Doctor! Doctor!

For the clinical trial that I participate in,. I am required to make a daily call into their phone banks "journaling" my symptoms for that day.  Not only do I not like making the call because the information they request is not detailed enough - IMHO - to really let them know if things are improving or not, but there is the added frustration that about one out of every three calls proves to be difficult to make.  The phone bank is located in Britain, 8 hours ahead of Los Angeles, and they are downloading data based on the noises I hear and Eric's input.  Eric would know.

I have advised my research nurse of this difficulty and her attitude to date has been just try for 1/2 hour, and if I don't get through by then, I shouldn't worry about it.  Her exact quote is "not to worry."

Then came the call from her two days ago, chastising me for not having made regular calls over the prior week, and threatening to kick me out of the program.  I was very upset; I told Eric about it and since he has been witness to how many times I try to get through and can't, he was upset too.  But the call I made that day sailed right through and I hoped - admittedly stupidly - that the trouble would be over.  It was not, as evidenced in the following series of e-mails:

Subject: call-in

Hi Laura,

I hope you are doing well!

As you probably know, we are regularly audited for completion of all study-related documents.  I want to remind you to call in regularly to the computer system. I know there are a lot of pressures, distractions, and demands on your time. However we really need you to regularly call in to the system or your continued participation may be jeopardized by FDA-mandated regulations beyond our control.  

I know it’s a pain, and seems repetitive, but it is required. If email reminders would be helpful we can do that.

I look forward to seeing you at your next visit.

Best

Gil Melmed

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Subject: Re: call-in

Dear Dr. Melmed,

I would like to say that this would not be a problem since Chisom and I spoke yesterday (and before that too on several occasions) about the frustrations I have been experiencing calling in.  As I explained to her, I have been going to bed around midnight due to a new lifestyle and at that time, when I call the number, it is more often than not that when the call picks up, it is only emitting fax-signal sounds which Eric (my fiancee) tells me is their computer transferring data.  Chisom and I agreed during yesterday's call that I could call in well prior to bedtime and I successfully did it last night.

Unfortunately, I started calling this evening at around 9pm, and I am experiencing the same phenomena.  It is now 9:40 and the phone line is not yet clear to receive me 40 minutes later.  I don't know if there is a change in protocol on the receiving end, but as irritating as the call is, it's far worse to make it and not get through after multiple attempts.  I used to have a good track record of calling even as I hated doing so, and even thinking that my position in the study might be jeopardized is extremely worrisome. 

I offered Chisom a printed record of my phone calls - Eric told me that all incoming and outgoing calls are recorded in our system - and if this would be helpful to you, I will ask him how to pull documentation proving that I have been trying to do what you request.  As it is, I did connect yesterday with no issue and will continue to try this evening up until midnight.  At that point, if I have not connected, I think I will have exercised due diligence and hope that I will not be kicked out.

Thank you for your interest.  Please let me know if you need me to provide proof of my attempts in the last few weeks.

Laura

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Subject: Re: call-in

Dear Dr. Melmed,

Eric came home from his meeting at about 10pm and when I told him about your e-mail, he was very upset too.  He has been witness to me attempting to call in nightly and has been as frustrated as I.

At 10:04, 65 minutes after I started trying to make my connection today, Eric set up a recording of another of my many attempts to demonstrate to you what I am hearing each and every time I try to call in.  You can listen for yourself on the attachment.

I have tried twice to get through since then, and as I said, will continue to call until midnight when I really need to go to bed, but if I am kicked out of the trial for failing to get through when this is what I hear over and over and over again for lengthy periods of time, it really seems unfair.   Again, while I have never been happy about this particular requirement, I have been mostly compliant and the attachment to this e-mail should highlight why I am extra frustrated now at first hearing from Chisom and then you.  I will be happy to provide a complete record of all my calls over the past few weeks if you find it necessary.  No audio recordings exist going back as our system has to be set up specially to capture them, but if a full set of recordings is what it takes to prove to you that I am trying, at your request, we will start documenting every call attempt and connection with an audio recording and forward them to you daily. 

Again, thank you.

Laura

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Subject: Re: call-in - E-mail # 3

Dear Dr. Melmed,

It's now approximately 11:10 pm; I have been unsuccessfully calling in every three to five minutes for the last 130 minutes.  According to Eric (a mathematician by trade), assuming I called only once every 5 minutes this evening alone, I have now made 26 attempts at completing my "journal."  He said that equates to three weeks worth of calls, and wants to know if this makes up for all the "missed" calls reported.  He points out that it would be better if I could get credit towards future calls to be made over the next three weeks.  Quite the sense of humor he has, doesn't he?

Laura

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Dear Dr. Melmed,

At 11:15, the line finally picked up and I completed my journal for the day.  2 hours and 15 minutes before I connected.  I can only wonder what tomorrow holds.

Laura

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Hi Laura,

I understand your frustration with the telephone system. I will make sure that the study is aware of all of your attempts to call in as well the difficulty that you are having with the system. Your efforts are greatly appreciated. I will continue to let the study personnel know of the difficulties that you are having.

Chisom 

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Subject: RE: call-in - E-mail # 4

Laura, thank you for your attempts last night. I was unaware of these issues and we will report them to the sponsor this morning.  I don’t think we need further documentation of your efforts, but will let you know if we need anything further to demonstrate to them that you have indeed been trying and that the problem is that their system needs to be fixed asap. We will investigate and get right back to you. I am truly sorry that you are having these frustrating experiences.

GM

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Thank you Dr. Melmed.  Please be aware that I have been making Chisom aware of this issue for months and her instructions have always been to try for about 1/2 hour and if I didn't get through by then, I was not to worry.  I would have escalated the problem to you long before now had I known that I could be thrown out of the program over it. 

Not only have I spoken to Chisom, but I have also asked her if there was a way to check in via the internet or e-mail, simply bypassing the phone all together.  To date, the answer has been no, but it seems that a web contact system to record answers would be fast and easy to set up.  Even with my own rudimentary HTML coding experience, I have written similar programs and it's not hard.

Thank you for your understanding.  Again, last night was exceptional in that fear drove me to continue calling in for hours.  Prior to last night, as advised, I would simply stop trying after 1/2 an hour.

Laura