Acute gastroenteritis (AGE), characterized by frequent diarrhea or vomiting, is a leading cause of morbidity in children aged <5 years [1]. The majority of pediatric AGE cases are caused by viral infections and can be managed at home using oral rehydration strategies [2,3]. Despite this, AGE accounts for a large portion of children’s visits to the pediatric emergency department (ED), resulting in substantial health care costs, along with emotional and financial stress for the children’s parents and caregivers.

Parental knowledge about management of pediatric AGE has been shown to be low [4] and is often related to accessibility of health care information [5]. Parents have expressed a desire for information on AGE management strategies, such as identifying symptoms and treatment as well as understanding the normal course of illness and causes of AGE [6]. To address this gap, we codeveloped with parents a web-based knowledge translation (KT) tool in the form of a whiteboard animation video [7]. The video presents evidence-based home management strategies and identification of dehydration symptoms in the form of a narrative story that builds on parents’ reported experiences of having a child with AGE [8]. Storytelling has been shown to be effective for communicating health care information and influencing behavior [9-12]. In addition, video instructions may be more effective than written instructions at increasing knowledge of caregivers of children in the ED [13] and influencing behavior [14]. Finally, around the world, the prevalence of web-based health information searching by parents is high, with recent studies reporting a prevalence of 75% to 90% [15].

To date, there is little research on the effectiveness of web-based KT tools that deliver evidence-based health information to parents. Previous studies exploring the effect of KT tools on parent knowledge, experience, and health behavior have reported mixed results [16]. However, a recent study has demonstrated the effectiveness of a KT tool that was relevant to parents’ needs and built confidence to increase parent-reported uptake of evidence-based strategies [17]. It is hypothesized that providing information to parents empowers them to make effective health care decisions (eg, when to seek medical care or go to the ED) and reduces health system costs [18].

Undertaking a rigorous effectiveness evaluation is often resource intensive. Nevertheless, it is essential to understand whether KT tools are effective for their intended audience before making investments in large-scale implementation. The primary aim of this pilot randomized controlled trial (NCT03234777) was to assess the potential effectiveness of a web-based KT tool for pediatric AGE in terms of parent knowledge, confidence in knowledge, decision regret, health care use, and usability and satisfaction. We embedded a qualitative study to gather a greater understanding of parents’ perceptions of the KT tool. The results from this usability trial involving the intended end users will be important to inform future tools and optimize investments in research and KT.

The study was approved by the University of Alberta health research ethics board (Pro00091675) before commencement.

The protocol for this parallel-group 2-arm pilot randomized controlled trial was published [19], and the study was registered at ClinicalTrials.gov (NCT03234777). The trial collected scientific (potential effectiveness) and feasibility outcomes [19]; this paper reports on the scientific outcomes. No changes to the web-based intervention or methods were made after trial commencement. Refer to Multimedia Appendix 1 for the CONSORT (Consolidated Standards of Reporting Trials) eHEALTH checklist.

Recruitment occurred between December 18, 2020, and August 10, 2021. A convenience sample of parents or legal guardians of children aged <16 years presenting to the ED with diarrhea or vomiting were invited. Parents had to be fluent in English and agree to be contacted via email for follow-up. Parents were not eligible if the children had chronic gastrointestinal problems or inflammatory bowel disease (ie, Crohn disease or ulcerative colitis), were taking immunosuppressive therapy or had known immunosuppression, had undergone oral or gastrointestinal surgery in the preceding 7 days, or had had a prior ED visit for vomiting or diarrhea in the preceding 14 days.

The intervention (KT tool) was a web-based 3-minute whiteboard animation video codeveloped by the research team and parents and caregivers and tested with stakeholders (Multimedia Appendix 2) [8]. The video content was informed by research evidence for the treatment and management of pediatric AGE [20]. The control intervention (sham video) was a 3-minute video about hand hygiene produced by the US Centers for Disease Control and Prevention, a reputable government health agency [21]. This resource was chosen with input from a pediatric infectious disease physician and a pediatric emergency physician. It was felt that an active control intervention was preferable so that all participants received some evidence-based information. The content of the control video has widespread relevance and is important for infection control but did not overlap in content with the intervention video.

Figure 1 provides details regarding study process and participant flow. Parents or caregivers of children presenting with vomiting or diarrhea were approached by a research coordinator in the ED waiting room after triage. Research coordinators explained the study process and, if they were interested, parents were handed an iPad containing a web-based application developed by Nooro Inc. The web-based application was used to capture implied consent (by overt action), randomly assign participants to groups, deliver the intervention, and collect data in the ED. This occurred while the parent was in the waiting room before their child received treatment. The same web-based application was used to capture follow-up questionnaire data and automatically send reminders to participants. The web-based application was pilot tested to identify and fix any issues before recruitment.

Parents were randomly assigned (1:1 ratio) to view the KT tool or sham video. A randomization table was generated by a statistician using a computer program with an alternating block balanced approach with block sizes of 4. Research personnel and participants were unaware of the next group assignment. Parents and research personnel were blinded to the interventions being compared.

