has repeatedly shown the challenges in diffusing EBPs, particularly pharmacotherapy, to treatment programs.

In our research, survey and interview data with program leaders and counselors have highlighted key barriers to implementing medications, such as limited access to medical professionals and restrictions on program funding (Knudsen, Abraham, and Oser, 2011; Knudsen and Studts, 2011). We have also shown that even in programs that have overcome the barriers to adoption, very few patients actually receive "adopted" medication (Knudsen and Roman, 2012; Knudsen, Abraham and Roman, 2011). The focus of this line of research has been on organizations and the environments in which they operate. Despite the seeming obviousness of doing so, we have never collected data from patients as part of this implementation research.

In retrospect, it seems fair to call this lack of attention to patients a limitation of our own research, and indeed we have noted it in our papers. We are not alone—it is a limitation of many EBP adoption and implementation studies. Collectively, we as health services researchers have not fully grappled with the question, "What do patients want as part of SUD treatment?" and the implications of the answers to that question.

It is not a question that is unique to the SUD treatment field. Across the specialties of medical practice, the Institute of Medicine (2001) has advocated for "patient-centered care," and one element of such care is the notion that patients' preferences and values should be a major influence on decision-making processes that occur throughout medical care. This aspect of patient-centered care remains a challenge for medicine in general, and it remains a notion that has not been fully embraced by practitioners.

So how do patient preferences and values fit into the picture of pharmacotherapy implementation in SUD treatment? There are no easy answers from the existing literature, and perhaps the most honest answer is simply, "We don't know yet." At best, we can approach this question indirectly for the purpose of this article, with qualitative information from a small pilot study that we conducted with cocaine users who were not currently in treatment.

This pilot study began with a series of conversations around the "What do patients want?" question and the sense that this is a question that should be considered relatively early in the treatment development process. Specifically, we were interested in how cocaine users perceived the idea of a cocaine vaccine and whether such a pharmacological intervention would be acceptable from their perspective. Such a vaccine has been in the medication development pipeline for some time, and research is ongoing regarding its efficacy (Kosten, Domingo, Orson, and Kinsey, in press; Shorter and Kosten, 2011). If approved, a cocaine vaccine would be the first FDA-approved pharmacological intervention for cocaine dependence, as currently there are not any FDA-approved medications for this condition (Young, Sisti, Rimon-Greenspan, Schwartz and Caplan, 2012). In part, our research question about vaccine acceptability was influenced by earlier qualitative findings about a nicotine vaccine, in which some participants voiced substantial concerns about its acceptability (Studts et al., 2007).

With the support of a pilot grant from the University of Kentucky's Center on Drug and Alcohol Research, we conducted a small, qualitative study to begin to consider the acceptability of a cocaine vaccine among cocaine users. Face-to-face semi-structured interviews were conducted with 12 individuals who reported weekly cocaine use for the past year; these interviews were recorded and transcribed. Participants received $25 for their effort and travel expenses. Using a qualitative description approach to analyze the interview data (Neergaard, Olesen, Andersen, and Sondergaard, 2009; Sandelowski, 2000), transcripts were coded for key themes related to the acceptability of the cocaine vaccine. This protocol was approved by the university's Institutional Review Board, a Certificate of Confidentiality was obtained from NIDA, and all participants provided informed consent before the interview.

These interviews revealed three key themes about the acceptability of the cocaine vaccine. First, respondents were generally enthusiastic about the possibility of a vaccine. In the words of one participant, "I was excited once I heard you say, 'a cocaine vaccine.' I was like, is that something to make you stop? I was telling everyone…it was like a thing." In part, this interest in a cocaine vaccine seemed to reflect an awareness of the power of cocaine addiction and the many ways that cocaine use had negatively affected their lives. As another participant said: "I need to stop. I have destroyed a seven-and-a-half-year relationship. I have, I just need to stop. If my family ever found out I was back on drugs, oh my gosh, it'd be over. And I'm getting too old for this, you know. It's just like I spend every dime I get. I don't even feed myself. The first thing I think about you know is, if I get money is saving it so I can get more. So I can buy [cocaine.] If it [the vaccine] worked, I'd want to use it. You know if I could just go one day without doing it, it would be a big help for me…I mean, if it [the vaccine] just helped me get through one day without using it, or even cut me down to where I only used a half amount of what I do…I mean if it would just help through that, that would be a miracle in itself right there." Participants noted a number of benefits that would come from being able to stop or reduce their cocaine use, including repairing relationships, financial benefits, being able to hold a job, and having more stable housing.

Participants' enthusiasm for a cocaine vaccine was tempered by two issues, namely the potential side effects of a vaccine and its cost. Some participants wondered about the potential physical side effects; in the words of one participant, "That would depend on what [the side effects] might be. Now if it was a little wooziness or something of that nature, I could tolerate it, but if it was to cause me headaches or muscle cramps or anything like that, I might have to discontinue it." Others raised concerns about how the vaccine might impact daily functioning, as noted by this participant: "Well, for myself, it depends what the side effects were, you know. As long as it didn't affect my day-to-day living…As long as I could eat, as long as I could sleep and didn't make me paranoid and stuff like that." Most were not concerned about the vaccine being delivered via an injection, but two participants specifically noted that a "shot" would be a negative and reduce their willingness to use the vaccine.

Cost was a common theme elucidated in these interviews. Several participants noted that the lack of insurance, coupled with limited economic resources, would be a barrier. As noted by one participant, "It would be a problem right now because of my work situation…because I don't have no insurance…I'd have to pay out of pocket for it. If it [the vaccine] was available, I'd have to pay out of pocket and that would be a hard thing to do right at this minute." Another participant said, "That would be the only thing that I could see in my situation that would be a hindrance to me not being able to get it—if it came down to me having to pay for it." Although most respondents saw challenges with regard to cost, two participants articulated cost-benefit arguments about the vaccine if it were effective in reducing cocaine use. In the words of one of these two participants: "I think in the long run, cost shouldn't be a problem because you'd say, 'Look at the money I'm going to spend on using drugs. And look at the money I'm going to spend as far as getting off drugs.' So cost shouldn't be a problem." However, implicit within this reasoning, is the notion that cost savings will be a longer term trade-off, which for several of these participants would seemingly be difficult in their current economic situation.

While these interviews provide some unique information about the potential acceptability of a cocaine vaccine from the perspective of current users, there are a number of limitations that must be noted. Among the key limitations are the small number of participants in the study, the limited geographical area represented (i.e., a single city), and the focus on a pharmacological intervention that is not yet available. Users' perspectives may be different once the actual vaccine is approved and its properties are known.

Nonetheless, we think that this pilot study is an example of directions that health services researchers who are interested in the "research-to-practice gap" might take in the future. In particular, research that integrates the multiple levels of this phenomenon—patients, clinicians, organizational leaders, and stakeholders who influence treatment funding as well as regulatory requirements—may yield important knowledge about methods to increase the implementation of pharmacotherapy and other EBPs in specialty SUD treatment. The voices of patients regarding other medications, particularly their views on acceptability, the tolerability of side effects, and how costs of care are related to access, may help to explain the limited implementation that continues to vex researchers and policymakers.

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