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Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care.

ABSTRACT: Co-infection with HIV and hepatitis C virus (HCV) results in a threefold increase in relative risk of progression to end stage liver disease and cirrhosis compared to HCV alone. Although curative treatments exist, less than one quarter of people with HCV are linked to care, and even fewer have received treatment. The Care2Cure study is a single-blinded, randomized controlled trial to improve the HCV care continuum among people co-infected with HIV. This ongoing study was designed to test whether a nurse case management intervention can (i) improve linkage to HCV care and (ii) decrease time to HCV treatment initiation among 70 adults co-infected with HIV who are not engaged in HCV care. The intervention is informed by the Andersen Behavioral Model of Health Services Use and consists of nurse-initiated referral, strengths-based education, patient navigation, appointment reminders, and care coordination for drug-drug interactions in the setting of HIV primary care. Validated instruments are used to measure participant characteristics including HCV knowledge, substance use, and depression. The primary outcome is linkage to HCV care (yes/no) within 60 days. In this protocol paper, we describe the first clinical trial to examine the effects of a nurse case management intervention to improve the HCV care continuum among people co-infected with HIV/HCV in the era of all-oral HCV treatment. We describe our work in progress, challenges encountered, and strategies to engage this hard-to-reach population.

SUBMITTER: Starbird LE

PROVIDER: S-EPMC6493333 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care.

Starbird Laura E LE Han Hae-Ra HR Sulkowski Mark S MS Budhathoki Chakra C Reynolds Nancy R NR Farley Jason E JE

Research in nursing & health 20180828 5

Co-infection with HIV and hepatitis C virus (HCV) results in a threefold increase in relative risk of progression to end stage liver disease and cirrhosis compared to HCV alone. Although curative treatments exist, less than one quarter of people with HCV are linked to care, and even fewer have received treatment. The Care2Cure study is a single-blinded, randomized controlled trial to improve the HCV care continuum among people co-infected with HIV. This ongoing study was designed to test whether ...[more]

PMID: 30152537

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Project description:Aims and objectivesTo assess the effects of intensive follow-up by primary care nurses on cardiovascular disease self-management and compliance behaviours after myocardial infarction.BackgroundAlthough cardiovascular disease prevention and cardiac rehabilitation take place in hospital settings, a nurse-led approach is necessary in primary care during the first few months after a myocardial infarction. Therefore, it is important to assess self-management of cardiovascular disease and levels of compliance with the prescribed diet, physical activity, and medication.DesignThe study used a multicentre, quasi-experimental, pre-post design without a control group.MethodsPatients with acute coronary syndrome from 40 healthcare facilities were included in the study. A total of 212 patients participated in a programme including 11 interventions during the first 12-18 months after myocardial infarction. The following Nursing Outcomes Classification (NOC) outcomes were assessed at baseline and at the end of the intervention: Self-management: Cardiac Disease (1617) and Compliance Behaviour: Prescribed Diet (1622), Compliance Behaviour: Prescribed Activity (1632), and Compliance Behaviour: Prescribed Medication (1623). Marjory Gordon's functional health patterns and a self-care notebook were used in each intervention. Pre-post intervention means were compared using Student's t-tests for related samples. The results of the study are reported in compliance with the TREND Statement.ResultsA total of 132 patients completed the intervention. The indicators for each NOC outcome and the variations in scores before and after the intensive follow-up showed a statistically significant improvement (p-value = 0.000). Compliance Behaviour: Prescribed Diet (pre = 3.7; post = 4.1); Compliance Behaviour: Prescribed Activity (pre = 3.9; post = 4.3); Compliance Behaviour: Prescribed Medication (pre = 3.9; post = 4.7).ConclusionIntensive, immediate follow-up after myocardial infarction improves compliance behaviours and self-management of heart disease. A combined self-care and family care approach should be encouraged to empower post-myocardial infarction patients. To facilitate patients' self-efficacy, the use of health education tools such as a cardiovascular self-care notebook can also be helpful.Relevance to clinical practiceThis study highlights the benefits of intensive, protocolised, comprehensive patient follow-up in primary care during the first few months after an acute myocardial infarction (AMI). Primary care nurses train patients in cardiovascular self-care.Patient or public contributionPatients were not involved in either the design or the carrying out of the study. However, at the end of the study, they participated in an evaluation process about the utility of the research study and their satisfaction with it. This process was carried out using an ad hoc survey consisting of 10 questions assessing the nursing care and follow-up inputs that were received.