Parents completed a web-based preintervention baseline questionnaire assessing knowledge about AGE, confidence in knowledge, and decision regret. Immediately after viewing the intervention and control, participants completed a postintervention web-based questionnaire. This questionnaire repeated knowledge, confidence in knowledge, and decision regret questions, and included questions about usability and satisfaction regarding the intervention. Participants were automatically sent a follow-up web-based questionnaire by email 4 days after the ED visit (the date on which the baseline questionnaire was completed). This questionnaire repeated knowledge and decision regret questions and contained additional questions on health care use after the ED visit and intervention usability. Research personnel contacted the parents by telephone every 3 days to remind them to complete the follow-up questionnaire. Parents had 10 days to complete this questionnaire.

Outcomes, methods of assessment, and timing of assessment are listed in Table 1. The primary outcome was change in parental knowledge measured using an 8-item questionnaire informed by the abridged Caregiver Gastroenteritis Knowledge Questionnaire [22]. The questionnaire was tailored to the information in the intervention and pilot tested with parents. Scores are summed and range from 0 to 13, with higher scores indicating a higher level of knowledge (ie, more correct answers; Multimedia Appendix 3). The secondary outcomes included parental decision regret, confidence in knowledge, post-ED visit health care use, and perceived benefit and value of the intervention. Decision regret was assessed using a validated decision regret tool [23]. Scoring involved reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items, with higher numbers indicating greater regret (Multimedia Appendix 4 [23]). Parents’ self-reported confidence in knowledge was assessed using a 5-point Likert scale (ranging from 1=very confident to 5=very not confident). Post-ED visit health care use was captured by asking parents whether they had to bring their child back to the ED for vomiting or diarrhea or seek additional care from another health professional since the initial ED visit. Usability and satisfaction of the interventions were assessed based on responses to 5 statements using a 5-point Likert scale (ranging from 1=strongly agree to 5=strongly disagree). The perceived benefit and value of the web-based intervention were further explored through qualitative interviews with a subset of parents who received the KT tool.

The perceived benefit and value of the KT intervention were also evaluated through qualitative interviews, which were conducted to help understand and contextualize the results of the trial and provide more detailed feedback from participants about their experience with, and perceptions of, the intervention [24,25]. The interviews allowed parents to elaborate on elements of the KT tools that were not assessed via questionnaires and to provide in-depth details about their experience of managing a child with AGE. At the end of the last follow-up questionnaire, parents were asked about their willingness to participate in a 30- to 60-minute one-on-one web-based interview. The semistructured interview guide was developed by the research team and pilot tested with parents (available on request). The interview questions moved from the general to the specific regarding the KT tool, with interviews later in the data collection period becoming increasingly more focused [26] on certain aspects of the KT tool (eg, usefulness of messaging, timing of receiving the KT tool, and modality [ie, whiteboard animation video]). Parents were interviewed using Zoom videoconferencing software (Zoom Video Communications, Inc). The interviews were recorded and transcribed verbatim.

Of the 116 parents enrolled and randomized, 103 (88.8%) viewed the intervention and control and completed questionnaires in the ED (Figure 2). The groups were comparable at baseline (Table 2). Of the 36 parents who viewed the KT tool and completed all questionnaires, 12 (33%) participated in an interview.

Connecting parents and families to effective evidence-based resources has the potential to improve knowledge and confidence in decision-making, which may subsequently reduce health care use and costs. We found that the KT tool codeveloped with parents and tailored to their needs increased their knowledge; however, the intervention had no effect on parents’ regret regarding their decision to take their child to the ED. These findings suggest that increasing knowledge may not be sufficient to change behavior (decisions and actions by parents to seek emergency care for their child). It is well established in behavioral research that knowledge is only 1 factor that drives behavior, for example, the capability, opportunity, motivation, and behavior (COM-B) model outlines different elements that influence behavior, including physical capability, psychological capability, reflective motivation, automatic motivation, and physical and social opportunity [31]. Knowledge and understanding can affect psychological capability and reflective motivation, but other inputs are required to affect the other components that influence behavior. Parents are not rational actors; our findings highlighted that parents’ decisions are shaped by a multitude of potentially interacting factors, including seeking information from a variety of sources. Although the KT tool scored favorably in terms of usability and satisfaction, parents indicated that the tool would only supplement decision-making and not be the determining factor. External elements (eg, calling a health helpline or asking a family member) were also drivers of behavior and decision-making.

Knowledge and experience of a childhood illness can also affect motivation; for instance, it has been shown that previous experience can influence a parent’s ability to determine the severity of their child’s illness and make a decision regarding their care [32]. McWilliams et al [33] found that a standardized education program for parents on acute otitis media was associated with a reduction in ED visits for otitis media in the year after the intervention. By increasing parental knowledge on treatment and management strategies for childhood illnesses such as AGE, parents may be better equipped to make future decisions regarding their child’s health and when it is appropriate to take them to the ED.

