Developing Best Practices for Obtaining Assent of Pediatric Patients

What if children were educated and empowered to make decisions about their own healthcare?

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Founding Story: Share a story about a key experience or spark that helps the network understand why this project got started or a story about how you became inspired about the potential for this project to succeed.

Imagine a parent hopes to enroll their 8-year-old son in a clinical trial of a Duchenne muscular dystrophy (DMD) treatment that might slow or prevent the advancement of the debilitating disease. At the clinic, the medical assistant working with the boy tries to break down information about his condition, as well as the trial’s potential benefits and risks, tests that will be conducted, the drug name and dosage, and any potential side effects, so that the boy can understand. Unfortunately the medical assistant lacks training in this area or any age-appropriate materials, so they cannot provide the information in a way the boy will understand. He doesn’t feel comfortable asking questions because he doesn’t understand the situation, so how can he give informed consent?

This is not an uncommon experience for children with fatal or potentially fatal illnesses such as cancer, DMD, or cystic fibrosis. These diseases require clinical research for new therapies. Both parents and clinicians of pediatric patients are perplexed by such questions as when the treatment is worse than the disease, whether prolonging the child’s life at any cost is truly in the child’s interest, and at what age and in what ways the child should be involved in making these decisions. Providing clear and authoritative guidelines and well-researched, age-appropriate materials would help reduce the uncertainty these parents and clinicians feel, as well as enable appropriate participation by the child involved.

Website

http://www.pediatricinnovation.org
See note on Global Alliance for Pediatric Therapeutics at:
http://www.pediatricinnovation.org/drug-reformulation/

Location: Where is your organization headquartered? [State]

  • Massachusetts

Location: Where is your organization headquartered? [City]

Cambridge

Location: Where is your project primarily creating impact? [State]

  • Massachusetts

Location: Where is your project primarily creating impact? [City]

The project is coordinated by the Institute for Pediatric Innovation, located in Cambridge, Massachusetts. Implementation will be through a world-wide collaboration network.

Problem: What problem is this project trying to address?

Although not legally required, ethical regulation agencies often require researchers to obtain agreement from young patients participating in clinical trials. However, legal, cultural, and social differences have hindered the development of age-appropriate educational materials for clinicians to use when obtaining assent, thus preventing pediatric patients from being fully informed about the clinical trial in which they are participating. This diminishes any autonomy children have over their bodies and disenfranchises them from the opportunity to be involved in the decisions that will affect their bodies.

There is a need to develop (1) a library of validated audio-visual and text materials to educate children about their particular health condition, the clinical research process in general, and specific experiences they may have in a proposed clinical trial; and (2) exemplary instructional materials, guidelines, and best practice recommendations for researchers in selecting and employing these tools. Based on research conducted among pediatric patients and their parents, there is consensus that these tools should be designed for use on an electronic device.

Accessing a platform of such materials will expedite the enrollment of children in trials of potentially life-saving and health-enhancing devices and drugs. Our research team will continue interviewing experts, collecting and characterizing guidelines and materials currently in use for obtaining assent, and conducting a stakeholders’ workshop. The team will produce a report for applying guidelines for obtaining assent, a peer-reviewed article on our findings, and a roadmap for developing additional education materials as needed.

Each stage of this project will be guided by input and feedback from children through The International Children’s Advisory Network (ICAN). The project will benefit those in all stages of clinical research, from subjects to researchers and their institutions, to sponsors and site managers. Clinical researchers and their institutions and Internal Review Boards (IRBs) will have guidelines to follow for obtaining assent, thereby facilitating more clinical trials for innovative products. Research sponsors and site managers should experience more streamlined assent processes, supporting more timely completion of clinical trials. And children, perhaps the most important part of the process, will receive age-appropriate and condition-specific information necessary for providing assent for participation in clinical studies as informed as possible.

Is your model focused on any of the following traditionally underserved communities?

  • Children who are differently abled

Does your model work within any of the following sectors?

  • Other

If you chose "other," please share the sector you work within here:

Healthcare
Clinical Research

Year Founded

2006

Project Stage

  • Scaling (the solution has passed the previous stages, and the next step will be growing its impact on a regional or global scale)

Example: Walk the network through a specific example of what happens when a person or group engages with your solution.

