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How a multidisciplinary vascular access care program enables implementation of the DOQI guidelines. Part I.

This comprehensive, proactive, multidisciplinary team approach to access management has enabled the achievement of center-specific best-demonstrated clinical practiCes for vascular access care. It has also resulted in significant cost savings to the health care delivery process. It has not been an easy task; if it were, access care outcomes would be better nationally than they are today. The VACP approach to vascular access care improvement employs four key implementation principles that ensure the success of Gambro's program and form the infrastructure supporting any successful team approach to care. These core processes, known as the four "C's, include: 1. Commitment, 2. Continuous Quality Improvement, 3. Core Competency, and 4. Communication.

Arteriovenous Shunt, Surgical↗

How a dedicated vascular access center can promote increased use of fistulas.

Fistula First, now a CMS "Breakthrough Initiative", sets the eventual goal of 66% prevalence of arteriovenous (AV) fistulas in the U.S. dialysis population. The benefit of an AVfistula as the hemodialysis access has been clearly demonstrated; yet the current incidence of AV fistulas in patients new to dialysis in the U.S. is extremely low and prevalence rates are approximately half the eventual target rate. In this article, the components of an Integrated Vascular Access Program are described. One of these is a dedicated Vascular Access Center (VAC), a facility specializing in radiographic and interventional procedures for the vascular access care of patients with ESRD. Procedures carried out in a dedicated VAC are described and are shown to support both K/DOQI and the Fistula First "Change Package" in terms of promoting increased prevalence of AV fistulas. These include preoperative vessel mapping, fistula maturation, fistula maintenance, and identification of candidates for secondary fistula. The above type procedures that were carried out in our dedicated VAC in 2004 are described. These included vessel mapping (n=220), fistula maturation procedures (n=104), and fistula maintenance procedures (n=103). The results suggest that the shift to a "fistula culture" within a dialysis practice requires a significant number of interventional procedures--both maturation and maintenance types. A dedicated VAC can efficiently carry out these procedures and is an important component of an Integrated Vascular Access Program.

Alabama↗

Case management models for persons who are homeless and mentally ill: the ACCESS demonstration project. Access to Community Care and Effective Services and Supports.

Persons who are homeless and mentally ill present unique challenges to service providers and human service systems. In vivo case management approaches such as assertive community treatment (ACT) have shown promise in engaging this population. This paper explores case management models employed within the ACCESS program, a five year, 18-site demonstration program enriching services for homeless persons with serious mental illness. We describe the implementation of case management with ACCESS programs and determine the extent of variation across sites using a measure of fidelity to ACT. While programs reported using four models, much similarity was found among programs on multiple dimensions.

Case Management↗

Immune reconstitution syndrome after highly active antiretroviral therapy in human immunodeficiency virus-infected thai children.

BACKGROUND: There is little information about the immune reconstitution syndrome (IRS) in children, especially from resource-poor countries. OBJECTIVE: To determine the incidence and spectrum of IRS in advanced stage human immunodeficiency virus (HIV)-infected children after initiation of highly active antiretroviral therapy (HAART). METHODS: Between May 2002 and April 2004, 153 symptomatic HIV-infected children who had CD4 lymphocyte percentage < or =15% initiated HAART in a national antiretroviral drug access program. All patients were followed for 48 weeks. In this study, IRS was defined as a disease event caused by microorganisms or conditions previously reported to be associated with IRS in patients having immunologic and/or virologic response to HAART. RESULTS: The incidence of IRS was 19% (95% confidence interval, 13.1-26.1). The median time of onset was 4 weeks after start of HAART (range, 2-31). There were 32 episodes of IRS, including 14 caused by mycobacterial organisms, 7 by varicella-zoster virus, 7 by herpes simplex virus, 3 by Cryptococcus neoformans and 1 episode of Guillain-Barré syndrome. Patients who had IRS develop had lower baseline CD4 lymphocyte percentages compared with those who did not (P = 0.02). CONCLUSIONS: IRS is common among HIV-infected children who received HAART in their advanced stage of disease. Educational programs for patients and health care workers on recognizing and treating these conditions should be integrated into antiretroviral treatment access programs.

AIDS-Related Opportunistic Infections↗

The effect of victimization on clinical outcomes of homeless persons with serious mental illness.

OBJECTIVE: The study examined the prevalence and correlates of criminal victimization and the relationship between victimization and client outcomes for homeless clients with mental illness. METHODS: Subjects were clients in community treatment programs participating in the Access to Community Care and Effective Services and Supports (ACCESS) program of the Center for Mental Health Services. Data were obtained through interviews conducted at program entry and at three and 12 months after entry with ACCESS clients in 18 sites during the first year of program operation (N = 1,839). Self-reports of victimization during the past two months as well as data on sociodemographic, health, and social adjustment indicators were obtained at each time point. Multiple regression was used to determine both the correlates of victimization among this population and the effect of recent victimization on client outcomes three and 12 months after program entry. RESULTS: Forty-four percent of the clients were the victims of at least one crime during the two months before entering the program. Women were significantly more likely than men to have been victimized. Multivariate analysis showed that the more severe the client's psychotic symptoms, alcohol abuse, and criminal history, the more likely he or she was to have been victimized. Recent victimization had a significant impact on client outcomes in terms of increased homelessness and decreased quality of life. Victimization shortly before program entry was also the single most important predictor of victimization at both follow-up points. CONCLUSIONS: These findings suggest the critical need for service providers who work with homeless people with serious mental illness to assess the extent to which they have been victims of crime and to address issues of victimization and safety along with psychiatric and social adjustment problems.

