Literature Review on Effective Sex- and Gender-Based Systems/Models of Care

January 30, 2007

Research Question 4: Integrating a Model Program

4. How does a service delivery site successfully integrate a model program into its current infrastructure of delivering care? How are results tracked?

This research question addresses how model health programs can be successfully implemented. We discuss five categories of successful models: Centers of Excellence (CoEs); Community Centers of Excellence (CCOEs); other U.S. Federal women's health programs; other women's health programs in the United States; and other women's health programs outside the United States. For each identified model, we focus on factors that help and hinder successful implementation. We also discuss other healthcare models, with a focus on what such models can teach us about successfully implementing change.

The Centers of Excellence (CoEs) sponsored by the Office on Women's Health have been recognized as changing the landscape of women's health (Collins, 2002). Each Center successfully implemented a new model for women's care. While each Center took a slightly different approach to implementing this model, the CoEs collectively offer many important lessons. Here, we discuss lessons learned from CoEs in implementing this new model program.

We mark with an asterisk those CoEs which have not continued in the program, as there has been some turnover among the CoEs. However, we include these examples because even the CoEs that are no longer funded have made a variety of contributions to our understanding of these issues.

The Indiana University CoE was funded in the second round of CoE competitions in 1997. Crucial to the success of implementing this Center was the extensive collaboration of multiple partners:

[The CoE was] able to create a strong and collegial alliance that initially included the Schools of Medicine and Nursing; the Wishard Health Services, the community hospital for Marion County that is located on our medical school campus and is staffed by our faculty, and its community health centers around the city. ... We also discovered that we were not alone in not knowing who all of our potential partners might be, and one of the truly valuable and enduring outcomes of the creation of the IU CoE has been the development of links among so many groups providing care and support to women (Fife, 2003).

These partners were crucial to enabling the CoE to garner additional needed funding, to secure space for the new Center, and to generate publicity for Center activities, all necessary factors for a successful implementation. The IU CoE believes that cross-collaboration, creativity, and funding have been critical to its success in implementing a new model (Fife, 2003).

Yale University established an Interdisciplinary Women's Health Clinic (IWHC) in 1995, prior to its selection as one of the first CoEs in 1996. The goal of the clinic was to train internal medicine residents in women's health issues (Henrich, Chambers, & Steiner, 2003). The clinic was subsequently expanded after the CoE designation.

One of the university's considerations was where to house the IWHC. The decision was made to house it within an existing clinical facility because of financial considerations, internal politics, and ease of access for patients, all critical factors to consider in implementing a new model:

Funds were not available for the creation of a geographically separate facility, and the IWHC, designed primarily as an education and training model, would not be self-supporting as a separate clinical cost center. The development of a new women's health care facility would have also raised potentially divisive discussions about departmental ownership and control, political issues we wished to avoid. From the patients' perspective, the Primary Care Center was an established site that provided a comprehensive range of services in a location that was accessible and convenient to women in the community (Henrich et al., 2003).

In addition to careful consideration of its location, one of the reasons for the project's success was the strong interdisciplinary coordination that promoted learning, one of the goals of the CoE program: "The complexity of the cases seen in the IWHC and the choices regarding care provoked a level of discussion that stimulated each practitioner, whether faculty or resident, to constantly expand his or her understanding of the interconnection of the disciplines that provide the majority of care to women" (Henrich et al., 2003).

Based on its experiences, the Center offers the following advice to others seeking to establish model programs: "Our recommendations ... are to embed the program into the educational and training mission of the institution, align the program with broader departmental or school-wide initiatives, and seek long-term programmatic support through research-based clinical studies and educational grants" (Henrich et al., 2003).

In addition to the experiences of individual CoEs, cross-cutting studies from multiple CoEs provide additional lessons learned on how to implement a model program.

