JAIDS Journal of Acquired Immune Deficiency Syndromes:
Intersection of Biology and Behavior
Involving Behavioral Scientists, Health Care Providers, and HIV-Infected Patients as Collaborators in Theory-Based HIV Prevention and Antiretroviral Adherence Interventions
Fisher, Jeffrey D PhD*; Cornman, Deborah H PhD*; Norton, Wynne E BA*; Fisher, William A PhD*†
From the *Center for Health, Intervention, and Prevention, University of Connecticut, Storrs, CT; and †Departments of Psychology and Obstetrics and Gynecology, University of Western Ontario, London, Ontario, Canada.
Supported by a grant from the National Institutes of Health (RO1MH066684).
Reprints: Jeffrey D. Fisher, PhD, Center for Health/HIV Intervention and Prevention, University of Connecticut, 2006 Hillside Road, Unit 1248, Storrs, CT 06269-1248 (e-mail: firstname.lastname@example.org).
Summary: Health care providers are often hesitant to attempt health behavior change interventions with patients, although such interventions are frequently needed. When provider-initiated health behavior change interventions are attempted, they are often based on intuition or consist solely of delivering information and are insufficient to change behavior, rather than being based on well-validated and effective behavior change models. We argue that provider-initiated health behavior change interventions are effective and efficient if they are based on appropriate empirically validated theoretical models and developed in collaboration with behavioral scientists and patients. We present a new model for developing such collaborative interventions and initial evidence for its success.
Health care providers are often hesitant to attempt health behavior change interventions with their patients, although such interventions are essential in many cases. Reasons for providers' hesitation to engage in behavior change interventions include perceived lack of time, lack of training in health behavior change intervention strategies, lack of faith in the ability of interventions to change patients' behavior, lack of faith in patients' ability to change their health behavior, and other factors.1-7 When health behavior change interventions are initiated by providers, they are often intuitively based, solely focused on the provision of information, and insufficient to promote behavior change, rather than being based on well-validated effective behavior change theory and intervention techniques.8
In this article, we propose that theory-based collaborations involving health care providers, behavioral scientists, and HIV-infected patients in the design of interventions to affect patient behavior (eg, to increase a patient's HIV preventive behavior or adherence to antiretroviral therapy) result in far better outcomes. To this end, we present a new model for the collaborative design, implementation, and evaluation of provider-initiated behavior change interventions in the HIV domain.
NEED FOR COLLABORATIONS BETWEEN PROVIDERS, BEHAVIORAL SCIENTISTS, AND PATIENTS
It is increasingly argued that collaboration across disciplines (eg, medical sciences, behavioral sciences, public health) and across roles (involving patients and providers) is essential for developing effective and sustainable health behavior change interventions.9-13 Given the complex nature of health behavior change, it is critical to obtain input from all the stakeholders in attempting to understand the dynamics of unhealthy behaviors and, ultimately, to change them. Interdisciplinary collaborations contribute significantly to understanding the complex interplay of social, environmental, personal, and structural elements that work together to influence an individual's health behavior.14
The National Academy of Sciences has endorsed the critical importance of integrative and interdisciplinary research focusing on psychologic, biologic, social, and behavioral aspects of health and disease,12,15,16 and the National Institutes of Health (NIH) has incorporated this perspective as part of its “roadmap for medical research.”17 Similarly, behavioral scientists view interdisciplinary partnerships as one of the most promising approaches to advancing health behavior change research.18
Despite endorsements from physicians, scientists, and government organizations, collaborative health behavior change research is not an easy undertaking. Barriers may exist at each stage of a project. At start-up, individuals from different disciplines may have difficulty in reaching consensus on a unified approach to change the health behavior at focus and may even disagree on a common hypothesis.19 Another area of contention may be the use of theory. Behavioral scientists are often motivated to apply and test theory, whereas public health scientists and physicians often eschew it for a seemingly more practical approach.20 In fact, the connotation of “theory” may be different for behavioral scientists (who often view well-validated theory as a plausible basis for health behavior change intervention) and medical and public health scientists (who may see theory as a superfluous, unproven, and impractical academic exercise, particularly because there are so many different health behavior change theories). Tensions may also occur regarding methodology, measurement, outcome measures, time frames, how data should be collected, how work should be funded, and how it should be published.14,18 Differences in perspectives can also be problematic (eg, providers sometimes think that nonproviders' intervention objectives and strategies are not readily applicable to patient care or to the quality of patients' lives5). In sum, different orientations of research team members may introduce conflict in the design, implementation, and evaluation phases of collaboratively initiated health behavior change interventions.
