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1.
N Engl J Med ; 381(1): 13-24, 2019 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-31150574

RESUMO

BACKGROUND: Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined. METHODS: In this double-blind, phase 3 trial, we randomly assigned patients with metastatic, castration-sensitive prostate cancer to receive apalutamide (240 mg per day) or placebo, added to ADT. Previous treatment for localized disease and previous docetaxel therapy were allowed. The primary end points were radiographic progression-free survival and overall survival. RESULTS: A total of 525 patients were assigned to receive apalutamide plus ADT and 527 to receive placebo plus ADT. The median age was 68 years. A total of 16.4% of the patients had undergone prostatectomy or received radiotherapy for localized disease, and 10.7% had received previous docetaxel therapy; 62.7% had high-volume disease, and 37.3% had low-volume disease. At the first interim analysis, with a median of 22.7 months of follow-up, the percentage of patients with radiographic progression-free survival at 24 months was 68.2% in the apalutamide group and 47.5% in the placebo group (hazard ratio for radiographic progression or death, 0.48; 95% confidence interval [CI], 0.39 to 0.60; P<0.001). Overall survival at 24 months was also greater with apalutamide than with placebo (82.4% in the apalutamide group vs. 73.5% in the placebo group; hazard ratio for death, 0.67; 95% CI, 0.51 to 0.89; P = 0.005). The frequency of grade 3 or 4 adverse events was 42.2% in the apalutamide group and 40.8% in the placebo group; rash was more common in the apalutamide group. CONCLUSIONS: In this trial involving patients with metastatic, castration-sensitive prostate cancer, overall survival and radiographic progression-free survival were significantly longer with the addition of apalutamide to ADT than with placebo plus ADT, and the side-effect profile did not differ substantially between the two groups. (Funded by Janssen Research and Development; TITAN ClinicalTrials.gov number, NCT02489318.).


Assuntos
Adenocarcinoma/tratamento farmacológico , Antagonistas de Androgênios/uso terapêutico , Antagonistas de Receptores de Andrógenos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Tioidantoínas/uso terapêutico , Adenocarcinoma/mortalidade , Adenocarcinoma/patologia , Adenocarcinoma/secundário , Adulto , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Androgênios/efeitos adversos , Antagonistas de Receptores de Andrógenos/efeitos adversos , Método Duplo-Cego , Exantema/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Intervalo Livre de Progressão , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/patologia , Qualidade de Vida , Radiografia , Tioidantoínas/efeitos adversos
2.
Cancer ; 125(15): 2610-2620, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31173362

RESUMO

BACKGROUND: We performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS). METHODS: Patients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every 3 weeks. The primary objective was overall survival (OS). Secondary objectives were progression-free survival, objective response rate, safety, and patient-reported outcomes, all previously reported and demonstrating superior disease control with trabectedin. Results of the final OS analysis in preplanned subgroups of patients with LPS/LMS are presented. RESULTS: At the time of the final OS analysis, 577 patients had been assigned randomly, including 423 (73%) with LMS and 154 (27%) with LPS. The median duration of treatment exposure was higher in the trabectedin arm compared with the dacarbazine arm (4 vs 2 cycles), as was the proportion of patients receiving an extended number of therapy courses (≥6 cycles: 42% vs 22%). This pattern was consistent across histological subgroups: the median number of treatment cycles (4 vs 2 for both subgroups) and proportion of patients with ≥6 treatment cycles (LMS, 43% vs 24%; LPS, 40% vs 16%). Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49). Sensitivity analyses of OS suggest confounding by post-study anticancer therapies, which were utilized in most patients in both treatment arms (71% vs 69%, respectively). CONCLUSION: The final OS results demonstrated comparable survival between LPS/LMS patients receiving trabectedin or dacarbazine, which is consistent with the interim analysis results. Both LPS and LMS demonstrated improved disease control with trabectedin.

