Reflections and Learnings from the Hospital of the University of Pennsylvania
Our
early efforts with the EFFORT trial were truly enlightening. As the first site
to enroll patients, we worked with the CERU team to make the data fields and
resources more intuitive. As a former INS site, we understood the scope of the
variables needed, but a number of factors are different with EFFORT than with
INS and adjustments in our approach were needed.
There
were a number of hurdles that we needed
to overcome:
Some of our
clinicians (both physicians and dietitians) did not have equipoise about
protein dose.
Increasing protein intake was sometimes a response to deterioration in clinical
status. Thus, a protocol with a fixed protein goal felt too inflexible to some.
·
To overcome this obstacle, we used the abbreviated slide deck from the
EFFORT trial to educate our staff about the limited and conflicting existing
data regarding outcomes associated with protein dose, ICU by ICU.
·
The slides also present the novel concept of embedding a RCT into an
existing registry, an idea that excited clinicians about potential trials that
they might initiate after learning from this experience.
Identifying only
the high-risk patients to enroll was an adjustment from our prior INS experience.
·
To identify high risk patients, we began daily screening of our ICU
census. We identified all patients
requiring mechanical ventilation and began discussions with our ICU
physicians.
·
Identifying patients who were likely to have prolonged ventilation was
challenging in some situations despite close discussions with the ICU
team. Patients sometimes remained
intubated when the ICU team anticipated rapid extubation
and other patients who were anticipated to have prolonged ventilation were extubated
right after enrollment. After missing a couple of patients who ultimately met
enrollment criteria and enrolling a couple of short-stay patients, we learned
to observe patients in this gray area for an additional day to better determine
their clinical course. Daily screening
of the ICU census gave us the flexibility to monitor the patient’s course and
enroll the target patients.
Setting up a system
to collect data prospectively in order to adjust protein intake to ensure
delivery of the goal was a new challenge. We had also adopted a new electronic
medical record (EMR) since our last INS participation, and needed to identify
data fields. Furthermore, our nurses’ documentation of intake from enteral
feedings was highly variable with the new EMR.
·
We had two graduating senior nursing students who volunteered with
EFFORT in order to learn about clinical research. At least one of them came into the hospital
every morning to collect enteral feeding volume data from the pump history and
to confer with the bedside nurse about actual intake. They then compared this
information to that in the EMR and sent an informative email to the ICU
dietitian so that she could adjust the enteral orders as needed to deliver the
goal.
·
As their final step, they created a procedures manual for future
students that delineates in detail where to find each of the variables in our
EMR.
Patient enrollment
and data gathering takes time.
·
Because data collection is occurring prospectively and is likely to
occur as part of routine clinical care, it is important for clinicians to build
a process into their daily work flow. It
may be helpful to begin data collection on a sample patient to more accurately
assess the time commitment for each patient.
·
Daily screening for new patient enrollment can take 15-30 minutes;
communication with clinicians and enrollment of each patient may take
additional time depending on the complexity of the patient situation.
·
Once a patient is enrolled, baseline data collection, including APACHE
II and SOFA score variables, can take 30-45 minutes.
·
Daily data collection of nutritional adequacy data takes approximately
15 minutes and is likely able to be completed during routine clinical
care. There may be additional time
required to communicate necessary changes in the nutrition regimen to the
provider.
·
The efficiency of your site will be dependent on the availability and
reliability of medical record data.
Testing the process of data collection prior to patient enrollment will
allow you to have a better sense of the time needed at your institution.
Key learning points:
·
Teamwork is needed to conduct a clinical trial, even when the data are
embedded into a database with which you are familiar. Ensuring that the key data collectors have a
process to follow and adequate time is the key to success.
·
The value of a project like EFFORT to experiential learning for students
cannot be under-estimated. Their contributions to our data gathering were important,
they convinced the bedside nurses that their data were meaningful to the
trial’s success, and they advertised to the other students in their cohort the
importance of nursing documentation.
Charlene
Compher, PhD, RD | Marianne Aloupis, MS, RD | Jennifer Dolan, MS, RD
For the photo of the Penn EFFORT
Medical ICU Team, from the left:
·
Marianne Aloupis, MS, RD is an
Advanced Practice Clinical Dietitian who coordinates quality assurance and
research data for Penn’s Clinical Nutrition Support Service.
·
Charis Anderson is now a graduate
nurse who loved her contributions to the EFFORT trial because she learned so
much.
·
Barry Fuchs, MD, is the medical
director of the Medical ICU who embraced the EFFORT project.
·
Jennifer Dolan, MS, RD is an
Advanced Practice Clinical Dietitian who leads nutrition care in the MICU.
·
Rachael Peters is a graduate nurse
whose first experience with research was on EFFORT. She values the organized
systems and contributions that she can make as a nurse in her first ICU
position.
·
Charlene Compher, PhD, RD is an
Advanced Practice Clinical Dietitian and coinvestigator with EFFORT at Penn and
with the trial overall. She came to doctoral education with a burning desire to
develop the skills needed to use clinical data to answer important clinical
questions, such as the best dose of protein for critically ill patients.