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At least 19 recordsLinked to original sources

PubMed2002

Overview of the ACCESS Program. Access to Community Care and Effective Services and Supports.

The authors provide an overview of the ACCESS program (Access to Community Care and Effective Services and Supports), which evaluated the integration of service systems and its impact on outcomes for homeless persons with severe mental illness. The ACCESS program provided funds and technical assistance to nine community sites to implement strategies for system change that would promote systems integration. These experimental sites, along with nine comparison sites, also received funds to support outreach and assertive community treatment for 100 clients a year for four years at each site. Data on the implementation of system change strategies were collected from 1994 to 1998 during annual visits to the sites. Data on changes in systems integration were obtained from interviews with key informants from relevant organizations in each community. Client outcome data were obtained at program entry and three and 12 months later from 7,055 program participants across the four annual client cohorts at all sites. Detailed findings from the ACCESS evaluation are presented in two accompanying articles, and overall conclusions are offered in a fourth article.

Community Mental Health Services↗

PubMed2002

Service systems integration and outcomes for mentally ill homeless persons in the ACCESS program. Access to Community Care and Effective Services and Supports.

OBJECTIVE: The authors evaluated the second of the two core questions around which the ACCESS (Access to Community Care and Effective Services and Supports) evaluation was designed: Does better integration of service systems improve the treatment outcomes of homeless persons with severe mental illness? METHODS: The ACCESS program provided technical support and about $250,000 a year for four years to nine sites to implement strategies to promote systems integration. These sites, along with nine comparison sites, also received funds to support outreach and assertive community treatment programs to assist 100 clients a year at each site. Outcome data were obtained at baseline and three and 12 months later from 7,055 clients across four annual cohorts at all sites. RESULTS: Clients at all sites demonstrated improvement in outcome measures. However, the clients at the experimental sites showed no greater improvement on measures of mental health or housing outcomes across the four cohorts than those at the comparison sites. More extensive implementation of systems integration strategies was unrelated to these outcomes. However, clients of sites that became more integrated, regardless of the degree of implementation or whether the sites were experimental sites or comparison sites, had progressively better housing outcomes. CONCLUSIONS: Interventions designed to increase the level of systems integration in the ACCESS demonstration did not result in better client outcomes.

Community Mental Health Services↗

PubMed1997

Creating integrated service systems for homeless persons with mental illness: the ACCESS Program. Access to Community Care and Effective Services and Supports.

The Access to Community Care and Effective Services and Supports (ACCESS) demonstration program was initiated in 1993 by the U.S. Department of Health and Human Services as part of a national agenda to end homelessness among persons with serious mental illness. Demonstration projects have been established in nine states to develop integrated systems of care for this population. This paper provides an overview of the ACCESS program and presents definitions of services integration and systems integration. Evaluating the effectiveness of integration strategies is a critical aspect of the program. The authors describe the evaluation design and the integration strategies being evaluated and summarize findings from a formative evaluation of the project's first two years. The evaluation revealed several problems that were addressed by providing technical assistance to the states. States were helped to articulate a broader mission of addressing system-level barriers, develop an expanded plan, strengthen the authority of interagency councils, involve leaders at the state and agency levels, and develop joint funding strategies.

Adult↗

PubMed2002

Lessons from the evaluation of the ACCESS program. Access to Community Care and Effective Services.

The authors summarize the main findings of the ACCESS (Access to Community Care and Effective Services) program and offer lessons for policy makers. Data from studies at the site level and the client level, which were presented in the two previous articles in this issue of Psychiatric Services, are summarized and synthesized with the authors' collective experience with the ACCESS program. The results of the evaluation suggest that although service systems integration can be improved, targeted efforts to implement strategies for integration do not produce better client outcomes. Efforts to integrate service systems can be supported by their effects on some organizational relationships within the mental health service system but not by their widespread effects across human services or their direct effects on clients.

Community Mental Health Services↗

PubMed2002

Integration of service systems for homeless persons with serious mental illness through the ACCESS program. Access to Community Care and Effective Services and Supports.

