Development of the Tool to Empower Parental Telling and Talking (TELL Tool): A digital decision aid intervention about children's origins from donated gametes or embryos

Abstract

Objective

This study aimed to create and develop a well-designed, theoretically driven, evidence-based, digital, decision Tool to Empower Parental Telling and Talking (TELL Tool) prototype.

Methods

This developmental study used an inclusive, systematic, and iterative process to formulate a prototype TELL Tool: the first digital decision aid for parents who have children 1 to 16 years of age and used donated gametes or embryos to establish their families. Recommendations from the International Patient Decision Aids Standards Collaboration and from experts in decision aid development, digital health interventions, design thinking, and instructional design guided the process.

Results

The extensive developmental process incorporated researchers, clinicians, parents, children, and other stakeholders, including donor-conceived adults. We determined the scope and target audience of the decision aid and formed a steering group. During design work, we used the decision-making process model as the guiding framework for selecting content. Parents’ views and decisional needs were incorporated into the prototype through empirical research and review, appraisal, and synthesis of the literature. Clinicians’ perspectives and insights were also incorporated. We used the experiential learning theory to guide the delivery of the content through a digital distribution plan. Following creation of initial content, including storyboards and scripts, an early prototype was redrafted and redesigned based on feedback from the steering group. A final TELL Tool prototype was then developed for alpha testing.

Conclusions

Detailing our early developmental processes provides transparency that can benefit the donor-conceived community as well as clinicians and researchers, especially those designing digital decision aids. Future research to evaluate the efficacy of the TELL Tool is planned.

Introduction

Given the long history of secrecy surrounding donor conception—often promulgated by clinicians with the goal of protecting future parents and their donor-conceived offspring from stigma and even claims of unlawful birth^1,2 —it is not surprising that many parents who successfully use donated gametes (sperm and eggs) or embryos find that informing their child(ren) about their genetic origins is challenging.

To demonstrate this point, a systematic review and meta-analysis examined 26 studies that included 2814 parents and compared those who underwent medical reproduction (e.g. in vitro fertilization) with their own (i.e. autologous) gametes to those who underwent medical reproduction using donated gametes or embryos. ³ The investigators found that only 23% of the total sample of parents had told their children about the origins of their conception; among the subgroups of parents, 23% of donor egg, 21% of donor sperm, and 11% of donor-embryo recipients reported having told their children about how they came to be. ³ Moreover, US parents who use donor gametes find that it becomes increasingly difficult to tell their children about their origins even and despite early intentions to do so.^4,5 There are now well-documented calls from both parents and clinicians for information on appropriate timing of when to tell and for more strategies and tools for how to tell children about their origins.^4,6–8

Multiple professional organizations currently endorse telling children about their genetic origins.^9–11 Meanwhile, direct-to-consumer genetic tests (e.g. 23andMe and Ancestry) have ushered in a radical change that allows individuals to trace their genetic origins with relative ease. Coupled with the exponential growth of social networking sites (e.g. Facebook and Instagram), these modern technological developments have and will continue to make secrecy only an illusion for parents.^12–15 In response, thought leaders have recommended a shift in psychosocial counseling from emphasizing assessment and evaluation of prospective parents to emphasizing psycho-educational partnership and strategies for building healthy families, such as information about how (prospective) parents can begin the telling process.^9,16,17

Other developments in the move toward openness is the promotion of knowledge about genetic heritage, which is increasingly important for health histories and personalized medicine—defined as “an emerging practice of medicine that uses an individual's genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease.” ¹⁸ An accurate health history remains the least expensive and most universal, accessible, and practical genetic risk assessment tool. ¹⁹ Recommendations to increase its use and implementation, including expanding lay education about the importance of inherited genetic risks, are underway.^19–21 Reports about parents being prompted to tell their offspring about their genetic origins because of genetically related health issues that arise are also surfacing. ²² Identity development, in regards to the ability of donor-conceived people to understand themselves through knowledge of where their traits are from, has also been mentioned in the literature as an extenuating factor in the move toward openness about genetic origins. ²³

