PartII:DevelopProject
PartI:Define
Project
QUalityImprovementPublication(QUIP)Worksheet
Background:Thisdocumentisdesignedtobeaworkingrepositorytohelpinformationtoflowfromideainception,
toliteraturesearch,throughIRBexemptionandmanuscriptgeneration.TheintendeduseoftheQUIPistocomplete
insequentialsegmentsandsendtodepartmentsindicatedpriorproceedingwiththenextstep.ThecompletedQUIP
documentwillthenserveasatoolformanuscriptpreparation.
Problem/processdefect:
Keyquestion/goalofstudy:
InitiatingInvestigatorNameandDegree:
Telephone:
MailingAddress:
Fax:
Email:
IIa:Describetheproblem/process
defectinthecurrentstateatVM.
IIb:Whatarethekeyquestionsyou
wanttoanswer?
IIIc:Whatistheproposed
interventionandmethod,ifknown?
Whatarethetimelinesofyourwork?
Haveyoudoneasearchforarticleson
thetopic?Aretherekeyarticlesthat
contributedtoplanning?Ifsowhatare
they?
Whattermscouldbeusedtodescribe
theproblem/projectintheliterature?
Doyouknowofanyexternalresources
thatmaybesearched?(i.e.professional
organizations,governmentagenciesand
databases)
Whatpotentialtargetjournalswould
youpublishin?
Doyouneedtodocumentyoursearch
strategies?
PleasesubmittheQUIPELECTRONICALLYtotheMedicalLibrarybysavingandattachingittoane‐mail
messageandsendingittomedlib@vmmc.org.Librarystaffcanhelpformulateliteraturesearch
strategies.
02JAN2013
CompletionofthisformisintendedforobtainingIRBexaminationandwaiverofoversight(given
QIaspectofstudy).AwaiverfromtheIRBwillbeimportantinmeetingpublication
requirementsofIRBinvolvement.
Federal regulations and Benaroya Research Institute at Virginia Mason policy requires that ALL research
projects involving humans as subjects (including involvement of humans in one or more of the categories
of research exempted or waived under the federal regulations), OR the use of identifiable protected
health information (PHI) be reviewed and approved by an IRB PRIOR to initiation of any research related
activities, including recruitment and screening activities. The Benaroya Research Institute Institutional
Review Board (IRB) is the sole body designated to make human subject research determinations at
Benaroya Research Institute at Virginia Mason.
PartIII:HumanSubjectsResearchDetermination
Some categories of research are difficult to discern as to whether they qualify as human subject research.
The Benaroya Research Institute IRB will review the QUIP to assist in this determination. The IRB will
review the information provided to determine whether the study needs to be submitted to the IRB as
Human Subject Research. You will be notified as to the final determination.
Please allow a minimum of 1 week for review and determination.
Project Title:
Is this project being performed as part
YES
NO
of the requirements for a graduate or
(If yes, you will need advanced sign-off by the Clinical Education department)
nursing degree?
Describe the problem/process defect
in the current state at VM. (revision
of IIa)
What are the key questions you want
to answer? (revision of IIb)
What is the proposed intervention
and method, if known? (revision of
IIc)
Sponsor or Funding Source (Identify all
source(s) of funding for the project):
Describe the subject population/type of
data/specimens to be studied. Indicate
whether the data will be identifiable, deidentified, or coded
Do you intend to send data outside the
Virginia Mason Health System? If Yes,
you are required to provide
documentation of an Institutional
agreement with said entities to the IRB.
Electronic Signature
By checking this box you are attesting that the above
information is representative of the proposed activities. The
IRB acknowledges this, and accepts it in lieu of your actual
signature.
IRB Determinations
(For IRB Office Use Only)
The proposed activity, as described, DOES NOT constitute Human Subjects Research per 45 CFR
46.102(d). Submission of a BRI IRB research application is not required.
