Product Details

Author Information

Corresponding Author
Howard Taras
University of California, San Diego
9500 Gilman Dr. #0990
La Jolla, CA 92093-0990
United States
p: 858-657-5143
htaras@ucsd.edu

Authors (listed in order of authorship):
Howard Taras
University of California, San Diego

Rodney von Jaeger
University of California, San Diego

Product Description and Application Narrative Submitted by Corresponding Author

What general topics does your product address?

Medicine, Research

What specific topics does your product address?

Community engagement, Community health , Health disparities, Health equity, Social marketing, Health Research

Does your product focus on a specific population(s)?

Seniors

What methodological approaches were used in the development of your product, or are discussed in your product?

Focus group , Interview

What resource type(s) best describe(s) your product?

Lecture/presentation, Training material

Application Narrative

1. Please provide a 1600 character abstract describing your product, its intended use and the audiences for which it would be appropriate.*

Compared to most other age groups, older adults are more affected by most illnesses. Yet, they are less likely to participate in clinical research to address those health conditions. Many senior adults do not adequately understand the research process and have questions about what is involved. This video was created to provide information from seniors with first-hand experiences in clinical research studies. Research volunteers share their reasons for choosing to participate in research studies. Medical researchers also talk about translational health research and how it works. People over 55 years of age or who are retired have many reasons for joining research studies. Some get involved to stay socially active and connected, others because they want to learn something new, and some because they want to potentially help their families and future generations. This video is intended to encourage older adults to get involved with research and make informed decisions about their own health.

The intended audience of this video is people who are over 55 years of age and have questions about research participation.

2. What are the goals of the product?

This video is intended to (a): provide information about participation in clinical research; (b) allow seniors to understand why others, like them, have participated; and (c) help them to feel comfortable about asking questions if they are ever asked to participate.

3. Who are the intended audiences or expected users of the product?

The intended viewers of this product are older adults of diverse backgrounds. The video was produced in San Diego and highlights the San Diego research community, but was designed to allow seniors in any part of the country to feel that it is pertinent to them.

4. Please provide any special instructions for successful use of the product, if necessary. If your product has been previously published, please provide the appropriate citation below.

Programs with internet access can stream the video directly from the web to a computer monitor or TV screen.

The video file is relatively small and can be downloaded and saved to a hard drive, flash drive, or CD.

The MP4 file type is common and, once downloaded, can be used with freely available software to create a DVD that can be used on standard DVD players.

Programs are encouraged to have printed materials with information about local research opportunities available whenever the video is shown.

5. Please describe how your product or the project that resulted in the product builds on a relevant field, discipline or prior work. You may cite the literature and provide a bibliography in the next question if appropriate.

As the percentage of the US population over the age of 65 increases, those health conditions associated with aging are gaining importance in clinical research. While older adults are affected disproportionately by certain health conditions, they are less likely to get involved in research that addresses those conditions. For example, one study showed that though over 60% of people in the general population age 65 and older had cancer, only 25% of patients in that age group were represented in clinical trials (Hutchins, 1999). Among ethnic minority older adults, this underrepresentation may be even more pronounced (Moreno-John et al., 2004). When senior adults are excluded from clinical trials, the treatments that are developed may not adequately address their unique circumstances. For example, heart failure medications are typically developed using clinical trials comprised of volunteers largely less than 75 years of age with no other health conditions. However, most heart failure medications are taken by people over 75 years old, with multiple other health conditions (Arean et al., 2003). Without researching the effects of treatments on the types of patients that will use those treatments, the medical community may not have a full understanding of whether those treatments will be effective.

Senior adults are excluded from clinical research studies for several reasons. Some factors include age restrictions in study eligibility criteria and low referral rates from primary care physicians. However, older adults' perceptions and understanding of research are significant barriers to their participation in clinical trials. Some seniors misperceive research participation as a legally binding obligation, instead of a voluntary activity (Ridda et. al., 2010). They may also have concerns about the science underlying clinical research, such as institutional oversight, randomization, placebo groups, and potential risks and benefits (Ridda et. al., 2010).

This video addresses these concerns by providing information about the research process from the perspectives of participants and researchers.

6. Please provide a bibliography for work cited above or in other parts of this application. Provide full references, in the order sited in the text (i.e. according to number order). .