Patient decision aids and digital health resources

Decision aids are tools used to inform people who want to actively participate in health decision-making. They have been found to help people feel more knowledgeable, better informed, and clearer about their values and thus to help them think about their options from a personal view. ²⁴ As the field of decision aids expanded, an International Patient Decision Aids Standards (IPDAS) Collaboration was formed to provide recommendations for reporting on the developmental process of decision aids. ²⁵

Digital health is a burgeoning field of practice for innovative forms of information and communication that address a variety of health needs. Digital health encompasses a broad scope of technologies, including mobile Health (mHealth), electronic Health (eHealth), and biosensors.^26,27 Increases in internet access and smartphone use worldwide have allowed for a vast array of digital health applications across populations and communities.^26,28 While digital technologies were already transforming health care pre-COVID-19, ²⁸ the post-COVID-19 era has provided even more opportunities for digital health. ²⁶

When digital technology is combined with decision aids, a broad range of features can be used to help people think about their preferences and their role in the decision-making process. Such features include text, images, digital media such as audio and video clips, animation, and other interactive and personalized features. ²⁹ A key characteristic of these digital tools is that they offer the convenience of accessibility: people can choose to use them almost anywhere, at any given time, and in the privacy of their homes. ³⁰

Need for resources for donor-recipient parents

Recent recommendations from the ESHRE Working Group on Reproductive Donation ⁹ call for clinicians to provide resources to support parents and inform them about how they can talk with their children, using age-appropriate language, about their children's genetic origins. Several resources already exist for prospective and successful donor-recipient parents to assist them in the telling process. For over 25 years, the Donor Conception Network, a support group based in the United Kingdom, has offered workshops for members along with a variety of educational materials including a wide range of children's story books for purchase by members and nonmembers. ³¹ Another resource is the government-funded “Time to Tell” campaign in Victoria, Australia, which provides various educational materials to donor-recipient parents.^32,33 There is also a growing number of books (e.g. Let's Talk About Egg Donation ³⁴ ) and websites (e.g. National Network of LGBTQ Family Groups ³⁵ ) aimed at supporting parents to talk about their experiences with donor gamete and embryo use. However, to our knowledge, there are no existing research-based or digital health resources that will systematically assist parents with the decision-making process surrounding telling their children about their genetic origins or collect data to better understand and examine parents’ telling processes.

The purpose of this paper is to describe the rigorous developmental process that was implemented to create the prototype of the digital Tool to Empower Parental Telling and Talking (TELL Tool), as recommended by the IPDAS Collaboration for reporting standards for patient decision aids. ²⁵

Methods

Ethical approval

The University of Illinois Chicago and the University of Michigan Institutional Review Boards (Protocols #2020-1086 and #HUM00230985, respectively) approved the development of the TELL Tool prototype (i.e. TELL Tool) as part of a larger program of research where we also implemented alpha testing of the tool. The findings from our alpha test are reported elsewhere. ³⁶ Written informed consent was obtained from all participants prior to their participation in the study.

Study design and methods

Statistical analysis. Our iterative developmental process incorporated the IPDAS Collaboration standards ²⁵ and exemplars ³⁷ along with recommendations for developing digitally delivered (electronic and web-based) decision aids ³⁸ as guidelines for developing the TELL Tool. Additional recommendations for digital health interventions and decision aids^39,40 were reviewed, considered, and incorporated as appropriate. We drew heavily on Coulter et al.'s ⁴¹ systematic process for developing patient decision aids, in which the developmental process is broken down into smaller steps during the early stages of development. This process allowed us to create, develop, and make iterative improvements and revisions to the TELL Tool as we prepared for alpha testing. An investigative team formed in January 2020 and began the process, which continued through January 2021 (over 1 year), when the alpha test was launched. This process is depicted in Figure 1 and elaborated in the Results section below.

Figure 1.

Developmental process for creation of the TELL Tool.