OBJECTIVE: The aim of this study was to evaluate the first of the two core questions around which the ACCESS (Access to Community Care and Effective Services and Supports) evaluation was designed: Does implementation of system-change strategies lead to better integration of service systems? METHODS: The study was part of the five-year federal ACCESS service demonstration program, which sought to enhance integration of service delivery systems for homeless persons with serious mental illness. Data were gathered from nine randomly selected experimental sites and nine comparison sites in 15 of the nation's largest cities on the degree to which each site implemented a set of systems integration strategies and the degree of systems integration that ensued among community agencies across five service sectors: mental health, substance abuse, primary care, housing, and social welfare and entitlement services. Integration was measured across all interorganizational relationships in the local service networks (overall systems integration) and across relationships involving only the primary ACCESS grantee organization (project-centered integration). RESULTS: Contrary to expectations, the nine experimental sites did not demonstrate significantly greater overall systems integration than the nine comparison sites. However, the experimental sites demonstrated better project-centered integration than the comparison sites. Moreover, more extensive implementation of strategies for system change was associated with higher levels of overall systems integration as well as project-centered integration at both the experimental sites and the comparison sites. CONCLUSIONS: The ACCESS demonstration was successful in terms of project-centered integration but not overall system integration.

Community Mental Health Services↗

PubMed2006

Single-arm, open label study of pemetrexed plus cisplatin in chemotherapy naïve patients with malignant pleural mesothelioma: outcomes of an expanded access program.

BACKGROUND: An expanded access program (EAP) provided patient access to pemetrexed prior to its commercial availability. The current report consists of US patients in the EAP who had chemotherapy naïve pleural mesothelioma. METHODS: Eligible patients had a histologic or cytologic diagnosis of malignant mesothelioma that was not amenable to curative treatment with surgery. Study treatment consisted of pemetrexed 500mg/m(2) in combination with cisplatin 75mg/m(2) once every 21 days. Vitamin B12, folic acid, and dexamethasone were administered as prophylaxis. Serious adverse events (SAEs) were reported by investigators and compiled in a pharmacovigilance database for all patients enrolled in the EAP. RESULTS: Of 1056 patients receiving at least one dose of pemetrexed in the EAP, 728 had chemotherapy naïve pleural mesothelioma. Median age of this group was 70 years (range 23-89 years) and 84% were male. Among 615 patients, overall response rate was 20.5%, including 12 complete responses (2.0%) and 114 partial responses (18.5%). An additional 290 patients (47.2%) had stable disease. Median survival for all 728 patients was 10.8 months (95% CI=9.8, 12.3; 60.3% censorship) and 1 year survival was 45.4%. The most commonly reported SAEs in the overall EAP irrespective of causality were dehydration (7.2%), nausea (5.2%), vomiting (4.9%), dyspnea (3.8%), and pulmonary embolism (2.4%). CONCLUSIONS: In this large cohort, 67.7% of patients treated with first-line chemotherapy experienced a response or stable disease. Survival time and toxicity from this EAP were promising for this difficult-to-treat disease.

Adult↗

PubMed2003

Use of program logic models in the Southern Rural Access Program evaluation.

The Southern Rural Access Program (SRAP) evaluation team used program logic models to clarify grantees' activities, objectives, and timelines. This information was used to benchmark data from grantees' progress reports to assess the program's successes. This article presents a brief background on the use of program logic models--essentially charts or diagrams specifying a program's planned activities, objectives, and goals--for evaluating and managing a program. It discusses the structure of the logic models chosen for the SRAP and how the model concept was introduced to the grantees to promote acceptance and use of the models. The article describes how the models helped clarify the program's objectives and helped lead agencies plan and manage the many program initiatives and subcontractors in their states. Models also provided a framework for grantees to report their progress to the National Program Office and evaluators and promoted the evaluators' visibility and acceptance by the grantees. Program logics, however, increased grantees' reporting requirements and demanded substantial time of the evaluators. Program logic models, on balance, proved their merit in the SRAP through their contributions to its management and evaluation and by providing a better understanding of the program's initiatives, successes, and potential impact.

Benchmarking↗

PubMed1994

Rates and risk factors for adverse events associated with didanosine in the expanded access program.