In implementing any new model, it is important to "adapt to the local climate and circumstances" (Milliken et al., 2001). One of the key lessons learned from multiple CoEs is that flexibility is important in implementing any model program:

[Although] CoEs share a common mission and set of core program components, they reflect broad geographic and cultural diversity as well as important differences in their organizational characteristics and structures. As a result of this diversity, the CoE model has had to remain sufficiently flexible to accommodate the variations among centers and to capitalize on their experiences and resources while still defending the model's integrity in the face of an ever changing healthcare environment (Gwinner, Strauss, Milliken, & Donoghue, 2000).

This flexibility in action means that some CoEs provide "one-stop shopping" where women can get all the care they need for themselves in one location, whereas others are "centers without walls" that offer services at multiple locations within one healthcare system. Significantly, most of the CoEs have employed some aspects of each of these approaches, further demonstrating the importance of flexibility (Milliken et al., 2001).

Another crucial component in each Center's success is the Center of Excellence designation itself, which enhances credibility and provides an impetus for change. The designation of a Center as a CoE has value in and of itself to the recipient institution (including as a marketing and fundraising vehicle), and serves as a useful tool to begin the process of change (Weiner, Frid, Droker, & Fife, 2001). The CoE designation has "encouraged-or is giving visibility to-academic health centers that are furthering the institutional integration of women's clinical care, women's health research, and medical education in women's health" (Weisman & Squires, 2000). Additionally, the designation "has further helped the CoEs to resolve institutional divisions" (Gwinner et al., 2000) by creating a common vision and direction for innovation in women's health.

Funding is an important initial barrier that must be overcome for the implementation of any model program. While OWH was able to provide some initial funding to each Center (averaging $172,000 per Center per year prior to 1998 (Gwinner et al., 2000), and slightly less than that after 1998), the collective experience of the CoEs has been that these funds served only as seed money. Fortunately, the combination of initial funding with the status and recognition provided by CoE designation has allowed the Centers to leverage a significant amount of additional funding:

The CoEs have indeed delivered the leveraging results, in terms of both finances and recognition, hoped for since their inception. The sources of the funding include the institutions themselves (and not merely the 25% institutional match required by the DHHS/OWH contract), other federal sources, not-for-profit foundations, philanthropists, industrial sources, in-kind donations (e.g., space, furniture, computers), and others. These numbers are substantive and demonstrate that this model has indeed worked, probably beyond the most optimistic visions of the OWH (Weiner et al., 2001).

Related to this need to leverage funding, the CoEs have built strong partnerships to maximize their potential to impact change. A common theme among all the CoEs is "collaboration and coordination between the CoE and existing community groups, from state agencies to patient advocacy groups" (Fife et al., 2001). This has allowed the CoEs to make "even more substantial contributions to their communities through interactions with other groups involved in women's health," instead of "duplicating already extant services" (Fife et al., 2001).

To secure funding and build partnerships, CoEs have also found it beneficial to maximize their credibility as expert spokespeople. CoEs have the ability to "become the community spokespersons for desired projects and for the dissemination of important information necessary to activate specific healthcare policy" (Weiner et al., 2001). As part of this effort, CoEs have taken advantage of marketing opportunities, consistently using their logos, participating in health fairs, granting interviews, and collaborating with community groups (Weiner et al., 2001).

An important component of implementing a new model program is creating internal support to provide the structure, resources, and leadership to accomplish change. The CoEs have found that necessary institutional buy-in components include "fully operational women's health clinical service facilities, research facilities, teaching facilities, student training and placement opportunities, technological infrastructure, staff resources, education specialists, administrative support, outreach workers, information specialists, technical support staff, service providers, researchers, and teaching faculty from numerous disciplines" (Gwinner et al., 2000). Key to securing such resources is the presence of an effective internal spokesperson who can exert constant pressure for change (Gwinner et al., 2000).