Source: Adapted from Coulter A, Stilwell D, Kryworuchko J, et al. A systematic development process for patient decision aids. BMC Med Inform Decis Mak 2013; 13 Suppl 2: S2. Reprinted with permission from BioMed Central, Ltd.

To enable a parent- and family-centered approach to developing the TELL Tool, we also incorporated the main pillars of design thinking: empathy, collaboration, and experimentation. ⁴² Empathy was included through understanding the emotions or reactions of parents and children by diving into their worlds and hearing how they live and what they experience. We embraced collaboration by having our investigative team and larger steering group (including the parents’ advisory board and children's advisory board) work as a team with each other and with others. And we have and will continue to embody experimentation to obtain observations in different circumstances through our prior, ongoing, and planned research. ⁴²

Our methods also incorporated modern online instructional design for how people learn in the modern world. ⁴³ In particular, we used Dirksen's recommendations for designing behavioral change interventions ⁴⁴ to understand how parents’ decisions throughout the telling process can result in changes that benefit them and their families. Our team's experiences and insights garnered from creating and implementing CHOICES, a web-based intervention to assist young adults affected by sickle cell disease or trait with decision-making about becoming parents,^45–47 and ENGAGE-IL, a web-based evidence-based platform that uses emerging technologies and cutting-edge pedagogy to improve learners’ proficiency in primary care of older adults, ⁴⁸ also guided the development of the TELL Tool.

Results

Determining the scope and target audience

The first step in developing a decision aid is to determine the tool's scope and target audience. ⁴¹ After consideration of feasibility and impact, we designed the TELL Tool for a target audience of parents who live in the United States and used donated eggs, sperm, or embryos to establish their families. Our scope is to help these parents make informed and sequential decisions (e.g. about language and about where and when) that are needed when telling their 1- to 16-year-old children about their genetic origins.

Forming the steering group

Forming a steering group is the second step in decision aid development. Our steering group's members were considered based on the scope of the decision aid and its target audience (i.e. US parents) in an iterative process. All members of the multidisciplinary investigative team (e.g. nurses, psychologists, and statisticians) were also members of the steering group; all are based in the United States and are highly skilled in research and/or clinical practice. Consistent with Coulter et al.'s ⁴¹ recommendations, a parents’ advisory board and a children's advisory board were formed and included within the steering group to increase representation of relevant stakeholders. The parents’ advisory board consisted of three parents (two sperm donation recipients and one egg donation recipient) from different ethnicities, gender identities, sexual orientations, and single or coupled parent families who had informed their children about their genetic origins. The children's advisory board consisted of four children who were either donor conceived (n = 3) or adopted (n = 1) and were between 5 and 14 years of age. The parents and children were recruited to serve on their respective board through previous contact and conversations with the principal investigator (PI) (PEH) where they expressed an interest to serve. In the case of the children's advisory board, the PI also communicated with each child's parent to receive parental permission prior to the child's participation on the advisory board. Other stakeholders included two members of the donor-conceived adult community and three leaders of community-based groups or foundations within the wider donor-conceived community. The steering group also included two graduate students with expertise in computer science and/or computer engineering who were members of the study's technology team.

Completing the design work

Identifying a theoretical model to guide content. To begin the necessary design work and to develop the content for the TELL Tool, we reviewed the existing literature about factors that influence donor-recipient parents’ decisions about telling children about their genetic origins.^4,49,50 We also gained insights from systematic reviews.^51,52

Because of the multiple and interwoven factors identified in this field, experts have specifically called for the use of explanatory theories and models to situate the underlying factors. ⁵² To address this gap, we validated our decision-making process (DMP) model (Figure 2), which describes intended parents’ decision processes related to preimplantation genetic diagnoses^53,54 and young women's decisions about fertility preservation following a diagnosis of cancer.^55,56 The DMP model was then used to explain underlying processes about donor-recipient parents’ decisions to tell or not tell their children. ⁵

Figure 2.

The decision-making process (DMP) model.