Digital and web-based KT tools offer a promising approach to communicate complex health information to parents and support their health care decision-making; however, there are many aspects of this complex process that remain unclear; for instance, how and when to provide these tools to parents during the overwhelming situation of having a child who is acutely ill. It is also unclear how to sustain the effects of these tools to shape future health care interactions. A previous study by our group that assessed the effects of storytelling as a communication tool found that a KT tool in the form of story booklets had a small but statistically significant impact on decision regret [9]. Although the difference was statistically significant, it was unclear whether the change would be clinically important. Similarly, a recent study performed by Jove-Blanco et al [34] found that video discharge instructions improved parental knowledge but did not have an effect on ED revisits. Chande et al [35] also found that the effects of an education intervention were not sustained; as a result, ED use habits in the 6 months after the ED visit were not altered.

Around the globe, many jurisdictions are developing approaches to reduce avoidable ED visits to improve appropriateness of care. However, many educational interventions seem to have had little to no effect on initial or subsequent ED visits [34,36,37]. The decision to take a child to the ED is complex, often overwhelming, and may be informed by a variety of different sources such as internet searches, consultation with family members, or communication with health care professionals [38]. In this study, half of the parents reported contacting a health professional (49/103, 47.6%) or looking up information on the web before going to the ED (55/103, 53.4%).

It is difficult to determine what a potentially avoidable ED visit is compared with a necessary visit for pediatric AGE. Measuring appropriateness of pediatric ED visits is challenging [39]. A recent study found low levels of agreement among clinicians on what constitutes an appropriate visit [39]. In our interviews, some of the parents stated that they were instructed by health care providers to take their child to the ED, whereas others referenced “following their gut” to make the decision. Although the information presented in the KT tool may be relevant and informative regarding the parent’s current situation, it may not carry the same influence as a conversation with a health care provider or “gut feelings.” The interviews provided additional illumination, with parents indicating that viewing the KT tool would not influence their decision if a health care provider had already advised taking their child to the ED; however, if viewed before the decision was made, it could be useful (likely in combination with other sources) to decide whether an ED visit was necessary.

Overall, parents provided positive feedback on the KT tool, indicating that it is useful, increased knowledge, and could be used to help with decision-making about their child’s health. This is consistent with our previous usability testing in which the tool was described as “informative, clear, and to the point” and that the checklists in the video are helpful for decision-making [8]. When asked about the best context in which to view the KT tool, parents indicated that the tool would be most helpful if viewed before going to the ED, and suggestions for dissemination included prenatal classes or regular clinic visits. Furthermore, having a web-based KT tool supports access when parents need information.

Health research funding agencies are prioritizing and making large investments in KT (or knowledge mobilization). Nevertheless, it is essential to conduct rigorous evaluations to understand whether KT efforts and interventions are having their intended impact, as well as how and when they need to be delivered. This trial with a qualitative component provides an important starting point for understanding the potential effectiveness of a KT tool codeveloped with parents. We found an impact on knowledge and parents’ confidence in their knowledge, which are important precursors to decision-making and behavior change [40,41]. A limitation of this trial is that parents had already made the decision to take their child to the ED. An important next step will be to share KT tools with parents before they make the decision to seek care to assess the impact of the KT tools on decision-making and service use. Mixed methods approaches using both quantitative and qualitative data collection will be important to understand impacts as well as contextualize how the KT tools affect the decision-making process. Continued research to understand the impact of web-based KT tools and their features that influence decision-making and use of health care services is critical. Furthermore, evaluation with a more diverse population (in terms of demographics and web literacy) would inform generalizability.

Few KT interventions for parents and patients undergo rigorous effectiveness evaluations, which is a key strength of our study. Although we evaluated effectiveness using a randomized and blinded design, this was a pilot trial and may not have had the power to detect differences for some of our secondary outcomes, in particular, decision regret. However, our data will allow for sample size calculations for future trials in this area. Another key limitation is the timing of delivering the intervention. Because of practical considerations, we recruited parents in the ED after they had already made the decision to bring their child. We assessed decision regret using a validated tool; however, this may not capture the impact a KT tool could have on decision-making before going to the ED.

It is important to note that the results might not be generalizable across parenting roles, given the higher percentage of mothers participating in the study; however, this is similar to previous child health studies, which report that mothers assume a care provider role and more often participate in child health research [42-44]. Because of the sample size, there may have been some imbalances between the groups with respect to some characteristics (eg, the intervention group had more participants with 4-5 children). It is unclear how this would have influenced the results; however, there were no differences at baseline between the groups with respect to the primary outcome of knowledge. In addition, loss to follow-up, particularly for the postintervention questionnaire (although similar across the groups; 10% difference), may have biased the results; for instance, those who participated in the follow-up questionnaires and interviews may have been more engaged and overestimated the effects.

This pilot randomized controlled trial showed that a KT tool codeveloped with parents compared with a sham control significantly increased parents’ knowledge about AGE. No differences were observed for decision regret, suggesting that other factors may affect the multifaceted decision-making process of when to seek ED care. The qualitative results offered important insights and underscored the idea that multiple factors influence parents’ decision-making when their child is sick. Although the KT tool scored favorably in terms of usability and satisfaction, parents indicated that the tool would only supplement decision-making and not be the determining factor. Further research into understanding what information and factors influence parents’ decision-making is warranted.