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Background Evidence-based interventions to reduce hospital readmissions may not generalize to resource-constrained safety-net hospitals. Objective To determine if an intervention by patient navigators (PNs), hospital-based Community Health Workers, reduces readmissions among high risk, low socioeconomic status patients. Design Randomized controlled trial. Participants General medicine inpatients having at least one of the following readmission risk factors: (1) age ≥60 years, (2) any in-network inpatient admission within the past 6 months, (3) length of stay ≥3 days, (4) admission diagnosis of heart failure, or (5) chronic obstructive pulmonary disease. The analytic sample included 585 intervention patients and 925 controls. Interventions PNs provided coaching and assistance in navigating the transition from hospital to home through hospital visits and weekly telephone outreach, supporting patients for 30 days post-discharge with discharge preparation, medication management, scheduling of follow-up appointments, communication with primary care, and symptom management. Main Measures The primary outcome was in-network 30-day hospital readmissions. Secondary outcomes included rates of outpatient follow-up. We evaluated outcomes for the entire cohort and stratified by patient age >60 years (425 intervention/584 controls) and ≤60 years (160 intervention/341 controls). Key Results Overall, 30-day readmission rates did not differ between intervention and control patients. However, the two age groups demonstrated marked differences. Intervention patients >60 years showed a statistically significant adjusted absolute 4.1 % decrease [95 % CI: −8.0 %, -0.2 %] in readmission with an increase in 30-day outpatient follow-up. Intervention patients ≤60 years showed a statistically significant adjusted absolute 11.8 % increase [95 % CI: 4.4 %, 19.0 %] in readmission with no change in 30-day outpatient follow-up. Conclusions A patient navigator intervention among high risk, safety-net patients decreased readmission among older patients while increasing readmissions among younger patients. Care transition strategies should be evaluated among diverse populations, and younger high risk patients may require novel strategies.

Background Children and families from priority populations experienced significant psychosocial and mental health issues to the COVID-19 pandemic. Yet they also faced significant barriers to service access, particularly families from culturally and linguistically diverse (CALD) backgrounds. With most child and family health nurse clinics ceasing in-person consultations due to the pandemic, many children missed out on health and developmental checks. The aim of this study was to investigate the perspectives and experiences of family members and service providers from an urban, CALD community regarding the implementation of a digital, developmental surveillance, Watch Me Grow-Electronic (WMG-E) program. Methods Semi-structured interviews were conducted with 17 family members, service navigators, and service providers in a multicultural community in South Western Sydney, Australia. This qualitative study is an implementation evaluation which formed as part of a larger, two-site, randomised controlled trial of the WMG-E program. A reflexive thematic analysis approach, using inductive coding, was adopted to analyse the data. Results Participants highlighted the comprehensive and personalised support offered by existing child and family health services. The WMG-E was deemed beneficial because the weblink was easy and quick to use and it enabled access to a service navigator who support family access to relevant services. However, the WMG-E was problematic because of technology or language barriers, and it did not facilitate immediate clinician involvement when families completed the weblink. Conclusions Families and service providers in this qualitative study found that using WMG-E empowered parents and caregivers to access developmental screening and learn more about their child’s development and engage with relevant services. This beds down a new and innovative solution to the current service delivery gap and create mechanisms that can engage families currently not accessing services, and increases knowledge around navigating the health and social care services. Notwithstanding the issues that were raised by families and service providers, which include accessibility challenges for CALD communities, absence of clinical oversight during screening, and narrow scope of engagement with available services being offered, it is worth noting that improvements regarding these implementation factors must be considered and addressed in order to have longevity and sustainability of the program. Trial registration. The study is part of a large randomised controlled trial (Protocol No. 1.0, Version 3.1) was registered with ANZCTR (registration number: ACTRN12621000766819) on July 21st, 2021 and reporting of the trial results will be according to recommendations in the CONSORT Statement.