Sources: Adapted from Dr Hershberger's and team's research: Hershberger PE, Gallo AM, Kavanaugh K, et al. The decision-making process of genetically at-risk couples considering preimplantation genetic diagnosis: initial findings from a grounded theory study. Soc Sci Med 2012; 74: 1536–1543. Reprinted with permission from Elsevier. Hershberger PE and Pierce PF. Conceptualizing couples’ decision making in PGD: emerging cognitive, emotional, and moral dimensions. Patient Educ Couns 2010; 81: 53–62. Reprinted with permission from Elsevier. Hershberger PE, Finnegan L, Altfeld S, et al. Toward theoretical understanding of the fertility preservation decision-making process: examining information processing among young women with cancer. Res Theory Nurs Pract 2013; 27: 257–275. Reprinted with permission from Springer Publishing Company, Inc. Hershberger PE, Sipsma H, Finnegan L, et al. Reasons why young women accept or decline fertility preservation after cancer diagnosis. J Obstet Gynecol Neonatal Nurs 2016; 45: 123–134. Reprinted with permission from Elsevier.

Within the contemplate phase of the DMP model (see Figure 2), there are five interrelated dimensions: cognitive appraisals (e.g. perceived risk of unintended disclosure and knowledge of how to tell the child), emotional responses (e.g. fear of harming the parent–child relationship), moral judgments (e.g. desire to protect the child and belief that secrets are harmful), decision partners (e.g. influence of partner, close family members or friends, and healthcare professionals), and contextual influences (e.g. age of the child, type of gamete used, family type, sociopolitical milieu, and religious background). ⁵ These five dimensions work interactively with two vital decision processes that are active during the contemplate phase: processing information and formulating beliefs and values. As we evaluated and synthesized the scientific literature, these five dimensions provided a theoretical foundation for guiding the content within the TELL Tool. Examples of TELL Tool content mapped to the five dimensions of the contemplate phase of the DMP model are displayed in Table 1.

Table 1.

TELL Tool content examples mapped to Kolb's experiential learning theory ⁵⁷ and the decision-making process model.^5,53–56

Experiential Learning Theory: Stages and Constructs/Definitions related to the TELL Tool	TELL Tool content examples	Decision-Making Process Model: Dimensions and Content examples within the TELL Tool
Concrete experience Centering the positives and the challenges of telling	A “welcome” video that includes children and adolescents of all ages and ethnicities precedes Module 1 to prepare parents for their decision to talk with and tell their children about their genetic origins. This video provides an opening to help parents overcome fears and see and hear from children who have normalized donor conception and are healthy and have sound relationships with their parents.	Emotional responses Fear of harming parent–child relationships
	A video in Module 2 shows a couple, Gabe and Rachel, who are grappling with the decision to tell their son about his donor conception. Gabe and Rachel discuss their conflicting emotions and their challenges to telling their son about his genetic origins.	Emotional responses Specific emotions (e.g. shame and distress) presented Decision partners Role-modeling dyadic partners
	Parents are asked to select the age range of their donor-conceived child, to allow the tool to tailor the information and multimedia (e.g. photos, video clips, and audio clips) presented in Module 3 to be tailored to the specific age of their child.	Contextual influences By age of child
Reflective observation Reflecting on and managing emotions	Following the Gabe and Rachel video in Module 2, parents are asked to reflect on their underlying beliefs and emotions around talking with and telling their child(ren) about their donor conception.	Moral judgments Desire to protect child and belief that secrets are harmful Emotional responses Wide range of emotions presented
	In Module 2, parents are asked to select, from 11 colorful boxes of emotions, the emotion(s) they find most challenging in regard to telling their child about their genetic origins. After parents make their selection, the tool provides information and tips for management of each emotion selected, along with recordings of parents’ personal stories about how they managed that emotion.	Emotional responses Impact and management of a wide range of feelings and emotions discussed
Abstract conceptualization Thinking about creating a TELL Plan	Parents are offered four guiding principles for telling children in Module 3 and then presented with six steps to help them organize and create their own TELL Plan based on their child's age range (1–7, 8–12, or 13–16 years of age).	Cognitive appraisals Knowledge of how to tell the child
	In Module 4, parents can view video clips of 14 specific situations (e.g. how to manage public vs. private information, a child's questions about the donor, direct-to-consumer genetic tests, and when to seek help) where information is provided that can help parents build confidence for their telling conversations.	Cognitive appraisals Knowledge of what to expect after telling and information about managing subsequent telling conversions Emotional responses Increasing joy, hope, and optimism
Active experimentation Actively creating an individualized TELL Plan	In Module 3, parents answer embedded decision points about what to include in their TELL Plan (e.g. language, setting, and telling process). For parents to decide what to include, text, photos, cartoons, video clips of parents and specialists, and multiple opportunities to engage and think through their TELL Plan are offered. In this way, parents co-create an individualized TELL Plan that aligns with the content provided in the TELL Tool.	Cognitive appraisals Knowledge of how to tell the child
	In Module 4, parents can select specific situations where information about the telling process is tailored to parent's donor conception circumstances, such as when the gamete donor is a family member (e.g. a parent's sister or brother).	Cognitive appraisals Knowledge of how to tell the child Contextual influences By type of gamete donor used

