A survey of caregiver preferences regarding research participation in the paediatric emergency department

Abstract

Objectives

Emergency department (ED) visits can be stressful for families and can affect caregiver willingness to consent to participating in research. Our objective was to describe when and how caregivers wish to be informed about clinical research during their child’s ED visit.

Methods

An electronic survey was performed for families presenting to 10 Canadian paediatric EDs. A convenience sample of 1456 caregivers with children aged 0 to 17 years were enrolled. The survey tool was created (with an expert panel) using published methodological guidelines, including item generation/reduction, pre- and pilot-testing, and clinical sensibility assessment. Research-specific questions included the best time to be approached, the breadth of study opportunities presented, and best ways to encourage families to participate.

Results

Caregivers reported that the best times to be approached regarding research were in the waiting room (45.3%, 653/1441), after physician assessment (39.0%, 562/1441), or just prior to discharge (9.9%, 143/1441). 52.2% (351/672) wanted to hear about all available research studies, while 47.8% (321/672) wanted to be informed of studies relevant only to their child’s condition. Reported best ways to encourage families to participate in research included: incentives (e.g., gift cards/parking passes [31.2%, 230/737]), providing a clear explanation of study intent (30.7%, 226/737), and appealing to altruism (25.4%, 187/737).

Conclusions

There is wide variability in family preferences for timing of research-related conversations, suggesting that families could be approached in the waiting room, and if that is inconvenient or impractical, they could be offered a deferred conversation (i.e., after physician assessment or prior to discharge).

High quality child health research is necessary for continual improvement of standards of care in paediatric healthcare (1). Historically, child health research was often cross-sectional, single-centred and with smaller sample sizes, resulting in sub-optimal quality of evidence (2). This was due in part, to limited opportunities in funding trials for children (2). Unfortunately, this has resulted in therapeutic strategies being extrapolated from adults, with up to 40% to 60% of paediatric medication use being off-label for children (3). Ethical considerations are also important for children as a vulnerable group, and protectionist approaches need to be balanced with proper informed consent from parents and assent from children who are able to provide it (4).

Respectful family engagement is essential to good paediatric research (5). Increasingly, research trials are incorporating caregiver involvement right from the inception and design of the study (6,7). Most caregivers are generally amenable to their children participating in research, citing altruism as a driving factor in their decision-making (8). However, depending on experience, healthcare providers can have varying perceptions of obtaining consent, and sometimes overestimate the burden of research on their families (9,10). Knowing how to balance invitations to participate in research while respecting and supporting families through a potentially stressful healthcare visit is essential (11). A UK research group has previously explored caregiver perspectives around deferred consent in the emergency department (ED) setting; however, preference of timing was not assessed (12). To date, there has been no Canada-wide study examining caregiver preferences for research involving prospective informed consent. Our objective was to describe when and how caregivers wish to be informed about clinical research during their child’s ED visit.

METHODS

Study design, setting, and time period

A descriptive cross-sectional survey design was employed. Caregivers and children presenting to 10 Canadian paediatric EDs were recruited over 1-week periods every 3 months, for a total of 4 weeks of recruitment per site. The aim was to recruit 50 caregivers per site, every week, for a total of 200 caregivers per site. Responses were collected between October 2018 and March 2020, with staggered start dates. Families were recruited during daytime and evening hours, per research assistant availability. Sites included: Stollery Children’s Hospital (SCH) (Edmonton, AB), Alberta Children’s Hospital (Calgary, AB), BC Children’s Hospital (Vancouver, BC), Children’s Hospital at London Health Sciences Center (London, ON), Children’s Hospital of Eastern Ontario (Ottawa, ON), CHU Ste Justine (Montreal, QC), Hospital for Sick Children (Toronto, ON), IWK Health Centre (Halifax, NS), McMaster Children’s Hospital (Hamilton, ON), and Winnipeg Children’s Hospital (Winnipeg, MB).