3.
J Ment Health ; : 1-9, 2019 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-30862215

RESUMO

BACKGROUND: Understanding consumer service preferences is important for recovery-oriented care. AIMS: To test the influence of perceived service needs on importance attached to treatment for alcohol, drug, mental health, and physical health problems and identify the influence of service needs and preferences on service use. METHODS: Formerly homeless dually diagnosed Veterans in supported housing were surveyed in three waves for 1 year, with measures of treatment interests, health problems, social support, clinician-assessed risk of housing loss, and sociodemographics. Multiple regression analysis was used to identify independent influences on preferences in each wave. Different health services at the VA were distinguished in administrative records and baseline predictors for services used throughout the project were identified with multiple regression analysis. RESULTS: Self-assessed problem severity was associated with the importance of treatment for alcohol, drug, mental health, and physical health problems. Social support also had some association with treatment interest for alcohol abuse, as did baseline clinician risk rating at the project's end. Preferences, but not perceived problem severity, predicted the use of the corresponding health services. CONCLUSIONS: The health beliefs model of service interests was supported, but more integrated service delivery models may be needed to strengthen the association of health needs with service use.

4.
Psychiatr Serv ; 70(4): 333-336, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30755129

RESUMO

OBJECTIVE:: Peer specialists are individuals with behavioral disorders who complete training to use their experiences to help others with similar disorders. Recent analyses have suggested that greater engagement with peer specialist services is associated with fewer psychiatric symptoms. This study assessed predictors of engagement with peer specialist services. METHODS:: Using the Andersen model of health service utilization with a sample of veterans (N=71) receiving housing support, investigators constructed a negative binomial regression model to evaluate the association between peer specialist service engagement and the model's three factors assessed at baseline of a larger trial: predisposing (personal demographic and social variables); enabling (support variables), and need (perceived and evaluated health problems). Demographic characteristics and behavioral health service use six months before baseline were also predictors. RESULTS:: Greater hope (predisposing), psychiatric symptoms (need), and service utilization significantly predicted greater peer specialist engagement. CONCLUSIONS:: These results suggest subpopulations with whom peer specialists would be most likely to engage successfully, perhaps improving their efficiency.

5.
Implement Sci ; 14(1): 5, 2019 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-30658658

RESUMO

BACKGROUND: Mitigating the risks of adverse outcomes from opioids is critical. Thus, the Veterans Affairs (VA) Healthcare System developed the Stratification Tool for Opioid Risk Management (STORM), a dashboard to assist clinicians with opioid risk evaluation and mitigation. Updated daily, STORM calculates a "risk score" of adverse outcomes (e.g., suicide-related events, overdoses, overdose death) from variables in the VA medical record for all patients with an opioid prescription and displays this information along with documentation of recommended risk mitigation strategies and non-opioid pain treatments. In March 2018, the VA issued a policy notice requiring VA Medical Centers (VAMCs) to complete case reviews for patients whom STORM identifies as very high-risk (i.e., top 1% of STORM risk scores). Half of VAMCs were randomly assigned notices that also stated that additional support and oversight would be required for VAMCs that failed to meet an established percentage of case reviews. Using a stepped-wedge cluster randomized design, VAMCs will be further randomized to conduct case reviews for an expanded pool of patients (top 5% of STORM risk scores vs. 1%) starting either 9 or 15 months after the notice was released, creating four natural arms. VA commissioned an evaluation to understand the implementation strategies and factors associated with case review completion rates, whose protocol is described in this report. METHODS: This mixed-method study will include an online survey of all VAMCs to identify implementation strategies and interviews at a subset of facilities to identify implementation barriers and facilitators. The survey is based on the Expert Recommendations for Implementing Change (ERIC) project, which engaged experts to create consensus on 73 implementation strategies. We will use regression models to compare the number and types of implementation strategies across arms and their association with case review completion rates. Using questions from the Consolidated Framework for Implementation Research, we will interview stakeholders at 40 VAMCs with the highest and lowest adherence to opioid therapy guidelines. DISCUSSION: By identifying which implementation strategies, barriers, and facilitators influence case reviews to reduce opioid-related adverse outcomes, this unique implementation evaluation will enable the VA to improve the design of future opioid safety initiatives. TRIAL REGISTRATION: This project is registered at the ISRCTN Registry with number ISRCTN16012111 . The trial was first registered on 5/3/2017.