Project description:ImportanceExperts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear.ObjectiveTo test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs.Design, setting, and participantsThis randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (≥4 drinks per day for women and ≥5 drinks per day for men).InterventionsNurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care.Main outcomes and measuresPrimary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems.ResultsOf 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n = 150) and usual care (n = 154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P = .32-.44). Findings at 3 months were similar.Conclusions and relevanceThe CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care.Trial registrationclinicaltrials.gov Identifier: NCT01400581.

Project description:Background:The Six Building Blocks for improving opioid management (6BBs) is a program for improving the management of patients in primary care practices who are on long-term opioid therapy for chronic pain. The 6BBs include building leadership and consensus; aligning policies, patient agreements, and workflows; tracking and monitoring patient care; conducting planned, patient-centered visits; tailoring care for complex patients; and measuring success. The Agency for Healthcare Research and Quality funded the development of a 6BBs implementation guide: a step-by-step approach for independently implementing the 6BBs in a practice. This mixed-method study seeks to assess practices' use of the implementation guide to implement the 6BBs and the effectiveness of 6BBs implementation on opioid management processes of care among practices using the implementation guide. Methods:Data collection is guided by the Consolidated Framework for Implementation Research, Proctor's taxonomy of implementation outcomes, and the Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain. A diverse group of health care organizations with primary care clinics across the USA will participate in the study over 15?months. Qualitative data collection will include semi-structured interviews with stakeholders at each organization at two time points, notes from routine check-in calls, and document review. These data will be used to understand practices' motivation for participation, history with opioid management efforts, barriers and facilitators to implementation, and implementation progress. Quantitative data collection will consist of a provider and staff survey, an implementation milestones assessment, and quarterly opioid prescribing quality measures. These data will supplement our understanding of implementation progress and will allow us to assess changes over time in providers' opioid prescribing practices, prescribing self-efficacy, challenges to providing guideline-driven care, and practices' opioid prescribing quality measures. Qualitative data will be coded and analyzed for emergent themes. Quantitative data will be analyzed using descriptive statistics and clustered multivariate regression. Discussion:This study contributes to the knowledge of the implementation and effectiveness of a team-based approach to opioid management in primary care practices. Information gleaned from this study can be used to inform efforts to curtail opioid prescribing and assist primary care practices considering implementing the 6BBs.

Project description:BACKGROUND: Most evidence on the effect of collaborative care for depression is derived in the selective environment of randomised controlled trials. In collaborative care, practice nurses may act as case managers. The Primary Care Services Improvement Project (PCSIP) aimed to assess the cost-effectiveness of alternative models of practice nurse involvement in a real world Australian setting. Previous analyses have demonstrated the value of high level practice nurse involvement in the management of diabetes and obesity. This paper reports on their value in the management of depression. METHODS: General practices were assigned to a low or high model of care based on observed levels of practice nurse involvement in clinical-based activities for the management of depression (i.e. percentage of depression patients seen, percentage of consultation time spent on clinical-based activities). Linked, routinely collected data was used to determine patient level depression outcomes (proportion of depression-free days) and health service usage costs. Standardised depression assessment tools were not routinely used, therefore a classification framework to determine the patient's depressive state was developed using proxy measures (e.g. symptoms, medications, referrals, hospitalisations and suicide attempts). Regression analyses of costs and depression outcomes were conducted, using propensity weighting to control for potential confounders. RESULTS: Capacity to determine depressive state using the classification framework was dependent upon the level of detail provided in medical records. While antidepressant medication prescriptions were a strong indicator of depressive state, they could not be relied upon as the sole measure. Propensity score weighted analyses of total depression-related costs and depression outcomes, found that the high level model of care cost more (95% CI: -$314.76 to $584) and resulted in 5% less depression-free days (95% CI: -0.15 to 0.05), compared to the low level model. However, this result was highly uncertain, as shown by the confidence intervals. CONCLUSIONS: Classification of patients' depressive state was feasible, but time consuming, using the classification framework proposed. Further validation of the framework is required. Unlike the analyses of diabetes and obesity management, no significant differences in the proportion of depression-free days or health service costs were found between the alternative levels of practice nurse involvement.