Population and sample size

A convenience sample of 1456 English or French proficient caregivers with children aged 0 to 17 years were consented and responded to the research-specific questions nested within a larger study of global family needs in the ED, which had a total of 2005 responses, overall. Inclusion criteria were caregivers of children aged 0 to 17 years, who presented to a participating ED with any chief complaint and were able to read and write in either English or French. Families would be excluded if (a) the child remained medically unstable throughout their ED stay, as determined by a treating nurse or doctor, (b) there was a suspicion of child abuse, as determined by a clinical team member, (c) the child was presenting with an altered level of consciousness, or (d) if the accompanying caregiver was not a legal guardian of the child. Although having a child with an altered level of consciousness would not directly impact the results of this sub-study, this exclusion criteria was part of the larger overarching study that included child surveys.

Survey tool

This de novo survey was created using previously published methodological guidelines (13). Survey item generation was supported through literature review of the topic, expert team input, and consultation with a University of Alberta parent advisory group. The 11-member expert panel (including paediatric emergency medicine, nursing, child life services, parents, youth, and ED administrators) then used the Delphi process to review, rank, and reduce the items (13). Surveys were then pre-tested by the panel members for flow, salience, acceptability, and administrative ease to evaluate how easily the questions were understood (13). Following that, surveys were pilot tested with 10 caregivers and children to identify unusual, redundant, irrelevant, or poorly worded question stems and responses (13). Finally, the survey underwent clinical sensibility testing with 10 caregivers and children to ensure comprehensiveness, clarity and face value of the survey (13) (Supplementary Appendix 1).

Intervention and outcome measures

Caregivers were asked some personal demographic questions, including age, relationship to child, number of other children, and level of education. For the research-specific questions, caregivers were asked (a) whether they would want to be provided with information about all possible studies or only those deemed relevant to their child’s condition, which were mutually exclusive options. They were also asked (b) the best time during their ED visit to ask families to participate in research, which had four mutually exclusive options to choose (waiting room, after being seen by a doctor, right before leaving, or free text, in which they could mention multiple themes). Finally, caregivers were also asked (c) the best way to encourage families to participate in research, which was a free-text question, in which caregivers could mention multiple themes.

Data collection

A medical record review was conducted for demographic and visit-related variables, including child age and sex, length of ED stay, and time to see a physician. Caregivers were able to complete the surveys either in the ED (at the end of their visit) or via an email or phone follow-up, up to 7 days post visit. Of note, participants were permitted to skip any questions that they wished, resulting in differing denominators for each survey questions, when presenting results. Study data was collected and managed using REDCap electronic data capture tools hosted and supported by the Women and Children’s Health Research Institute at the University of Alberta (14).

Ethics

Ethics approvals were obtained from the Research Ethics Boards (REB) of all sites, including the University of Alberta Health REB; the University of Calgary Conjoint Health REB; the University of British Columbia Children’s and Women’s REB; the Western University Health Sciences REB; the Children’s Hospital of Eastern Ontario REB; the CHU Ste Justine REB; the SickKids REB; the IWK Health Centre REB; the McMaster University REB; and the University of Manitoba Health REB.

Data analysis

Descriptive statistics (means, medians) were completed for continuous variables (e.g., age) while frequency distributions summarized categorical variables (e.g., sex). Thematic coding for free-text responses was completed by two team members, and the consensus between these two members was used to categorize responses (KM, MR).

RESULTS

The median age of caregivers was 37.9 ± 7.6 years; 75.1% (1080/1438) were mothers. Full demographic details can be found in Table 1.

Table 1.

Demographic and visit characteristics

	All patients n (%)
Child
Age, years mean (SD) (n = 1456)	6.0 (5.1)
Sex, female n (%) (n = 1456)	701 (48.1)
Previous ED visits (lifetime) n (%) (n = 1437)
None	261 (18.2)
1–5	842 (58.6)
6–10	206 (14.3)
>10	128 (8.9)
Reported chronic disease (n = 1437)	288 (20.0)
Length of ED stay, hours median (IQR) (n = 1450)	4.0 (2.7–6.2)
Time to see physician, minutes median (IQR) (n = 1418)	81.0 (38.0–142.0)
Discharge disposition n (%) (n = 1451)
Discharged	1255 (86.5%)
Admitted	186 (12.8%)
Other	10 (0.7%)
Caregiver
Age, years mean (SD) (n = 1406)	37.9 (7.6)
Relationship to child n(%) (n = 1438)
Mother	1080 (75.1)
Father	336 (23.4)
Other	22 (1.5%)
Total number of children n (%) (n = 1392)
1	334 (24.0)
2	648 (46.6)
3	262 (18.8)
>3	148 (10.6)
Main language spoken at home n (%) (n = 1435)
English	1049 (73.1)
French	156 (10.9)
Non-English/Non-French language	230 (16.0)
Highest level of education n (%) (n = 1430)
Elementary School	5 (0.3)
Some High School/High School	125 (8.7)
Diploma/Certificate	274 (19.2)
Some Post-Secondary/University	244 (17.1)
University/Professional Degree	760 (53.1)
Decline to answer	22 (1.5)

