Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept.

BACKGROUND: Access 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. METHODS: A 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. RESULTS: Seven 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%. CONCLUSION: Five 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.

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 ±â€¯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.

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.

Survey of bereavement practices of cancer care and palliative care physicians in the Pacific Northwest United States.

PURPOSE: Physicians caring for patients with cancer frequently encounter individuals who will die as a result of their disease. The primary aim of this study was to examine the frequency and nature of bereavement practices among cancer care and palliative care physicians in the Pacific Northwest United States. Secondary aims included identification of factors and barriers associated with bereavement follow-up. METHODS: An institutional review board (IRB) -approved, anonymous online survey of cancer specialists and palliative care physicians in Alaska, Washington, Oregon, Idaho, Montana, and Wyoming was performed in fall 2010. Potential participants were identified through membership in national professional organizations. Summary statistics and logistic regression methods were used to examine frequency and predictors of bereavement practices. RESULTS: A total of 194 (22.7%) of 856 physicians participated in the online survey, with 164 (19.1%) meeting study inclusion criteria. Overall, 70% of respondents reported always or usually making a telephone call to families, sending a condolence letter, or attending a funeral service after a patient's death. The most common perceived barriers to bereavement follow-up were lack of time and uncertainty of which family member to contact. Sixty-nine percent of respondents did not feel that they had received adequate training on bereavement follow-up during postgraduate training. CONCLUSION: Although a significant portion of respondents engaged in some form of bereavement follow-up, the majority felt inadequately trained in these activities. Efforts to identify available resources and address bereavement activities in postgraduate training may contribute to improved multidisciplinary treatment of patients with cancer and their families.

Developing an easy-to-use tablet computer application for assessing patient-reported outcomes in patients with cancer.

BACKGROUND: In order to be practically useful, computer applications for patients with cancer must be easily usable by people with limited computer literacy and impaired vision or dexterity. We describe the usability development process for an application that collects quality of life and symptom information from patients with cancer. METHODS: Usability testing consisted of user testing with cancer patients to identify initial design problems and a survey to compare the computer application's ease of use between elderly and younger patients. RESULTS: In user-testing phase, seven men aged 56 to 77 with prostate cancer were observed using the application and interviewed afterwards identifying several usability concerns. Sixty patients with breast, gastrointestinal, or prostate cancer participated in the ease of use survey, with 40% (n=24) aged 65 or older. Younger patients reported significantly higher scores than elderly patients (14.0 vs. 10.8, p = .001), even when prior computer and touch screen use was controlled. CONCLUSION: Elderly users reported lower ease of use scores than younger users; however, their average rating was quite high-10.8 on a scale of -16 to +16. It may be unrealistic to expect elderly or less computer literate users to rate any application as positively as younger, more computer savvy users-perhaps it is enough that they rate the application positively and can use it without undue difficulties. We hope that our process can serve as a model for how to bridge the fields of computer usability and healthcare.

Incorporating routine survival prediction in a U.S. hospital-based palliative care service.

BACKGROUND: Prognostication is a core component of palliative care consultation. We sought to incorporate predicted survival into the routine practice of our hospital-based palliative care team. METHODS: The predicted survival was determined by the physician and/or nurse at the time of initial palliative care consultation using categories that parallel the rough time frames often shared with patients and used in planning care: (1) ≤3 days, (2) 4 days to 1 month, (3) >1 month to 6 months, (4) >6 months. One year later, survival status at 6 months was determined using death certificates, the Social Security online database, and other methods. RESULTS: Over 1 year, complete data were obtained for 429 of 450 (95.3%) consecutive new patient consults. Patients' mean and median age was 63, 48.5% had cancer, 83% were Caucasian, and 50% were female. For the 283 patients who were discharged alive, median survival was 18 days and 58 patients were still alive after 6 months. Fifty-eight percent of patients were assigned to the correct survival category, whereas 27% of prognoses were too optimistic and 16% were too pessimistic. In logistic regression analysis, predicted survivals of ≤3 days were much more likely to be accurate than longer predictions. DISCUSSION: The team recorded a predicted survival in 95% of new patient consults. Fifty-eight percent accuracy is in line with prior literature. Routinely incorporating survival prediction into palliative care consultation raised a number of questions. What decisions were made based on the 42% incorrect prognoses? Did these decisions negatively affect care? Survival prediction accuracy has potential as a quality measure for hospital-based palliative care programs, however to be truly useful it needs to be shown to be "improveable" and the downstream effects of predictions need to be better understood.

The role of mood states underlying sex differences in the perception and tolerance of pain.

While sex differences in pain reporting are frequently observed, the reasons underlying these differences remain unclear. The present study examined sex differences in self-report and physiological measures of pain threshold and tolerance following the administration of two laboratory pain-induction tasks. The primary study aim centered on determining whether repeated exposure to such tasks would yield sex differences in terms of pain threshold and tolerance. In addition, it was hypothesized that if such differences did exist, negative mood states might account for changes in pain ratings, threshold, and/or tolerance in subsequent exposure to noxious stimuli. Recruited from a convenience sample, 66 participants (44 female and 22 male) were exposed to both thermal and cold noxious stimuli at three separate times, while psychophysiological and self-report data were collected. Because women outnumbered men 2:1, Fisher z transformations were performed to determine whether the observed associations between mood states and pain ratings differed. We found stronger associations between fatigue and thermal-heat pain ratings for men at their first and third exposure to the pain task compared to women (z = 2.11, P < 0.05; z = 3.14, P < 0.001, respectively). Results indicated that women evidenced greater pain tolerance than men on both a behavioral and physiological level; however, they reported greater pain severity than men. Fatigue was also found to be particularly important to reports of pain severity in men and pain tolerance in response to noxious stimuli for women. Possible pathways in which mood states influenced these endpoints are discussed.