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. Author manuscript; available in PMC: 2025 Jun 1.
Published in final edited form as: J Adv Nurs. 2023 Dec 2;80(6):2592–2597. doi: 10.1111/jan.15983

Research Electronic Data Capture (REDCap) in an Outpatient Oncology Surgery Setting to Securely Email, Collect, and Manage Survey Data

Jennifer R MAJUMDAR 1,2,*, Jillian B FROMKIN MMS 1, Stephen J YERMAL 2, Alexandria M FATATA-HAIM 1,3, Margaret BARTON-BURKE 1,3, Nalini N JAIRATH 4
PMCID: PMC11088533  NIHMSID: NIHMS1944893  PMID: 38041582
Criteria Author Initials
Made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; JM, JF, MB,NJ
Involved in drafting the manuscript or revising it critically for important intellectual content; JM, JF, SY, AF,MB,NJ
Given final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content; JM, JF, SY, AF,MB,NJ
Agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. JM, JF, SY, AF,MB,NJ
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Background

Vigilant assessment, providing patient-specific instructions, and ensuring continuity of care are important elements of postoperative nursing care necessary for a safe and efficient recovery following a surgical procedure. Nursing interventions in the postoperative time period including psychological and emotional support, adverse event education, and instructions for follow-up care contribute patient satisfaction, safety, and quality of life(Cardoso et al., 2023). However, the time spent in the post-anesthesia care unit (PACU) and hospital continues to shorten around the world to reduce health care spending and improve patient outcomes. The number of ambulatory surgeries performed in the United States alone rose to over 19.2 million surgeries in 2018(Mcdermott & Liang, 2019). Therefore, as more surgeries become outpatient procedures, nurses conducting research during the important postoperative recovery period need to utilize unique techniques and emerging technologies to contact, recruit, and collect data outside of the hospital setting. More importantly, these technologies need to protect patient information(Bowman & Maxwell, 2018; Colpas, 2013; Shuren & Livsey, 2001). One such tool ideal for nursing research is the Research Electronic Data Capture (REDCap) platform (Dunn et al., 2016; Klipin et al., 2014; Maré et al., 2022; Obeid et al., 2013).

As of February 2023, 6361 organizations in 151 countries utilize REDCap (REDCapCon – REDCap, n.d.). Research Electronic Data Capture (REDCap) is a secure web application specifically created to support data capture for research studies(Harris et al., 2009, 2019). REDCap provides 1) an intuitive interface for validated data capture; 2) audit trails to track data manipulation and export; 3) automated export for seamless data downloads to statistical packages; and 4) the ability for data integration and interoperability with external sources(Harris et al., 2009, 2019). REDCap was created in 2004 at Vanderbilt University (VU) and was shared with a limited number of additional sites in 2006. VU then created a consortium for sharing and supporting free access to academic, non-profit, or government partners (Harris et al., 2019).

This paper describes the feasibility and acceptability, facilitators, and barriers of the software application, REDCap, to complete a repeated-measures, descriptive correlational study in patients undergoing outpatient breast cancer surgeries. The methods described here provides a framework for others developing a survey-based study for patients outside of the in-patient hospital setting.

Methods

The recruitment, data collection, and storage were completed utilizing the secure REDCap Platform. The Institutional Research Board (IRB)-approved study was a repeated-measures, descriptive, correlational study with data collection at three time points. The data points aligned with important transitions and routine visits to improve data collection feasibility and increase relevance to clinical practice. The important transitions included the first surgical visit, the surgery, and the discussion of biopsy results with the surgeon. Specifically, these timepoints were: Baseline (T1) Data Collection Point, before the initial surgical consult; T2 -Data Collection Point, Postoperative Day 1; and T3-Data Collection Point, Postoperative Day 14 following patient receipt of diagnostic results. The data is stored on the REDCap Platform until the IRB expiration date.