The didanosine Expanded Access Program was the largest AIDS treatment program to prospectively evaluate the safety of an antiretroviral agent among patients with advanced human immunodeficiency virus (HIV) disease in whom therapy with zidovudine was failing. A total of 21,198 patients who had infections refractory to zidovudine or who were intolerant of the drug received didanosine as a buffered powder for oral solution (sachet), with total daily doses of 6.6-10 mg/kg; the median CD4 lymphocyte count was 0.04 x 10(9)/L for this population. At the currently recommended dose (6.6-8.29 mg/[kg.d]), 6-month estimated rates of pancreatitis ranged from 1.2% for patients with AIDS-related complex (ARC) and CD4 lymphocyte counts of > or = 0.1 x 10(9)/L to 6.7% for patients with AIDS and CD4 lymphocyte counts of < 0.05 x 10(9)/L. Laboratory toxicities of World Health Organization grades 3 and 4 developed in fewer than 4% of patients entering the study with normal baseline values; the sole exception was leukopenia, which was documented in 8% of these patients. The results of this program demonstrated that patients with CD4 lymphocyte counts of < 0.10 x 10(9)/L or with a diagnosis of AIDS (defined by the 1987 classification system of the Centers for Disease Control and Prevention) were less tolerant of didanosine and significantly more likely to develop adverse clinical reactions and myelosuppression than other patients.

Acquired Immunodeficiency Syndrome↗

PubMed2003

Improving access to capital for health care infrastructure: the experience of the Southern Rural Access Program's revolving loan fund.

Lack of access to affordable capital is a formidable barrier that compromises rural health care infrastructure development in poor rural areas. Commercial lending institutions are often limited in their ability to respond to those needs due to traditional lending criteria: creditworthiness, equity, management ability, experiences, and cash flow or profits. In the Southern Rural Access Program, a development model more frequently used in other sectors has been successfully applied to health care to help clear these hurdles. This paper describes the 5 operational loan funds in Arkansas, Louisiana, Mississippi, South Carolina, and West Virginia receiving support from the Southern Rural Access Program. Two models of loan funds have evolved: those led by health agencies and those led by community development finance institutions whose mission is rural economic development. This paper outlines major distinctive features of these 2 approaches and describes major implementation challenges these loan funds face. Key accomplishments are high-lighted, including the ability to leverage additional resources from state, federal, philanthropic, and private sources through these funds. These loan fund programs provide models for other states interested in improving access to capital to help build the rural health care infrastructure while making health care more economically viable through integration with other community development initiatives.

Capital Financing↗

PubMed2001

Safety profile and tolerability of amprenavir in patients enrolled in an early access program.

BACKGROUND: The amprenavir (APV) early or expanded access program was designed to provide open-label APV to patients who would potentially receive benefit beyond that expected from currently available protease inhibitors (PIs) and who were at risk of disease progression before the drug's expected time of regulatory approval. OBJECTIVE: This study was conducted as part of an early access program to assess the safety profile and tolerability of APV in adults and children (> or =4 years of age) who were either intolerant to or, in the opinion of the patient's physician, virologically failing a previous PI-containing antiretroviral regimen. Specific CD4+ cell count and viral load limits were not imposed by this early access protocol. METHODS: This open-label, nonrandomized study was conducted at multiple sites throughout the United States. Adults received APV at a dosage of 1200 mg BID. Patients weighing <50 kg received APV at a dosage of 20 mg/kg BID for the solid formulation or 1.5 mL/kg BID for the liquid formulation. RESULTS: A total of 489 physicians registered for this program; 364 (74.4%) enrolled patients. The safety population of 2217 patients (2048 males [92.4%] and 169 females [7.6%] aged 2 to 74 years) received APV for a median duration of 85 days (range, 2-218 days). Patients in the intent-to-treat population (n = 1427) had extensive experience with antiretroviral therapy. Drug-related treatment-emergent adverse events reported in >3% of patients in the safety population were nausea in 279 patients (12.6%), diarrhea in 197 patients (8.9%), rash in 177 patients (8.0%), vomiting in 148 patients (6.7%), and fatigue in 89 patients (4.0%). Adverse events and laboratory test abnormalities were graded for severity on a scale of 1 to 4 in accordance with AIDS Clinical Trials Group guidelines. Grade 3 treatment-emergent abnormal laboratory values regardless of causality occurring in >3% of patients were neutropenia in 69 of 1887 patients (3.7%; grade 3 toxicity = 500-749/mm3) and elevated triglycerides in 80 of 1593 patients (5.0%; grade 3 toxicity = 751-1200 mg/dL). Most common grade 4 treatment-emergent laboratory abnormalities were elevated serum creatine phosphokinase levels in 36 of 1266 patients (2.8%; grade 4 = >6 times upper normal limit), elevated triglycerides in 39 of 1593 patients (2.4%), and neutropenia in 41 of 1887 patients (2.2%). CONCLUSIONS: The results of this large cohort of patients support the data from the phase II/III clinical development program and suggest that APV has an acceptable safety profile and is generally well tolerated when used in combination with other antiretroviral drugs in a heavily treatment-experienced, heterogeneous patient population.