Assuntos
Analgésicos Opioides/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Overdose de Drogas/prevenção & controle , Implementação de Plano de Saúde , Política de Saúde , Humanos , Estudos Multicêntricos como Assunto , Política Organizacional , Ensaios Clínicos Controlados Aleatórios como Assunto , Gestão de Riscos/organização & administração , Estados Unidos , United States Department of Veterans Affairs
6.
Psychol Serv ; 2018 Nov 08.
Artigo em Inglês | MEDLINE | ID: mdl-30407058

RESUMO

Although peer specialists play an increasing role in mental health service delivery, little is known about the best program structures for maximizing effective service delivery. This study reports on qualitative data from a larger study on peer specialists working with veterans in a Veterans Affairs homelessness program who were dually diagnosed with substance abuse and mental health concerns. Peer specialists were trained to deliver a recovery support program that is carried out weekly over 9 months and includes 20 structured sessions using a workbook and 20 unstructured, individually planned sessions. A sample of 20 veterans who were in the program were interviewed, along with 8 case managers and 3 peer specialists involved with the program. Interview transcripts were coded for 3 elements of program structure: time, content, and delivery. Results show that the program structure allowed flexibility for individual needs and that the workbook sessions were useful. Veterans ascribed value to the peer specialist delivering the content, compared to working alone on the material. Deliberate use of unstructured time with the peer specialist was seen as reducing isolation, increasing community integration, and encouraging recovery activities. The weekly, dependable nature of the program was seen as highly positive, whereas the 9-month duration was seen as too short. All groups interviewed expressed satisfaction with the program, although the case managers reported some reservations related to supervision and boundaries. Results suggest that, compared to completely structured or unstructured approaches that are common for peer specialist services, a middle level of structure for peer specialist programs could be a useful alternative. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

7.
Psychiatr Serv ; : appips201800118, 2018 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-30286707

RESUMO

OBJECTIVE:: Peer specialists are individuals with mental illness and substance use disorders trained to use their experiences to help others with similar disorders. Evidence for the effectiveness of peer specialist services has been mixed in previous randomized trials using intent-to-treat analyses, possibly because of variation in the intensity of treatment delivered. This study, which was part of a larger randomized trial, assessed whether level of peer specialist engagement was associated with reliable positive change on measures of psychiatric symptoms and hope. METHODS:: The Reliable Change Index was used to compute whether veterans (N=140) achieved reliable positive change on standardized baseline-to-posttest assessments of psychiatric symptoms and hope. Logistic regression analyses were conducted to predict positive change in symptoms and hope by level of peer specialist engagement, with controls for relevant demographic factors, several baseline mental health and substance abuse measures, and service use during the study. RESULTS:: Logistic regression models showed that veterans with higher peer specialist engagement were more likely than those in a control group to show reliable positive change in psychiatric symptoms but not in hope. Compared with the control group, those with lower peer specialist engagement did not show positive change on either measure. White veterans were less likely than those from minority groups to exhibit positive change in psychiatric symptoms. CONCLUSIONS:: Results suggest that peer specialists can benefit those with mental illnesses and substance use disorders who engage in more frequent interactions. Studies are needed to further assess the circumstances under which peer specialists can be effective.

