Recommendations

Exclusion criteria that disproportionately affect older adults: co-occurring conditions (comorbidity), functional limitations, hearing and vision impairment, cognitive impairment, inability to give informed consent, recent hospitalization/health event, living in a nursing home or assisted living facility, serious illness, or limited life-expectancy. Discretionary exclusions such as "deemed inappropriate," "unlikely to complete study protocol," or "at risk for adverse events" also exclude older adults. Do not use age as a proxy for frailty or risk for adverse events.

References:

• pubmed.ncbi.nlm.nih.gov/32897289/
• pubmed.ncbi.nlm.nih.gov/30326521/

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/

Older adults often look to their family, caregivers, community leaders, and healthcare providers for advice about participating in research. In many cases older adults may depend on others for transportation, scheduling appointments, or help adhering to study protocols. Rather than seeing these people a "gatekeepers," researchers should identify how these "team members" may help support participation in the study.

Useful Link: https://clic-ctsa.org/education/community-engaged-research-cenr-diverse-older-adults

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/

“Our older participants are more likely to miss visits due to acute illness or dependence on less-than-reliable transportation (or, dependence on family members to help them with remote technology). These visits often need to be rescheduled multiple times, and rescheduling, sending reminders, checking on whether the participant has any mailed materials, maintaining participant’s trust and enthusiasm, etc., can result in hours of additional invested time in each participant -- far beyond the study visits themselves. This investment is worth it, but study teams should anticipate this challenge and budget for the extra effort.” –Principal Investigator

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

"I feel that Time is the most important factor when it comes to working with older adults. It is imperative to make sure that we allow time for them to process everything that is going [on] around them and with them. None of us like feeling rushed or pressured to do something - especially when we do not understand what is being asked of us." -Research Coordinator

Avoid collecting data "just in case" or for unplanned future research. Often measures that are collected in research are never analyzed or used. Prioritize measurement plans based on outcomes that are important to older adults. Pilot test data collection in older participants to obtain a more accurate estimate of time burden. Select "short form" measures when possible or use item response theory to limit the number of questions within an instrument. Examples include the Patient-Reported Outcomes Measurement Information System (PROMIS).

Useful Link: https://www.healthmeasures.net/search-view-measures

"Accommodating visits to when [participants] feel more comfortable would help (some people might be morning people!). These things can be said for any age group really, but when working with older adults there are a lot of little things at play. Technology, failing eyesight, mobility issues, even hearing loss. Providing a comfortable environment to where a subject feels as though they are setting the pace might help them feel more at ease and willing to participate." - 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.

Research studies often focus on one condition or disease at a time. However, older adults commonly have multiple chronic conditions (MCC) or health issues. Some older adults were concerned that participating in a research study would affect their other conditions. Acknowledging this concern and having relevant information on the impacts of research participation on common co-occurring conditions may help accommodate the needs of older adults with MCC.

Useful Link: https://clic-ctsa.org/education/aging-multimorbidity-polypharmacy-and-inter-current-health-events-research-implications

The prevalence of moderate hearing loss (40 dB) increases from 3% among people 50-59 years old to 45% among those ≥ 80 years old. In a study setting, moderate hearing loss would cause difficulty hearing a lowered voice in a noisy waiting room. Rather than excluding those with hearing impairment and to avoid miscommunication, a "hearing protocol" can encourage best practices. See example hearing protocol in resources.

Resource:

The prevalence of mobility limitations and slow gait speed (<1.0 m/s) increases from 25% in adults 65-69 years old to 75% among those ≥ 80 years old. As walking across a street at a cross-walk may require a gait speed > 1.4 m/s, ambulating to many research settings may be difficult for older adults. The use of assistive devices are also common among older adults. By 80 years old, more than 1 in 10 older adults use more than one assistive device. Matching the right device with the research setting is important. For example, canes or walkers may work for short distances, but wheelchairs may be needed for longer distances.

By age 70, nearly 20% of older adults have farsightedness and 3% have significant eye disease which can impact one's ability to see. Simple strategies to increase visibility of written materials can support participation. With aging, it is also common for people to have more difficulty high glare situations (see a researchers face when there is a glare from a window). Certain eye diseases affect central (macular degeneration) or peripheral vision (glaucoma). This could cause vision to be worse with different orientations of rooms or based on the angle of screens or monitors.