Incorporating parents’ views and decisional needs into content. As the content for the TELL Tool was developed (guided by the five interrelated dimensions of the DMP model), we built upon our systematic review ⁵⁸ by appraising the research literature for parents’ strategies, information, and outcomes of decisional needs related to the telling process. These findings were then used to create the evidence-based content for the TELL Tool. For example, Mac Dougall and colleagues ⁵⁹ interviewed 141 parents who used sperm or egg donation and identified 2 strategies—seed planting and right time—that parents used to determine the timing of when to initiate the telling process with their children about their genetic origins. TELL Tool content was then written to inform parents about how to implement seed-planting and right-time strategies. Other examples of evidence-based content within the TELL Tool are that parents who have told children aged 7 and younger often give a brief, storylike description of how they needed help to have a baby^60,61 and that many parents use children's books to begin or supplement their telling process.^62,63

Additional examples where we identified and incorporated evidence into content were about the specific language parents use to describe the donors and/or gametes,^59,60,64 adolescents’ perspectives,^65–67 children's reactions to learning they are donor conceived,^68,69 and the views of donor-conceived adults.^22,70–72 The literature on adoption was also appraised for additional insight,^73–75 as was literature on child development^76–78; family relationships, particularly surrounding disclosure and donor-conceived families^79–83; and the larger body of literature about disclosing other types of sensitive information to children.^84–86 As content was identified, written, and developed, we considered health literacy guidelines with the goal of keeping language simple, clear, and effective. ⁸⁷

As we appraised the scientific literature, a gap emerged in that many studies examining disclosure among donor conception families were completed outside of the United States (US). This directly affects the contextual influences dimension of the DMP model. Moreover, the IPDAS Collaboration ²⁵ and other experts in decision aid development ³⁸ recommend the inclusion of parents who have direct experience making the decision that the decision aid is designed to affect. To provide content with details and insights from parents’ telling experiences, we completed research among US parents who used donated sperm, eggs, or embryos to conceive their children and who had talked with their children, ages 4 months to 16 years, about their genetic origins. ⁶³ These findings were then incorporated into the TELL Tool content, primarily linked with the cognitive appraisal dimension because the findings provided insights, verbiage, nuances, and data about the decisions parents need to make regarding the who, what, when, and where within the telling process among US parents. ⁶³

Incorporating clinicians’ views on parent needs into content. Insights from the investigative team's extensive research and clinical expertise, described elsewhere,^5,75,88–92 were also incorporated into content for the TELL Tool. For example, Susan Klock, a leading psychologist in the infertility and third-party reproductive field and a member of the research team, prepared a short video that provides information on how partners in two-parent families can approach the issue of telling their children when the partners disagree or partially disagree about telling. The content for the video resulted both from evidence by Isaksson et al. that 24% of parents in two-parent families do not agree, only partially agree, or do not know the opinion of their partner regarding telling their children about their genetic origins ⁶ and from insights from Dr Klock's extensive clinical practice, in which she evaluates and addresses the psychological needs of donor-conceived recipient parents.