Background Screening for gastrointestinal (GI) cancers, specifically colorectal cancer (CRC) and hepatocellular carcinoma (HCC), is often inadequately and inequitably implemented, leading to preventable morbidity and mortality. This protocol paper describes a study designed to compare the effectiveness of external facilitation with patient navigation across hospitals in the Veterans Health Administration (VA). Methods Two hybrid type 3, cluster-randomized trials will compare the effectiveness of patient navigation versus external facilitation for supporting HCC and CRC screening completion. Twenty-four sites will be included in the HCC trial and 32 in the CRC trial, cluster-randomizing Veterans by their site of primary care. The primary outcome of reach of cancer screening completion will be measured after intervention and during sustainment. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Discussion Comparing findings in the two trials will allow researchers to understand how implementation barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC). Trial registration This project was registered at ClinicalTrials.Gov (NCT06458998) on 6/13/24. 

Purpose The current number of breast cancer survivors (BCS) in the United States is approximately 3.8 million, and this number is further expected to increase with improvement in treatments. Survivorship care plans (SCPs) are patient-centered tools that are designed to meet cancer survivors' informational needs about their treatment history, recommended health care, and health maintenance. However, the data on SCP benefits remain uncertain, especially in low-income and racial and ethnic minority cancer survivors. Patient navigation is an effective intervention to improve patient adherence and experience of interdisciplinary breast cancer treatment. Objectives This study sought to understand the role of lay patient navigators (LPN) in survivorship care planning for BCS in safety-net settings. Methods This study is a mixed methods pilot randomized clinical trial to understand the role of patient navigation in cancer survivorship care planning in a public hospital. We invited BCS who had completed active breast cancer treatment within 5 years. LPNs discussed survivorship care planning and survivorship care-related issues with BCS in the intervention arm over a 6-month intervention period and accompanied patients to their primary care appointment. LPNs also encouraged survivors to discuss health care issues with oncology and primary care providers. The primary objective was to assess BCS’ health-related quality of life (HRQOL). The secondary objectives were self-efficacy and implementation. We assessed implementation with 45–60-min semi-structured interviews with 15 BCS recruited from the intervention arm and 60-min focus groups with the oncologists and separately with LPNs. Results We enrolled 40 patients, 20 randomized to usual care and 20 randomized to LPN navigation. We did not find a statistically significant difference between the two arms in HRQOL. There was also no difference in self-efficacy between the two arms. Qualitative analysis identified implementation barriers to intervention that may have contributed to less effective intervention. Implications for Cancer Survivors Future survivorship care planning interventions need to consider: Cancer survivors’ needs and preferences, the need for dedicated resources, and the role of electronic health records in survivorship care plan delivery.

Background Practical and motivational barriers can deter people from engaging in substance use disorder (SUD) treatment, even those who seek treatment. Care navigation is a psychosocial intervention that seeks to facilitate patients’ timely access to care by identifying and intervening upon barriers . Few trials have tested the effectiveness of care navigation when embedding in real-world healthcare, and no trials have studied the process of implementing care navigation into clinical practice. This protocol describes a study that will evaluate whether care navigation can increase treatment engagement among patients seeking SUD treatment. Methods The Addressing Barriers to Care for Substance Use Disorder (ABC-SUD) study is a hybrid type I cluster-randomized effectiveness-implementation trial. It is conducted in a mental health access center of an integrated healthcare system in Washington state. Within this center, licensed mental health clinicians assess patient needs and use shared decision-making to establish SUD treatment plans for patients (usual care). This study tests whether an added care navigation intervention can improve patient engagement in SUD treatment. Care navigation begins after a treatment plan is made and provides up to 7 weeks of support focused on enhancing patient motivation to initiate and engage in treatment, problem-solving barriers (e.g., transportation logistics), and accommodating patient preferences (e.g., preferred language of care, cultural preferences). This trial uses a two period, two sequence crossover design. Clinicians are randomized to offer care navigation to patients during the first or second study period (i.e., clinicians are assigned to an initial study condition and switch conditions halfway through the trial). Care navigation is implemented with several strategies: leadership engagement, clinical workflow specifications, electronic health record (EHR) tools, training, performance improvement, and electronic learning collaborative. The primary outcome—obtained from EHRs and insurance claims—is engagement in SUD treatment, defined as ≥3 SUD treatment visits within 48 days of a treatment plan. This study uses standardized measures of implementation climate and outcomes to examine mechanisms with which the intervention strategies exert their impact on implementation and effectiveness outcomes. Discussion The ABC-SUD study will test whether care navigation improves SUD treatment engagement while concurrently generating information about its implementation in healthcare. Trial registration: This study was prospectively registered at www.clinicaltrials.gov (NCT06729957) on December 9, 2024.

