Hello again, it's Catherine Castillo Castro reporting from the field in Raleigh and Durham, NC.
My internship under Dr. Jason Stout this summer has been divided between spending time at the Wake County Health Department observing/doing Spanish interpretation in the Communicable Disease Clinic, and developing a research project with Dr. Anna Person, a fellow at Duke working in the Division of Infectious Disease. In the past couple of weeks, we completed creating all of our forms and revising them in order to finally get all of our IRB approval, and we began recruiting participants.
The study we are doing is very simple. It is a randomized controlled trial which seeks to determine if using text message reminders for clinical appointments improves the attendance rate of HIV positive patients in the Infectious Disease clinic at the Duke Clinics. Basically, we're trying to generate numbers in a very scientific way that prove that a text message is a good way to get people to remember to come to their appointments (for many patients, it's once every three months). Numbers are good, because after the study is completed and published, it becomes a handy tool for justifying the expense and investment (albeit small) of setting up a text message reminder system at the Infectious Disease Clinic, and many other potential places where no-show rates are higher than favorable.
For example, at the Duke clinic, 20% of appointments last year where no-shows! There is definitely a need to improve that. The more appointments people attend, the better it is for their own health as well as the operations of the clinic. Everybody wins. The study is pretty simple and straight forward. Participants must be HIV positive and receiving care at the Duke Clinic 2J, and they must also own a cell phone and be able to receive text messages. We approach patients after their doctor has seen them and if they agree to hear more about the study, we go over the consent form. Then, if they would like to participate, they are placed into one of two groups; one group will receive a text message the day before their appointment that says "You have a doctor's appointment tomorrow" (it is purposefully lacking in any information about where, for what, or with who in order to protect the patient's privacy about their health), and the other group will not receive a text.
We will also collect information about a person's previous attendance at the clinic and health status information, such as clinical and lab data (CD4 count, viral load, history of mental illness, substance abuse). All the information we collect is kept in a password protected database. Because studies are voluntary, patients can choose not to participate or withdraw later at any time and it will not affect the care they receive at Duke. The paragraph you just read is absolutely everything vital you need to know about the study if you are a participant. However, as with all studies, the consent form takes all of that information, and adds some more stuff we need to say in order for everything possible to be disclosed for the protection of subjects and Duke University, according to the Institutional Review Board. This makes the consent form FIVE pages long and makes the entire process take at least 15 minutes per person. Just for one text! Now, don't get me wrong. While the informed consent is something I respect very much and am grateful for, having been a study participant myself, it definitely does make a simple study into something very complex.
Recruiting subjects is more difficult the longer it takes to go over forms, and it can put some people off. Many of the people I have approached are puzzled as to why it has to take so long just to sign up to get a text message, and others I think get scared that all the paperwork might be a sign that the study staff are trying to cover their bases in case something bad happens. But, having approached many kinds of patients, I have also seen how vital it is to cover all the details with people before they agree to participate. For example, some people are really not comfortable with someone else going through their medical record or knowing their clinical data or lab results, even if it's only the study staff, who are held accountable for protecting the privacy of all participants. If you did not make the details clear about this part of the study, some people might be very upset to find this out later, and so you save everyone a lot of trouble by laying it out from the start. In another case, if you did not make it very clear what exactly the text message will say, some people may be afraid to get a text message which might let someone know they are HIV positive.
Then you lose another vital participant. So far, about 50% of the people we approach agree to enroll in the study. While it is a hit or miss sort of thing, it's the way it has to be done, and I have a newfound appreciation for the refined skills of study recruitment. More to come later on just what skills I mean...for now, I will keep this post from getting much longer.