8.
BMC Health Serv Res ; 18(1): 332, 2018 05 05.
Artigo em Inglês | MEDLINE | ID: mdl-29728148

RESUMO

BACKGROUND: Evidence-based treatment for co-occurring disorders is needed within programs that serve homeless Veterans to assist with increasing engagement in care and to prevent future housing loss. A specialized co-occurring disorders treatment engagement intervention called Maintaining Independence and Sobriety Through Systems Integration, Outreach and Networking - Veterans Edition (MISSION-Vet) was implemented within the Housing and Urban Development - Veterans Affairs Supportive Housing (HUD-VASH) Programs with and without an implementation strategy called Getting To Outcomes (GTO). While implementation was modest for the GTO group, no one adopted MISSION in the non-GTO group. This paper reports Veteran level outcome data on treatment engagement and select behavioral health outcomes for Veterans exposed to the MISSION-Vet model compared to Veterans without access to MISSION-Vet. METHODS: This hybrid Type III trial compared 81 Veterans in the GTO group to a similar group of 87 Veterans with mental health and substance use disorders from the caseload of staff in the non-GTO group. Comparisons were made on treatment engagement, negative housing exits, drug and alcohol abuse, inpatient hospitalizations, emergency department visits and income level over time, using mixed-effect or Cox regression models. RESULTS: Treatment engagement, as measured by the overall number of case manager contacts with Veterans and others (e.g. family members, health providers), was significantly higher among Veterans in the GTO group (B = 2.30, p = .04). Supplemental exploratory analyses between Veterans who received "higher" and "lower" intensity MISSION-Vet services in the GTO group failed to show differences in alcohol and drug use, inpatient hospitalization and emergency department use. CONCLUSIONS: Despite modest MISSION-Vet fidelity among staff treating Veterans in the GTO group, differences were found in treatment engagement. However, this study failed to show differences in alcohol use, drug use, mental health hospitalizations and negative housing exits over time among those Veterans receiving higher intensity MISSION-Vet services versus low intensity services. This project suggests that MISSION-Vet could be used in HUD-VASH to increase engagement among Veterans struggling with homelessness, a group often disconnected from care. TRIAL REGISTRATION: Clinicaltrials.gov, registration number: NCT01430741 , registered July 26, 2011.


Assuntos
Pessoas em Situação de Rua/psicologia , Transtornos Mentais/terapia , Veteranos/psicologia , Medicina Baseada em Evidências , Feminino , Pessoas em Situação de Rua/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Habitação/estatística & dados numéricos , Humanos , Masculino , Saúde Mental , Serviços de Saúde Mental/estatística & dados numéricos , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Substâncias/terapia , Resultado do Tratamento , Estados Unidos , United States Department of Veterans Affairs , Veteranos/estatística & dados numéricos
9.
Gynecol Oncol ; 146(3): 531-537, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28651804

RESUMO

OBJECTIVE: Trabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%). METHODS: Of 577 patients randomized 2:1 to receive trabectedin 1.5mg/m2 by 24-hour IV infusion or dacarbazine 1g/m2 by 20-120-minute IV infusion once every three weeks, 232 had uLMS (trabectedin: 144; dacarbazine: 88). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR: complete responses+partial responses+stable disease [SD] for at least 18weeks), duration of response (DOR), and safety. RESULTS: PFS for trabectedin was 4.0months compared with 1.5months for dacarbazine (hazard ratio [HR]=0.57; 95% CI 0.41-0.81; P=0.0012). OS was similar (trabectedin 13.4months vs. dacarbazine 12.9months, HR=0.89; 95% CI 0.65-1.24; P=0.51) between groups. ORR was 11% with trabectedin vs. 9% with dacarbazine (P=0.82). CBR for trabectedin was 31% vs. 18% with dacarbazine (P=0.05); median DOR was 6.5months for trabectedin vs. 4.1months for dacarbazine (P=0.32). Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients in the trabectedin group included transient aminotransferase (aspartate/alanine) elevations, anemia, leukopenia, and thrombocytopenia. CONCLUSIONS: In this post hoc subset analysis of patients with uLMS who had received prior anthracycline therapy, trabectedin treatment resulted in significantly longer PFS versus dacarbazine, with an acceptable safety profile. There was no difference in OS.


Assuntos
Antineoplásicos Alquilantes/uso terapêutico , Dacarbazina/uso terapêutico , Dioxóis/uso terapêutico , Leiomiossarcoma/tratamento farmacológico , Tetra-Hidroisoquinolinas/uso terapêutico , Neoplasias Uterinas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Alanina Transaminase/sangue , Anemia/induzido quimicamente , Antraciclinas/uso terapêutico , Aspartato Aminotransferases/sangue , Dacarbazina/efeitos adversos , Dioxóis/efeitos adversos , Intervalo Livre de Doença , Feminino , Humanos , Leucopenia/induzido quimicamente , Pessoa de Meia-Idade , Retratamento , Taxa de Sobrevida , Tetra-Hidroisoquinolinas/efeitos adversos , Trombocitopenia/induzido quimicamente , Trabectedina , Falha de Tratamento
10.
Implement Sci ; 12(1): 57, 2017 05 02.
Artigo em Inglês | MEDLINE | ID: mdl-28464935

