As much as we want to say that patient problems stop with recruitment, this is usually not the case. In clinical research, many sites are able to recruit their necessary number of subjects, but then they start struggling to retain those patients until the end of the study.
Patient retention is crucial for the development of a study and for producing good data and results in the end. However, there are cases when retention becomes a challenge. This can happen for many different reasons, some of which can be prevented by the site and some not.
Seeing the high number of sites who face different problems with patient retention, we’ll give you an idea of what are the most common challenges you might face and how to fix them as much as possible.
2. Introduction
As much as we want to say that patient problems stop with recruitment, this is
usually not the case. In clinical research, many sites are able to recruit their
necessary number of subjects, but then they start struggling to retain those
patients until the end of the study.
Patient retention is crucial for the development of a study and for
producing good data and results in the end. However, there are
cases when retention becomes a challenge. This can happen for
many different reasons, some of which can be prevented by the
site and some not.
Seeing the high number of sites who face different problems with patient
retention, we’ll give you an idea of what are the most common challenges you
might face and how to fix them as much as possible.
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4. Bad Atmosphere
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As the clinical trial staff starts the day, they
can be faced with many challenges.
However, it’s a bad practice to show or
share your problems in front of the patients.
Doing this will create a bad and unfriendly
environment where patients won’t feel safe
and protected.
5. Difficult Protocols
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In some cases, the difficulty of the study
protocol can be the main reason for patients
dropping out. For example, a protocol which
requires the patients to document their daily
food intake can be difficult to manage for a
lot of people. In such cases, the subjects who
failed to do this will have to be dismissed due
to a lack of data. Another example is if the
subjects are required to follow a diet that’s
too restrictive. Most of them will probably
not be able to follow through, so they will
drop out pretty soon. When this is the case,
talk to your sponsor to amend the protocol if
possible and make some changes.
Optimizing protocol design
Evaluating protocol complexity
Coverage analysis of the study
Preparing budgets and billing compliance
Meeting all regulatory requirements
6. Failing to Follow Up
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Many times, sites tend to forget how important
follow up is for retaining patients. No matter how
busy your PI or coordinator is, always try to find the
time for following up with your patients.
One of the most important things to remember
when it comes to following up is the appointment
reminder.
All sites should have a member of the staff
responsible for reminding patients of their next visits.
7. Lack of Communication
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Failing to communicate with patients is yet another
reason why they might start to drop out. Ensure that
you’ve figured out the best lines of communication
for each patient, and then stay in touch. Apart from
reminding them about different visits, you will be
able to make them feel like they can trust you.
Communication is crucial for retaining
patients, no matter the type of study!
9. Protocol Amendments
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If you’re doing everything right, but you still notice that
patients are dropping out of your study, then probably
there’s a problem with the protocol. When facing this
problem, try to encourage your patients to stick to it as
much as possible. However, some protocols can be pretty
demanding, so not all patients will comply.
If more than half of your patients have dropped
out due to the protocol difficulty or complexity,
try to ask your sponsor to make some
amendments. In some cases, this will be possible
and manageable while in others not so much.
New, amended protocol
- Easier to follow
10. Spread Positivity
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Patients that enroll to clinical trials are
facing a lot of ‘’unknowns’’, so it’s up to
you to try and calm them down. Staying
positive and cheerful will remove this
fear from the patients and they will
start feeling comfortable in this
surrounding.
Positivity
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Share
success
stories
Laugh
Be
polite
Show
empathy
Help
and
support
Smile
and
greet
11. Communicate Openly
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The reason why many people avoid enrolling
in clinical trials or drop out once they’ve been
enrolled is misunderstandings. Lack of
communication and openness is fatal for
patient retention. Almost all patients will have
questions regarding the protocol and the
safety of the trial, so communicating openly
and giving them the answers they need is the
best way to retain them.
Tell them every detail that they want to know,
including the fact that they’re free to quit the
trial at any time and without any
consequences. Once you explain all this, your
patients will lose their sense of being trapped
in a trial.
01 How safe is the clinical trial?
02 What are the short-term and long-term side
effects/risks?
03 What’s the exact protocol?
04 Will I be able to quit without consequences?
05 What are the short-term and long-term
benefits?
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Are there any unpleasant or painful
procedures or treatments?
07 What responsibilities will I have if I decide to
participate?
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Provide Transportation
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Another excellent and a bit ‘’tricky’’ way to ensure
patient retention is to provide transportation to
and from the study site.
Since many patients tend to forget their next
visits, picking them up is a foolproof way to
make sure that they will come.
If your budget allows this, providing
transportation is a really smart idea to increase
patient retention!
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Use Simple and Understandable Language
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When explaining the study to a patient,
avoid using medical phrases and jargons.
Instead, explain them every medical
procedure and every adverse event in
simpler and more understandable words.
This will allow for every type of patient to
actually be aware of what is going to
happen.
Examples:
BP = Blood Pressure
Negative = Normal (test results)
Positive = Abnormal (test results)
CBC = Complete Blood Count
IM = Intramuscular
BMP = Basic Metabolic Panel
ADE = Adverse Drug Event
H&P = History and Physical
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Pleasant Accommodation and Clinic
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high level of
cleanliness
available parking
places
colorful and warm
space to avoid the
‘’hospital feeling’’
comfortable
waiting room
Creating a pleasant and warm clinic
environment will be of further help for
retaining patients. For example, you can
make sure that there are enough
available parking places, a comfortable
waiting room, a high level of cleanliness,
etc. Another thing you could try doing is
to lose the typical ‘’hospital feeling’’ of
white and empty hallways. Do this by
bringing in some color, or by making the
waiting room feel more like a living room
where patients can socialize and feel
comfortable.
15. Follow Up!
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Even excessive follow-up is better than no follow-up! Many sites can often disregard this
area of patient retention just because of ‘’being too busy’’. However, this is something
that has to be done! Lack of organization is usually the main culprit for not following up
on patients, in the sense of not knowing who should do this task. Even though the
coordinator is usually supposed to follow up with patients, any site member could do!
Remember - more follow up is
always better!
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CONCLUSION
All of these above challenges can be improved with a better site organization and a bit more dedication. No matter
how simple or trivial something seems to you, even the smallest of details can help you retain your patients.
Patient retention is one of the most challenging areas for almost all research sites, so developing a good strategy,
organization, and delegation of retention tasks among site staff is crucial. After all, no study can have success
without patients to participate!
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