Background In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. Objective To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD. Methods This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD ( N  = 250; n  = 83 trans women; n  = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care ( n  = 187) or SOC ( n  = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP , while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP  + CM, or (b) shift the primary focus to their SUD (CM alone). Results Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027. Discussion Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances. Trial registration This trial has been registered at ClinicalTrials.gov under the number NCT05934877.

Social needs and social determinants of health (SDOH) significantly outrank medical care when considering the impact on a person's length and quality of life, resulting in poor health outcomes and worsening life expectancy. Integrating social needs and SDOH data along with clinical risk information within operational clinical decision support (CDS) systems built into electronic health records (EHRs) is an effective approach to addressing health-related social needs. To achieve this goal, applied research is needed to develop EHR-integrated CDS tools and closed-loop referral systems and implement and test them in the digital and clinical workflows at health care systems and collaborating community-based organizations (CBOs). This study aims to describe the protocol for a mixed methods study including a randomized controlled trial and a qualitative phase assessing the feasibility, acceptability, and effectiveness of an EHR-integrated digital platform to identify patients with social needs and provide navigation services and closed-loop referrals to CBOs to address their social needs. The randomized controlled trial will enroll and randomize adult patients living in socioeconomically challenged neighborhoods in Baltimore City receiving care at a single academic health care institution in the 3-month intervention (using the digital platform) or the 3-month control (standard-of-care assessment and addressing of social needs) arms (n=295 per arm). To evaluate the feasibility and acceptability of the digital platform and its impact on the clinical and digital workflow and patient care, we will conduct focus groups with the care teams in the health care system (eg, clinical providers, social workers, and care managers) and collaborating CBOs. The outcomes will be the acceptability, feasibility, and effectiveness of the CDS tool and closed-loop referral system. This clinical trial opened to enrollment in June 2023 and will be completed in March 2025. Initial results are expected to be published in spring 2025. We will report feasibility outcome measures as weekly use rates of the digital platform. The acceptability outcome measure will be the provider's and patient's responses to the truthfulness of a statement indicating a willingness to use the platform in the future. Effectiveness will be measured by tracking a 3-month change in identified social needs and provided navigation services as well as clinical outcomes such as hospitalization and emergency department visits. The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of such interventions in digital and clinical workflows to enhance the health care system and CBO ability related to social needs assessment and intervention. These results may inform the construction of a future multi-institutional trial designed to test the effectiveness of this intervention across different health care systems and care settings. ClinicalTrials.gov NCT05574699; https://clinicaltrials.gov/study/NCT05574699. DERR1-10.2196/57316.

Low-income minorities often face system-based and personal barriers to screening colonoscopy (SC). Culturally targeted patient navigation (CTPN) programs employing professional navigators (Pro-PNs) or community-based peer navigators (Peer-PNs) can help overcome barriers but are not widely implemented. In East Harlem, NY, USA, where approximately half the residents participate in SC, 315 African American patients referred for SC at a primary care clinic with a Direct Endoscopie Referral System were recruited between May 2008 and May 2010. After medical clearance, 240 were randomized to receive CTPN delivered by a Pro-PN (n = 106) or Peer-PN (n = 134). Successful navigation was measured by SC adherence rate, patient satisfaction and navigator trust. Study enrollment was 91.4% with no significant differences in SC adherence rates between Pro-PN (80.0%) and Peer-PN (71.3%) (P = 0.178). Participants in both groups reported high levels of satisfaction and trust. These findings suggest that CTPN Pro-PN and Peer-PN programs are effective in this urban primary care setting. We detail how we recruited and trained navigators, how CTPN was implemented and provide a preliminary answer to our questions of the study aims: can peer navigators be as effective as professionals and what is the potential impact of patient navigation on screening adherence?