Although interdisciplinary collaborations can be problematic, following a unidisciplinary approach can prove costly. It has been our experience that health behavior change is a biobehavioral challenge par excellence, that no single profession (eg, health psychology, infectious disease) has broad enough training to address this challenge alone, and that sensitive and open-minded collaboration is a necessity rather than a luxury in this domain.
Any attempt to characterize the way members of a field practice their discipline risks inaccuracy through generalization. Nevertheless, health behavior change work by behavioral scientists, who tend to have less “real world” experience in medical settings, has sometimes been characterized as giving inadequate attention to issues of intervention feasibility, acceptability, and cost.21 On occasion, behavioral scientists have also been criticized for work that is low in external validity, that is, failure to produce effective and robust health promotion interventions that can be disseminated widely across settings and populations.18,22
Health behavior change interventions developed by physicians without behavioral scientist input may have limitations as well. Behavior change interventions by physicians tend to be atheoretical and intuitively based; to rely solely on the provision of information rather than on increasing motivation or teaching relevant behavior skills; and even, occasionally, to be authoritarian, evaluative, and “enforcement oriented” in efforts to change patients' behavior.8,23 Such interventions are generally less effective than those based on appropriate, well-researched, and well-validated theory.8 In addition to providing conceptual insights, behavioral scientists may have an armamentarium of design, methodology, and measurement skills that can contribute to rigorous intervention design and evaluation research in health behavior change efforts.5
The allure of collaborative health behavior change research is its potential power to unite insights from theory and practice into state-of-the-science health behavior change interventions. Optimally successful collaborative efforts involve the expertise from disciplines with complimentary strengths and weaknesses. Individuals from separate disciplines can “meet in the middle” and communicate in a common language, avoiding jargon and synergizing their strengths.9 Successful collaborators develop a clear set of goals and objectives for their research aims in terms understood by all parties.14 Such collaborations also involve serious attempts to learn something substantial about each other's disciplines.
For the past 10 years, working on large projects funded by the NIH, we have been engaged in collaborative interventions involving providers, patients, and behavioral scientists that are aimed at supporting HIV-infected patients' HIV preventive behavior and their antiretroviral adherence. In these collaborations, physicians have functioned as experts with respect to medicine, the health care environment, and patients' medical needs; behavioral scientists have functioned as experts on behavior and behavior change; and patients have functioned as experts on their healthy and unhealthy behavior and how to change and/or maintain it. Nevertheless, we have continually found that these categories overlap considerably and that each of these stakeholders has unique insights into the others' domains and has especially important insights in certain areas in which the true experts have a “blind side.” We have observed that the synergy that results when each stakeholder has input into intervention design is remarkable and results in more effective, sustainable, and ecologically valid interventions than if any group were absent from the process (Fig. 1).
One of the reasons why collaborative interventions provide a great deal of added value is that neither providers nor behavioral scientists are trained to meet at the intersection of biology and behavior, which is the domain of health behavior change and the collaborative interventions that we are developing. To collaborate on health behavior change interventions, physicians and behavioral scientists have to go well beyond their training and “comfort zone.” Unless both parties are involved in intervention design, it can be difficult to get “buy in” from either in the ultimate product. Although true collaboration is critical, it is also sometimes important for each group to respect a sort of “fuzzy” line between themselves and the other groups (eg, for behavioral scientists not to try too hard to be physicians, for physicians not to attempt to be “full-fledged” behavioral scientists, for neither physicians nor behavioral scientists to presume to understand all the needs and concerns of patients). In the domain of HIV, where patient populations may be highly diverse and may differ dramatically from providers and behavioral scientists in terms of race, sexual orientation, socioeconomic status, chemical dependency status, and the like, a “disconnect” is especially likely, underscoring the critical importance of representing patients in the intervention design process.
