KEY POINTS This article described the process of how an electronic data capture system, specifically REDCap, was used for (1) consenting, (2) intervention distributions via scheduled email, (3) incentive coordination, and (4) data management by a decentralized research team to complete a fully electronic research study with clinical nurses who work at night. Including a study team member with previous experience in using REDCap and coding can reduce the learning curve that study teams may experience if not familiar with building all study components in an electronic data capture system. Consider creating educational opportunities, such as an e-consenting simulation, for study team members to familiarize themselves with the REDCap environment before moving the completed project into the production phase and initiating subject recruitment.

Conducting nurse-led research in a clinical setting is an essential scholarly endeavor. Identifying tools and systems that can help facilitate all aspects of a nursing research study establishes standardization; allows collaborative work and coordination across settings, which is critical to the success of this study; and ensures streamlined processes.1–4 In this article, we describe the process of delivering an electronic integrative health curriculum to promote wellness behaviors and highlight self-care content for nurses working at night in an academic health system. The study team selected a Web-based platform—Research Electronic Data Capture (REDCap)—to manage and deliver a curriculum to participants over a 13-week intervention period. REDCap is a secure, Web-based, HIPAA-compliant software platform for building and managing online databases and surveys generally approved by institutional review boards.5 This electronic data capture system was specifically selected for its robust functionality and relative ease of use for the study team and subjects.6–8 The 10-person decentralized, remote study team required an integrated electronic system that could be used both to design and deploy a longitudinal, asynchronous, wellness-focused electronic curricular intervention to clinical nurses working across 4 campuses in an academic health system.9 In addition, the electronic data capture system must provide data management and reporting capabilities compatible with the organization's firewall to safeguard participants' confidentiality and electronic security. The purpose of this article is to provide a practical description of how this study team, which comprised nurse leaders, nurse researchers, a research coordinator, nursing professional development specialists, a Web developer, and a data manager, used the electronic data capture system to design, create, deliver, and manage an integrative health nursing research intervention for clinical nurses who work at night in an academic health system. Although the outcomes of the Midnight Monday Campaign (MMC) study are drafted in a separate article, we will briefly describe the MMC intervention and research procedure to contextualize the use and application of REDCap's functionality.

The Midnight Monday Campaign Intervention

Over the last several years, the COVID-19 pandemic has compounded the typical stress experienced by clinical staff nurses10–12 and has amplified the conversation regarding healthcare workers' well-being. Nurse leaders on the study team made investigating nurse wellness at the study site a top priority. The MMC intervention was designed to evaluate the engagement with health and wellness content for a demographic of clinical nurses who typically miss opportunities offered throughout the academic health system to participate in health and wellness activities because of their shift work. For example, an in-person workshop on visualization for relaxation at noon time would likely not be conducive to the sleeping hours of someone working the night shift. The MMC was designed to explore methods to disseminate this content that would be accessible to nurses despite the typical time constraints associated with night shift work and allow for asynchronous participation. The three primary categories for the MMC curriculum included stress reduction, purposeful movement, and nutrition (Table 1), which were based on contemporary issues in nursing, existing nursing literature regarding topics that are most applicable to nurses who work at night,13–15 and the expertise of the subject matter experts on the study team (eg, nursing professional development specialists and nursing administrative leaders who work at night). They were in alignment with the study site's nursing strategic plan. The integrative health and wellness resources that the MMC curriculum was based on came from an external evidence-based health and wellness repository (eg, The Monday Campaigns, themondaycampaigns.org) and the catalog of available programs and offerings internal to the organization (eg, through the Integrative Health Department). The study team reviewed the preexisting Web-based resources available from Integrative Health and The Monday Campaigns to identify complementary material. This content was then combined and synthesized into a 13-week microlearning curriculum targeted to meet the needs of clinical staff nurses working at night. The curriculum was posted on an intranet Web page, created explicitly for the study and behind the enterprise-wide firewall. Only study participants and study team members had access to this Web page through the unique link embedded in the weekly electronic data capture automated survey and content email. The institution's information technology department maintained this page and provided analytics reports of the Web traffic.

