Abstract
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.
| Original language | English (US) |
|---|---|
| Article number | 100623 |
| Journal | Contemporary Clinical Trials Communications |
| Volume | 19 |
| DOIs | |
| State | Published - Sep 2020 |
Bibliographical note
Funding Information:The workgroup identified and selected the Million Veterans Program (MVP), an observational research study, to pilot the MoRe recruitment strategy, based on the following considerations: 1) the study sponsor agreed to the proposal; 2) all Node sites participated as MVP study sites; 3) it was an observational study with simple inclusion criteria (i.e., Veterans using the VA healthcare system for their medical care); and 4) study participants typically completed enrollment in a single visit. It was proposed that the recruitment strategy would be explored for VA clinical trials following the outcome of this pilot.Each Node site developed a process that was conducive to recruitment of participants from either their main VA medical facility or one of their VA CBOCs. It was based on each site's respective clinical infrastructure and research operational model. NODES, MVP site teams, and the CSP Coordinating Center submitted an amendment request to the VA Central Institutional Review Board (CIRB) for approval to conduct research activities at the CBOCs that were aligned with each VA medical facility participating as an MVP study site. Since some VA CBOCs are contract facilities i.e. these facilities are not VA-operated clinics but are VA-funded or reimbursed health care facilities that are separate from the main VA medical facility, these sites were not approved by the CIRB to serve as locations for research participant recruitment [6]. Once the approval to recruit at the VA CBOCs was obtained, meetings were scheduled with CBOC Clinical Managers to discuss the operational logistics of conducting research activities at their clinics before research patient visits were scheduled. These clinical managers were receptive because using MoRe required minimal resources from the CBOC. The MoRe unit enabled study teams to conduct all research activities within an unconventional area in the clinic e.g. conference room, office area, etc. The MoRe unit components provided participant privacy and confidentiality during the recruitment process; the ability to provide printed and signed copies of the informed consent and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents to the study participant; supplies to collect and store blood samples; and a mechanism to secure original research documents for authorized transport to the main VA medical facility.
Publisher Copyright:
© 2020
Keywords
- Access to research
- Innovative enrollment strategies
- Mobile recruitment
- Recruitment barriers
- Veteran research