Effective interventions also need to reflect the provider's perspective. Because of the time pressures on providers, collaboratively designed provider-initiated interventions need to be brief, nondemanding, and practical.9,24,25 Indeed, many successful interventions in the clinical care setting require only a few minutes to implement.1,26 Although theory can and should be involved in intervention design, significant knowledge of theory should not be necessary for providers to implement the intervention. In addition to consultations with providers, for interventions to succeed, it is critical to get input and buy-in from the entire medical staff and for the intervention to fit in well within the ecology of the clinical care setting.6,25,27,28 Collaboration can create a strong intervention, but without great attention to clinic logistics and staff sensibilities (eg, clinic flow, time constraints), it is likely to fail.9
In designing a health behavior change intervention, one can leverage aspects of the patient-provider relationship and aspects of the ecology of the health care setting to great advantage to facilitate patient behavior change. Many providers have long-term, trusting, and highly influential relationships with their patients, as reported by Fisher et al,29 and if a behavioral intervention can capitalize on this relationship, behavior change can occur even with relatively brief interventions.6,29,30,31 In our Options Project intervention, to be described more fully elsewhere in this article, a brief provider-delivered intervention (approximately 5 minutes per patient visit) repeated in the context of routine HIV clinical care visits at approximately 3-month intervals for 18 months was able to promote long-term changes in patients' HIV transmission risk sexual behavior.29 Moreover, we have learned that collaboratively designed health behavior change interventions with elements that conform to provider's and patient's expectations for the “script” of health care interactions are especially acceptable to both parties. In the Options Project intervention, providers dispense behavioral intervention elements according to a treatment algorithm, similar to dispensing medical treatments based on clinical findings, and prescribe a “prevention prescription” to patients, putting it on par with a script for medication.
COLLABORATIVE INTERVENTIONS WITH PROVIDERS, BEHAVIORAL SCIENTISTS, AND PATIENTS
Our collaborations with physicians, patients, and behavioral scientists on the design, implementation, and evaluation of health behavior change interventions have been based on the information, motivation, and behavioral skills (IMB) model of health behavior change32,33 and have used motivational interviewing34 as a “delivery system” for theory-based discussions between providers and patients concerning behavior change. Both the IMB model and the motivational interviewing (MI) delivery system have been well validated and found to be effective in health behavior change interventions across domains, as reported by Fisher et al33 and Rollnick et al34.
The IMB model is one of several theories of individual-level behavior change (eg, Theory of Reasoned Action,35 Theory of Planned Behavior,36,37 Social Cognitive Theory,38,39 Health Belief Model,40 Transtheoretical Model41) that have been used in the development of health behavior change interventions (see the article by Fisher and Fisher42 for a critical review of these theoretical approaches). The IMB model (Fig. 2) assumes that unhealthy behavior is often caused by deficits in the patient's levels of health behavior-specific information, motivation, and/or behavioral skills, and that if one can address these deficits through behavioral interventions, the result is changes in unhealthy behavior and the maintenance of such changes. According to the model, health behavior-specific information is a prerequisite to practicing healthy behavior. For example, for a patient to practice HIV prevention, he or she must possess critical information about how HIV is transmitted and prevented and must acquire knowledge to combat common misinformation (eg, patients on antiretrovirals are not infectious, anyone willing to have unprotected sex is surely HIV positive). For a patient on antiretrovirals to adhere to his or her medical regimen, he or she must have information about the medications (eg, when and how to take them) as well as information about their side effects and drug interactions, and, again, must not possess critical misinformation (eg, believe that if he or she is “feeling well,” he or she is taking “enough” of his or her medications).
The IMB model specifies that health behavior-specific motivation is an additional, critical determinant of health behavior change. Motivation includes personal motivation (eg, attitudes toward practicing the health behavior at focus) and social motivation (eg, perceptions of social support for its practice). For a patient to practice HIV prevention (eg, condom use), he or she must have positive attitudes toward this behavior, perceived social support from others for its practice, or ideally, both. For a patient to adhere to antiretrovirals, he or she must have positive attitudes toward his or her medications, social support for adhering to them, or both.