Table 1 - Midnight Monday Campaign Topical Content Outline Week Topic 1 Introduction 2 Sleep hygiene 3 Stress reduction 4 Coping mechanisms 5 Meditation 6 Exercising for restful sleep 7 Walking is really exercise! 8 Overcoming exercise challenges 9 Mindful eating 10 Foods to eat and avoid before bed 11 Meatless Monday 12 Gratitude 13 Self-affirmations for the workforce
METHODS

Because the electronic data capture was used for all aspects of intervention design, delivery, and data management (Table 2), the balance of work was executed in the preimplementation stage (Figure 1). To coordinate and manage this intensive preparatory phase of the study, an internal collaborative drive (OneDrive [Microsoft Inc., Redmond, WA, USA]) containing all pertinent study materials (ie, institutional review board documents, reference articles, weekly meeting minutes, project planning timelines, training materials including e-consenting tip sheets and videos, stakeholder presentations) was set up and accessible to all study team members to ensure transparency, fidelity of the education and study messaging, and version control. Following institutional review board approval and the deployment of the study intervention, the immediate postimplementation phase was focused on troubleshooting, monitoring, and maintaining the delivery of the intervention, data management, and incentive distribution.

Table 2 - Midnight Monday Campaign Study Activities in the Electronic Data Capture System Steps Activity Details 1. Recruit participants - eConsent in person or via video conference
- Participant completion of eConsent triggers immediate pretest deployment 2. Complete enrollment - Cosign eConsent
- Enter Monday start date 3. Pretest - Maximum of three reminders to complete the pretest
- Completion triggers first incentive
- Completion triggers automatic deployment of the 13 wk of content 4. Weekly content - Content sent every Monday at midnight
- Maximum of three weeks reminders per week
- Next week's content is deployed whether prior week's content was completed or not 5. Posttest - Posttest fires automatically either on completion of week 13 or on the Wednesday of week 13 6. Second incentive - PI reviews incentive report and emails final incentive to those who qualify 7. Usability survey - PI sends anonymous survey link to provide usability feedback and end-user experience to participants who agreed to receive it by entering their email address during the presurvey phase
FIGURE 1:

Technical architecture and process management flowchart.

Enrolling Participants With Electronic Consent

Participants were enrolled during a 3-month recruitment period and started receiving emails containing their weekly curricular content on the first Monday after the electronic consent (eConsent) was signed. Study participants were enrolled via an online video appointment or in person using an eConsent. Participants entered their email addresses as part of this process. Completion of the eConsent form automatically triggered the preintervention survey instrument. Study team members then manually filled in the Monday start date field from a drop-down calendar menu as part of their cosigning process. This start date was necessary for automating the weekly surveys at a specific time and day. The email field in the eConsent form was automatically entered into the email address field for subsequent automatic survey invitations for each participant. Participants were offered two $25 gift card incentives. The first incentive was given for enrolling and completing the preintervention survey, and the second was for completing the postintervention survey.

Survey Instruments

Curriculum development and design of survey instruments co-occurred. The study team made full use of the features of the electronic data capture system survey instrument. A self-report survey was developed to ascertain the participant's level of engagement with integrative health and wellness materials and modalities. This survey was administered before curriculum deployment and after the 13-week intervention period. In addition, three-question weekly surveys were included with each week's curricular content. The subject would review the topic and content page for the week, which included a short, evidence-based overview of the topic, reference list, and links to relevant internal (ie, Integrative Health) and external (ie, The Monday Campaigns) resources. The participants would then be presented with three questions about the topic: (1) “Were you able to access the content using the email link or QR code, and if yes, to select which method(s)?” (2) The participant was asked to identify something from that week's content that they were committed to trying, for example, visualization. And (3) a 5-point Likert scale rating the usefulness of the content. Features within the electronic data capture system's survey instruments provide the capability to include GIFs, QR (quick response) codes, and a Web link for each week's learning curriculum delivered inside a survey instrument. This enabled participants to open new tabs and windows to view the content without leaving the survey page. Variable values such as the Monday start date and participant email addresses were automatically entered from the eConsent forms. Participants were not allowed to return to any surveys once they were submitted.

Automatic Survey Invitations

The MMC curriculum was sent to participants every Monday at midnight via prescheduled automatic survey invitations using a study-specific email with an organizational domain ([email protected]). This email address was created by the academic health system's information technology department. All surveys were sent from this study-specific email address via the electronic data capture system's automatic survey invitation feature. Completing the preimplementation survey triggered the automatic delivery of weekly content for the 13 weeks and the postimplementation survey. Two subsequent reminder emails were sent at midnight on the Wednesday and Friday of that week if that week's survey still needed to be submitted. The postimplementation survey was either triggered by completing the last week's content (week 13) or sent out automatically midweek of the 13th week. Several participants indicated they were willing to receive an anonymous usability survey to provide feedback on their end-user experience with the intervention after the study. This process was done manually. The principal investigator (PI) sent the usability survey links individually to the email address provided through a separate survey platform (eg, Qualtrics). Using this different platform was to ensure the anonymity of the participants and provide assurance that their response would not be linked in to their demographic and intervention survey results.