Journal Articles
Evans CM, Williams OW, Tuvim MJ, Nigam R, Mixides GP, Blackburn MR. Mucin is produced by Clara cells in the proximal airways of antigen-challenged mice. Am J Respir Cell Mol Biol 2004;31:382-394.

Articles in Press
Kimelman D, Kirschner M. Synergistic induction of mesoderm by FGF and TGF-B and the identification of an mRNA coding for FGF in the early Xenopus embryo. Cell (In press)

Complete Books
Weibel ER. Stereological Methods. London: Academic Press; 1979.

Articles in Books
Burgess JK, McParland BE. Analysis of gene expression. In: Conn MP, editor. Laser capture microscopy. San Diego: Academic Press; 2002. p. 259-270.

Abstracts
Carré PC, King TE Jr., Mortenson RL, Riches DWH. Overexpression of the interleukin 8 and fibronectin genes by alveolar macrophages in bronchiolitis obliterans with organizing pneumonia [abstract]. Am Rev Respir Dis 1993;147:A479.

Government or Association Reports
U.S. Public Health Service. Smoking and Health. A Report of the Surgeon General. Washington DC: U.S. Government Printing Office; 1979. DHEW Publication No. (PHS)79-50066.

Journal Article in Electronic Format
Risk for Pneumonocytis carinii transmission among patients with pneumonia: a molecular epidemiology study. Emerg Infect Dis [serial online] Jan [cited Feb. 14, 2003] Vol. 9(1). Available from http://www.cdc.gov/ncidod/EID/vol9no1/02-0141.htm

Arean PA, Alvidrez J, Nery R, Estes C, Linkins K. Recruitment and retention of older minorities in mental health services research. Gerontologist 2003, 43(1); 36–44.

Kilgore ML, Goldman DP, Trimble EL, Kaplan R, Montello MJ, Housman MG, Escarce JJ. Participation of Patients 65 Years of Age or Older in Cancer Clinical Trials. JCO 2003; 1383-1389.

Hutchins, L. F., Unger, J. M., Crowley, J. J., Coltman, C. A., & Albain, K. S. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 1999, 341(27); 2061-2067.

Moreno-John, G., Gachie, A., Fleming, C. M., NÁpoles-Springer, A., Mutran, E., Manson, S. M., et al. Ethnic minority older adults participating in clinical research: Developing trust. Journal of Aging and Health 2004, 16(5 suppl); 93S-123S.

Ridda, I., MacIntyre, C. R., Lindley, R. I., & Tan, T. C. (2010). Difficulties in recruiting older people in clinical trials: An examination of barriers and solutions. Vaccine 2010, 28(4); 901-906.

7. Please describe the project or body of work from which the submitted product developed. Describe the ways that community and academic/institutional expertise contributed to the project. Pay particular attention to demonstrating the quality or rigor of the work:

• For research-related work, describe (if relevant) study aims, design, sample, measurement instruments, and analysis and interpretation. Discuss how you verified the accuracy of your data.
• For education-related work, describe (if relevant) any needs assessment conducted, learning objectives, educational strategies incorporated, and evaluation of learning.
• For other types of work, discuss how the project was developed and reasons for the methodological choices made.

UC San Diego Clinical and Translational Research Institute's (CTRI's) Community Engagement program is charged with providing community members with information about clinical research and increasing their involvement in the research process. As part of this mission, we launched a project to produce a short series of educational videos for specific community audiences.

Two videos have been created at this point, with a third video in process. The audiences for these videos have been selected based on assessments of clinical trials participation, Community Advisory Board input, and local demographics.

Learning objectives for these videos include:
* Why clinical research exists and what its outcomes are
* Basic clinical study design and methods, and reasons for these methods
* Experience of being a research participant, from the point of view of actual participants
* Eligibility criteria for research studies
* Reasons that older adults join clinical studies
* Commitment of research volunteers
* Protection of research volunteers
* How to learn more and get involved in a research study

8. Please describe the process of developing the product, including the ways that community and academic/institutional expertise were integrated in the development of this product.

The CTRI Community Advisory Board provided valuable input regarding which audiences to address; older adults were recommended as a first priority. This recommendation was supported by the literature: as stated earlier, seniors experience health conditions more frequently than younger adults but participate in research that addresses those conditions with less frequency.

