Tuesday, March 11, 2014

What are the right tools for the recruitment toolkit?


Last month, I discussed the question of what mix of recruitment initiatives are right for your clinical trial. Ultimately, I concluded that there are too many variables in an individual research study to make a blanket assumption about which tactics to use every time out.

The same question is often asked regarding which materials to develop for recruitment kits for sites. Some of the most commonly used items include:

Study fliers
Patient/caregiver brochures
Physician brochures (for local outreach)
Study overview cards (for site staff)
Appointment reminder cards
Physician-to-physician letter templates 
Physician-to-patient letter templates 
Patient email templates
Social media posting templates (Facebook, Twitter, Craigslist, etc.)
Site website posting templates

In many cases, these materials are given to the sites en masse so that each study center can use them as appropriate. While that can be a sensible strategy, it bears further investigation as to whether throwing the “kitchen sink” at a site can do more harm than good.

If you give the sites an overwhelming amount of toolkit items to choose from, even with the guidance that they can use the materials at their discretion, they may waste time and energy pursuing initiatives (like sending out letters to local physicians) that do not ultimately pan out. This can create frustration for sites without providing any tangible benefit to enrollment. In some cases, a robust toolkit can make sense, but it should be scrutinized to determine if the materials truly will be effective.

One way to ensure the materials will help bolster enrollment is to engage your sites up front and get direct feedback about what they actually want. It can also be helpful to develop multiple electronic toolkit options and customize their distribution as needed. What I mean by that is to develop materials that can be printed per site in short runs, as opposed to legacy production processes where you print a gross of study brochures or flyers all at once. In the virtual world we now live in, this is an increasingly attractive option, as it allows you to warehouse multiple materials for a study and provide it on-demand on an individual basis, in some cases customizing items to meet specific site needs. 

While this seems like a sensible choice, there is a lot to be said for actually sending an actual toolkit to a site, as a means for branding your study and keeping awareness elevated at the site level. The question of whether to actually produce a toolkit or distribute all of the materials electronically is something that might be dictated by your study budget, timeline, and the need for branding and awareness.

Site materials usage rates from a past CAHG pediatric study 

While every study is different, site adoption will be dictated by the relevance of the study materials and the needs of your individual sites. Anecdotally, CAHG has found that adoption rates for site materials are higher in pediatric studies (see the accompanying table for usage rates from a past study). The graph shown illustrates site responses to a question in a post-study questionnaire (another good exercise that should be used after every recruitment campaign) polling their use of study materials offered as part of a centralized recruitment campaign.

Much like developing an enrollment strategy for a clinical study, a one size fits all approach is not something that should be applied when determining what materials to include in a recruitment toolkit. There are a number of different strategies you can use, and it is important to ensure that you think things through so that you maximize the benefit of the selected materials. The toolkit is an excellent opportunity to engage with your sites and create a sense of investment in your study for them. Do not waste this chance by unilaterally developing items without significant input from all of your study stakeholders.

1 comment:

  1. Hi Don, lots of kernels of goodness here. I would say that site engagement is more important than patient recruitment materials. I love your suggestion to survey what works and offer only what the coordinators want. Space at many clinical sites is limited and a lot of these materials end up in the bin and never get used. I like putting the resources into truly engaging with site personnel rather than loading them up with posters and templates. The most important tool in the toolkit for study managers is to learn to connect more with the site representatives who are working directly with the patients. Find out what the site staff need and give it to them, in a recent study I worked on we had our recruitment vendor produce and distribute Inclusion/Exclusion cards, spiral bound mini-protocols, and newsletters. None of these items went to patients but they had a measurable impact on enrollment. http://clinopstoolkit.com/2013/01/improved-investigator-and-site-relationships-part-ii.html

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