Adolescent↗

PubMed1995

Establishing a direct laboratory access program.

Direct Laboratory Access (DLA) refers to a program whereby individuals who wish to have laboratory testing performed can avail themselves of such testing independently of a physician referral. DLA benefits both physicians and consumers. Physicians benefit by not having to invest time and office resources for consumers who do not seek medical intervention but rather who visit physicians for the sole purpose of obtaining permission to have laboratory tests performed. Consumers benefit by avoiding physician encounters they do not want, by receiving state-of-the-art laboratory testing they do want, and by avoiding the added expense and inconvenience of a physician office visit. DLA appeals to an anxious, educated, and somewhat affluent niche market. The program fills a void in the provision of health services while providing a small stream of revenue for laboratories.

Clinical Laboratory Techniques↗

PubMed1993

The didanosine Expanded Access Program: safety analysis.

The didanosine Expanded Access Program was designed by the Bristol-Myers Squibb Company (Princeton, NJ) to provide didanosine for treatment of patients who could not be enrolled in clinical trials. This program consisted of two protocols: a treatment IND (investigational new drug) protocol for patients intolerant of zidovudine and an open-label protocol for patients whose clinical condition was deteriorating despite continued therapy with zidovudine. Information from the safety data base derived from study of the first 7,806 patients enrolled has shown that the major adverse events associated with didanosine therapy are pancreatitis (which can be life-threatening), peripheral neuropathy, and diarrhea. Pancreatitis was reported for 5% of the patients. Those with a history of pancreatitis were more likely to develop pancreatitis. In contrast to zidovudine, didanosine has been found to be minimally myelosuppressive. In general, hematologic parameters remained stable, especially for patients who entered the program with normal baseline values. The results of this program suggest that patients pretreated with zidovudine for prolonged periods are able to tolerate didanosine well.

Clinical Protocols↗

PubMed2002

Reboxetine: a preliminary report on its use through the Special Access Program.

OBJECTIVE: To describe the effectiveness and tolerability of reboxetine under Special Access Program conditions in Canada in a group of patients with refractory depressive disorders. DESIGN: Retrospective open-label study. SETTING: Six clinical academic settings in Canada, primarily tertiary institutional settings. PATIENTS: Twenty-six female and 19 male outpatients with depressive disorders, primarily unipolar depression. Most of the patients were treatment resistant. INTERVENTION: Reboxetine through the Special Access Program. OUTCOME MEASURE: Severity of depression before treatment with reboxetine was retrospectively assessed with the Clinical Global Impression (CGI) Global Severity Scale; change with treatment was evaluated with the CGI Global Improvement Scale. RESULTS: Before reboxetine treatment, 20 (44%) patients scored in the moderate CGI severity category, 11 (24%) in the marked category and 12 (27%) in the severe category. The dose range for reboxetine was 2-16 mg, with 40 (89%) patients in the 4-10 mg range. With reboxetine treatment, 25 (56%) patients were considered "very much improved" or "much improved"; 8 (18%) patients were "minimally improved"; 7 (16%) received ratings that reflected "no change" or minimal worsening, and 5 (11%) were rated as "much worse" or "very much worse." CONCLUSIONS: Reboxetine was effective at a clinically meaningful level in decreasing severity of depression in 56% of patients. Given the high rate of prior resistance to other antidepressant therapies, there is a definite role for this agent in the treatment of depressive disorders.

Adrenergic Uptake Inhibitors↗

PubMed2003

Southern Rural Access Program: an overview.

