Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
Trials. 2013 Aug 21;14:267. doi: 10.1186/1745-6215-14-267.
The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.
As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.
We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.
Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.
ClinicalTrials.gov NCT01029288.
糖尿病决策辅助工具（DAD）试验探索了在基于社区的基层医疗实践中测试关于冠状动脉预防和糖尿病药物的决策辅助工具（DA）的有效性的可行性，包括为 2 型糖尿病患者提供服务的农村诊所。
最初设计时，我们邀请了 8 家诊所的临床医生参与试验，审查了接受我们邀请的有资格的潜在患者的临床医生的患者小组，并通过电话联系这些患者，招募那些接受我们邀请的患者。由于招募未能达到目标，我们又招募了 4 家新的诊所。在与临床医生讨论了这项研究并获得他们的支持后，我们审查了所有诊所的潜在合格患者名单。与临床医生联系以确认参与和患者资格，并在患者就诊前征得书面知情同意。这种门诊方法需要研究协调员在诊所旅行和停留更长时间，以及筛选更多符合条件的患者记录。这种门诊方法与更高的招募率、更低的患者保留率和结局完成率以及更好的干预效果相关。
我们得出了四条经验教训：1）难以确定潜在合格患者会威胁到实用的 DA 试验的可行性；2）为了提高招募效果，在患者就诊前，在诊所招募临床医生和患者参加研究；3）提高招募率的方法可能与保留率和调查响应率降低相关；4）涉及与实践密切合作的程序可能会提高招募率，并且可能会影响干预措施实施的质量。
在包括农村诊所在内的常规基层医疗中的基于实践的试验取得成功可能需要在实践中尽可能减少研究足迹，同时实施简化的方案，有利于与临床医生和患者进行门诊、面对面的互动。
ClinicalTrials.gov NCT01029288。