Part of implementing successful internal change is also good timing. Organizations may be more receptive to change during times of restructuring: "At these times, institutions are examining old structures and creating blueprints for conceptualization of program missions and goals. ... These formal processes have served to rationalize the institutional approach to women's health and to underscore the similarities and common women's health goals of differing departments within the institution" (Gwinner et al., 2000).

Another lesson learned by the CoEs is the importance of paying attention to multiple factors simultaneously. For example, to create a woman-centered atmosphere, CoEs have focused on:

(1) availability of primary care services for women that include both reproductive health and preventive care, (2) high visibility of female providers and staff, (3) an atmosphere and environment that is welcoming to women, (4) availability of information of particular interest to women, and (5) absence of materials and attitudes that would be perceived as threatening or inappropriate to women (Milliken et al., 2001).

Finally, to maximize their own success once implemented, CoEs have found that it is important to create continued opportunities for internal collaboration, for example by bringing faculty and researchers together "through interdisciplinary workshops, seminars, and meetings" (Gwinner et al., 2000). This creates learning but also helps to foster "contacts among those investigators in disparate fields who may be unaware of particular funding opportunities in women's health or who have not considered a gender or hormonal slant to their current studies" (Weiner et al., 2001).

In addition to CoEs, OWH has also created Community Centers of Excellence (CCOEs). These community centers are based on a model designed to "develop an integrated, innovative, community-based, comprehensive, and multidisciplinary care delivery system that extends quality services to women of all ages and racial and ethnic groups" (Office on Women's Health, 2004). This program was implemented in 2000, and 14 CCOEs are currently funded (Office on Women's Health, 2004).

We found one report on the implementation of CCOEs (Office on Women's Health, 2004). CCOEs have found that several staff positions have been crucial to their success. These include a Center Director, a Program Coordinator, and Community Health Workers (Office on Women's Health, 2004).

In addition, establishing early and effective partnerships has been critical to the success of the CCOEs. CCOEs have aggressively used existing partners, as well as their advisory boards, to reach out to and include the community in center activities (Office on Women's Health, 2004). Another important aspect of the CCOEs' success has been a commitment to maintain ongoing communications with the CCOEs' parent organizations, to ensure that their missions are complementary and not in conflict (Office on Women's Health, 2004).

While the CoEs and CCOEs have been leaders in implementing a model program for women's health, numerous other federally supported efforts exist to promote women's health. We identified several programs sponsored by the Centers for Disease Control and Prevention (CDC), the Department of Veterans Affairs (VA), and the Department of Defense (DOD). In this section of the report, we discuss how such programs have been implemented.

CDC sponsors the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) project. WISEWOMAN is a cardiovascular "risk reduction program for underinsured and uninsured women ages 40-64 years" whose goal "is to implement interventions to improve diet, increase physical activity, and promote smoking cessation, thus decreasing clinical CVD [cardiovascular disease] risk factors and optimizing participants' health" (Jilcott et al., 2004). WISEWOMAN funds more than a dozen projects in as many states, and has been generally successful in achieving its health promotion goals (Jilcott et al., 2004).

WISEWOMAN promotes behavioral change interventions, and has found that "health department staff accustomed to passively distributing health education materials to clients may lack the training and experience to engage in a more involved and tailored counseling process" (Jilcott et al., 2004). Accordingly, WISEWOMAN projects have found that effective staff training is crucial to implementing the model. Staff training needs to overcome doubts about the effectiveness of the model, as well as bolster patients' motivation to change. Staff training is most effective when it is offered both before and during the intervention (Jilcott et al., 2004).

Historically, patients served by the VA have been almost exclusively male. Increasingly, however, VA patients are female, and the VA has engaged in a comprehensive effort to revamp its services to meet the needs of these female veterans. The Veterans Health Care Act of 1992 and the Veterans' Health Care Eligibility Reform Act of 1996 require the VA to provide high-quality services to female patients (Washington, Yano, Goldzweig, & Simon, 2006). "Although VA facilities have reconfigured themselves to address this legislative mandate," it has proved difficult to provide quality care "to a group that is an extreme minority within the VA" (Washington et al., 2006).