Many study protocols are designed with the goal of maximizing efficiency from the study team perspective. Examples include using pill blister packaging cards, packaged data specimen collection instruments, small monitoring devices that can be easily mailed. Age-related issues including hand arthritis/reduced grip strength, tremors, or visual impairment, can reduce one's ability to complete study protocols. Occupational therapists can often recommend strategies to support this type of function in older adults.

"One idea that I feel would help our workflows is to address each subject individually and find out what works for the individual instead of the group. A subject is more likely to be receptive to participation if they are comfortable." -Research Coordinator

"I'm willing to overcome some barriers, but not if means pain and suffering. My walking causes pain. I'm a strong supporter of research...I will do almost anything I can if the barrier to accessing the location doesn't cause pain." -Emeritus professor in public health and dedicated research participant

Inconveniences of participating in a research study are not limited to the participant. For older adults, caregivers often contribute by scheduling research visits, providing transportation, and helping participants follow research protocols. The needs and preferences of caregivers, including spouses, adult children, friends, community members, or paid caregivers should be accommodated.

Useful Link: https://eldercare.acl.gov/Public/index.aspx

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/

"Before enrollment started, our team walked down to check out the space that had been provided for our study. It was obvious that it was not going to work for our older participants who often use wheelchairs and are accompanied by their caregivers. Luckily, we were able to find a room that better fit the needs of our study population. Finding space to conduct research study visits in a busy medical center can be a challenge and it helps to plan ahead." -Principal investigator

Example: Research facilities dedicated to studying older populations can serve as models for the types of equipment that may be helpful for recruiting older adults.

Useful Link: https://aging.ufl.edu/research/research-facilities/clinical-research-rc1-facilities/

Proxy informants are often used in aging research. See references for best practices and guidance maximizing reliability of data collection.

References:

• https://pubmed.ncbi.nlm.nih.gov/11129756/
• https://pubmed.ncbi.nlm.nih.gov/29733342/

"In my experience recruiting participants, and particularly older adults, I have realized that it is essential to make the process of participating in a research study as easy as possible. Often one way to do this is to meet them at a convenient location for them -- whether that be in a community center, a location closer to where they live with easier parking, or even at their house for some studies." -Research Coordinator

"I always meet participants at the entrance of a building and escort them to the study area. It can be confusing and overwhelming to have to park, locate a building, and then figure out how to get to the right floor, etc. A friendly face meeting them to help them through that process goes a long way in making them feel comfortable and ready to participate." -Research Coordinator

Older adults in rural areas and those with functional limitations are more likely to report transportation problems. Transportation can be arranged by contracting with local transportation venders, providing cab vouchers, or arranging transportation using mobile ride-share services. Budgeting 15% for transportation services will ensure that funding will be available. Additional information on transportation is available from the Eldercare Locator, a public service of the U.S. Administration on Aging.

Useful Link: https://eldercare.acl.gov/Public/Resources/LearnMoreAbout/Transportation.aspx

Resource:

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

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

Resource:

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Example: The PREVENTABLE Study includes a single telephone number as well as an information on the call center team.

Useful Link: https://preventabletrial.org/Call%20center%20brochure%20v2EnglishandSpanish.pdf

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

Table 1 from Mody et al Recruitment and Retention of Older Adults in Aging Research (linked below) provides strategies for tracking accrual and loss to follow-up.

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

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

The Health in Aging Foundation has a registry of geriatrics care providers by state (linked below).

Useful Link: https://account.americangeriatrics.org/findageriatricshealthcareprofessional

Example: The National Center on Elder Abuse has important information including state resources.

Useful Link: National Center on Elder Abuse (acl.gov)

Examples: Great examples of measures can be found from the Duke Pepper Center, the Geriatric Research Instrument Library (GRIL), and from the CTSA Inclusion of older adults in research workgroup.

Useful Links:

• https://agingcenter.duke.edu/functional-assessment
• https://www.peppercenter.org/public/gril.cfm
• https://clic-ctsa.org/education/gerontologized-measures

"The study team will need to consider which tools should be utilized to assist our older adults on an individual basis."
-Research Coordinator

"I help to accommodate the needs of older adults by providing larger print when needed, comfortable sitting area with good lighting for discussion, and being mindful of their time. Should they need a break or would like to reconvene at a later time, I will do all that I can to make sure that happens." -Research Coordinator

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