In addition to the study management, the electronic data capture system was used to facilitate testing and training for the study team for eConsenting and reporting. Using the electronic data capture system for this was a new process for most of the study team. The preproduction phase of the build was used as a practice environment and is described next.

Onboarding and Technical Training

Each study team member tested the project extensively in its preproduction mode and utilized hands-on eConsenting exercises with each other as beta testing. The research coordinator created a 10-minute narrated video demonstration of the eConsent process in the electronic data capture system and a step-by-step reference document, including screenshots of the electronic data capture system's menus with specific instructions for entering the required data, such as dates and signatures. The video was created by recording the electronic data capture system's screens on a virtual meeting application. After the study team viewed the video in an online meeting and received the accompanying instructional packet, they paired up to do a practice eConsent. The training video and instructional documents, along with hands-on practice simulations, helped maintain the fidelity of the education of our study team members.

The research coordinator utilized practice enrollments to test the automatic survey invitation settings and the deployment and receipt of emails on the backend. The research coordinator and data managers reviewed the future invitations in the survey invitation log (located in the survey distribution instrument menu) to confirm that the automatic survey invitations were queuing correctly for Mondays at midnight with two reminder emails per survey. When onboarding, training, and testing were complete, the research coordinator and data manager cleared the test data. They moved the project from preproduction to production status to collect the study data.

Some study team members received more extensive and personalized 1:1 training in the electronic data capture system features specific to their roles. For example, the PI was trained to manage an incentive distribution log and run related reports. An additional data manager was onboarded and trained to maintain the backend of the electronic data capture system, create reports, develop instructional packets, and enroll participants. Individualized training was conducted via a video conference platform and included real-time use of the reporting and log maintenance features.

Defining Study Team Member Roles, Custom Reports, and Data Entry Instruments

Custom team member roles were defined within the electronic data capture system's User Rights features, which included the “create new reports” menu. This was used to limit access to the minimum necessary personnel for each report. Study team members who recruited and enrolled participants had access to features required for their role: the eConsent survey and a report of current recruitment counts for each campus. The PI and coinvestigators, research coordinator, data manager, and data analyst had full access to survey responses, survey distribution instruments, data exports, the incentive log, and all other reports (Table 3). The study team utilized the robust, customizable reporting features to manage the logistics of the study, including screening for participants who qualified for incentives, keeping campus counts during the recruitment phase, checking that Monday start dates were entered and correct, confirming content delivery, and generating a list of email addresses for the anonymous usability survey.

Table 3 - Study Specific Reports Created in the Electronic Data Capture System Name of Report Purpose Primary User Incentive distribution log Subject-specific Amazon gift card numbers, dates that gift cards were emailed, and dates of return receipt for Amazon gift card emails PI First incentive qualifiers Indicated when the presurvey was completed and the date the first incentive was emailed PI Second incentive qualifiers Indicated the status of each week's content (complete, skipped) AND when postsurvey was completed to send the second incentive PI Monday start dates Reviewed to ensure entry of Monday start date was present and accurate Research coordinator/data manager Content delivery A question for each week's content affirming that no issues were experienced by subjects in accessing the content via a link or QR code. Used as a quality assurance check by the team Research coordinator/data manager Campus count Able to filter the number of consented subjects and associated subject IDs by campus Study team members who were involved with enrolling subjects ID and email cross-reference Subject name, email, and study number. Used to identify the associated record if the subject notified the team of a problem with the intervention or incentive PI/research coordinator/data manager Email list for usability feedback surveys Report that collated subject IDs and preferred emails for those who indicated that they would be willing to provide anonymous feedback at the end of the intervention period via the usability survey PI
RESULTS

The strategies and methods described can serve as a framework for other institutions seeking to implement evidence-based or nurse research initiatives. There are several lessons learned that we wish to highlight. The first is that using the external or open REDCap version allows for great flexibility for participants. The academic health system maintains and supports two versions of the electronic data capture system (internal and external) and is available to researchers. The internal version of the electronic data capture system can be accessed only while connected to the organization's on-site network (behind the organization's firewall). The external version is available on the public Internet, making it ideal for collecting survey data from research study participants. In addition, participants in this study were advised that study-related activities needed to take place in their own time. Therefore, the external version was selected to enable participants to access the content off-site, view it asynchronously, and use an email address of their choosing rather than their organization-associated email.