Determining the delivery format and distribution plan. While the five dimensions of the contemplate phase of the DMP model guided the content of the TELL Tool, Kolb's experiential learning theory ⁵⁷ guided the delivery of the content and resulted in the four-module, multicomponent, interactive, multimedia (e.g. audio and video clips, visuals, and parent workbook) TELL Tool. The experiential learning theory includes four stages: concrete experience, reflective observation, abstract conceptualization, and active experimentation. ⁵⁷ The learning process is introduced by a concrete experience, which calls for reflection and review (i.e. reflective observation); next, in abstract conceptualization, conclusions and assimilation of new information from a clearly well-structured presentation of ideas give rise to active experimentation—trying out what is learned. Within the TELL Tool, we actualized these four stages through, for example, (a) a concrete experience that centers the importance and challenges of telling children about their genetic origins; (b) reflective observations that include several vignettes (parent stories using audio and/or video clips) about how parents can manage their emotions about telling; and (c) an abstract conceptualization stage that provides parents with information in an interactive way to build confidence in telling. In (d) the active experimentation stage, parents create their own personalized TELL Plan and try out what they’ve learned. (See Table 1 for additional examples and mapping of content to theory.)

We opted for a digitally delivered decision aid because parents in our prior research and on the parents’ advisory board expressed interest in a readily accessible tool that could be completed in the privacy of their homes. This would obviate many logistical barriers to more traditional face-to-face delivery formats such as navigating work schedules and obtaining childcare.^5,63 Meanwhile, clinicians on our team reported a need for high-quality, evidence-based decision support tools for parents to augment the education and counseling groundwork that takes place in the clinical setting. Our team's prior successes with the CHOICES web-based intervention among young adults^45–47 and the ENGAGE-IL web-based platform of educational video modules,^48,90 as well as emerging data from other digitally delivered parent interventions that show good promise for intervention efficacy and expanding the reach of parent support into the digital space, ⁹³ were also considered.

The delivery and distribution of the TELL Tool was completed in conjunction with a skilled technology team consisting of graduate students in computer science or computer engineering. With the investigative team and technology team working closely together, design elements were added to help parents navigate the digital program. These included a “progress” bar to visually show progression through the program and a screen icon clearly depicting the length of time needed for each of the audio or video components. Because confidentiality is of critical concern to many parents, the TELL Tool is delivered through a password-protected digital platform that meets all institutional review board approvals for the protection of human subjects.

Creating the early TELL Tool prototype

After completing the initial design work, and in keeping with IPDAS recommendations, we created an early and nimble prototype that underwent iterative changes following feedback from the investigative and technology teams’ ongoing meetings. An essential and early component of creating a decision aid is to develop storyboards (e.g. patient experiences, stories, and testimonies), ⁴¹ which we accomplished by creating several hypothetical parents and families. These parents and families represented diverse families by types of parental structures (e.g. single parents and coupled parents), gamete-donation families (e.g. egg, sperm, and embryo), donors (e.g. directed/identified and non-identified), parent's sexual orientation (heterosexual and same-sex), and children's ages, to align with our scope and target audience. Over 40 scripts were created to personify the various types of parents and families representing the target audience and then woven throughout the tool. As the storyboards and parent and family personas were created, we also strove to maintain diversity in culture, gender, race, and ethnicity. Regarding this latter point, we engaged over 35 volunteer undergraduate and graduate nursing students, from a variety of backgrounds and genders, including races and ethnicities known to be underrepresented or discriminated against in US health care settings (e.g. Blacks or African Americans and Hispanics), to serve as voice actors for the persona scripts.