Finally, the IMB model assumes that health behavior-specific behavioral skills are a third critical determinant of practicing healthy behavior. Even well-informed and highly motivated persons are incapable of practicing health behaviors if they do not have the requisite skills needed for initiation and maintenance of a specific health behavior. Behavioral skills involve an individual's objective ability and perceived self-efficacy for the performance of the component behaviors necessary to practice the health behavior at hand.32,43 For example, to practice condom use, a patient may need to be able to discuss safer sex with a partner and to acquire and use condoms properly, with minimal interference to valued goals (eg, sexual pleasure, spontaneity). To adhere to an antiretroviral regimen, patients must be able to acquire medications, incorporate pill taking into their daily routines, minimize side effects, reinforce themselves for adherence over time, and communicate effectively with health care providers when regimen adjustment becomes necessary or problems arise. The behavioral skills necessary to practice healthy behaviors are often complex and must be acquired and rehearsed until patients have the sense that they could practice them even under relatively difficult circumstances (eg, convince a partner who does not want to wear a condom to wear one, take one's antiretrovirals reliably even when one is homeless and addicted to drugs).
The IMB model specifies that health behavior-specific information and motivation generally work through health behavior-specific behavioral skills to influence the practice of a given health behavior. In effect, health behavior-specific information and motivation are expressed through the application of health behavior-specific behavioral skills to the initiation and maintenance of healthy behavior practices (see Fig. 2).
The IMB approach to promoting health behavior change specifies a set of operations for constructing and implementing health behavior change interventions for specific target populations and health behaviors. The first step involves elicitation research, which is conducted to assess a group's initial levels of health behavior-specific information, motivation, behavioral skills, and healthy and unhealthy behavior. The second step involves the design and implementation of empirically targeted population-specific interventions, constructed on the basis of elicitation research findings, that address identified deficits in health behavior-specific information, motivation, behavioral skills and behavior. The third step involves conducting methodologically rigorous evaluation/outcome research to determine whether a health behavior change intervention has had significant and sustained effects on health behavior-specific information, motivation, behavioral skills, and behavior.
EMPIRICAL SUPPORT FOR THE INFORMATION, MOTIVATION, AND BEHAVIORAL SKILLS MODEL
The IMB model has been confirmed as a basis for understanding and predicting HIV-relevant health behavior and health behavior change in almost 2 decades of research (for a review, see the article by Fisher and Fisher44). In addition, interventions based on the model and its elicitation, intervention, and evaluation research sequence have been effective in changing risky sexual behavior among HIV-negative and HIV-infected individuals in more than 25 studies performed worldwide (see the articles by Avants et al,45 Carey et al,46 Fisher et al,29,47,48 Kalichman et al,49-51 St. Lawrence et al,52 Warren and King,53 and Weinhardt et al54), and in changing levels of adherence behavior among People Living With HIV/AIDS (PLWHA) (F. Starace et al, unpublished data, 2006).
APPLYING THE INFORMATION, MOTIVATION, AND BEHAVIORAL SKILLS MODEL FOR COLLABORATIVELY DESIGNED PROVIDER-INITIATED INTERVENTIONS WITH PATIENTS
We have taken the IMB approach to promoting health behavior change and used it to create a new model for collaborations among practitioners, behavioral scientists, and patients in the design of provider-initiated HIV-relevant behavior change interventions. Our approach explicitly recognizes that the design of effective health behavior change interventions for use in health care settings involves 3 sources of expertise. In addition to behavioral science expertise on behavior change, health care providers' expertise (on medicine, on their patients, and on the ecology of the health care environment) and patient's expertise (on their healthy and unhealthy behavior, on what drives it, and on what is needed to change it), must be represented. Only then can health behavior change interventions in clinical care settings be optimally effective (see Fig. 1).
Our model for creating collaborative IMB/MI interventions designed by behavioral scientists, providers, and patients involves the following elements (Fig. 3). First, elicitation research (consisting of focus groups, questionnaires, and expert informant interviews) is conducted by behavioral scientists with separate groups of patients and providers as participants. The goal of this work is to understand the dynamics, or reasons for, the unhealthy behavior in question. As part of this work, behavioral scientists also review the published literature on the dynamics of the unhealthy behavior. At the conclusion of the elicitation phase, any IMB elements found to contribute to the unhealthy behavior are targeted for intervention, and a preliminary intervention design is developed. This protocol is presented to each stakeholder (patients, providers, and behavioral scientists), and their feedback is used for its refinement.
