Coronado Gloria D, Retecki Sally, Schneider Jennifer, Taplin Stephen H, Burdick Tim, Green Beverly B
The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA
The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.
Clin Trials. 2016 Apr;13(2):214-22. doi: 10.1177/1740774515608122. Epub 2015 Sep 29.
Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening.
In partnership with STOP CRC's advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with Oregon Community Health Information Network, a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation.
From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow-up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements.
Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research.
在务实性试验中招募参与者面临诸多挑战,尤其是在卫生系统层面,这些挑战在很大程度上仍未得到充分探索。作为“优先人群中阻止结肠癌的策略与机遇”(STOP CRC)项目的一部分,我们招募了八个独立的社区卫生中心(由26个个体安全网诊所组成)参与一项大型比较效果务实性研究,以评估提高结直肠癌筛查率的方法。
我们与STOP CRC的咨询委员会合作,确定了识别合格卫生中心的标准,并将这些标准应用于俄勒冈社区卫生信息网络附属的华盛顿、俄勒冈和加利福尼亚的卫生中心名单上,该网络是一个由联邦资助的卫生中心组成的覆盖16个州的基于实践的研究网络。项目工作人员联系了符合资格标准的中心,并安排主要研究调查人员与卫生中心领导团队进行面对面会议。我们使用实施研究综合框架对这些会议期间讨论的内容进行主题分析,以确定卫生中心参与的主要促进因素和障碍。
在最初列出的41个卫生中心中,11个符合初始纳入标准。其中,三个中心的领导拒绝参与,八个中心(26个诊所地点)同意参与(73%)。参与和未参与的卫生中心在诊所规模、西班牙裔患者百分比和未参保患者百分比方面相似。参与的卫生中心有更高比例的医疗补助患者和更高的基线结直肠癌筛查率。参与的常见促进因素是中心领导认为该项目是提高结直肠癌筛查率以及使用电子健康记录工具进行人群管理的机会。参与的障碍包括中心领导对为未参保患者提供粪便检测和确保其后续跟进能力的担忧、诊所准备研究方案要求的邮件的能力有限、对随机分组的不适以及对一些诊所因研究要求而延迟项目实施的担忧。
我们的研究结果填补了一个重要的研究空白,并可能为未来招募社区卫生中心参与务实性研究的努力提供参考。