As we envisioned how parent users would navigate the TELL Tool, we created four interactive and multimedia modules to deliver the content: (a) Understanding the Reasons, (b) Managing the Emotions, (c) Creating the TELL Plan, and (d) Selecting Specific Situations. We envisioned that parents would complete the TELL Tool in one session, or they could “suspend” the tool and return at a later point in time, ideally within 1 week. Giving parents control over their ability to navigate the content was a key design feature. Other examples of user control embedded in the design were to allow for parents’ personal needs. In Module 2: Managing the Emotions, for example, we created pre-set selection points where parents are instructed to select which of the 1 to 11 emotions discussed in the module are of interest to them personally. For instance, stigma and enduring grief are known barriers to disclosure. Thus, parents that select the emotions surrounding stigma or grief are provided with information and strategies to navigate each of these emotions. Parents then view the corresponding webpages that contain content for managing their selected emotions and not necessarily the entire content of the module.

Another key design element, developed by working closely with the technology team, is users’ ability to co-create a personalized TELL Plan in Module 3: Creating the TELL Plan. Each TELL Plan is co-created by parents and investigators: the parents, as they progress through the investigator-developed content within the module, are asked to make decisions at various “decision points” about how to tell their child(ren) about their genetic origins. After they complete the TELL Tool, their TELL Plan becomes an accessible resource, because it can be saved on their personal digital device for when they need to refer back to it.

Incorporating steering group review. Development of the prototype included iterative feedback from members of the larger steering group (e.g. parents’ advisory board and other stakeholders). Steering group members who were members of the parents’ or children's advisory boards met in groups or individually with members of the investigative team to provide feedback. Other steering group members provided feedback individually. This feedback was obtained verbally, and written summaries were kept to maintain the accuracy of the feedback. One key change made following feedback was to allow parents to select tailored information based on their children's age. This feedback resulted in the development of three age categories based on Piaget's stages of cognitive development ⁹⁴ : children of 1–7 years, 8–12 years, and 13–16 years.

As content was created and redrafted, we continued to design elements such as the length of time (i.e. intervention “dose”) that parents would need to complete the TELL Tool. A length of 60 min was set as a target time frame for an individual parent to complete the entire tool in consideration of participant burden, insight from our prior intervention work, ⁴⁶ and feedback from the steering group. We also opted for an audio-narration format that used images and short text on a visual screen versus providing extensive text for parents to read on the visual screens.

Finalizing the TELL Tool prototype. The final prototype of the TELL Tool, as prepared for alpha testing, consisted of 181 viewable screens across the 4 modules. Parents are not required to view all the screens, as children's ages and parents’ pre-set selections and responses to decision points exert some control over the order, level of detail, and type of content presented; this approach has been shown to increase the quality of user's decision-making. ⁹⁵ Figure 3 shows examples of the TELL Tool screens used during alpha testing.

Figure 3.

Example screens from the TELL Tool prototype.

Discussion

To create the digital TELL Tool prototype, the investigative team used an inclusive, systematic, and iterative process guided by IPDAS Collaboration recommendations. The resulting decision aid for parents of children who were conceived through donated eggs, sperm, or embryos is comprehensive, theoretically driven, and evidence based. The digital format, which can be delivered to parents through the internet and mobile devices, provides a much needed, convenient, and readily accessible tool.

The design process documented here provides transparency about the early design steps employed to create and develop the TELL Tool prototype. Transparency about the developmental process can support the trustworthiness of a decision aid, which can in turn enable its implementation into clinical practice and/or the target community.^25,96,97 Documentation of the participation—or lack thereof—of end users (i.e. parents who received donor gametes or embryos) and other stakeholders is also paramount to transparency and essential for establishing a high-quality decision aid. ⁹⁷ For the TELL Tool, we engaged parents early in development through our parents’ advisory board. For example, members of the parents’ advisory board met during our formation and then twice during the year as the TELL Tool developed. They were also available for impromptu consultations (n = 4–5) throughout the year as needed. One member of the investigative team is also a gamete-recipient parent. Our stakeholders were integral to the early tool developmental process and actively participated at multiple steps. Moving beyond the IPDAS Collaboration's recommendations and aligning with the three pillars of design thinking, ⁴² we also established and engaged a donor-conceived children's advisory board. Members of this board allowed us to better understand children's perspectives about what is important in the telling process (empathy) and to actualize our work as an inclusive team (collaboration). Members of our children's advisory board met once prior to the development of the tool and due to considerations regarding the COVID-19 pandemic and school or other scheduling conflicts were available for individual consultations throughout the year (n = 2–3 individual consultations). Our report of the multiple categories where we examined, appraised, and synthesized a wide range of literature also adds to transparency.

