Determinants of implementation effectiveness: adapting a framework for complex innovations.

Many innovations in the health sector are complex, requiring coordinated use by multiple organizational members to achieve benefits. Often, complex innovations are adopted with great anticipation only to fail during implementation. The health services literature provides limited conceptual guidance to researchers and practitioners about implementation of complex innovations. In the present study, we adapt an organizational framework of innovation implementation developed and validated in a manufacturing setting and explore the extent to which it aptly characterizes implementation in health sector organizations. Through comparative case studies of four cancer clinical research networks, we illustrate how this conceptual framework captures key determinants of the implementation of new programs in cancer prevention and control (CP/C) research and helps explain observed differences in implementation effectiveness. Key determinants include management support and innovation-values fit, which contribute to an organizational "climate" for implementation. We explore the implications for researchers and managers.

Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience.

PURPOSE: The National Cancer Institute's (NCI) Minority-Based Community Clinical Oncology Program (MBCCOP) seeks to enhance minority participation in cancer clinical trials by building clinical trials outreach and management capacity in healthcare institutions serving large numbers of minority cancer patients. This article examines temporal trends in MBCCOP accruals to cancer prevention and control (CP/C) and cancer treatment trials and the racial distribution of study participants, along with the major factors affecting minority enrollment. METHODS: We used NCI databases to analyze temporal trends in overall accruals and accruals by race. We analyzed transcripts from an NCI-sponsored meeting with MBCCOP principal investigators and data from a follow-up survey to identify factors affecting minority enrollment. RESULTS: Between 1992 and 2003, annual patient accruals to treatment trials increased 39% despite little change in the number of MBCCOP grantees. During this same period, annual participant accruals to CP/C trials more than doubled. Between 1995 and 2003, minorities comprised 51% to 67% of the MBCCOP patients accrued to cooperative group treatment trials compared with < or = 23% of the patients accrued by other cooperative group members and affiliates. Major factors affecting minority enrollment include the availability of "clinically relevant" protocols, regulatory requirements, characteristics of the patient population, and the level of support from sponsoring institutions and community physicians. CONCLUSION: MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials. However, the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

Delivering HIV services to vulnerable populations: a review of CARE Act-funded research.

This article summarizes key findings from evaluation and research studies that have received financial support from the HIV/AIDS Bureau of the Health Resources and Services Administration or from Ryan White Comprehensive AIDS Resources Emergency (CARE) Act grantees. These studies suggest that the CARE Act has improved but not equalized service accessibility, quality, and outcomes for different populations living with HIV disease. Evaluations of access to highly active antiretroviral therapy (HAART) found that uninsured patients, women, people of color, and injection drug users waited much longer than others to receive the new therapies. These disparities were not uniform across study sites, suggesting that clinic characteristics and geographic location have a major influence on prescribing patterns. Once patients gained access to HAART, health insurance status made little difference in clinical outcomes.

Delivering HIV services to vulnerable populations: an evaluation and research agenda.

In May 2000, the HIV/AIDS Bureau of the Health Resources and Services Administration convened HIV experts from throughout the country to identify new and emerging areas of research needed to guide policy and programmatic decisions on HIV service delivery to vulnerable populations. This article describes the process used to develop an evaluation/research agenda, discusses key findings and recommendations of the conference, and proposes a set of principles to guide the design and conduct of future investigations. Conference participants identified nine major evaluation/research themes that span the continuum of HIV behavioral prevention services and treatment. They recommended focusing future research on questions relevant to populations experiencing rapid rates of increase in HIV infection (for example, women, people of color, and adolescents and young adults) and considering explanatory factors at multiple levels of analysis (individual, clinician, organization, service delivery system, and environment).

Variations in rural AIDS epidemiology and service delivery models in the United States.