Project description:IntroductionDirect-acting antiviral drugs (DAAs) have changed the paradigm of hepatitis C therapy for both HCV/HIV co-infected and HCV mono-infected patients. We aimed to describe the HCV continuum of care of HIV-infected patients treated in an HIV clinic after a free DAA program in Indonesia and identify factors correlated with sofosbuvir-daclatasvir (SOF-DCV) treatment failure.MethodsWe did a retrospective cohort study of adult HIV/HCV co-infected patients under routine HIV-care from November 2019 to April 2020 in the HIV integrated clinic of Cipto Mangunkusumo Hospital, Jakarta, Indonesia. We evaluated some factors correlated with sofosbuvir-daclatasvir treatment failure: gender, diabetes mellitus, previous IFN failure, cirrhosis, concomitant ribavirin use, high baseline HCV-RNA, and low CD4 cell count.Results and discussionOverall, 640 anti-HCV positive patients were included in the study. Most of them were male (88.3%) and former intravenous drug users (76.6%) with a mean age of 40.95 (SD 4.60) years old. Numbers and percentages for the stages of the HCV continuum of care were as follows: HCV-RNA tested (411; 64.2%), pre-therapeutic evaluation done (271; 42.3%), HCV treatment initiated (210; 32.8%), HCV treatment completed (207; 32.2%), but only 178 of these patients had follow-up HCV-RNA tests to allow SVR assessment; and finally SVR12 achieved (178; 27.8%). For the 184 who completed SOF-DCV treatment, SVR12 was achieved by 95.7%. In multivariate analysis, diabetes mellitus remained a significant factor correlated with SOF-DCV treatment failure (adjusted RR 17.0, 95%CI: 3.28-88.23, p = 0.001).ConclusionsThis study found that in the HCV continuum of care for HIV/HCV co-infected patients, gaps still exist at all stages. As the most commonly used DAA combination, sofosbuvir daclatasvir treatment proved to be effective and well-tolerated in HIV/HCV co-infected patients. Diabetes mellitus was significant factor correlated with not achieving SVR12 in this population.

Project description:BackgroundAs the organization of primary care continues to evolve toward more interdisciplinary team structures, demonstrating effectiveness of care delivery is becoming important, particularly for nonphysician providers. Nurses are the most common nonphysician provider within primary care. The purpose of this study was to examine the relation between primary care delivery models that incorporate registered nurses and clinical outcomes of patients with type 2 diabetes.MethodsPatient data from the Canadian Primary Care Sentinel Surveillance Network were matched with survey data from 15 Family Health Team practices in southeastern Ontario. Included patients were adults with type 2 diabetes mellitus who had at least 1 primary care encounter at a Family Health Team practice that completed the organizational survey between Apr. 1, 2013, and Mar. 31, 2014. The clinical outcomes explored included hemoglobin A1c, fasting plasma glucose, blood pressure, low-density lipoprotein cholesterol and urine albumin:creatinine ratio.ResultsOf the 15 practices, 13 (86.7%) had at least 1 registered nurse. The presence of 1 or more registered nurses in the practice was associated with increased odds of patients' having their hemoglobin A1c, fasting plasma glucose, blood pressure and low-density lipoprotein cholesterol values meet recommended targets. Practices with the lowest ratios of patients with diabetes to registered nurse had a significantly greater proportion of patients with hemoglobin A1c and fasting plasma glucose values on target than did practices with the highest ratios of patients to registered nurse (p < 0.01 and p = 0.03, respectively).InterpretationThe findings suggest that registered nurse staffing within primary care practice teams contributes to better diabetic care, as measured by diabetes management indicators. This study sets the groundwork for further exploration of nursing and organizational contributions to patient care in the primary care setting.

Project description:IntroductionTransitions in Care (TiC) are vulnerable periods in care delivery associated with adverse events, increased cost and decreased patient satisfaction. Patients with cancer encounter many transitions during their care journey due to improved survival rates and the complexity of treatment. Collectively, improving TiC is particularly important among patients with cancer. The objective of this scoping review is to synthesise and map the existing literature regarding TiC among patients with cancer in order to explore opportunities to improve TiC among patients with cancer.Methods and analysisThis scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis-Scoping Review Extension and the Joanna Briggs Institute methodology. The PubMed cancer filter and underlying search strategy will be tailored to each database (Embase, Cochrane, CINAHL and PsycINFO) and combined with search terms for TiC. Grey literature and references of included studies will be searched. The search will include studies published from database inception until 9 February 2020. Quantitative and qualitative studies will be included if they describe transitions between any type of healthcare provider or institution among patients with cancer. Descriptive statistics will summarise study characteristics and quantitative data of included studies. Qualitative data will be synthesised using thematic analysis.Ethics and disseminationOur objective is to synthesise and map the existing evidence; therefore, ethical approval is not required. Evidence gaps around TiC will inform a programme of research aimed to improve high-risk transitions among patients with cancer. The findings of this scoping review will be published in a peer-reviewed journal and widely presented at academic conferences. More importantly, decision makers and patients will be provided a summary of the findings, along with data from a companion study, to prioritise TiC in need of interventions to improve continuity of care for patients with cancer.

Dataset Information

Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care.

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Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care.

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