Rural residents experience significant disparities in health status and access to care. These disparities and access barriers are particularly prevalent in rural communities in the South. The Southern Rural Access Program, a national program of the Robert Wood Johnson Foundation, was designed as a long-term effort to improve access to basic health care in 8 of the most underserved states in the country. The program was launched in 1998 with 3 goals: (1) to increase the supply of providers in underserved areas, (2) to strengthen the health care infrastructure, and (3) to build capacity at the state and community level to solve problems. The first 3-year phase of the program made $13.8 million available to communities in the 8 target states, and a January 2002 reauthorization of the program will make an additional $18.9 million available in the next 4 years. This article will provide an overview of the Southern Rural Access Program, focusing on the development and evolution of the program during its first 3-year phase. The article will also highlight some of the refinements that the foundation has made during the 2002-2006 second phase of the program.

Community Health Planning↗

PubMed2000

Louisiana Rural Health Access Program.

Louisiana Rural Health Access is part of a Robert Wood Johnson Foundation project to address primary and preventive medical care for indigent, uninsured people residing in underserved rural parishes. This 15-month grant funds the development of a pilot program to improve access to health care in Acadia, Evangeline, Iberia, Lafayette, St Landry, St Martin, St Mary, and Vermilion parishes. Led by representatives from the Department of Health and Hospitals and the Louisiana State University Health Sciences Center, team committees designed the program's innovative use of telemedicine, loan development, network integration, and community involvement. A benefit of the program will be to measure the outcomes of each objective in order to determine which intervention works best. This information will be invaluable for the design of a five-year rural health care development plan.

Capital Financing↗

PubMed2003

Lessons learned in phase I of the Southern Rural Access Program.

The Robert Wood Johnson Foundation's Southern Rural Access Program has been an important investment of philanthropic funds to augment resources and improve health care access in underserved rural communities. The program's first phase has taught important lessons about building capacity in rural health care. This article uses a variety of data to document the program's major accomplishments and most significant challenges to date. The program's revolving loan fund efforts are promising. The program has also played a catalytic role in stimulating rural health network development in the South and has helped stimulate partnerships with Southern philanthropies and multiple local, state, and federal agencies. Challenges have included the broad geographic and programmatic focus of the initiative as well as changing and often difficult state policy environments. Additional challenges include maintaining interagency coordination over time and managing staff and lead agency turnover. Overall, the experience suggests that a concentrated regional approach has merit.

Community Health Planning↗

PubMed1983

Linn County Dental Health Center--a successful dental public health access program of treatment and prevention.

The Linn County Dental Health Center is an example of what appears to be a highly successful dental society access program. A target population, the children of the poor and working poor in Linn County, have an opportunity to enter a system of continuous dental care for the prevention and control of dental disease. This example of dental society and community involvement, in the form of the ADA's guidelines for establishment and management of such access programs, may provide an impetus for action by other concerned individuals and dental societies.

Adolescent↗

PubMed2002

Abacavir expanded access program for adult patients infected with human immunodeficiency virus type 1.

Expanded access programs (EAPs) provide medication to patients with life-threatening, treatment-refractory illnesses before regulatory approval and allow the acquisition of safety information. A 2-part, multisite EAP to evaluate abacavir, a carbocyclic nucleoside reverse-transcriptase inhibitor for use in combination antiretroviral therapy, was conducted. The EAP involved >13,000 adults infected with human immunodeficiency virus type 1 (HIV-1) who no longer responded to commercially available treatment regimens. Part A (open-label trials) examined the efficacy, safety, and tolerance of abacavir, and part B (provision of abacavir through expanded access) assessed only the occurrence of serious adverse events. By month 2 of abacavir-containing treatment, plasma HIV-1 RNA levels decreased by > or =0.5 log(10) in 31.4% of patients, and 5.6% of the patients had HIV-1 RNA levels decrease to <400 copies/mL. Drug-related serious adverse events were reported by 7.7% of patients, the most common of which were nausea, skin rash, diarrhea, malaise or fatigue, and fever. Approximately 4.6% of patients experienced a hypersensitivity reaction that was possibly drug related. Overall, the types and incidences of adverse events reported in the abacavir EAP were similar to those reported in phase 2 and 3 clinical trials evaluating abacavir.

Adult↗