A strength of our developmental process is the explicit use of two theoretical frameworks. The five dimensions of the DMP model guided the content for the TELL Tool, while Kolb's experiential learning theory ⁵⁷ guided the delivery. The DMP model is an outgrowth of our investigative team's past research program, in which we sought to examine the underlying processes that influence parents’ decision-making about whether and, if so, how to talk with and tell children about their genetic origins. This model now provides a theoretical foundation for selecting content, where a grounding in theory is often missing from other reports of decision aid development. ⁹⁸ This transparency is important because as future research unfolds, insight about the efficacy of the TELL Tool can be linked back to these theoretical models. These models can also inform the development of other decision tools—especially in the field of medical reproduction, which is what the DMP model is based on.

Another strength of our tool developmental process includes incorporating the extensive clinical expertise of the multidisciplinary investigative team along with health literacy guidelines, which are being increasingly recognized in decision aid development. ⁹⁹ The length of time taken to create and develop the tool (∼1 year) is a testament to the care, quality, and attention to detail by the investigative team. Other investigators have also reported a prolonged and expensive, albeit necessary, process for developing a high-quality decision aid. ¹⁰⁰

Limitations and future directions

We acknowledge several limitations to this study, including the impact of the onset of the COVID-19 pandemic. When we created the TELL Tool, the evidence was unclear about how much information parents want or need and how much detail about disclosure is optimal, especially in a digital format. Our recently completed alpha test ³⁶ and the beta test (i.e. field testing) that is now in progress will provide insights to address these concerns. Because the launch of our developmental study (January 2020) coincided with the emerging COVID-19 pandemic, our study was impacted by issues the investigators, students, and stakeholders experienced as economic shutdowns, public health emergencies, travel bans, stay-at-home bans, and other issues that accompanied the pandemic took hold. These issues limited the face-to-face meetings that took place and may have created limits as to what we could accomplish technologically.

Another limitation is that although we followed the IPDAS Collaboration's recommendations and used a systematic and rigorous developmental process, we still do not know whether the TELL tool is effective. Pending our beta test findings, the next phase in our program of research is to complete efficacy testing to determine whether the TELL Tool can aid parents’ decision-making processes and enable them to begin talking with and telling their children about their genetic origins. We also plan to investigate if the tool results in parents taking actionable steps in the telling process and if this improves the health and well-being of parents, children, and families.

Finally, the TELL Tool was designed specifically for parents who reside in the US, which limits generalizability. We do hope to implement future research to adapt the tool to align with contextual influences (e.g. the sociopolitical milieu and language) that affect parents’ decision-making processes regarding disclosure in other countries. Extending the tool for use with parents who have adult children who are unaware of their donor conception is another adaptation of the TELL Tool that we plan to explore.

Conclusions

To create and develop the TELL Tool prototype, our research team used an inclusive, systematic, and iterative process based on the IPDAS Collaboration recommendations. This process allowed us to develop a well-designed, theoretically driven, evidence-based digital decision aid for parents of children, ages 1 to 16 years, who were conceived through donated eggs, sperm, or embryos. The TELL Tool provides a much needed, convenient, and readily accessible tool to support these parents’ decision-making process by enabling them to begin talking with and telling their children about their genetic origins. Detailing our early developmental processes provides transparency that can benefit clinicians, researchers, and the donor-conceived community. Future research to determine the efficacy of the TELL Tool is planned, while additional research will also be needed to refine the tool for use on a global scale and with a broader scope of end users.