The refined intervention design is then taught to a small number of providers to pilot with a small number of patients. Feedback from providers and patients is solicited on intervention content and delivery as well as on (1) the feasibility of implementing the intervention in the clinical care setting, (2) its acceptability to providers and patients, and (3) the likelihood of it leading to behavioral change. Suggested modifications and improvements are then integrated into a final intervention protocol, which is taught to a larger number of providers, implemented widely, and, if possible, evaluated with a randomized controlled design. For evaluation purposes, preintervention (baseline) measures are taken before intervention delivery, followed by short- and long-term intervention outcome measures taken after intervention delivery.
Our collaborative intervention approach involves MI as the delivery system for IMB model-based interventions in health care settings. MI is essentially a patient-centered, supportive, nonjudgmental technique designed to enhance individuals' motivation to change.34 MI puts the provider and the patient on more of an equal footing than in traditional health care interactions, which may lead to more patient disclosure of unhealthy behavior and a more rapid internalization of provider-based behavior change interventions. MI has received extensive support for its ability to motivate behavior change in a variety of health domains (see the articles by Rollnick et al,34 Project Match Research Group,55 and Smith et al56). Certain MI strategies, as articulated by Rollnick et al,34 permit the provider to identify the dynamics of the patient's unhealthy behavior quickly and how to change it, and thus are attractive in the time-constrained health care setting. Interventions containing IMB and MI elements can be taught to providers in a relatively brief time frame and track nicely on other aspects of the provider-patient interaction.29,57
It is critical that the intervention be implemented with fidelity over time. To ensure this, providers receive extensive training in intervention content and delivery until performance criteria are reached. During the intervention implementation phase, booster sessions are offered to providers by the behavioral science team to strengthen fidelity. In addition, brief patient exit interviews (in which patients indicate which intervention elements they received) and provider notes on intervention elements dispensed are monitored regularly. If “drift” or other threats to fidelity occur, retraining of providers is scheduled.
In general, intervention visits focus on having the provider assess the dynamics of a patient's HIV risk or nonadherence behavior using MI and then targeting behavior change by administering appropriate IMB content. This theory-based intervention content facilitates the initiation or maintenance of increased safer sex or adherence. The provider and the patient are actively involved in the discussion.
An example of a collaborative intervention designed in accord with this model is the Options Project, created by several of the current authors,29,57 which involves a provider-initiated intervention to assist PLWHA to practice safer sex. The Options Project was designed consistent with the process depicted in Figure 3, first conducting elicitation research with providers and patients to assess their perceptions of the dynamics of HIV risk behavior among PLWHA and how each group would feel about having discussions on HIV prevention during regular medical visits. Based on the elicitation research findings, a provider-initiated HIV risk reduction intervention was designed for HIV-infected patients that integrated HIV prevention into routine HIV clinical care. The intervention reflected the preferences for intervention content and style indicated by providers and patients in the elicitation work and addressed the major IMB deficits that were found to drive continuing HIV risk behavior in the PLWHA population at focus. The intervention was piloted, and extensive feedback from each of the stakeholders was incorporated into its final design and content. Providers were then trained in the final intervention protocol by our team, and the intervention was implemented (for details on the elicitation research findings, the development of the intervention, and the training, see the articles by Fisher et al29,57).
Briefly, the Options Project intervention involves collaborative patient-centered discussions between the provider and the patient conducted during routine clinical visits and repeated over a study interval of approximately 18 months (or approximately 6 visits). Clinicians verbally assess patients' sexual and injection drug use behaviors, evaluate patients' readiness to change risky behaviors (or to maintain safer behaviors), identify patients' barriers to changing (or to maintaining) safer behaviors, and elicit strategies from patients about how to change (or to maintain) safer behavior. The clinician and patient then negotiate an individually-tailored behavior change (or maintenance) goal or plan of action, and the session ends with the patient being given a “prevention prescription” written on a prescription pad, which summarizes the agreed-on goal to be accomplished by the next visit (specific scripts for provider interactions with patients that can be modified by providers as appropriate are available from the authors or on the Options Project training Web site, available at: http://www.optionstraining.org).58 Clinicians are directed to implement the intervention at the end of each regularly scheduled clinical visit with every patient unless pressing medical concerns preclude intervention delivery.