This article reviews AIDS surveillance data and the rural health literature to summarize what is known about the rural AIDS epidemic, characteristics of rural environments that affect HIV service delivery, and approaches that rural areas are using to address the health and support service needs of HIV-positive residents. During 1999, nonmetropolitan (non-MSA) adult/adolescent AIDS rates were highest in the South (11 per 100,000) and Northeast (9 per 100,000). The South had the highest non-MSA proportion of adult/adolescent AIDS cases (12%), followed by the North Central region (9%), the West (4%), and the Northeast (3%). Variations in rural HIV/AIDS epidemiologic patterns and the demographic, socio-economic, and cultural characteristics of rural environments are likely to require different levels of resource investment and different methods of organizing and delivering HIV services. Currently, many HIV-positive rural residents are traveling to metropolitan areas for medical care because of concerns about confidentiality or a lack of confidence in the HIV management capabilities of local physicians. Rural communities are attempting to address these problems by developing the HIV care capacity of existing clinics, building local networks of physicians with HIV management experience, and cultivating "shared care" arrangements with urban-based specialists.

Recruiting participants to cancer prevention clinical trials: lessons from successful community oncology networks.

PURPOSE/OBJECTIVES: To describe the organizational designs and task environments of community oncology networks with high accrual rates to cancer prevention clinical trials. DESIGN: Replicated case study design; structural contingency theory. SETTING: Local Community Clinical Oncology Programs (CCOPs) funded by the National Cancer Institute to test preventive and therapeutic interventions in community settings. SAMPLE: Primary sample: oncology professionals affiliated with four CCOPs ranking among the top 10 in earned cancer control accrual credits in fiscal years 1999-2003. Secondary sample: oncology professionals affiliated with three CCOPs ranking among the top 10 three to four times during the study period. A total of 63 people participated in the interviews. METHODS: Primary sample: on-site interviews with CCOP investigators, clinical research staff, and nononcology physicians. Secondary sample: telephone interviews with each CCOP's nurse administrator and at least one prevention research nurse. MAIN RESEARCH VARIABLES: Staffing patterns, organizational processes, recruitment strategies, and environmental characteristics. FINDINGS: All of the CCOPs employed dedicated prevention research staff. Recruitment through media publicity, mass mailings, or group information sessions worked best when prevention trials had flexible eligibility requirements and evaluated interventions with few health risks. Prevention trials evaluating agents with known toxicities in high-risk populations required more targeted recruitment through cancer screening programs, physician referral networks, and one-on-one discussions with protocol candidates. CONCLUSIONS: High-performing CCOPs configured their structures, processes, and recruitment strategies to fit with accrual goals. They also benefited from stable and supportive task environments. IMPLICATIONS FOR NURSING: Nurse-coordinated research networks have great potential to generate new knowledge about cancer prevention that can reduce cancer incidence and mortality significantly.

Adapting clinical trials networks to promote cancer prevention and control research.

BACKGROUND: Since 1987, cancer centers and clinical cooperative groups serving as 'research bases' for the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) have been required to design and conduct cancer prevention and control (CP/C) clinical trials in addition to therapeutic trials. The study describes the structural and strategic adaptations that CCOP research bases have made to incorporate CP/C research into their scientific agendas and operations. METHODS: Approaches to CP/C research in four cooperative groups with different scientific agendas were investigated: the Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the North Central Cancer Treatment Group, and the Southwest Oncology Group. Sixty-five individual interviews with group leaders and investigators were conducted. Data were coded and thematically analyzed from transcribed interviews, observations of scientific sessions, and secondary documents. RESULTS: The cooperative groups have tailored CP/C research programs to fit the interests, skills, and practice settings of their investigators without making significant adaptations in administrative and statistical infrastructures. Ongoing challenges include finding ways to broaden the pool of investigators designing CP/C protocols, involve more nononcologists in protocol design, and secure more stable and adequate funding for CP/C research. CONCLUSION: The cooperative groups' experiences with CP/C research suggest that, with adequate resource investments, existing clinical research networks can expand into new areas of scientific investigation.

Developing and implementing a statewide breast cancer action plan.

BACKGROUND: This article describes a model used by the Kentucky Breast Cancer Task Force to develop and implement a statewide breast cancer action plan. METHODS: The authors examine the challenges encountered during different phases of plan development and the ways in which these challenges were addressed. CONCLUSIONS: To successfully move from planning to implementation, task forces must have broad-based participation, a "lead organization" to coordinate the planning process, focused work agendas, and firm commitments from cancer-related organizations and groups to spearhead activities in specific implementation areas.