Recommendations

The 5Ts Framework serves as a valuable organizing model for the best practice recommendations we have gathered for improving inclusion across the lifespan. To see recommendations for each “T” select Target population, Team, Time, Tips to Accommodate, or Tools. Or to narrow the list of recommendations to those most relevant to your study, use the filters to select your “Data collection method,” “Study design,” “Study setting”, current study “Activity,” or “Person.”

Displaying 15 Recommendations
Know the range of preferred languages of your target population, and ensure materials and communication are inclusive of preferred languages.

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

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

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Understand common motivations for participating in research, as well as concerns about participating in research.

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

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Build culturally competent and inclusive research teams that include members of the target community.

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: 

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Engage experts in aging research, and assemble study teams with experience interacting with older participants.

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/

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Involve participants, their family, their caregivers, their health care providers, and/or their community advocates as active members of the team.

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

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Train team members to recognize and accommodate age-related sensory, functional, and cognitive limitations.

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/

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Allocate time for study staff to provide updates, reschedule missed visits, obtain missing study measures or devices and connect with participants. (Be flexible with timing)

“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

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Allow more time for all study activities including screening, reviewing materials, educating participants about research, obtaining consent, and data collection. (Set the right pace)

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

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Anticipate various literacy levels and familiarity with consent documents and allow adequate time to review written study materials. (Set the right pace)

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

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Allow participants to complete some or all of the data collection from home (telephone, web-based, zoom). (Mobility limitations)

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.

icon Tips to Accommodate
Ask about or observe for signs of hearing difficulty, and if identified use a standardized hearing protocol - reduce ambient sound, use hearing aids, have pocket-talkers available. (Sensory limitations)

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:

icon Tips to Accommodate
Provide door-to-door transportation (budget for at least 15% of proposed study participants).

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

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Data collection tools that allow multiple ways to enter data - online, tablet, paper, interviewer entered. (Tools for data collection and follow-up)

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

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Electronic enrollment tracking system with capability to provide periodic enrollment reports by age. (Tools for recruitment and enrollment)

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/

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Select appropriate tools that measure outcomes important to older adults (Measurement tools specific to older adults, Choose tools that measure function, physical performance, and patient-reported outcomes as appropriate). (Cognitive limitations)

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:

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

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