RESUMO

BACKGROUND: Over 1100 Veterans work in the Veterans Health Administration (VHA) as peer specialists (PSs). PSs are Veterans with formal training who provide support to other Veterans with similar diagnoses, primarily in mental health settings. A White House Executive Action mandated the pilot reassignment of VHA PSs from mental health to 25 primary care Patient Aligned Care Teams (PACT) in order to broaden the provision of wellness services that can address many chronic illnesses. An evaluation of this initiative was undertaken to assess the impact of outside assistance on the deployment of PS in PACT, as implementation support is often needed to prevent challenges commonly experienced when first deploying PSs in VHA settings. We present the protocol for this cluster-randomized hybrid type II trial to test the impact of standard implementation (receive minimal assistance) vs. facilitated implementation (receive outside assistance) on the deployment of VHA PSs in PACT. METHODS: A VHA Office of Mental Health Services work group is recruiting 25 Veterans Affairs Medical Centers to reassign a mental health PSs to provide wellness-oriented care in PACT. Sites in three successive cohorts (n = 8, 8, 9) beginning over 6-month blocks will be matched and randomized to either standard or facilitated implementation. In facilitated implementation, an outside expert works with site stakeholders through a site visit, regular calls, and performance data to guide the planning and address challenges. Standard implementation sites will receive a webinar and access the Office of Mental Health Services work group. The two conditions will be compared on PS workload data, fidelity to the PS model of service delivery, team functioning, and Veteran measures of activation, satisfaction, and functioning. Qualitative interviews will collect information on implementation barriers and facilitators. DISCUSSION: This evaluation will provide critical data to guide administrators and VHA policy makers on future deployment of PSs, as their role has been expanding beyond mental health. In addition, development of novel implementation strategies (facilitation tailored to PSs) and the use of new tools (peer fidelity) can be models for monitoring and supporting deployment of PSs throughout VHA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02732600 (URL: https://clinicaltrials.gov/ct2/show/NCT02732600 ).


Assuntos
Serviços de Saúde Mental/normas , Equipe de Assistência ao Paciente/normas , Assistência Centrada no Paciente/normas , Grupo Associado , United States Department of Veterans Affairs/normas , Saúde dos Veteranos/normas , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
11.
Implement Sci ; 12(1): 34, 2017 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-28279207

RESUMO

BACKGROUND: Incorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO). METHODS: This Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview. RESULTS: No case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet. CONCLUSIONS: This project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence-based program like MISSION-Vet. TRIAL REGISTRATION: ClinicalTrials.gov NCT01430741.


Assuntos
Prática Clínica Baseada em Evidências/métodos , Pessoas em Situação de Rua/estatística & dados numéricos , Transtornos Mentais/terapia , Avaliação de Programas e Projetos de Saúde/estatística & dados numéricos , Transtornos Relacionados ao Uso de Substâncias/terapia , Veteranos/estatística & dados numéricos , Administração de Caso/estatística & dados numéricos , Análise por Conglomerados , Implementação de Plano de Saúde/métodos , Humanos , Estados Unidos , United States Department of Veterans Affairs
12.
Psychiatr Rehabil J ; 39(3): 256-65, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27618462

RESUMO

OBJECTIVE: Research on peer specialists (individuals with serious mental illness supporting others with serious mental illness in clinical and other settings) has not yet included the measurement of fidelity. Without measuring fidelity, it is unclear whether the absence of impact in some studies is attributable to ineffective peer specialist services or because the services were not true to the intended role. This article describes the initial development of a peer specialist fidelity measure for 2 content areas: services provided by peer specialists and factors that either support or hamper the performance of those services. METHOD: A literature search identified 40 domains; an expert panel narrowed the number of domains and helped generate and then review survey items to operationalize those domains. Twelve peer specialists, individuals with whom they work, and their supervisors participated in a pilot test and cognitive interviews regarding item content. RESULTS: Peer specialists tended to rate themselves as having engaged in various peer service activities more than did the supervisors and individuals with whom they work. A subset of items tapping peer specialist services "core" to the role regardless of setting had higher ratings. Participants stated the measure was clear, appropriate, and could be useful in improving performance. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Although preliminary, findings were consistent with organizational research on performance ratings of supervisors and employees made in the workplace. Several changes in survey content and administration were identified. With continued work, the measure could crystalize the role of peer specialists and aid in research and clinical administration. (PsycINFO Database Record


