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 6 Recommendations

5Ts

Data Collection Method

Study Design

Study Setting

Activity

Person

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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	Time
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	Time
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	Time
Be understanding that it may take longer to schedule follow-up visits as participants often require assistance from others for transportation and scheduling. (Be flexible with timing) "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	Time
Limit time requirements by reducing the number of study measures, using brief study measures, and avoiding low-priority study measures. (Limit time requirements) 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	Time
Work around the participant's schedule or clinic visits, including offering study times outside of normal business hours. (Be flexible with timing) "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	Time