The proposed activity, as described, DOES constitute Human Subjects Research. Submission of a
BRI IRB research application IS REQUIRED. IRB approval must be obtained before the
02JAN2013
investigator begins their research.
Printed Name
Signature
Title
Date
Please submit the QUIP ELECTRONICALLY to the IRB Office by saving and attaching it to an e-mail
message and sending it to [email protected]. Include all other relevant materials. You
will receive an e-mail acknowledging receipt of this form.
Also attach in an email to [email protected] that will trigger a mentorship meeting.
Mentor:
Co‐investigators:
ResearchPlan:
PartIV:DefineTeamandProject
ForumulatingthissectionwillbeusedtogeneratetheMethodssectionofyourmanuscript.
IVa:Describethestudy
location.
IVb:Describesthe
interventionitself.
IVc:Describesplans
forassessinghow
effectivelythe
interventionwas
implementedandstudy
designchosen.
IVd:Describes
instrumentsusedto
assesseffectivenessof
implementationand
anymethodsfor
assuringdataquality
andadequacy.
IVe:Describes
qualitativeand
quantitativeanalytic
methods,andpower.
IVf:Describeany
limitations.
02JAN2013
Effectiveness Measurement Recommendations for Improvement Efforts
Level of
Measurement
Metric
Description
Details of metric1
Key Issues
Problem of
Interest
(The Big Dot)
Metric that
describes the nature
and severity of the
overall problem or
system dysfunction.
Measure should relate directly to patient outcomes
or institutional needs (i.e. finances), and should
have face validity (i.e. obvious importance).
Examples include mortality, falls with injury, cost
of inventory, patient satisfaction, length of stay.
Ideally a validated,
externally reported
performance measure of a
clinical or patientexperienced outcome.
Extractable electronically
Large sample size
Accurate/valid
Availability of
benchmarks
Intended
improvement
(Intervention)
Metrics to measure
success of specific
improvement
efforts.2
Measures the improvements in care processes and
patient outcomes. This is whether our
improvement efforts are actually working.
Examples include: decrease in serum lactate,
dropped telephone calls, walking distance, quality
defects, accuracy of CAM scores, etc. There may
be multiple metrics for each problem.
Should be developed around
a specific improvement.
Ease of measurement
Precision/reproducibility
Relevance
Responsiveness to change
(speed, magnitude)
Sample size
Implementation
or Uptake
Metrics to measure
adoption of
improvement
efforts.
Measure of the success of implementation, usually
looking at processes. This is whether or not we are
following our own recommended practices.
Reflects the extent of change across the
organization. Examples include number of CAM
scores per patient, % of nursing medication rooms
redesigned, use of code sepsis bundle orders, use of
standard work, etc.
Should be able to assess the
desired extent of
implementation. May differ
for different improvement
efforts.
Ease of measurement
Precision/Reproducibility
Recommendations:
1. This summarizes how the outcome will be measured (frequency, inclusion/exclusion criteria, sample population, criteria for positive/negative), who
will measure or be the source of the data, and whether there are any outside reporting requirements and benchmarks.
2. Plans should identify measures for each quality improvement event. Additional intervention and implementation metrics can be added for future
events, but should relate to Problem of Interest
V 8.22.2013
Quality and Safety Research Paper Outline
Version 5.10.2010
This tool is designed to be a template to facilitate the initial drafting of the research manuscript. For each
section of the outline, customize or paraphrase to fit with the specifics of your project. The relevant
sections of the QuIP document are referenced. Ideally, cut and paste from the QuIP to form the
foundation of the draft. Sample text is in italics.
After the initial draft is formulated, more detail should be added to address the issues raised in the
SQUIRE document.
Title: Effectiveness of Intervention on Outcome at Setting (i.e. Effectiveness of Standardized Bedside
Handoffs on Intern, Nurse, and Patient Satisfaction at an Academic Medical Center)
Introduction
Para 1: Describe the problem in general terms (i.e.“Falls occur in xx% of US hospital admissions”).