As part of its response, the VA has established comprehensive women's health centers and full-time women veterans' coordinators (Grubaugh, Monnier, Magruder, Knapp, & Frueh, 2006). The VA now offers services for women such as "Pap smears, mammography, and general reproductive healthcare (including birth control and treatment of menopause)" (Lavela et al., 2006). The VA has moved toward a more "gender-sensitive" system of care over a 15-year period:

The development of women's health care in the VA mirrors the evolution of care delivery in other settings, from a "patchwork quilt with gaps" towards more gender-sensitive care models. ... [The VA established] eight Comprehensive Women's Health Centers [WHC] throughout the U.S. These "one-stop shopping" models, partnered with university-based women's health programs, had women's health training programs and created models of care delivery not unlike carve-outs designed to market women's health care in private sector settings. ... An underlying tension has resulted regarding how best to organize VA women's health care. Proponents of integrated primary care approaches argue that integrated care assures women veterans of access to a more cost-effective and coordinated system of care. ... Proponents of separate WHC models speak to the special needs of women veterans. ... Perhaps not surprisingly, these arguments parallel the competition for women patients across specialties (e.g., ob-gyns, internists, family practitioners) and may reflect the debate over women's health as a distinct specialization and concerns about possible erosions in gains made to create separate programs (Yano, Washington, Goldzweig, Caffrey, & Turner, 2003).

In the midst of this tension over how best to deliver care to women veterans, three main women's service models have emerged, with no one model dominating: "1) Separate women's health clinics providing specialty services such as preventive health screenings or gynecology services; 2) The integration of women's health into existing primary care services; and 3) The development of comprehensive women's health programs that provide both gender specific primary care and specialized services for women" (McNeil & Hayes, 2003).

Because women are still a very small minority of patients served, the VA must pay attention to issues such as scheduling multiple women's visits on the same day (to ensure a critical mass), making sure needed equipment is available (such as pelvic examination tables and Pap smear kits), and training staff on issues of special concern to women (such as domestic violence issues) (McNeil & Hayes, 2003). Almost all VA sites now offer basic healthcare services for women on-site, while other services (e.g., mammography) are available off-site (Washington, Caffrey, Goldzweig, Simon, & Yano, 2003). However, comprehensive services are more likely to be available on-site in geographic areas where no other such services are likely to be available (Washington et al., 2003).

In general, the VA has had to make efforts to be somewhat judicious with how it uses limited resources to provide care for women. For example, "a majority of VA facilities reported having women's health specialists available for gynecologic and mental health emergencies during usual clinic hours. However, a significant proportion rely on general surgeons and existing mental health personnel rather than women's health care specialists to deliver these services, particularly for after-hours care" (Washington et al., 2006). Likewise, "women's health care specialists for emergency mental health conditions specific to women were available at all times for 51.7% of sites and only during usual clinic hours for 31.0% of sites. Women's health care specialists for emergency gynecologic problems and emergency mental health conditions specific to women were not usually available, even during clinic hours, for 35.6% and 17.2% of sites, respectively" (Washington et al., 2006). Such staffing patterns "likely represent a practical solution for a health care entity with a small number of women patients and an inability to staff reliably or with women's health care specialists" (Washington et al., 2006).

Thus, the VA has responded to the challenge of better meeting the needs of women by expanding its health services for women (particularly as they relate to women's obstetrics and gynecological needs), as well as creating new centers for the study of female veterans and considering factors such as equipment and privacy needs to provide appropriate care.

A small-scale example of providing woman-specific services is the "Teen Women's Health Clinic" which was sponsored by an Army Community Hospital. The clinic was established to increase the use of preventive services by teen girls. Services were offered one day of the week, and comprehensive services were available through the simple cooperation of existing departments and resources. The result was successful on all fronts, demonstrating that "improved access to comprehensive teen women's healthcare is achievable at the community hospital level, at little expense, through cooperation between departments. This clinic was well attended, on average working near full capacity, with a low no-show rate for teenagers" (Adelman, 2004). The model is seen as replicable.