The intervention outcome findings revealed that the Options Project intervention was effective in changing HIV risk behavior among HIV-infected patients in clinical care. Briefly, patients in the intervention condition decreased in HIV risk behavior over time, whereas those in the standard-of-care control condition actually increased in risk behavior over time (participants in the control condition met with their clinicians for regularly scheduled visits and received standard medical care, which did not include systematic discussions about prevention). This pattern of effects was significant, or was evidenced as a significant trend, across 6 different indicators of HIV risk behavior.29 Based on its initial success, our collaboratively designed HIV intervention for PLWHA has been disseminated widely. It has been implemented in New York by the New York AIDS Institute59 and is soon to become the standard of care there. Moreover, it has been funded by the Health Resources Services Administration for dissemination and implementation in 15 hospitals across the United States60 and is being implemented in a trial in South Africa, and the Centers for Disease Control and Prevention (CDC) and the NIH have funded training in the Options Project intervention for providers involving “in vivo” train-the-trainer workshops and via a dedicated Internet Web site.58
We strongly believe that the success of the Options Project intervention research trial29,57 and its subsequent widespread dissemination were the result of the collaborative way in which it was designed and the multiple strengths of the contributions from behavioral scientists, health care providers, and patients. Without input from providers, it would not have been responsive to their time pressures, contained appropriate and accurate medical content, fit into the ecology of the clinic, reflected the “special relationship” between providers and patients, included characteristics of more typical medical interventions (eg, treatment algorithm, prevention prescription), or received the substantial buy-in needed from providers for widespread implementation. Without input from patients, it would not have promoted highly collaborative and respectful discussions of sensitive topics and elicited widespread willingness to participate in discussions involving intimate personal and sexual issues and, sometimes, illegal behaviors (eg, illicit drug use, unsafe sexual behavior by someone infected with HIV). Finally, without input from behavioral scientists, it might not have involved state-of-the-art theory on behavior change and its maintenance and a high degree of methodological rigor.
Based on the success of the collaborative development process that resulted in the Options Project, we have begun a new collaborative provider-initiated behavior change intervention project, which like the Options Project, is based on the IMB model (ie, the IMB model of adherence61,62) and an MI delivery system. It focuses on increasing adherence to antiretroviral medications, and like the Options Project, it began with elicitation research with providers and patients facilitated by behavioral scientists, supplemented by a thorough review of the literature on behavioral factors that affect antiretroviral adherence. The goal was to produce an intervention that would supplement provider efforts to facilitate adherence in a cost-effective way yet provide substantial IMB content to enhance adherence. To accomplish this, elicitation research findings on IMB deficits contributing to patient nonadherence were incorporated into an antiretroviral adherence enhancement intervention delivered via CD-ROM. At each clinical care visit, the patient completes a profile of his or her current IMB deficits (ie, participates in individualized elicitation research), which triggers a tailored menu of intervention choices designed to remediate these weaknesses and, in this way, increase adherence. The intervention is now in the field at 5 large HIV clinical care sites, and a randomized, controlled trial is underway to determine whether this collaboratively designed intervention is more effective than standard of care at those sites. Given the critical importance and the limited attention that adherence sometimes gets in the clinical care setting,63 we are hopeful that, like the Options Project, this collaboratively designed intervention is going to be effective.
SUMMARY AND CONCLUSIONS
We have proposed an initial theory-based approach for collaboratively designed HIV-relevant behavior change interventions implemented by health care providers with patients in clinical care. This approach rests on recruiting and capitalizing on the strengths of behavioral scientists, health care providers, and patients alike. To illustrate the approach, we have provided examples of HIV prevention and antiretroviral adherence promotion projects that have used it. We believe that such an approach and others like it offer promise of increasing the frequency and efficiency of provider-initiated health behavior change interventions with patients.
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HIV prevention; ARV adherence; interventions; PLWHA; IMB; health care providers
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