Sample Size Calculation

Using G*Power (Version 3.3) software set for a general linear model, we calculated the required sample size (Faul et al., 2009) to evaluate the effect of predictors and coping strategies on the outcomes. The appropriate sample size for this study was based on several factors, including effect size, desired statistical power level, the number of predictors, and the level of significance. Based on the literature review and study conceptualization, 10 potential predictor variables were identified: age, preoperative pain, preoperative distress, and whether each participant received neoadjuvant chemotherapy, was a current smoker, was employed, had access to sick leave, had perceived social support, had children at home or had a history of postoperative nausea or vomiting (De Feudis et al., 2015; Goetz et al., 2019; Hanalis-Miller et al., 2022; Majumdar et al., 2019; McFarland et al., 2018; Montgomery et al., 2010; Powell et al., 2016; Schreiber et al., 2019).

The level of significance (alpha) was set at .05, and the power to .80. A power level of .80 allowed for a 20% tolerance for a Type II error (Gray et al., 2017). Utilizing G*Power (Version 3.3) software set for a linear multiple regression model, the calculated sample size was 50 (Faul et al., 2009). To allow for sample attrition, 120 women were recruited for the study.

Subject Recruitment & Data Collection Procedures

The Institutional Review Board procedure at our institution included requesting access to electronic medical records to identify potential participants. A research coordinator screened all patients in the scheduling system on a predetermined start date using a consecutive sample recruitment strategy. Each patient meeting the inclusion and exclusion criteria received a unique identifier in the REDCap database. The sample consisted of women diagnosed with breast cancer who underwent outpatient breast-conserving surgery (BSC). Every patient in the sample was sent a secure REDCap email 24 hours following surgery. The email included an invitation letter and a link to access the two surveys.

Patients who completed the survey within 48 hours were included in the study. Patients who did not complete the survey were automatically removed from the REDCap database and no data were collected from their electronic medical records (EMR) by the research team. Two weeks after surgery, each enrolled patient was automatically sent an additional secure email through REDCap with a link to repeat the surveys. All other data was obtained from the EMR collected through routine care. The data from the EMR was combined with data from REDCap using the unique participant code and was deidentified prior to analysis.

Instruments

The primary measure consisted of validated questionnaires: the Ways of Coping (WAYS) and the National Comprehensive Cancer Network (NCCN) Distress Thermometer with Problem List (DT). The 66-item WAYS measures coping processes and strategies conceptualized in the Transactional Model of Stress and Coping (Folkman & Lazarus, 1988). The WAYS questionnaire serves as a research instrument in studies of the coping process. The WAYS provides researchers with a theoretically derived measure that allows them to explore the relationship of coping between stress and adaptational outcomes. It identifies an individual’s thoughts and actions to cope with a specific stressful encounter and measures the actual coping strategies. WAYS has a limited respondent burden, requiring an estimated 10 minutes to complete.

The NCCN Distress Thermometer includes a scale identifying how much distress a patient is experiencing on a scale from 0 to 10, where 0 indicates no distress and 10 indicates extreme distress(Riba et al., 2022). A score of 4 or greater indicates clinically significant level of distress (Ma et al., 2014). The Distress Thermometer serves as a rough, single-item screen that identifies distress from any source, even if it is unrelated to cancer.

Results

Working with our institutional liaison for REDCap, we inputted the instruments, survey letter, selected specific dates for sending emails, and created the plan to recruit patients. Inputting patients into the REDCap system was a simple process requiring limited training for the research team by the REDCap data support liaison. Within 24 hours of surgery, study participants were emailed an invitation letter and two instruments to complete. Study participant demographics were retrieved from the EMR and added to the REDCap database. Finally, all the deidentified data was exported to SPSS for analysis. The entire process was seamless, fast, and securely maintained all data.

Feasibility and Acceptability

The sample consisted of women diagnosed with breast cancer undergoing breast conserving surgery between August 15 and October 15, 2020. There were 123 potential participants, of which 76 started the surveys and 75 participated (61%) responded and participated in the study on Postoperative Day 1. 59 participants (78%) completed the surveys on Post-Operative Day 14. In addition to completing the surveys, the participants had the opportunity to write in free text if they had “additional concerns” and or “anything else they would like to share”. On Post-Operative Day 1, 19 participants (25%) shared additional concerns and comments. On Post-Operative Day 14, 23 participants (39%) shared additional concerns and comments. No comments or concerns were related to the email recruitment or data collection.