Assuntos
Transtornos Mentais , Grupo Associado , Apoio Social , Humanos , Pesquisadores , Inquéritos e Questionários
13.
Implement Sci ; 10: 79, 2015 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-26018048

RESUMO

BACKGROUND: The Housing and Urban Development-Veterans Affairs Supportive Housing (HUD-VASH) program is one of the largest initiatives to end Veteran homelessness. However, mental health and substance use disorders continue to reduce client stability and impede program success. HUD-VASH programs do not consistently employ evidence-based practices that address co-occurring mental health and substance use disorders. This paper presents a study protocol to evaluate the implementation of an evidence-based, co-occurring disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) in HUD-VASH using an implementation strategy called Getting To Outcomes (GTO). METHODS/DESIGN: In three large VA Medical Centers, this Hybrid Type III trial will randomize case managers and their clients by HUD-VASH sub-teams to receive either MISSION-Vet Implementation as Usual (IU-standard training and access to the MISSION-Vet treatment manuals) or MISSION-Vet implementation augmented by GTO. In addition to testing GTO, effectiveness of the treatment (MISSION-Vet) will be assessed using existing Veteran-level data from the HUD-VASH data monitoring system. This project will compare GTO and IU case managers and their clients on the following variables: (1) fidelity to the MISSION-Vet intervention; (2) proportion of time the Veteran is housed; (3) mental health, substance use, and functional outcomes among Veterans; and (4) factors key to the successful deployment of a new treatment as specified by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model. DISCUSSION: This project is an important step for developing an implementation strategy to increase adoption of evidence-based practice use in VA homeless programs, and to further examine efficacy of MISSION-Vet in HUD-VASH. This project has important implications for program managers, policy makers, and researchers within the homelessness field. VA Central IRB approval for this study was granted in October 2011. The three sites were trained on MISSION-Vet and GTO in the first half of 2013. The first GTO planning meetings began after training occurred, between January 2013 and November 2013, across the three sites. The data collection-via a fidelity measure embedded into the VA Computerized Patient Record System-began as each site initiated MISSION-Vet, between April 2013 and January 2014. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01430741.


Assuntos
Administração de Caso/organização & administração , Pessoas em Situação de Rua , Habitação , Serviços de Saúde Mental/organização & administração , Saúde Mental , Transtornos Relacionados ao Uso de Substâncias/terapia , Prática Clínica Baseada em Evidências , Humanos , Projetos de Pesquisa , Estados Unidos , United States Department of Veterans Affairs
14.
J Health Care Poor Underserved ; 23(3 Suppl): 210-24, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22864498

RESUMO

Homeless veterans are a vulnerable population, with high mortality and morbidity rates. Evidence-based practices for homelessness have been challenging to implement. This study engaged staff members from three VA homeless programs to improve their quality using Getting-To-Outcomes (GTO), a model and intervention of trainings and technical assistance that builds practitioner capacity to plan, implement, and self-evaluate evidence-based practices. Primarily used in community-based, non-VA settings, this study piloted GTO in VA by creating a GTO project within each homeless program and one across all three. The feasibility and acceptability of GTO in VA is examined using the results of the projects, time spent on GTO, and data from focus groups and interviews. With staff members averaging 33 minutes per week on GTO, each team made significant programmatic changes. Homeless staff stated GTO was helpful, and that high levels of communication, staff member commitment to the program, and technical assistance were critical.


