Cardiology clinical trial participation in community-based healthcare systems: Obstacles and opportunities

Somkin, Carol P.; Altschuler, Andrea; Ackerson, Lynn; Tolsma, Dennis; Rolnick, Sharon J.; Yood, Robert A.; Weaver, W. Douglas; Worley, Ann Von; Hornbrook, Mark C.; Magid, David J.; Go, Alan S.

doi:10.1016/j.cct.2008.02.003

Cited by 10 publications

(3 citation statements)

References 21 publications

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“…2 ). Our findings are consistent with previous studies that have demonstrated site characteristics such as supportive team environment, clinic engagement, adequate participant population, investigator motivation/engagement, and physician referrals as being critical elements of clinical trial enrollment and overall trial success [ [16] , [17] , [18] , [19] ].…”

Section: Discussionsupporting

confidence: 91%

Research site mentoring: A novel approach to improving study recruitment

Johnson

Kenworthy-Heinige

Beck

et al. 2018

Contemporary Clinical Trials Communications

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Background/AimsThe 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.ResultsSites 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.ConclusionsThe 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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Section: Discussionsupporting

confidence: 91%

Research site mentoring: A novel approach to improving study recruitment

Johnson

Kenworthy-Heinige

Beck

et al. 2018

Contemporary Clinical Trials Communications

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“…In conducting these trials, the participation of primary healthcare physicians in the community (general practitioners; GPs) and patient recruitment are important issues that need to be properly addressed. Various studies in the literature have reported factors affecting physicians' participation [ 1 , 2 ] and patient recruitment [ 3 , 4 ] in clinical trials, and infrastructure for clinical trials may affect these important issues.…”

Section: Introductionmentioning

confidence: 99%

View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area

Yanagawa¹,

Kishuku²,

Akaike³

et al. 2010

Int Arch Med

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BackgroundClinical trials in the general practice setting are important for providing evidence on the effectiveness and safety of different agents under various conditions. In conducting these trials, the participation of physicians and patient recruitment are important issues. Various investigations in the literature have reported views and attitudes of physicians on various types of clinical trials. Nevertheless, there is still little information concerning physicians participating in a clinical trial and among them, those who could not recruit any patients (unsuccessful physician recruiters).MethodsIn 2003, we collaborated in a large-scale multicenter study of Japanese hypertensive patients (COPE Trial). In Tokushima University Hospital and 18 other medical institutions, we investigated the views and attitudes of unsuccessful physician recruiters in comparison with successful physician recruiters, using a questionnaire.ResultsThe questionnaire was provided by mail to 47 physicians and 27 (57%) responded. The response rate was 79% for successful physician recruiters compared to 43% (P = 0.014) for unsuccessful physician recruiters. More successful physician recruiters (73%) than unsuccessful physician recruiters (42%) stated they had participated and enrolled patients in previous multicenter clinical trials. A significantly higher number of successful physician recruiters than unsuccessful physician recruiters (42%; P = 0.040) considered the presence of a support system with clinical research coordinators (CRC) as the reason for participation (80%). A large number of unsuccessful physician recruiters experienced difficulty in obtaining informed consent (67%), whereas a significantly smaller number of successful physician recruiters experienced such difficulty (20%; P = 0.014). The difficulties experienced by unsuccessful physician recruiters in the trial were as follows: inability to find possible participants (100%), difficulty in obtaining informed consent (58%), cumbersome procedures (58%), difficulty in long-term follow up (33%), and insufficient tools for explanation and obtaining informed consent (8%).ConclusionThis survey showed that successful physician recruiters consider a support system with CRC of value, and that they are skillful in obtaining informed consent. These views and attitudes may have originated from past experience involving clinical trials. In this regard, we need to develop an infrastructure to enlighten physicians on this support system for the promotion of clinical trials.

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“…71 – 74 Clinicians were enthusiastic about participation as long as their time demands were not excessive and research staff could complete IRB applications and manage timelines and budgets on their behalf. 71 , 73 Organizational leaders raised concerns about the financial impact of clinical trials, the alignment of trials with their organizational mission, and the impact on member satisfaction of informing members about their eligibility for trials. Health plan members worried that participating in trials might jeopardize their care, although these concerns could be alleviated by a trusted physician.…”

Section: Elements Of Sustainability For Scientific Networkmentioning

confidence: 99%

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

Steiner¹,

Paolino²,

Thompson³

et al. 2014

eGEMs

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Purpose:As multi-institutional research networks assume a central role in clinical research, they must address the challenge of sustainability. Despite its importance, the concept of network sustainability has received little attention in the literature, and the sustainability strategies of durable scientific networks have not been described.Innovation:The Health Maintenance Organization Research Network (HMORN) is a consortium of 18 research departments in integrated health care delivery systems with over 15 million members in the United States and Israel. The HMORN has coordinated federally funded scientific networks and studies since 1994. This case study describes the HMORN approach to sustainability, proposes an operational definition of network sustainability, and identifies 10 essential elements that can enhance sustainability.Credibility:The sustainability framework proposed here is drawn from prior publications on organizational issues by HMORN investigators and from the experience of recent HMORN leaders and senior staff.Conclusion and Discussion:Network sustainability can be defined as (1) the development and enhancement of shared research assets to facilitate a sequence of research studies in a specific content area or multiple areas, and (2) a community of researchers and other stakeholders who reuse and develop those assets. Essential elements needed to develop the shared assets of a network include: network governance; trustworthy data and processes for sharing data; shared knowledge about research tools; administrative efficiency; physical infrastructure; and infrastructure funding. The community of researchers within a network is enhanced by: a clearly defined mission, vision and values; protection of human subjects; a culture of collaboration; and strong relationships with host organizations. While the importance of these elements varies based on the membership and goals of a network, this framework for sustainability can enhance strategic planning within the network and can guide relationships with external stakeholders.

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Cardiology clinical trial participation in community-based healthcare systems: Obstacles and opportunities

Cited by 10 publications

References 21 publications

Research site mentoring: A novel approach to improving study recruitment

Research site mentoring: A novel approach to improving study recruitment

View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area

Sustaining Research Networks: the Twenty-Year Experience of the HMO Research Network

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