Recommendations

Adults ≥65 years old make up about 15% of the US Population (>55 million people) and this number is expected to increase over the next 20 years. Most disease populations and healthcare populations include an even higher percentage of older adults. Start by estimating the percentage of older adults in the target population (who should findings generalize to), then set recruitment goals by age and track inclusion during enrollment.

Useful Link: https://www.census.gov/topics/population/older-aging.html

Reference: https://pubmed.ncbi.nlm.nih.gov/19093934/

Example: The PREVENTABLE Study brochure is in English and Spanish (linked below).

Useful Link: https://preventabletrial.org/English%20and%20Spanish%20Brochure.pdf

Research teams often think of risks versus benefits, but for older adults and caregivers, decisions about research often come down to weighing motivations for participating versus the inconvenience of being in a study. In cases where motivation is low and inconveniences are high, they may be less likely to enroll in research. Many inconveniences are also compounded at older ages (e.g., travel to study visits + difficulty walking). Older adults want study teams to address their personal motivations for participating and make accommodations to reduce inconveniences.

Examples: The National Institute on Aging (NIA) at NIH, the Centers for Disease Control and Prevention (CDC), and the Administration for Community Living (ACL) Recruiting Older Adults into Research (ROAR) project has information for older adults on participating in research.

Reference: https://www.nia.nih.gov/health/recruiting-older-adults-research-roar-toolkit

Approaches to research inclusion of underrepresented populations designed for younger populations may not adequately address the added barriers that older adults face. These barriers may be at the individual or structural level. Lessons learned in the clinical care of older adults could be used in research. The American Geriatrics Society has several resources that may be helpful.

Useful Link: https://www.americangeriatrics.org/programs/achieving-equity-health-care-ags-work-intersection-structural-racism-ageism

References: 

• https://pubmed.ncbi.nlm.nih.gov/26804356/
• https://pubmed.ncbi.nlm.nih.gov/31074850/
• https://pubmed.ncbi.nlm.nih.gov/36260413/ 

Aging research experts include geriatricians (clinicians trained in caring for older adults) and gerontologists (sociologists, psychologists, and other scientists focused on issues related to aging). Also consider experts from the many fields that provide interdisciplinary healthcare or conduct research in older populations such as nursing, physical therapy, occupational therapy, pharmacy, social work, and audiology.

Useful Link: https://www.peppercenter.org/

Study staff often learn to enroll older adults through "trial and error" and by incorporating strategies from their own personal experiences with older adults. Few have formal training in aging. Consider providing brief aging sensitivity training focusing on how age-related sensory, functional, and cognitive changes might affect each activity in your study.

Useful Link: https://clic-ctsa.org/education/educating-research-teams-meet-nih-lifespan-inclusion-policy

Reference: https://pubmed.ncbi.nlm.nih.gov/35764920/

An important geriatric principle is that even at the same age, older adults can be very different in their health and function. This means that some older adults may require additional time to participate in research, however some will not. Setting a pace that only allows for the highest functioning older adults, will unintentionally exclude older adults who may be appropriate for research.

"One major way to adjust my workflow to accommodate older adults would be to allow for more time when planning visits. I have heard from many older adults that their visit felt rushed. I understand that each of us processes information differently and at different levels. Allowing more time for study visits would help make sure that the patients have a good understanding of the project and to have any questions answered they may have. I will also remain flexible in the lines of communication so that no patient feels pressured to make a decision right away without having time to process the information fully." -Research Coordinator

We often hear from study teams that many older adults need information on research in general before they can consider the risk and benefits of a specific research study. This includes defining terms like research, consent, protocol, and randomized.

Example: The National Institute on Aging has resources for describing research participation for older adults including definitions of informed consent which may be helpful for older adults who are not familiar with research terminology.

Useful Link: https://order.nia.nih.gov/sites/default/files/2019-06/clinical-trials-and-older-adults-booklet-508.pdf

Our aging population particularly in oncology, are enrolling on studies that are often complicated with more than one treatment modality. I will need to ensure there is enough time and flexibility to [ensure] older adults are fully informed, and comfortable with participating on a study. " -Research Coordinator

A key finding from our engagement with older adult research participants was the need for flexibility in data collection methods. Some older adults were comfortable with web-based data collection or using smart devices, others preferred "pen and paper." Knowing that data collection could be matched to their needs and preferences may make older adults be more likely to participate.

The use of Legally Authorized Representatives (LAR) to obtain consent varies by state and each study will need to work with their IRB to determine rules for the state in which they conduct research. This work is better done early in the IRB process rather than when enrollment start dates are looming.

Example: The Clinical & Translational Science Award (CTSA) Inclusion of Older Adults Working Group developed a helpful toolkit that includes resources for those with cognitive impairment (linked below).

Useful Link: https://clic-ctsa.org/education/including-vulnerable-older-adults-research-case-people-cognitive-impairments

Example: The Strategies to REduce Injuries and Develop Confidence in Elders (STRIDE) study provides good examples for developing a clear message including using "story cards" and a signed notecard from Martha Stewart.

Useful link: Health Literacy Checklist for Research Communication

Reference: https://pubmed.ncbi.nlm.nih.gov/30020415/

Example: The Clinical & Translational Science Award (CTSA) Inclusion of Older Adults Working Group developed a helpful toolkit that includes resources for those with cognitive impairment (linked below).

Useful Link: https://clic-ctsa.org/education/including-vulnerable-older-adults-research-case-people-cognitive-impairments

Reference: https://pubmed.ncbi.nlm.nih.gov/17679641/

Useful Link: https://preventabletrial.org/clinicians.cfm 

Useful Link: https://clic-ctsa.org/education/including-vulnerable-older-adults-research-case-people-cognitive-impairments

Resource:

Example: The Strategies to REduce Injuries and Develop Confidence in Elders (STRIDE) study reduced redundancy in recruitment letters and informed consent documents.

Reference: https://pubmed.ncbi.nlm.nih.gov/30020415/

Example: The National Institute of Aging (NIA) provides information for older adults on participating in research (linked below). OutreachPro is an NIA-developed resource that helps research teams create customized outreach materials for clinical trials on Alzheimer's and related dementias (linked below).

Useful Links: 

• https://www.nia.nih.gov/sites/default/files/clinical-research-infographic-508.pdf
• https://outreachpro.nia.nih.gov/

Example: Due to the pandemic, the CARDIA study had to transition from all in-person data collection to multiple strategies including in-person, phone, online, and paper data collection instruments. The CARDIA Manual of Operations provides detailed descriptions of best practices for different data collection methods.

Useful Link: https://www.cardia.dopm.uab.edu/exam-materials2/manual-of-operations/year-35

"Allow an older research participant [to] go at their pace and set the tone for the process. If they would prefer paper copies of a consent, questionnaire, etc, it would be best to try and accommodate the request and make the participant feel comfortable. -Research Coordinator

"For consents, if an eConsent is used, it would help if a hard copy was available as well. Same for any questionnaires that may need to be answered." -Research Coordinator

Useful Link: https://heroesresearch.org/wp-content/uploads/2020/04/HERO-Research-Program-FAQ-10APR2020-v-1.pdf

Example: The CARDIA study manual of operations for conducting physical performance measures is a good example (linked below).

Useful Link: https://www.cardia.dopm.uab.edu/images/more/pdf/MooY35/Phase2/chapter13.pdf

Resource:

Created by the Duke Recruitment Innovation Center