What is the significance of the problem (morbidity, dollars, etc)?
Para 2: What is the intervention in general terms? “Handwashing can decrease nosocomial infections”
Why might it help (previous studies, theory, etc.)
Para 3: What is intervention specifically (briefly in 1 sentence)? “We initiated an expanded surgical time
out checklist detailing 14 specific actions that must occur prior to initiation of the procedure”
How is it novel?
Para 4: The objective of the study, including intervention and outcome to be mesured: “The objective of
this study was to assess the effect of structured handwashing instruction on handwashing rates in the
inpatient setting.”
Methods
Para 1: State if IRB approval —sample text: “This investigation was performed as part of a quality
assurance project and a waiver was granted from the Institutional Review Board.”
Para 2: Study setting: Detail the setting—including institution, ward/clinic, providers as relevant. “The
investigation was performed at a multidisciplinary health care network in the Pacific Northwest with
approximately 450 physicians, 800,000 outpatient visits, 17,000 hospital visits and 260,000 radiology
exams annually. The institution includes a central urban campus as well as multiple suburban satellite
imaging and outpatient care centers.” (QuIP section IVa)
Para 3: Intervention: Describe succinctly the intervention including why the specific intervention was
selected, and how it was implemented. “The intervention was a structured checklist for use during the
surgical timeout consisting of the following elements…. This was implemented using a series of one on
one tutorials for each physician, nurse and other OR staff” (QuIP section IVb)
Para 4: Study design: State basic study type (cohort, case-control, clinical trial, etc) (e.g. “The overall
study design was a retrospective cohort evaluation of the effect of staged implementation of a clinical
decision support system on imaging utilization, with historical and concurrent controls. (Figure 1)”
(QuIP section IVb)
Para 5: Describe how effects of intervention are to be measured, including any quality controls. “The
effect of the intervention was evaluated through direct observation of physician behavior at random
intervals by trained nurse research coordinators using the validated DOC instrument.” (QuIP section
IVd)
Para 6: Data analysis: Detail the analysis approach, including statistics. “Differences pre and post
intervention were assessed using the chi-sq test at a significance level of p<0.05.” (QuIP section IVe)
Results
Para 1: Describe the implementation of the intervention. “The handoff procedure was implemented
sequentially on 3 wards over the course of 2 months”
Para 2: Describe the study population (if relevant). Use table 1.
Para 2: Describe the pre and post measures and differences. “Prior to the intervention, 97 physicians
washed 125 hands (65%) with an average of 4.6 seconds of wet time. Post intervention, the proportion of
hands washed increased to 83% (161/193) with average wet time of 9.6 seconds (p=0.006)(Table 2)”
Para 3: Detail any subanalyses. “Among right handed nurses, implementation was 2.5 times more
effective (RR=2.5, 95% CI 1.8-3.6, p=0.01), with over 92% success rate (258/280)”
Discussion
Para 1: Quick summary of the results. “In this report, we demonstrate that computer assisted dose
determination at point of care can decrease medication errors. Further, our results show that..”
Para 2: Reasons for success/failure of intervention, specifically focused on setting/VM. “The study setting
likely has a substantial effect on the success of the program. An advantage to being a multispecialty clinic
is that most referrals for imaging are from within the system, enhancing the ability to influence physician
ordering behavior.”
Para 3: Comparison to other reports in the literature. “Prior studies have shown only limited success
with…. Our work does agree with the investigation of …”
Para 4: Study Limitations. “We acknowledge several limitations to our evaluation. The study is
performed retrospectively using historical controls.”
Para 5: Conclusion—Quick summary of intervention, results and setting. “In summary, implementation
of post-operative radiography at an academic medical center decreased the rate of missed surgical
intraabdominal objects by over 22%.”
Tables:
Table 1: Description of study sample
Table 2: Summary of main results
Figures:
Figure 1—Flow-Sheet of Research Design