Assuntos
Prática Clínica Baseada em Evidências/organização & administração , Pessoas em Situação de Rua , Melhoria de Qualidade/organização & administração , United States Department of Veterans Affairs/organização & administração , Veteranos , Fortalecimento Institucional , Estudos de Viabilidade , Grupos Focais , Pesquisa sobre Serviços de Saúde , Humanos , Modelos Organizacionais , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Pesquisa Qualitativa , Estados Unidos
15.
J Stroke Cerebrovasc Dis ; 18(5): 381-3, 2009 Sep-Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19717023

RESUMO

BACKGROUND: In several animal studies of young and aged rats with ischemic stroke, treatment with sildenafil improved functional outcomes compared with placebo. We conducted a safety study of sildenafil (25 mg daily for 2 weeks) shortly after ischemic stroke onset. METHODS: We recruited patients aged 18 to 80 years with ischemic stroke, National Institutes of Health stroke scale (NIHSS) score 2 to 21, between days 2 and 9 after symptom onset. Patients were treated with sildenafil for 2 weeks (25 mg daily). The primary outcome measure was the adverse occurrence of any of the following during the treatment period: stroke worsening, new stroke, myocardial infarction, vision loss, hearing loss, or death from any cause. Secondary outcome measures were NIHSS score, Barthel indices, and modified Rankin score at 90 days. RESULTS: Twelve patients were recruited. Mean age was 57 years, 5 were female, and median NIHSS score at entry was 9.5 (range 2-20). The primary outcome measure occurred in one patient (sudden death). Another patient committed suicide 2 months after study entry (and 6 weeks after treatment with sildenafil had been completed). Among the 10 survivors, at 90 days, median NIHSS score was 2 (range 0-12), median Barthel index was 95 (range 15-100), and median modified Rankin score was 1.5 (range 0-5). CONCLUSIONS: Sildenafil (25 mg daily for 2 weeks) appeared to be safe in this group of patients with mild to moderately severe stroke. Further studies of higher doses will be tested.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Piperazinas/administração & dosagem , Acidente Vascular Cerebral/tratamento farmacológico , Sulfonas/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea/efeitos dos fármacos , Pressão Sanguínea/fisiologia , Isquemia Encefálica/prevenção & controle , Artérias Cerebrais/efeitos dos fármacos , Artérias Cerebrais/fisiopatologia , GMP Cíclico/metabolismo , Relação Dose-Resposta a Droga , Esquema de Medicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores de Fosfodiesterase/administração & dosagem , Inibidores de Fosfodiesterase/efeitos adversos , Piperazinas/efeitos adversos , Embolia Pulmonar/induzido quimicamente , Purinas/administração & dosagem , Purinas/efeitos adversos , Recuperação de Função Fisiológica/efeitos dos fármacos , Recuperação de Função Fisiológica/fisiologia , Citrato de Sildenafila , Acidente Vascular Cerebral/prevenção & controle , Sulfonas/efeitos adversos , Resultado do Tratamento , Vasodilatadores/administração & dosagem , Vasodilatadores/efeitos adversos , Trombose Venosa/induzido quimicamente , Adulto Jovem
16.
J Clin Sleep Med ; 3(3): 295-6, 2007 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-17561600

RESUMO

Recent reports have documented an association between patent foramen ovale and obstructive sleep apnea. We report on a 51-year-old man with obstructive sleep apnea and recent stroke who was enrolled in a clinic trial evaluating the efficacy of closure of patent foramen ovale following ischemic stroke. He was randomly assigned to device closure. There was subjective dramatic improvement in sleep-apnea symptoms and objective improvement in polysomnographic testing after device implantation. Aside from a drop in apneas and hypopneas from 181 and 8 on the first polysomnogram to 19 and 0 on the second, there was no significant weight loss nor were there other significant changes in sleep parameters or medications. He stopped using continuous positive airway pressure 2 months after implantation and has had no recurrent sleep complaints during 18 months of follow-up. Further studies evaluating the relationship among patent foramen ovale, sleep apnea, and device implantation are warranted.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/instrumentação , Pressão Positiva Contínua nas Vias Aéreas/estatística & dados numéricos , Comunicação Interatrial/complicações , Comunicação Interatrial/cirurgia , Apneia Obstrutiva do Sono/complicações , Apneia Obstrutiva do Sono/terapia , Procedimentos Cirúrgicos Cardíacos , Infarto Cerebral/complicações , Infarto Cerebral/patologia , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Polissonografia , Período Pós-Operatório , Índice de Gravidade de Doença , Apneia Obstrutiva do Sono/diagnóstico , Fases do Sono/fisiologia , Ronco/diagnóstico , Ronco/etiologia , Resultado do Tratamento
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