In addition to the CoEs, CCOEs, and various Federal women's health programs, we also encountered some literature on other women's healthcare models in the United States. For these models, one key theme that emerged is the importance of market research. Talking with people who will be affected by change, both at the patient level and at the administrative/staff level, is critical to creating and implementing successful model programs.

Columbia University's Center for Women's Health operates under a similar model to the CoEs. Established in 1994, the center's objectives were to achieve "comprehensive, integrated, multidisciplinary care for women of all ages" (Giardina et al., 2006). To achieve this vision:

The departments of medicine and obstetrics/gynecology took the lead in identifying physicians, financial resources, and space to support a multidisciplinary program. Physicians in specialties, such as internal medicine and obstetrics/gynecology, and advanced practice nurses formed the nucleus of the providers. In addition, on-site cardiologists, gastroenterologists, endocrinologists, breast surgeons, and experts in menopausal issues, social workers, and nutritionists were also considered necessary to address healthcare needs. Furthermore, this base of clinical faculty provided the opportunity to fulfill the institutional educational mission to teach students, physicians, and the public about the unique clinical presentation and treatment of gender-based health (Giardina et al., 2006).

The center's approach to integrating services was to use a common practice site and a common chart, which was seen as "an important way to unify encounters with providers at the center as well as others who do not practice within the center" (Giardina et al., 2006). A primary source of patients for the center was referrals (68% of all patients), which indicates a high degree of patient satisfaction with the center (Giardina et al., 2006). The founders of the center have been quite positive about the experience:

That a centralized model can be developed to transform traditionally fragmented activities into an integrated system, thereby improving and advancing care for the health of women, is compelling. One notion for advancing women's health is to streamline fragmented, multidisciplinary, and decentralized forces into an environment of coordinated care. Paradoxically, medical centers espousing comprehensive women-focused care are often examples of decentralized care (Giardina et al., 2006).

Three main barriers have been identified to implementing this program (Giardina et al., 2006):

• "If key departments, such as medicine or obstetrics/gynecology, are not able to meet a commitment to subsidize faculty or if revenues are expected to completely cover faculty salaries, fringe benefits, malpractice insurance, rent, administrative costs, and other costs, the program will falter."
• "If the institutional stakeholders do not acknowledge significant downstream revenues (from procedures, hospitalizations, and benefits to other programs), the program will not succeed."
• "If the women's health faculty does not step up to the responsibility of curriculum development and training the next generation of students and physicians, there is a limited future for women's health programs."

The University of Washington opened a Woman's Health Center in 1995 to provide ambulatory care services in a multidisciplinary team setting. The center conducted early market research with its potential client base and was established to meet both a staff and customer interest in specialized women's services. The center has been largely successful, perhaps because it has maintained a focus on women's health and educational materials while providing a team atmosphere during its consultations (Phelan, Burke, Deyo, Koepsell, & LaCroix, 2000).

Sutter Health runs 26 hospitals and has more than 35,000 employees in northern California, southern Oregon, and Hawaii. George F. Lee, M.D., senior vice president of medical affairs for the California Pacific Medical Center, remarked on the importance of integration across multiple healthcare settings in achieving successful change (Walowitz et al., 2000). He discussed the example of moving toward a single perinatal record as one example of Sutter's work in women's health, and the importance of the early involvement of nurse managers in accomplishing such a change. A summary of his remarks appears below:

"Those of you who are involved in management of an obstetrics unit know what it's like to have every physician bring in his or her own OB record and then to have the nurse managers and the nurse clinicians have to abstract from those records the pertinent information," Dr. Lee told the attendees [at a conference where his remarks were made]. He explained how the concept [of integrated records] initially met with great opposition from hospital managers and clinicians, but, he said, "If you are going to act like a system, what could be more basic in women's services than a standard OB record? If we can't accomplish this one thing, we have no future as a system." By engaging the early participation of nurse managers in all the OB units, as well as physicians who are department chairs, the system is now moving forward rapidly, Dr. Lee said, toward a single perinatal record across all 26 hospitals (Walowitz et al., 2000).