Sample Characteristics

The average age of the sample was 58.7 ± 9.51 years. Over half of the participants were employed (57.1%, n = 40), and the majority of employed women had access to sick leave (72.5%, n = 29). More than one-fourth of the participants were smokers (32.9%, n = 23); most did not have a history of post-operative nausea and vomiting (PONV) or motion sickness in surgeries prior to the surgery (96%, n = 72). The majority of participants did not have children at home (94.6%, n = 71) and reported that they had social support (88.6%, n = 62).

Discussion

Our study focused on women undergoing outpatient surgery as primary treatment of breast cancer. REDCap provided a secure web application for building and managing data for this repeated measures study. Previous studies have found the software application REDCap to be a feasible and acceptable data collection tool (Crane et al., 2019; Dunn et al., 2016; Maré et al., 2022; Obeid et al., 2013). Yet, this study demonstrates the unique opportunity of utilizing REDCap for patients undergoing outpatient surgeries and specifically focuses on previously overlooked period of high distress while recovering from surgery. The women in this study had the additional unique stress related to their cancer diagnosis and treatment in addition to the coping with the pain and stress associated with any type of surgical procedure.

Facilitators

An advantage of REDCap is that it requires minimal institutional support and frequently only requires one data support staff at each institution(Harris et al., 2019). Utilizing REDCap provided an opportunity to capture symptoms and experiences related to the surgery while not in the hospital setting. In addition, emailing the patients following discharge reduced patient and staff work for the short hospital stay during the outpatient procedure. Setting up an automatic delivery of the email reduced the workload of the research coordinator and ensured the email was delivered at the correct time. The REDCap software program also sent automated reminders, further reducing the workload for the research and clinical staff.

Barriers and Limitations

Although REDCap was an effective and secure data management software, barriers and limitations exist when utilizing REDCap and email for a repeated-measures study in the postoperative outpatient setting. First, although it is free for non-profit facilities, one must use REDCap through their institution which it does still require a person to develop the survey and there may not be a person available, or they may have limited time which could delay the publishing of the survey. There are also variable levels of benefit to researchers based on the ability to access other elements of the Electronic Health Record (EHR). We were able to seamlessly retrieve the data from the EHR, but other institutions may not have these types of data integration opportunities in place.

Second, our sample included patients undergoing oncology surgery which may limit to the applicability of REDCap to other samples and populations. Third, patients are required to have and be able to easily access email which limits the population. In particular, when recovering from surgery the patients with the most severe symptoms ideal for targeting with a study may not be able to access or respond to an email study invitation. Also, the email may be viewed as spam or junk. Furthermore, REDCap requires socializing patients to the process and knowing the intricacies of the system and the way REDCap is setup. In our study, only one participant accessed the surveys without completing any information which may have been related to a technical issue with REDCap. REDcap may exclude populations based on their literacy and the user interface for accessing the surveys.

Fourth and finally, contacting patients through email may not be the most ideal way to make a connection and may feel cold or detached. In theory, the emails may feel intrusive and upsetting to patients and the researchers cannot guarantee the patients are approached at an optimal time point. However, we did not receive any negative feedback from participants and our study had a high response and completion rate.

Conclusion

As the frequency of outpatient treatment increases, nurses conducting postoperative research will need to collect the data outside of the hospital setting. Email provides a method of studying new phenomena by recruiting participants, providing information about the study, and collecting results in a non-traditional setting. REDCap provides a method to facilitate nursing research through a securely encrypted integrated process. To achieve optimal results using REDCap, researchers require strong communication, coordinating, and delineation of responsibilities between the technology and the clinical research teams. Further research should explore the influence of social determinants of health on email recruitment, specifically ways to target populations potentially excluded by email recruitment and data collection such as those with limited literacy, low English proficiency, or a lack of access to the internet.

Acknowledgments

The authors have declared no financial relationships with any commercial entity related to the content of this article. The authors did not discuss off-label use within the article.

Funding Statement

This research was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748.

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