Let’s go back to that parent who wants to enroll their son in the clinical trial for the DMD treatment. Now the medical assistant is trained in assent practices and can interview the boy appropriately and show him brief, age-appropriate materials that explain his condition, the scope of the trial, potential benefits and side effects, etc. on a tablet. This time the boy is comfortable asking questions about anything he doesn’t fully understand, and after answering any he has, the medical assistant asks if he is willing to participate. If he is, he can indicate by pushing a button on the tablet. The medical assistant can also amend the materials based on the boy’s questions, thus adding to the library for the use by future participants.

Impact: What was the impact of your work last year? Please also describe the projected future impact for the coming years.

Our research team surveyed children and their caregivers, as well as healthcare professionals, to determine current attitudes towards and policies governing pediatric assent. The results of this Pediatric Assent Initiative Survey highlighted inconsistencies in the practice of obtaining pediatric assent arising from legal, social, and cultural variations. These findings have provided a framework for future standardization of the practice. The data will start to shape guidelines and educational materials for obtaining pediatric assent, which will be compiled in an electronic library to be presented at a healthcare professionals workshop in Washington, DC.

Organization Type

  • nonprofit/NGO/citizen sector

Annual Budget

  • $500k - $1m

Financial Sustainability Plan: What is your solution’s plan to ensure financial sustainability?

Sponsors donate for one of three levels of membership. The lowest level for academic and nonprofit organizations, requires a $1500 donation. With a $5000 or higher donation, Corporate Sponsors are invited to attend a stakeholders’ workshop. Premiere Corporate Sponsors donate $15000 or more to serve on the project steering committee. Furthermore, once the library of materials is available, users will pay a license fee to access the materials.

Unique Value Proposition: How else is this problem being addressed? Are there other organizations working in the same field, and how does your project differ from these other approaches?

A few commercial vendors of educational materials designed to help children understand hospitalization, illnesses, and other health matters do exist. However, our solution will be an integrated system managing such materials and facilitating the assent process. Our solutions will take a multi-dimensional approach by utilizing electronic visual, audio, and text materials to empower children and their caregivers and to guide health professionals during the assent process to ensure all parties are appropriately informed and involved.

Reflect on the Field and its Future: Stepping outside of your project, what do you see as the most important or promising shifts that can advance children’s wellbeing?

Two major trends are transforming how the healthcare system provides for children. One is reorientation away from centralizing care at the major tertiary and quaternary facilities to a community- and home-based care model. The other is an increasing recognition of the importance of educating and empowering parents, caregivers, and pediatric patients themselves to play a more proactive role in children’s care. These changes are essential in the age of technology and information because they keep children and their caretakers necessarily informed and involved in the decision-making process.

Source: How did you hear about the Children’s Wellbeing Challenge? (the answer will not be public)

  • Changemakers.com
  • Other

Referral: If you discovered the Challenge thanks to an organization or person other than Ashoka, who was it? (the answer will not be public)

We found this on the Ashoka website.

Program Design Clarity

The main beneficiaries are children with life-threatening or debilitating diseases that require research for treatment and the clinicians who do that treatment. The children benefit by being able to understand more about their conditions and being able to make informed decisions based on age-appropriate information. Researchers benefit from a streamlined consent process that speeds up the research process. After surveying children and their caretakers, our researchers are looking at ways to compile these databases and guidelines to streamline the process.

Community Leadership

Obtaining feedback from children and other stakeholders is inherent in the model design. When a child has further questions than are answered in the information provided, the medical practitioner can update the information to include the answers to those questions. And because the database will be electronic, it is easily accessed worldwide and can be translated into any number of languages.

Age of Children Impacted

  • 0-1.5
  • 1.5 -3
  • 3 - 5
  • 6 - 12
  • 12+

Spread Strategies

Our researchers found that culture, age, and disease symptoms are some of the main aspects that children and their caretakers believed affected a child's ability to give informed consent. The next stage of the process is compiling the information found from the survey and developing guidelines for clinicians to follow to provide children with appropriate information for making their own decisions.

Reflect on how your work helps children to thrive. How are you cultivating children’s sense of self, belonging, and purpose through your model?

