Participant Recruitment
Section 5
Recruitment Highlights
Recruitment strategies in the Collaboratory ePCT Trials have varied widely, both in terms of their plans and ultimately, for a few, in the actual scenarios that evolved. The table below briefly describes some of the trials. During the conduct of an ePCT, all may go as originally designed. In other ePCTs, circumstances may change and additional, relevant discoveries made. In these situations, study teams may wish to adapt the recruitment process and/or materials to optimize recruitment approaches.
| Trial | Recruitment Strategy |
|---|---|
| ABATE | The ABATE trial recruited hospitals within a health system and was informed by a prior trial’s experience, resulting in a mostly seamless recruitment. All recruitment was performed within 2 to 3 months using recruitment webinars and leveraging support from the health system’s corporate and division leadership on regular calls. Recruitment was remote but heavily reliant on internal leadership to encourage participation. Participating hospitals were required to have a commitment letter signed by a member of the executive team (i.e., C-suite). |
| Nudge | Patients eligible for the Nudge study were identified through the EHR and received opt out consent packets via the United States Postal Service. Thus, the study required minimal participation from clinicians and executive leadership at the clinic level. However, the Nudge study team believed providing education to the clinicians and leadership at each clinic was vital to ensure patients could be met with an additional layer of support with the intervention if needed.
The Nudge Study team first introduced the study to internal research committees, provider and healthcare leadership advisory groups, and patient stakeholder panels at the healthcare system level. Upon receiving approval from these groups, the Nudge Study team approached the clinic leads from 16 potential clinics across the 3 participating health care systems by providing an electronic summary of the study and scheduling a presentation during provider meetings. The in-person presentation provided background information about the study and copies of the study literature, including consent forms and sample “nudges” (text messages to participants delivered as part of the intervention). The team also offered to provide a list of potentially eligible patients from the clinic, allowing clinicians to note if there were patients who they would not recommend enrolling in the study. During these sessions, clinicians and leadership were encouraged to ask questions, provide input, and seek clarification from the study team. Of the 16 clinics approached across the 3 healthcare systems, all clinics participated in the Nudge study presentation and agreed to support the study |
| PROVEN | The PROVEN trial did not require active recruitment. The video intervention was introduced as a new program in the participating nursing homes, and all patients in the facilities during the implementation period were eligible and targeted to receive the intervention. Consent was waived. |
| SPOT |
In the SPOT trial, participants were automatically enrolled prior to any consent or contact with the study. Those assigned to intervention conditions were contacted and offered intervention services. Participants were enrolled in the trial regardless of whether they accepted the offer of intervention services.
|
| TiME |
Enrollment for the TiME trial was through an opt-out mechanism. The study team received information every 2 weeks about anyone who opted out. Few people opted out. The recruitment strategy during the trial did not require any changes or enhancements. |
| TSOS |
The TSOS trial was on track for 70%-80% recruitment of the targeted 960 patients. In 2018, due to regulatory issues, recruitment was suspended for all sites for an extended period of months. This recruitment suspension prevented the study team from meeting the original recruitment target, such that fewer patients were enrolled in the study. Because the recruitment pause occurred in the final wave of the trial, when all sites were recruiting intervention patients, the study is imbalanced with regard to intervention versus control patients. |
DISCLAIMER: The views expressed in this chapter are those of the contributors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.
SECTIONS
Resources
More on recruitment in the Living Textbook: