Recruiting and Communicating With Participants

Ensure that plans to reach referring physicians are being executed

Check your Recruitment and Retention Plan and think about how well the ideas are being executed. How effectively is your team keeping referring physicians informed about your study and its value? Letting them know about their patients' progress is essential to good working relationships. Good experiences today benefit today's and tomorrow's studies.

Ensure community outreach plans are being executed

Ask how well the community outreach ideas defined in your Recruitment and Retention Plan are being executed. How effectively are you working with partner organizations? Pay particular attention to whether your outreach efforts reflect the community's diversity.

Generate advocate buy-in

Advocates who value your study can be your greatest asset in reaching potential participants. Thus, it is important to share information and engage them early and often during the study. Good relationships with advocates will benefit today's and tomorrow's studies.

Engage patient navigators

Patient navigators help patients negotiate the complex web of health care, which can be even more complex with studies. Their compassion and knowledge of the system can reduce fear and stress for patients. Their central goal is to find ways around barriers—which can greatly help patients and clinical research staff who are navigating the requirements for a study.

Query your institution's paper or electronic medical record system(s)

Your institution's information system is an obvious starting point for identifying potential clinical study participants. If your medical records are electronic, then the process may be simpler. No matter which tools you use, it is important to know all the potentially eligible participants are being identified.

In other words, be alert to clues that a potential or existing participant may not be fully committed to the requirements of the study. Your team's awareness of these indicators will enable them to avoid enrolling participants who, while eligible, are not a good match for other reasons, and to work more effectively with those on the study who are having difficulty.

Follow up with potentially eligible but non-consented individuals

Keep track of individuals who are potentially eligible, but have not yet consented. Assure that they are undergoing work-up to confirm eligibility, and that any outstanding questions or concerns are addressed.

Identify and report on participant non-adherence indicators

In other words, be alert to clues that a potential participants may not be fully committed to study requirements such as randomization. Your team's awareness of these indicators will enable them to avoid enrolling participants who, while eligible, are not a good match for other reasons.

Use plain language

Researchers are used to talking about scientific studies every day. But, most people are not. In addition, the average adult in the U.S. reads between the 8th and 9th grade reading levels. Add to that the stresses of illness and you can see how important it is to simplify and avoid jargon when presenting a clinical study. If possible, rehearse what you will say so you can talk about the study in a way that is confident, balanced, and easy to understand.

Use participant-friendly materials

Use active voice and personal pronouns (Instead of ”The patient may contact his or her physician at any time….,“ say ”You may call me any time….“). Use white space, figures, diagrams, calendars, and simple outlines to make your document easier to read and understand. Leave wide margins and space so that participants or their friends and family can take lots of notes.

Present the study in a culturally appropriate manner

The racial and ethnic backgrounds of potential participants play an important role in the feelings, viewpoints, and communication needs they bring to conversations with you about a study. For example, ethnically diverse populations may have issues related to trust, differing cultural values, language barriers, and feelings about medical professionals that will impact their thinking about any study you present. Take into account these perspectives and any culturally-rooted communication preferences as you present the study.

Seek the help of translators when needed

There have been times when a participant and a clinical study seemed a perfect fit, but language barriers made informed consent impossible so the participant could not even be given the option to join. Even after informed consent, participants whose primary language is not English will likely need the aid of a translator to get answers and refresh their understanding of the study over time.

Present the study in a balanced manner—both pros and cons

It can be easy to overstate the pluses of a particular study when talking with potential participants. The pressures of accrual or even a clinician's heartfelt enthusiasm about the value of the study itself can play a role. By preparing your materials and what to say about a study, you can be sure to present it in a balanced way—so potential participants can make informed choices.

Provide continued support as people consider their decision to participate and continue on the study

The informed consent document and the informed consent discussion are critical. Yet, they represent only the start of the consent process. People need time to make thoughtful decisions about joining a study. As they consider this decision, provide access to any additional information or resources they may need. The two-way communication flow that helps participants feel comfortable and informed when originally joining the study should continue throughout the study.

Manage communication of screening results and failures

It is important to remember that participants, and their primary care providers, require communication about both successes and failures. Consistently ”close the loop“ with potential participants—both those who are screened into and out of the study. Doing so is common courtesy and, for those who are eligible, this step starts building your relationship. For those who are not eligible, thoughtful communication can help keep open the possibility of future study participation.

Be aware of and monitor regulatory issues such as HIPAA regulations

Regulatory and IRB issues can be fluid, so it is important to keep on top of potential changes that may be occurring, both at your site and on a national level.

Establish relationships with insurance companies to facilitate coverage

Coverage of clinical studies can be a major barrier to accrual, so it is important to understand the policies of insurers in your area concerning clinical research. A simple phone call might help you understand their viewpoints and constraints and give you an opportunity to share your ideas, too. Use the goals you share as a starting point for the relationship. If your institution's billing office has an insurance expert on staff, enlist his or her support to identify third-party payment options for your studies.

Track insurance coverage concerns for the study

One goal in all clinical study work is to limit the number of ”surprises.“ Minimize insurance surprises by tracking past study coverage and getting expert advice from your billing office. Tracking will enable you or your insurance specialists to speak knowledgeably with insurers about their past study-related coverage decisions and to help make the case for future coverage.

Work with specialists to identify alternative financing if a potential participant has no insurance

The anticipated financial burden of a study can easily become a deciding factor in whether or not a person enrolls. Therefore, it is helpful to have payment answers ready before questions arise. Find ways to include eligible participants who have inadequate or no insurance coverage in your studies. Specialists such as social workers can help identify local and national resources. Also, your institution or study sponsor may have funds set aside for such needs.

Watch for early signs of non-adherence and provide support to meet needs

Certain early signs of non-adherence are documented in the literature. You may notice some that are particular to your study as well. For example, indicators include losing interest and ”forgetting“ appointments or medications. Talk openly about the challenges together with the participant without pressure. Perhaps some of the issues can be easily resolved.

Keep in touch with participants on studies (e.g., through newsletters or reminders)

Which among the many varied ways to keep in touch—from newsletters, to email, to small branded items—will work best for your participants?

Offer support groups, participant networking, lists of local and online support resources

Making it easy for participants to get the support they need is one way of maintaining morale. For example, some study coordinators set appointments so that particular groups of participants tend to be on-site at the same time—forming a cohort of sorts and social bonds develop, which motivate participants to keep their commitment to the study. Ideas range from simply providing lists of resources to convening regular support groups.

Conduct satisfaction surveys with study participants

Openly encouraging feedback (and listening and acting on it!) has two benefits. First, your genuine interest shows participants that you care about them and their experiences. Second, you learn what is helping recruitment and retention as well as what might not be helping. Remember, keeping surveys short is important for obtaining thoughtful feedback.

Acknowledge and celebrate successes while also supporting any staff who need help

Even with perfect planning, recruitment can be challenging. Help maintain the enthusiasm and clarity of staff members about the important role they play. Reward staff for following the recruitment and retention plan and for spotting surprises and eliminating barriers. Remember that they have other duties in addition to recruitment. Recognize their exemplary efforts in data management, audits, and more—especially important if accrual is lagging and morale is low.

Regularly update staff on study accrual

Talking about accrual helps clinical studies and recruitment to be a part of the normal daily work. In addition, being open about how a study is accruing will help you gain the insights of others in solving problems. It also helps keep team members and leadership from feeling unpleasantly surprised if accrual goes poorly. Even with careful planning, new challenges will crop up. Empower staff to spot and solve problems and make it easy to give feedback about their study-related experiences.

Keep contact lists current and note the best way to communicate with individual participants (e.g., through email, newsletter, telephone call)

This activity is a basic step. Make sure you know how to reach your participants with study information—especially if that information needs to reach them quickly. Ask whether they prefer email, telephone, or other forms of contact.

Monitor media regularly and have a plan in place to respond to study-relevant media stories (to participants, to the media, and to stakeholders)

The Internet and the airwaves abound with advice, cautions, new scientific findings, and plenty of other information. Although you cannot monitor all of it, you can stay up-to-date on news (e.g., about a study drug or procedure) and anticipate questions. You can also be ready in the event of a major new and relevant finding or story.

Have a plan for notifying participants/families, staff, and stakeholders if the study is put on hold or closes unexpectedly

Prepare an explanation that is complete, clear and specific. Send it out to participants in a timely fashion. This will enable you to serve your participants in an ethically appropriate way, and can help engender positive feelings about the study and your institution—feelings that can carry forth to future studies.