This is just one example of how to enact women's care programs. Dr. Lee and other leaders in women's health offer the following tips on how to accomplish systems integration for women's health services:

Clinicians should be brought into the process as early as possible in the role of full partners. The system should be flexible enough to respond quickly to changes in both the market and the health care field. Competition and cultural dissimilarities should be identified and addressed among the system's different units and organizations. Women's health services must continually demonstrate its direct and indirect value to the system and find creative ways to differentiate itself in the marketplace (Walowitz et al., 2000).

The struggle to implement effective approaches to women-centered care is occurring in numerous countries, and there are many lessons to be learned from programs implemented outside the United States. We identified efforts in Canada, Brazil, and Thailand.

Health Canada implemented an effort in 1996 to create "Centres of Excellence for Women's Health" with initial funding of $12 million over a six-year period (1996-2002) (Health Canada, 1996). Each Centre is guided by a framework that

promotes the use of a health determinants approach, emphasizes the concept of gender as an important variable in health, draws attention to the need for a critique of the health system's traditional view of women and the implications for practice and service provision; identifies the need for change in our approach to women's health bearing in mind the health system is undergoing rapid change; points out some of the issues related to the status of women in the formal and informal health systems; and urges greater responsiveness of policy-makers at all levels to the health concerns of women (Health Canada, 1996).

Health Canada currently funds four of these Centres (Health Canada, 2005).

In addition to this national effort, other women's health efforts exist in Canada. For example, a Canadian study observed that "innovative and comprehensive approaches to women's health needs are required to encourage the development of health services that are based on the principles of women-centered care" (Bottorff et al., 2001). Bottorff, Balneaves, et al. (2001) examine three such approaches to enhancing cervical cancer screenings in Canada. One of their key findings is that to successfully implement such a program, it is important to involve affected physicians early on and to address their concerns (e.g., about losing patients to other systems of care).

A model to reach poor women with integrated reproductive healthcare was implemented by the Perola Byington Hospital in Sao Paulo, Brazil. One challenge with the new model was to create integrated services for women to treat women efficiently and with dignity for preventive care (Pinotti & Tojal, 2001). As part of its approach, the model relied on giving women a voice. The fundamental principles of the program included the following (Pinotti & Tojal, 2001):

• "Women's participation in the health system must be permitted and encouraged at all levels, not only at the level of leadership but also and particularly as users of services at the level at which they are attended."
• "Expansion of service provision by nonmedical personnel, so that women may, as far as possible, have all their needs taken care of at the same place and time."
• "The greatest reduction possible in existing bureaucracy and other obstacles to women's access to health care."

A project was undertaken in Thailand to train staff in rural reproductive health clinics to be more gender-sensitive. Staff "underwent five days of intensive technical training and three days of cultural training," on topics such as communication, counseling on sexual health topics, and technical competence in skills such as administering a Pap smear (Boonmongkon, 2000). Training also focused on "other aspects of reproductive health care such as care of cancer patients; provision of client-centred, gender-sensitive and holistic services that would help reduce clients' fear, anxiety and concern; the concept of one-stop reproductive health services; and the involvement of men" (Boonmongkon, 2000).

The project focused on changing staff attitudes, knowledge, and beliefs as a means of implementing a new care structure. The training was successful in broadening staff perceptions of what care meant:

Before the study intervention, health staff perceived reproductive health as referring to family planning and maternal and child health, and identified their target group as only women between the ages of 15-49. ... As a result of the training, health staff began to provide holistic and integrated services, cared for women's quality of life, involved men as target groups, used client-care approaches, became gender and culturally sensitive to clients' needs and tried integrating several aspects of reproductive health services into one visit (Boonmongkon, 2000).