Caregivers felt the best times to be approached regarding research participation during an ED visit were in the waiting room (45.3%, 653/1441), after being seen by a doctor (39.0%, 562/1441), or just prior to discharge (9.9%, 143/1441). 52.2% (351/672) wanted to hear about all available research studies, while 47.8% (321/672) wanted to be informed of studies relevant only to their child’s condition. Reported best ways to encourage families to participate in research included: incentives (e.g., gift cards, parking passes [31.2%, 230/737]), providing a clear explanation of study intent (30.7%, 226/737), and appealing to altruism (25.4%, 187/737) (Table 2).

Table 2.

Caregiver perspectives on future research participation

Learning about current research studies (n = 672)
Want to hear about all studies and then decide which to participate in	351 (52.2)
Approached on an individual basis, only if the study applies to child’s condition	321 (47.8)
Best time to discuss research participation opportunities (n = 1441)
Waiting room	653 (45.3)
After being seen by a doctor	562 (39.0)
Right before leaving	143 (9.9)
Other considerations (see next sub-heading)	83 (5.8)
Further considerations when approaching families for research (free text) (n = 83)
Avoid interrupting prolonging ED visit/care (i.e., not interrupting timeline of care, after ED discharge at home)	39 (48.1)
Situation-responsive (i.e., consider family situation, what questions will be asked, severity of child’s condition)	24 (29.6)
Integrate research processes better into ED flow (i.e., at triage, in a private room waiting to be seen by a doctor)	27 (33.3)
Best way to encourage families to participate in research* (free text) (n = 737)
Incentives (e.g., gift cards, parking passes, food)	230 (31.2)
Clear explanation of study intent	226 (30.7)
Appealing to altruism and benefit to others	187 (25.4)
Pleasant and attentive to family’s needs	82 (11.1)
Asking at the right time	81 (11.0)
Other**	149 (20.2)

^*Multiple responses permitted;

^**Something to occupy time while waiting (n = 45), Just asking (n = 34), Having alternative formats such as email, paper handouts, posters, social media, text (n = 34), shorter/simpler surveys (n = 31), assuring confidentiality (n = 5).

DISCUSSION

This study is the first national survey representing 10 out of the 15 Canadian paediatric EDs asking caregivers about their preferences for research participation. Almost half of caregivers wanted to be approached in the waiting room, while one-third preferred to hear about research after being seen by a doctor. Caregivers were almost evenly split between preferring to know about all ongoing studies versus only studies relevant to their child.

Offering every family the choice of timing as well as the option to hear about as much or little about research opportunities available is inherently family-centred and most likely to encourage their participation. This is not surprising, given that paediatric ED visits are often unplanned, and caregivers may have heightened anxiety and wish to better grasp their child’s condition and stability prior to engaging in further cognitive tasks such as consenting to research (15). On the other hand, with increasing wait times, boredom is often experienced by caregivers, and research participation may help occupy the time and facilitate turning waiting rooms into a ‘relational space’ (16).

In one specific multi-centre UK study that employed deferred consent, a related sub-study highlighted that it was important to ‘gauge when it is appropriate [to obtain consent] for each family, on a case-by-case basis’ (17). While this qualitative study included 17 families that were interviewed, our quantitative study had over 1400 caregivers and demonstrated that there is no one perfect time to approach all families for prospective informed consent, and multiple factors need to be taken into consideration. Some of these factors may include waiting until the child is medically stable, and consulting with bedside nurses who have developed rapport with the families to determine best timing for initial presentation of research opportunities (17). In the setting of deferred consent, it may also hold true that caregivers prefer to be approached ‘sooner rather than later’ (17).