In order to create the video for seniors, we convened two different focus groups of older adults. Focus group participants viewed existing videos produced elsewhere (for specific clinical trials, by private industry, etc.). Seniors commented on the visual images, setting, and background music. They recommended including a combination of seniors experienced in research participation and expert investigators. Mostly, they felt the video should be short in duration (about 10 minutes), and that it be amenable to accompanying discussion.

The video itself was produced in conjunction with UCSD-TV, a University of California San Diego-based non-commercial television production company. Actual research participants provided their voluntary testimonials through interviews with UCSD-TV producers. Researchers who work with senior adults were also interviewed and provided specific information regarding clinical research. No actors were used.

The format of the video is designed to introduce concepts and then demonstrate how those concepts applied to the cases of senior research participants. Their testimonies should make the experience of research participation more approachable and tangible to viewers.

9. Please discuss the significance and impact of your product. In your response, discuss ways your product has added to existing knowledge and benefited the community; ways others may have utilized your product; and any relevant evaluation data about impact, if available. If the impact of the product is not yet known, discuss its potential significance.

The product is used by representatives of the UC San Diego Clinical and Translational Research Institute when doing presentations at senior centers and senior residential programs. As part of a comprehensive presentation, the video presents basic information and serves as a catalyst for meaningful discussion between audiences of seniors and university staff.

We believe the resource can be used by various research-promoting agencies and professionals who work with seniors to increase research literacy and promote research participation. Programs with access to the Internet are encouraged to stream to content or download it for viewing off line.

Based on our experience with the product, we believe that it is a useful tool to help explain research in general, without reference to any specific research projects that are seeking to recruit members of the audience. We believe it may also be useful as a part of an education and outreach effort for a specific study, but have not yet tested it for that purpose. We encourage use and evaluation of the resource in that context.

As senior adults are an underrepresented group in clinical research, their specific health conditions, behaviors and potential responses to treatments are not being adequately addressed through the research process. This video encourages older adults to get involved in research.

A Spanish language video with comparable information that is presented in a format that is culturally sensitive and relevant for a Hispanic/Latino audience is also available at the site.

This video has demonstrated its value in the context of presentations and discussions and should also have utility as a stand-alone resource. For this reason, it is available to the public via the internet and can be made into a DVD that can be placed in resource centers, computer labs, or distributed to individuals.

As a resource for viewers who are interested in learning more, the video includes information about ResearchMatch.org, an NIH funded web site that helps individuals who are seeking information about research studies to connect with researchers who are conducting studies in their area.

Programs are encouraged to have printed materials with information about local research opportunities available whenever the video is shown.

10. Please describe why you chose the presentation format you did.

A short video format was chosen for this educational product to make the information widely accessible through formats such as DVDs and the internet. The video is intended to be entertaining, empowering, and provide sufficient information to be viewed individually

11. Please reflect on the strengths and limitations of your product. In what ways did community and academic/institutional collaborators provide feedback and how was such feedback used? Include relevant evaluation data about strengths and limitations if available.

This project's strengths include the collaborative process through which it was created, its accessibility, and its applicability to any region of the country and research on any clinical problem. Because it is intended for open dissemination, the video does not include an evaluation plan, limiting our ability to measure impact beyond our own experience here at San Diego senior centers.

Community and institutional representatives were invited to collaborate with this project throughout its development. Institutional collaboration included the participation of UC San Diego clinical researchers as interviewees, as well as UCSD-TV production. Community collaboration initiated with the Community Advisory Board, continued through two community focus groups to guide video style, and included community member input and feedback during the video production process.

12. Please describe ways that the project resulting in the product involved collaboration that embodied principles of mutual respect, shared work and shared credit. If different, describe ways that the product itself involved collaboration that embodied principles of mutual respect, shared work and shared credit. Have all collaborators on the product been notified of and approved submission of the product to CES4Health.info? If not, why not? Please indicate whether the project resulting in the product was approved by an Institutional Review Board (IRB) and/or community-based review mechanism, if applicable, and provide the name(s) of the IRB/mechanism.

This project and the video product are the results of a collaborative process that involved community members at several phases. Throughout the development of the video, community input was accepted and appreciated.

The advisory members contributing to this product were notified when it was posted. The Community Advisory Board encouraged dissemination via CES4Health and/or other methods to share its benefits.

The project resulting in this video was educational, not investigational, in nature. Therefore, IRB approval was not required. However, every individual that was interviewed/filmed for this video provided written authorization.