Background Interventions are needed to improve viral suppression rates among persons with HIV and substance use. A 3-arm randomized multi-site study (Metsch et al. in JAMA 316:156–70, 2016 ) was conducted to evaluate the effect on HIV outcomes of usual care referral to HIV and substance use services (N = 253) versus patient navigation delivered alone (PN: N = 266) or together with contingency management (PN + CM; N = 271) that provided financial incentives targeting potential behavioral mediators of viral load suppression. Aims This secondary analysis evaluates the effects of financial incentives on attendance at PN sessions and the relationship between session attendance and viral load suppression at end of the intervention. Methods Frequency of sessions attended was analyzed over time and by distribution of individual session attendance frequency (PN vs PN + CM). Percent virally suppressed (≤200 copies/mL) at 6 months was compared for low, medium and high rate attenders. In PN + CM a total of $220 could be earned for attendance at 11 PN sessions over the 6-month intervention with payments ranging from $10 to $30 under an escalating schedule. Results The majority (74%) of PN-only participants attended 6 or more sessions but only 28% attended 10 or more and 16% attended all eleven sessions. In contrast, 90% of PN + CM attended 6 or more visits, 69% attended 10 or more and 57% attended all eleven sessions (attendance distribution χ 2 [11] = 105.81; p < .0001). Overall (PN and PN + CM participants combined) percent with viral load suppression at 6-months was 15, 38 and 54% among those who attended 0–5, 6–9 and 10–11 visits, respectively (χ 2 (2) = 39.07, p < .001). Conclusion In this secondary post hoc analysis, contact with patient navigators was increased by attendance incentives. Higher rates of attendance at patient navigation sessions was associated with viral suppression at the 6-month follow-up assessment. Study results support use of attendance incentives to improve rates of contact between service providers and patients, particularly patients who are difficult to engage in care. Trial Registration clinicaltrials.govIdentifier: NCT01612169.

Background Although Colorado is perceived as a healthy state, in 2010, 14.1 % of children aged 2–5 were overweight and 9.1 % were obese. Despite the high prevalence of obesity in this population, evidence to support particular strategies to treat obese preschoolers is lacking. The efficacy of home-based, childhood obesity interventions to reduce a child’s body mass index is inconclusive. However, this model uniquely provides an opportunity to observe and intervene with the home food and activity environment and engage the entire family in promoting changes that fit each family’s unique dynamics. Methods/design Eligible participants are children aged 2–5 years who attended a well-child care visit at a Denver Health Community Health Service clinic within 12 months prior to recruitment and on that visit had a body mass index (BMI) >85th percentile-for-age. Participants are randomly recruited at study inception and allocated to the intervention in one of five defined 6-month stepped wedge engagements; the delayed intervention groups serves as control groups until the start of the intervention. The program is delivered by a patient navigator at the family’ home and consists of a 16-session curriculum focused on 1) parenting styles, 2) nutrition, and 3) physical activity. At each visit, a portion of curriculum is delivered to guide parents and children in selecting one goal for behavior change in each of three work areas to work on during the following week. The primary study outcome measure is change in BMI z-score from baseline to post-intervention period. Discussion This childhood obesity study, innovative for its home-based intervention venue, provides rich data characterizing barriers and facilitators to healthy behavior change within the home. The study population is innovative as it is focused on preschool-aged, Latino children from low-income families; this population has not typically been targeted in obesity management assessments. The home-based intervention is linked to clinical care through update letters and assessment of the program’s impact to the child’s medical providers. Informing primary care providers about a child’s accomplishments and challenges, allows the clinician to support the health weight effort when seeing families during subsequent clinical visits. Trial registration ClinicalTrials.gov NCT02024360 Registered December 21, 2013