6 research outputs found
Survey of Bereavement Practices of Cancer Care and Palliative Care Physicians in the Pacific Northwest United States
Research site mentoring: A novel approach to improving study recruitment
Background/Aims: The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine VA medical centers (VAMCs) with teams (nodes) dedicated to enhance performance, compliance, and management of CSP multi-site clinical trials. The West Haven CSP Coordinating Center (WH-CSPCC), study coordinating center for CSP #577, Colonoscopy Versus Fecal Immunochemical Test (FIT) in Reducing Mortality from Colorectal Cancer (CONFIRM) trial, and NODES piloted a “site mentoring” (hub-and-spoke) model. In this model, a node site would work one-on-one with a low enrolling CONFIRM site to identify and overcome barriers to recruitment. The aim was to determine the impact of a research site mentoring model on study recruitment and examine site-level characteristics that facilitate or impede it.
Results: Sites in the mentorship pilot had an average improvement of 5 ± 4 participants randomized per month (min −2.6; max 11.6; SD 4.3). Four of ten sites (40%) demonstrated continuous improvement in the average number of randomized participants per month after the pilot intervention and at three-month follow-up (post-intervention), as compared to the five-month period preceding the intervention. An additional two sites (20%) demonstrated improvement in the average number of randomized participants per month after the pilot intervention, and sustained that level of improvement at three-month follow-up (post-intervention). Additionally, six of ten sites (60%) demonstrated an increased number of participants screened for eligibility immediately following the intervention and at three-month follow-up (post-intervention). Only one site showed a decreased monthly average of randomized participants shortly after the intervention and through the three-month follow-up period.
Conclusions: The site mentoring model was successful in improving recruitment at low enrolling CONFIRM sites. An additional feasibility assessment is needed to determine if this mentoring model will be effective with other CSP trials
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Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept.
BackgroundAccess to healthcare delivery programs and systems is a primary correlate to the overall health and well-being of Veterans and the general population. Participation in clinical research is a gateway to novel therapies that are intended to address current global health issues. Meeting or exceeding recruitment goals in clinical research is one of the key determinants of the timely and successful completion of a study. The travel and time burdens experienced by study participants are often considered barriers to their enrollment into clinical research. The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established a consortium of nine VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES). The NODES program provides study site-level expertise and innovative approaches that address challenges to clinical research execution. In alignment with our mission, our program developed an approach to increase study participant access to clinical research through implementing "Mobile Recruitment (MoRe)" units. This manuscript describes the utility and challenges associated with employing this strategy to address three common barriers to clinical research participation: 1) research participant travel burden, 2) participant access to study opportunities, and 3) low participant enrollment.MethodsA plan to introduce the Mobile Recruitment (MoRe) unit as a recruitment strategy was piloted for a high-volume, observational cohort study and mega biobank in the VA health care system, the "Million Veteran Program (MVP)". MoRe is a recruitment strategy for CSP research integrating mobile technology and atypical research recruitment locations. Recruitment locations include primary or main VA hospitals and their assigned VA Community-Based Outpatient Clinics (CBOCs). Each Node site (n = 9) received components of the MoRe unit including a laptop, printer, portable cart with storage space, cooler/ice packs for specimen storage and transport. Each site's usage of these components varied based on its respective needs. Activities focused on both VA main facilities and CBOC facilities for recruitment.ResultsSeven of the nine Node sites compared the effectiveness of the MoRe unit on MVP study enrollment outcomes over three-time points: pre-intervention period, intervention period, and post-intervention period. The utilization of MoRe in the intervention period demonstrated a 36.9% increase in enrollment compared to the previous six months (pre-intervention period). There was a 2% enrollment increase at the six-month post-intervention period as compared to the intervention period. When comparing the pre-intervention period to the post-intervention period (duration of eighteen months), enrollment increased by 38.9%.ConclusionFive of the seven sites experienced an increase in enrollment during the intervention and post-intervention periods. The two sites without an increase in enrollment experienced various extenuating factors. Characteristics of sites using MoRe included the ability to utilize a smaller, unconventional space, i.e. not a traditional clinical research exam space for recruitment. MoRe was utilized in hospital laboratory space, CBOCs, primary care clinics, and other subspecialty clinics that allowed recruitment activities but did not have dedicated space to offer the research teams for that purpose. This initiative successfully demonstrated the benefit of deploying the unit, proving its utility in cases in where there was a lack of space or alternative workstations for research activities. The implementation of MoRe by NODES as a recruitment strategy for MVP may be transferable to other VA clinical research studies, as well as to other healthcare settings executing similar clinical research activities
Incorporating Routine Survival Prediction in a U.S. Hospital-Based Palliative Care Service
A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
Background: Recruitment into clinical trials remains a key determinant to study completion and success. While various strategies have been proposed, it is unclear how they apply across different populations, diseases, and/or study goals. The ability to effectively overcome challenges may require different approaches that more broadly focus on addressing obstacles among sites that cannot be overcome by individual studies.
Methods: The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established the Network of Dedicated Enrollment Sites (NODES) as a consortium of sites to generate systematic site-level solutions to more efficiently recruit in CSP studies. Initial activities identified priorities and developed approaches through team-based efforts. Metrics were also developed to assess overall network performance.
Results: Network efforts produced several new strategies and best practices for common problems in CSP research. Recruitment strategies included bringing studies to patients and developing data programs using algorithms for finding eligible patients. Efficiency efforts focused on cross-training and standardizing performance reports.
Conclusion: NODES addressed site challenges in clinical trial recruitment and management by taking an overall approach that looked at the system rather than individual studies. Practices and operational changes were implemented for CSP research related to recruitment, staff training and research methodology. The network activities suggest that team-based development of tools and insights may help better identify targets and increase efficiencies for clinical trials recruitment