Community Mental Health Centers↗

The fetal alert network: an innovative program of access to care, surveillance, and education for birth defects in Ontario.

Optimal pregnancy outcomes rely on coordinated timely access to appropriate evidence-based clinical care. This is particularly true for pregnant women carrying fetuses diagnosed with birth defects. A systematic approach to prenatal care is ideal, but Ontario has traditionally lagged behind other regions in this regard. In 2004, in response to this challenge, the Fetal Alert Network (FAN) was established with funding support from the Ontario Ministry of Health and Long-Term Care. FAN is composed of five multidisciplinary regional health care teams of nurse coordinators working in close collaboration with primary obstetrical care providers, medical geneticists, specialists in maternal fetal medicine, and pediatric specialists. The teams facilitate access to subspecialists through patient triage and referral, provide outreach education, and act as local experts and change agents to improve care. A key objective is to go beyond a traditional surveillance system to the linkage of service provision with outcomes and effectiveness. FAN's objectives are to ensure optimal health care access and delivery at all levels, to promote coordination and collaboration among providers, to provide timely and accurate information about health system utilization and clinical outcomes, and to educate patients and primary care providers about prenatal diagnosis. Program evaluation is currently underway. Preliminary analyses indicate that achievement of these objectives has resulted in seamless coordinated access to service for the targeted group of patients, as well as enhanced communication among providers; accessible education and information; and precise, accurate, and timely health care data and information.

Adult↗

Ongoing challenges of a global international patient assistance program.

The Glivec International Patient Assistance Program (GIPAP) that is supported by Novartis Oncology provides Glivec (imatinib), an innovative oral therapy for chronic myelogenous leukemia and gastrointestinal stromal tumours, at no cost to patients in developing countries who could otherwise not afford treatment. Using a novel direct-to-patient approach this program is currently successfully providing Glivec to underserved patients in 81 countries. A number of challenges were faced in the implementation of this program in countries where cancer is not a priority, and where the healthcare and other infrastructure can be very limited. By working within the existing healthcare system of each country, and with any national cancer control programme that may be in place, through careful selection of qualified institutions and physicians, while maintaining a global approach to ensure consistency and quality, GIPAP has become an efficient and sustainable access program. Novartis has made a long-term commitment to GIPAP, and is currently exploring new patient access programs for other drugs.

Administration, Oral↗

Gefitinib (ZD1839) monotherapy as a salvage regimen for previously treated advanced non-small cell lung cancer.

PURPOSE: A worldwide compassionate-use program has enabled >42,000 patients with advanced non-small cell lung cancer (NSCLC) to receive gefitinib treatment. Here we report the outcome of gefitinib therapy in patients who enrolled in the "Iressa" Expanded Access Program at the Samsung Medical Center. EXPERIMENTAL DESIGN: Patients with advanced or metastatic NSCLC who had progressed after prior systemic chemotherapy and for whom no other treatment option was available were eligible to receive gefitinib treatment as part of the Expanded Access Program. A post hoc assessment of potential prognostic factors for response and survival was performed by multivariate analysis. RESULTS: All 111 evaluable patients had stage IV disease; most patients had a baseline performance status of 2 [n = 52 (47%)] or 3 [n = 18 (16%)] and had received >/=2 prior chemotherapy regimens (56%). The objective response rate was 26%, the disease control rate (measured over >/=8 weeks) was 40%, and the 1-year survival rate was 44%. Adenocarcinoma histology was associated with better response and disease control rates, and a performance status of 0-2 was also associated with a better disease control rate. Both of these factors, as well as female gender, were significantly associated with longer survival. Gefitinib was well tolerated; the most common adverse event was grade 1 skin rash. CONCLUSIONS: Gefitinib demonstrated significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients with poor prognosis.

Adult↗

Diffusion of new technologies in the treatment of the Medicare population. Implications for patient access and program expenditures.

Patterns of diffusion were analyzed for three pairs of technologies: one of each pair represents a very recent innovation, and the other is more established. Tremendous growth in utilization from 1985-89 was documented, primarily due to more patients obtaining access to the technologies. Nevertheless, disturbing differences in levels of use remain between black and white patients.

Adult↗

Tolerability of combined ganciclovir and didanosine for the treatment of cytomegalovirus disease associated with AIDS.