Thus, detailed staff training was essential to the implementation of a gender-sensitive program in Thailand.

Various models have been developed to describe how to implement change in the healthcare system. In this section, we discuss several of these models, with a focus on what such models can teach us about how to implement gender-based approaches to medicine.

The chronic care model (CCM) "synthesizes the elements of successful chronic-disease-management programs, and relates them to improvements in outcomes" (Glasgow, Oreleans, Wagner, Curry, & Solberg, 2001). The model consists of six elements-resources, policies, self-management support, delivery system design, decision support, and clinical information systems-that work together to create productive interactions related to informed patients and prepared practice teams (Glasgow et al., 2001). The model was created after a literature search "for studies of practice innovations and interventions associated with improvements in care and outcomes" (Wagner et al., 2005). Its goal is

to shift the orientation and design of practice in order to promote a systematic, planned approach to care for those with ongoing health problems through productive (planned) interactions between informed, activated patients (and families) and prepared, proactive practice teams. To be productive, interactions must assure consistent delivery of evidence-based treatments in tandem with support for patient self-management. The literature on effective self-management support, with its emphasis on patient activation or empowerment and active participation in setting goals and developing action plans, appears consonant with emerging concepts of patient-centered care (Wagner et al., 2005).

While the model was developed for chronic diseases, its potential applications are broader: "The CCM can be used as a blueprint for efforts to improve the delivery of clinical preventive services, to help understand and analyze prevention failures, and to develop effective systems-based solutions" (Glasgow et al., 2001). In the case of gender-based medicine, the CCM could be used to outline the necessary components and interactions of any new care model.

The CDC Division of HIV/AIDS Prevention has developed draft guidance on how to adopt evidence-based behavioral interventions. The guidelines underscore "the idea that adaptation should be a planned process that maintains fidelity to core elements and is based on sound rationale from formative evaluation" (McKleroy et al., 2006). The guidelines are currently being pilot tested, and they will be reviewed and finalized in the coming years (McKleroy et al., 2006). In the meantime, the guidelines "can be used by researchers developing behavioral interventions to begin to think about adaptation during the early stages of conceptualization" (McKleroy et al., 2006).

The guidelines divide the adaptation process into three stages: assessment, preparation, and implementation. Each stage includes action steps, feedback loops, and monitoring and evaluation. In the assessment phase, the potential adaptation is studied for quality of fit with the affected population and other stakeholders. At the end of this stage, it is either selected for adoption or other interventions are considered. In the preparation phase, the adaptation is pre-tested with the target population, and the organization prepares for the change. Finally, in the implementation stage, the adaptation is adopted with minor refinements (McKleroy et al., 2006). Such a model is useful to consider when thinking about a potential new model for gender-based medicine, as it outlines some of the factors that potential adapters will need to consider before they can utilize the model.

A more specific model that still might have broad applications is a model to implement a local health information infrastructure (LHII). The premise of this model is that success is built incrementally, and that previous stages affect latter stages. Thus, the model is designed as a pyramid. The pyramid begins with community leadership and continues with commitment to the change, followed by initial and detailed planning, launch, and ongoing operation (Lorenzi, 2003).

Two successful local health information infrastructures were put into place in Indianapolis and Santa Barbara. Common success strategies across these two sites included the following (Lorenzi, 2003):

• Making partners feel valued.
• Gaining community support.
• Having a shared vision.
• Mobilizing around focused concepts.
• Ensuring strong physician involvement.
• Following a strong leader.
• Including the health department.
• Having a neutral managing partner.
• Forming appropriate leadership groups.
• Using a technical model.
• Communicating effectively.
• Having effective change management strategies.
• Paying attention to legal issues.
• Modeling for sustainable funding.
• Dealing with politics in a proactive manner.

