quality and safety in healthcare is a major concern of healthcare providers,
the general public, and policy makers.1,2,3,4 While
health care workers are among the most dedicated and well trained of any
labor force in the world, preventable errors and quality issues are a
leading cause of morbidity and mortality across the healthcare industry.5,6,7,8,9
Variation in risk adjusted neonatal intensive
care unit (NICU) outcomes suggests there are unmeasured, modifiable factors
contributing to poor neonatal outcomes.10,11,12,13,14 There
is a growing body of evidence that quality improvement (QI) methodology
can lead to changes in care practices resulting in improved patient outcomes.15,16,17
In the February 2008 edition of eNeonatal
Review, Edwards and Suresh discussed the history of QI in our young field
of neonatology including reviews of several of the sentinel manuscripts.
In this edition, we would like to discuss a model for effective implementation
of quality improvement methods including the use of measurement (as below).18,19,20
The improvement process can begin with identification
of a clinical outcome that is perceived as suboptimal (eg, our incidence
of surgical Retinopathy of Prematurity (ROP) is 50% higher than similar
NICUs) or a clinical curiosity (eg, it seems like we have a lot of catheter-related
blood stream infections). Below is a hypothetical QI project, focusing
noted that the incidence of severe ROP among very low birth weight (VLBW)
infants in our NICU is more than 50% higher than similar NICUs, a finding
that has been consistent for several years. Upon review of the literature,
we determined oxygen management to be a key modifiable factor affecting
the outcome of ROP. Furthermore, we found published examples of successful
ROP QI projects upon which to model the project.
then assembled a six-member, multidisciplinary ROP improvement team,
including representatives from every discipline that would be affected
by the improvement project. Our team included representatives from nursing,
respiratory therapy, neonatology, ophthalmology, and hospital management.
multidisciplinary ROP improvement team then created a specific aim statement:
we aim to reduce the incidence of stage 3 or worse ROP by 50% over the
next 2 years without an increase in mortality or other morbidities among
VLBW infants who are admitted to our NICU before the 5th day of life.
Our hypothesis was that a reduction in ROP could be achieved via use
of a multidisciplinary approach including: (1) the use of a guideline
concerning oxygen management, (2) a multidisciplinary education program,
and (3) use of an oxygen management contract that all frontline providers
in the NICU sign.
elements of our VLBW ROP reduction guideline included the following
oxygen like a drug with known toxicities
oxygen saturation goals to 85-93%
oximeter alarm limits to 80-95%
an infant prior to increasing FiO2 for
hypoxemia; if FiO2 is
increased, then the provider is to remain at the bedside until patient
the physician for FiO2 increase >10%
- No “prophylactic” increases
in FiO2 (eg,
prior to procedures)
of blended oxygen at all times, in all locations (including delivery
of an oximeter in the delivery room
primary outcome was to reduce the incidence of severe ROP (≥ Stage
3) in VLBW infants. In addition to our primary outcome, “balancing measures” were
needed to monitor for potential adverse consequences of our intervention.
For these, we chose mortality, severe intraventricular hemorrhage, periventricular
leukomalacia, chronic lung disease, necrotizing enterocolitis, and length
of stay. Intermediate outcome measures included the percentage of time
oxygen saturations resided in the target range, the oximeter’s alarm
settings, and whether target oxygen saturation reminders were posted
at each bedside.
data collection plan was to use the Pediatrix Clinical Data Warehouse
to monitor clinical outcomes. Four respiratory therapists (2 from day
shift, 2 from night shift) audited each VLBW bedside 4 times weekly.
They recorded time spent in the target saturation range (many oximeters
capture this information electronically), oximeter alarm settings, and
if the oxygen saturation targets were posted at every VLBWs bedside.
is critical to recognize that the typical QI project is not clinical research,
and that the goal is not pure knowledge acquisition. The typical QI project
is undertaken to improve the effectiveness of a care process with the goal
of improving clinical outcomes, patient safety, patient satisfaction, and/or
resource utilization. With this difference in mind, the approach to team
assembly and measurement is different in a QI project from a clinical trial.
intermediate outcomes were evaluated each month and our clinical outcome
measures were evaluated each 6 months. Data from these evaluations were
organized and interpreted at monthly ROP improvement team meetings,
and then relayed to management and frontline providers via email, presentation
at staff meetings, and education conferences.
Assembly: 4 to 8 people are commonly a good size for the improvement
team. Too small a team limits multidisciplinary input and provides too
few people to share the workload, while too large a team may lose focus
and spend more time talking about improvement than implementing improvement
Measures: For a clinical trial, intermediate measures are often required
only if there is a concern for safety. In QI projects, rapid cycle tests
of change with frequent feedback of data to frontline providers (and
concomitant encouragement) are critical to success of a project. Outcomes
that are relatively rare (such as severe ROP in our example) may take
a considerable period of time to become evident, often greater than
one year. Therefore, it is important to monitor some “intermediate” outcomes
or “process” measures to allow the team to evaluate if the project is
being implemented effectively earlier in the project time frame.
summary, quality improvement projects are rapid cycle interventions with
frequent measurements, adjustments, and deployments. Quality improvement
methodology allows for robust testing of change in situations where clinical
trials are not ethical or practical. Healthcare is fortunate to possess
such a dedicated and well-trained labor force. By following the principles
outlined herein, providers can capitalize on this unique workforce, achieving
measurable gains important to improving clinical outcomes.
Definitions: Clear, consistent definitions for key measures are critical
to QI projects. Not only do they assure that the team understands what
is being measured, but they also allow data to be comparable across
institutions. When possible, QI teams should use definitions currently
employed by large databases (eg, the NICHD Neonatal Network Database,
Pediatrix Medical Group’s Clinical Data Warehouse, or the Vermont Oxford
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