Educating children on their condition helps develop their sense of who they are and their abilities. Empowering them with the autonomy to make their own decisions shows them that they are valued members of the community. And demonstrating how their participation in a trial can affect the lives of other children with their same condition allows them to play a meaningful role in the world.

Leadership Story

The Institute for Pediatric Innovation is a nonprofit that believes pediatric patients deserve access to medical devices and drugs tailored to their needs. To identify these needs, IPI collaborates with major children’s hospitals to facilitate technology development by collecting data from healthcare professionals through comprehensive surveys, interviews, and focus groups.

Organization's Twitter Handle

@PedInnovation

Organization’s Facebook Page (URL)

http://www.facebook.com/PediatricInnovation/

Leader's LinkedIn Profile (URL)

http://www.linkedin.com/in/donald-lombardi-860359

Evaluation results

5 evaluations so far

1. Relevance: Does this project seem to help children (ages 0 to 12 years) develop a strong sense of self, belonging, and purpose?

5 - Yes, this is great! The project lays out a strong, compelling case for how its model nurtures children’s wellbeing. - 20%

4 - It seems like a good fit, and the model talks explicitly about children’s wellbeing. - 20%

3 - I think so. The project seems related to children’s wellbeing, but the logic is vague. - 40%

2 - Not sure. The project doesn’t have much to do with wellbeing, or it doesn’t give enough information. - 20%

1 - Nope, this project definitely doesn’t fit the challenge brief (e.g., It doesn’t help kids younger than 12, isn’t in the U.S., etc.) - 0%

2. Innovation: Does this project tackle children’s wellbeing from a new angle?

5 - I loved this! The project describes a novel model that addresses important cultural or systemic barriers. - 20%

4 - This is pretty cool. The project is addressing an important problem in a new or compelling way. - 60%

3 - I feel like there’s something there, but I want more details about what makes it distinctive. - 20%

2 - It’s a good project, but I’ve seen others like it before. - 0%

1 - It was confusing or hard to tell what it made it different. - 0%

3. Social Impact: What is this project’s potential for creating positive social impact?

5 - Lots of potential. This project is achieving impressive results, and it’s growing quickly. It could absolutely inspire changes in the ways we approach caring for kids nationally, across sectors (e.g. childcare, healthcare, education). - 0%

4 - Pretty good potential. This project demonstrates significant positive impact so far, and it could scale regionally or nationally one day and fundamentally change how a system operates (e.g. childcare, healthcare, education). - 80%

3 - Budding potential. This project is creating local impact, but it would take a few adjustments before it could scale. - 0%

2 - Some potential. This project demonstrates some initial positive impact, but it would require major changes before it could scale. - 20%

1 - Limited potential. This project has great intentions, but it looks like it does not include key drivers of a shift towards children’s wellbeing. - 0%

4. Overall, how do you feel about this idea?

5 - This idea rocked my world. It’s awesome! - 20%

4 - This idea seems really exciting. With a little more polishing, it’d be among my favorites. - 60%

3 - I think the idea is great, but it needs some work before it moves onto the next round. - 20%

2 - I liked it fine but preferred others. - 0%

1 - It didn’t make my heart beat faster. Needs significant revisions. - 0%

5. Offer some feedback. Where should this participant spend some time revising?

DEFINING THE PROBLEM. Make sure to articulate the root causes or main barriers of the social issue your project addresses. (Founding Story, Problem, Solution). - 100%

CLARITY OF MODEL. Make sure to mention (a.) the beneficiary, b) the main activities, and c) how those activities drive social impact. Keep it streamlined! - 0%

MARKETPLACE. Make sure to research other players in this space and articulate how this project is different. I didn’t get a complete sense of how this project compares to others. - 50%

IMPACT POTENTIAL. Make sure to use specific numbers to describe what your project has achieved so far! And consider how you might scale the model or its insights, through partnerships, trainings, or franchising. - 100%

WRITING STYLE. Try to stay concise and make it vivid. Avoid jargon. - 100%

Nothing stands out! I thought it was great. - 100%

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Photo of Michael
Team

Ha. I bet your reviews will be all over the place because most people won't fully grasp your proposal (myself included).

This seems to be a new frontier...and I love new frontiers. Keep it up!