Second, a significant amount of time was necessary to design all aspects of the research project before implementation. This ensured compatibility with features such as eConsenting, survey design, graphic file embedding, automated survey invitations and reminders, user rights, data management, and data reporting. The study team included a research coordinator with previous electronic data capture systems and coding experience. This expertise proved invaluable in developing the technical architecture and data capture instruments (ie, e-consent, automatic survey invitations) and in collaborating with the Web developer in the design of the curricular content Web site. Animated and static GIF (graphic interface format) files and live links to the curricular content Web site were embedded within the weekly automated surveys sent as emails from the system. Rigorous beta testing by study team members was required to deliver seamless, error-free content.

Finally, we used the preproduction environment for training purposes. All study team members were encouraged to access the survey forms and eConsenting features to familiarize themselves with the interface while the project was still in the design phase. This served two purposes. The first was to provide a training opportunity for the team members who would obtain informed e-consent to practice in the electronic data capture system environment, as this environment is not initially or inherently intuitive. Using the eConsent feature requires small amounts of data entry in real time to email the consent form to the participant during a phone call or video conference. Note that this electronic data capture system can only perform date calculations that return an integer—it cannot return a text string or an actual calendar date. This meant that the automation of the weekly curriculum on a specific day and time required study team members to manually select a Monday start date from a drop-down calendar as part of cosigning the eConsent form during participant enrollment. Because the study population worked at night, immediate technical support would not be available to study team members consenting participants during overnight hours. Second, the team's practice provided end-user feasibility feedback, including optimization suggestions, to the backend technical team members before moving the entire project into production. Given the rigorous testing in the design phase, no edits to any electronic data capture system elements or eConsenting procedures needed to be made once the study was moved into production and opened to enrollment and data collection.

DISCUSSION

This descriptive process article adds to the existing literature on the usage, flexibility, and application of an electronic data capture system in nursing research. In this work, our team found that this electronic data capture system's data management features and survey (ie, curricular intervention) delivery infrastructure were integral to the success of the original MMC study. The asynchronous nature of the MMC curriculum delivery provided the flexibility that busy clinical staff appreciated and removed a primary barrier to participating in a nursing research project. An electronic data capture system facilitates central management of data entry and progress monitoring of participants working from several campuses. It provides efficient and seamless oversight for research compliance purposes.

Furthermore, this article uniquely adds to the nursing literature in several ways. First, there is a specific recommendation to include study team members with technical experience, whether nurses or other interprofessional team members. Although this electronic data capture system can be used to design and facilitate nursing research studies, we recommend having team members with various expertise in informatics, information technology, and coding or previous experience in using electronic data capture systems to flatten potential learning curves and expedite the research process. Second, this work extrapolates the ease for future replication studies. For example, the original MMC work can be expanded to additional study populations, including advanced practice nurses, nursing attendants, nurses who work in outpatient settings, or nurses who may have more limited access to health and wellness offerings compared with acute care and inpatient-based staff. The technical structure can be replicated with edits to the curricular content, so it applies to additional populations, making subsequent studies using this existing electronic data capture system build resource-efficient. Finally, REDCap can be used as a training environment for study team members before moving the completed project into the production phase and subject recruitment.

Limitations

There were two primary limitations to note in this article. First, REDCap was the only data management platform our team explored for the MMC study, and it is not clear whether these survey designs, reports, workflow, and functionality will translate to other electronic data capture platforms. In addition, there was a learning curve associated with the use of the system, especially for those who may not be familiar with programming logic or coding language. Furthermore, institutions without in-house content experts, such as database managers, electronic data capture systems managers, and Web site developers, may need to access those resources via consultants. This article highlights the features in REDCap that this study team used and is not an exhaustive application of all functions. For example, an Application Programming Interface can incorporate objective physiological data from wearables (ie, pedometers, ActiGraphs, smartphone apps) into REDCap, allowing for additional analysis and subject self-reported outcomes measures. Finally, although electronic data capture systems have many automated features, manual data entry is still necessary for some elements and requires monitoring for user error.

The electronic data capture system proved to be an excellent platform for the MMC study. The system allowed the team access to all aspects of the study. This project demonstrated the methodological contribution of utilizing an electronic data capture system to the success of a nursing research study conducted on multiple campuses in an academic health system.

Acknowledgment

The authors thank Christopher Glazier for his guidance and John Best, MSN, RN, for his participation in the study.

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