Our study showed that almost half of caregivers were open to be approached in the waiting room, compared to a previous single site study which found that one-third of caregivers preferred this (18). Families might prefer being approached in the waiting room as it may minimize clinical care disruptions and make better use of wait times. Further, prior study has demonstrated that availability of a private space within the waiting room almost doubled participant willingness to be approached in the waiting room and may help facilitate research participation (18).

In keeping with previous literature, caregivers felt encouraged to participate in research with small incentives to offset the cost of parking or food and drink (19). A clear explanation of study intent and appealing to research as a means to improve the care of children in the future are both equally important to emphasize when explaining research opportunities to families. This is congruent with a review of two Cochrane analyses, which found four general approaches to encouraging research participation: appealing to social motivators, targeting individual psychology, reducing cognitive burdens, and providing incentives (20). Better understanding of the study intervention and the importance of research were also two factors supportive of research participation in another paediatric acute care setting (21). While a lack of paediatric trial inclusion was highlighted in one of the two Cochrane reviews, our study aimed to specifically engage caregivers in paediatric research (22). A recent online survey also found that families appreciate updates on study progress and results (19). To build on our study, future research could explore incorporating family updates into knowledge translation plans to provide continuity when appealing to the altruism of families to improve child health.

Limitations of this study include a recruitment bias of caregivers who are likely to be interested in participating in research already. Caregivers who filled out the survey were also disproportionately mothers. Additionally, limiting the survey to two official languages likely deterred families for whom English and French were not their primary language. Most caregivers were generally asked during daytime and evening hours when research assistants were available, so the unique needs of caregivers who attend the ED at night may not be represented. Caregivers could choose to skip any survey question; as such, the denominators for each question vary. Not ‘forcing’ respondents to answer any survey questions is considered ethical practice by our institution and others, so we adhered to this approach for this study. Of note, our question asking about interest in helping to improve the health care system by participating in further research was intended to be a screen for whether caregivers wanted to answer additional questions about research participation preferences; however, given the lower response rate for the immediate next question, this may have been misinterpreted as participating in further research during their visit ‘today’.

As this study was part of a larger national survey of caregivers across tertiary paediatric EDs, it was not feasible to ask more specific questions around research participation and preferences while maintaining a reasonable survey length as per our parent advisors and expert panel. Future studies could explore which modalities (i.e., video screens, pamphlet, website, in-person explanation) are preferred when presenting research opportunities to families, and whether the existence or creation of private research spaces within the waiting room would encourage more or earlier research participation. Prior studies have discussed the role of waived or deferred consent in acute care settings (12,23,24), and there may be further unique considerations for research in children who are critically ill. Lastly, researchers could explore if including participating families into knowledge translation and dissemination plans further encourages their future participation in child health research.

Research teams should strive to approach families early on in their visit, such as in the waiting room, and provide them the opportunity to hear about all or some studies at that point, or to defer the conversation to a later time. This enables families to participate earlier if they would prefer and have the capacity to or empowers them with knowledge around research opportunities should they choose to participate later. Families are clear in what encourages their participation in research; namely, small incentives, clear explanation of study intent, and appeals to altruism, which should be considered during the study explanation and consent process. While child health research has long lagged behind adult research, this national study is a starting point towards understanding caregiver’s preferences and uptake of child health research.

Supplementary Data

Supplementary data are available at Paediatrics & Child Health Online.

FUNDING

This work was supported by the Women and Children’s Health Research Institute Clinical/Community Research Integration Support Program grant through a generous donation from the Stollery Children’s Hospital Foundation. Dr. Stephen Freedman is supported by the Alberta Children’s Hospital Foundation’s Professorship in Child Health and Wellness. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The researchers are independent from the funders. Dr. Keon Ma, Dr. Samina Ali and Ms. Manasi Rajagopal had full access to all data (including statistical reports and tables) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

CONFLICT OF INTEREST

The authors declare no conflict of interest and have received no payments in the preparation of this manuscript.