Ganciclovir is one of only two drugs licensed by the U.S. Food and Drug Administration for the treatment of opportunistic cytomegalovirus (CMV) disease. The combination of ganciclovir and zidovudine has been reported to be poorly tolerated because of dose-limiting hematologic toxicity; thus we retrospectively examined the tolerability of combination therapy with ganciclovir and didanosine in 32 patients with AIDS. These patients were receiving ganciclovir for CMV disease in addition to didanosine in the Videx U.S. Expanded Access Program. During the period of combined therapy, dose-limiting hematologic toxicity (absolute neutrophil count, < 500 cells/microL) developed in only 9.4% of patients and severe anemia (hemoglobin level, < 8.0 g/dL) in only 12.5%. Rates of dose-limiting intolerance to didanosine were similar to those previously reported in the Expanded Access Program. Overall, 15 of 32 patients in the current study tolerated therapeutic doses of didanosine in combination with ganciclovir; in contrast, only 5 of 29 patients tolerated zidovudine (600 mg/d) in combination with ganciclovir in the largest trial of therapy with this combination whose results have been published to date (P = .02, Fisher's exact test). Since recent data suggest that the administration of some form of antiretroviral therapy prolongs survival in patients with CMV retinitis, coadministration of didanosine with ganciclovir should be considered for such patients who do not tolerate other regimens with activity against both retroviruses and CMV.

AIDS-Related Opportunistic Infections↗

Didanosine therapy in patients intolerant of or failing zidovudine therapy.

OBJECTIVE: To examine the effect of didanosine (2',3'-dideoxyinosine, ddI) on surrogate markers of HIV infection (CD4+ lymphocyte count, p24 antigen) and to evaluate the incidence of adverse effects from ddI. DESIGN: This study was performed as a retrospective chart review of patients who were enrolled in Bristol-Myers Squibb's expanded-access program for ddI. SETTING: Patient records were obtained from primary care physicians' offices. PATIENTS: Twenty-five HIV-infected patients diagnosed with AIDS or AIDS-related complex (ARC) who were intolerant of zidovudine (ZDV) therapy or deteriorating clinically despite ZDV therapy and were eligible for inclusion in the ddI expanded-access program. INTERVENTION: ddI was administered orally in a citrate-phosphate buffer every 12 hours. Patients were followed by their private physician on a monthly basis. MAIN OUTCOME MEASURES: Laboratory analysis at each month included CD4+ lymphocyte count, hemoglobin, hematocrit, serum amylase, uric acid, serum triglycerides, and p24 antigen. Mean CD4+ cell count, serum amylase, hemoglobin, and uric acid at each month during ddI therapy were compared with baseline concentrations for nine months. RESULTS: Patients had received prior ZDV therapy for an average of 15.5 months before starting ddI. Mean CD4+ cell counts increased from 53.9/mm3 at baseline to 72.4/mm3 after 4 months of therapy (p = 0.04) but returned to concentrations comparable with those at baseline after 5 months. One case of documented pancreatitis, two cases of suspected pancreatitis, and nine cases of peripheral neuropathy occurred during ddI therapy. The estimated mean cumulative dose for the development of neuropathy was 1.16 g/kg, which is lower than previously reported. CONCLUSIONS: Patients who have received prolonged therapy with ZDV or who have low initial CD4+ counts may not have sustained increases in CD4+ counts from ddI therapy. Also, development of peripheral neuropathy may occur at lower cumulative doses in these patient populations.

AIDS-Related Complex↗

Overcoming service barriers for homeless persons with serious psychiatric disorders.

OBJECTIVE: To help homeless persons with comorbid psychiatric and substance use disorders gain access to community services, in 1993 the Center for Mental Health Services implemented the five-year Access to Community Care and Effective Services, or ACCESS program, in 15 cities. One aim of the program is to encourage collaboration between agencies serving the multiple needs of this population. This study examined the extent of linkages between agencies in the 15 demonstration cities. METHODS: One respondent from each of the 1,060 community-based programs in tie 15 cities rated the extent to which his or her agency was linked with each of the other agencies in the local community in 1994 and again in 1996. Overall, there were 20,801 potential pairwise linkages. Linkages were classified into four types: a mutual tie, in which both agencies send and receive clients; a unidirectional tie, in which one agency sends and the other receives; an attempted tie, in which one agency sends but the other agency does not confirm receiving; and an unattempted tie. RESULTS: In 1994 and 1996, of the 20,801 pairs of potential service linkages, about a third were in place, while the remaining two-thirds were absent. Overall, linkages showed a slight but significant increase between 1994 and 1996. More than half of the linkages changed in type, indicating fluid service systems. CONCLUSIONS: Linkages between community agencies serving homeless persons with comorbid psychiatric and substance use disorders are not extensive. However, they increased slightly under the first two years of the ACCESS program, and there are good reasons to anticipate greater improvements in the future.

Community Mental Health Services↗

Medicaid case management: Kentucky's Patient Access and Care Program.

Since 1981, States have been experimenting with Medicaid managed care programs to improve access and continuity of care and to contain costs by reducing inappropriate and unnecessary utilization. To determine the impact of primary care case management (PCCM) on utilization, the authors examine data from the Kentucky Patient Access and Care program (KenPAC). Using monthly utilization data from 1984 to 1989 and an interrupted time-series research design, the authors find that PCCM reduces the use of independent laboratory, physician, emergency department, and outpatient hospital services. PCCM does not appear to affect utilization of inpatient hospital services or prescription drugs.

Health Services Accessibility↗