A similar model of incremental change may be helpful to think of in terms of how to successfully implement a gender-based approach to change. In addition, some of these issues may be important to consider for a gender model; however, which of these issues may be most important to gender-based medicine is a question that requires further investigation.

A final specific model (with a potentially more general application to consider) relates to severe head trauma. Severe head trauma affects multiple body systems, and its treatment involves multiple providers. Thus, to treat traumatic brain injury (TBI) requires "timely, consistent, and coordinated care" (March, 2006). A model for how to treat such injury and achieve care coordination was developed based on an analysis of barriers to compliance with treatment guidelines and an analysis of three case studies where such barriers were successfully overcome (March, 2006).

One of the key findings of this study is that "the fragmented structure of trauma care must be counterbalanced by an equally powerful set of forces for integration" (March, 2006). This effort must include investments in education and training for physicians and nurses, as well as leadership in the form of "physician champions, administrative and high-level medical support, and hands-on change agents" (March, 2006). These were the five main conclusions of the study (March, 2006):

• "Coordination across disciplines and clinicians is needed to provide unified care (from a provider perspective) for patients. But, from the patient's perspective, care becomes seamless only when there is consistency and continuity of care as well as coordination."
• "The 3Cs [consistency/continuity/coordination] model and the brain/skeleton/flesh [guidelines/protocols/pathways] metaphor are two ways of saying the same thing. One focuses on the goals of seamless care, and the other focuses on a set of tools for reaching them."
• "Well-implemented guidelines, protocols, and pathways redesign the default structure for care of a particular patient population. At their best, these three tools provide clear, well-considered default positions from which to deliver care."
• "They must, of course, be flexible and responsive to the patient and to accumulating bodies of experience and evidence. Excellence in health care requires finding a balance between default structures and individual patients."
• "Many kinds of decisions can appropriately be made for classes of patients, but all decisions must ultimately be tailored for individual patients, and some decisions must start with the patient and/or be made at that level."

Again, this model outlines overall issues to be considered with any new approach to healthcare, as well as offering suggestions for how to overcome likely barriers.

Our goal in research question 4 was to locate and discuss effective models of service delivery sites integrating model programs, and to cull from those successes guidance on how to implement similar programs for gender-based medicine. Unfortunately, we found the literature in this area to be particularly sparse.

As will be discussed in greater detail in question 5, there are very few currently existing gender-based approaches to medicine. There are a substantial number of programs that are designed to serve women, and a smaller (yet growing, see question 7 for more details) number of programs designed to serve men. Thus, all of the "gendered" examples in this section concern women. Additionally, the literature on existing programs tends not to contain much more than anecdotal details pertaining to how to successfully implement model programs, instead focusing on a description of such programs and results to date.⁴

The studies we found indicate that the CoEs have been pioneers in this field, and some of the best data about how to implement new model programs comes from the CoEs. However, an additional highly relevant model is the Center for Women's Health at Columbia University.

The themes that emerged from our analysis include the following:

• Funding is critical: Any new model program must begin with an initial funding source, but also must work to develop ongoing funding.
• Leadership matters: To create change, strong advocates for change must exist within organizations.
• Partnerships are essential: Community partners help to build support and spread the word, and also can be invaluable sources of funding.
• Market research sets the foundation: Model programs must be embraced by the people they are designed to serve, as well as the people who are being asked to implement them. Formative research with affected patients and staff is essential to identifying and overcoming barriers.
• Flexibility helps: Each healthcare setting is unique, and model programs may need to be tailored to individual healthcare settings.

Finally, we identified several models that offer helpful descriptions of factors to consider in implementing a model program, as well as potential barriers that must be addressed. Of particular interest is a new model being developed by CDC, which models factors related to the adoption of evidence-based guidelines. This model may be particularly helpful to OWH in thinking about how to implement a new evidence- and gender-based model of care.

Current as of March 2007