Download Tools to Keep - Vanderbilt University Medical Center

Tables, Flowcharts and Decision Trees:
Tools to Keep Research on Track
Research Support Services Presents
November 9, 2006
Doris Quinn, PhD
Assistant Professor
Division of Medical Education
Director Improvement Education
Center for Clinical Improvement
 2006 Vanderbilt University Medical Center
Intervention
Consistency
Strength
Population
Conditions
Etc.
 2006 Vanderbilt University Medical Center
Outcomes
Design
Sensitivity
Statistically
significant
2
For research support you need
to know:
•
•
•
•
•
Who
What
When
Where
How
 2006 Vanderbilt University Medical Center
3
Needs in Research
• Who is doing what?
• What is the process that will execute the
protocol?
• When are the steps to be done?
• Where are the steps/process taking
place?
• How should procedures/treatments be
done?
 2006 Vanderbilt University Medical Center
4
How many AEs are caused by
process issues
vs not related?
 2006 Vanderbilt University Medical Center
Flowcharts
 2006 Vanderbilt University Medical Center
START
PROCESS
DECISION
Y
INTERVENTION
PROCESS
END
Outcomes
N
PROCESS
 2006 Vanderbilt University Medical Center
7
Getting Started with
Flowcharts
• Start at a high level – 10-12 boxes
that show the overall process for the
research.
 2006 Vanderbilt University Medical Center
8
INQUIRY
Questions from family, ref. sources
and participants.
DECISION /
Admission Criteria
MARKETING
ASSIGNMENT
Diagnosis of memory loss
Community need (data on AD)
Ability to produce
Create Image
No behavior problems
Educate public & ref. sources
Intake assessment form
Advertise Mem. Works
Information
Costs, meals, hours, absences
meds, trial, transpor., payment
ASSESSMENT
Assessment
Trial period
Testing
Competence for w orking
Family dynamics
Motivation to w ork
Trial period
Appropriate behavior
Will participate?
Testing
Enrollment
ongoing eval. , visitors
Mini-Mental exam
attendance, discharge
Geriatric depression scale
Set of MW questions for
referral sources, family, participant
CASE FINDING
Analysis of:
Referral Form
Invitation to visit program
Referral Sources
Participant and caregiver
Global Deterioration Scale
Family dynamics
Supportive
Willing/ability to pay
Family members
Paperw ork
Application form
Agreement form
Billing
Permission to release info
Will not participate?
Referral to other services
Communication w ith:
EAPs
Referral Sources
Health providers
Physician
Assisted living facilities
CONTACT
Hospital disch. planners
Family
Visit the facility
Church leaders
Introduction to staff/peers
Senior citizen centers
Observe w ork in progress
Referral Source Netw ork
Staff observation of
participant/family
Information Sheet
Willingness to apply
INTAKE
 2006 Vanderbilt University Medical Center
EVALUATION
9
PROGRAM
Transportation to AWS
Self, family, car pool, other
Coffee (Socialization)
TRANSITIONS/EXIT
AM w ork
Self-select out
Ongoing training/support
Transportation
Break - Walk
Health
Lunch (socialization)
PM Work
Family / participant choice
Criteria for discharge
Ongoing training / support
Decline in productivity
Departure
Decline in social functioning
Inappropriate behaviors
Family burden
Feedback to:
Physician
CASE MANAGEMENT
Referral sources
Ongoing Evaluation
Families
Productivity / functional status
Follow -up
Behavior / emotional status
Next level of services
Physical health
Documentation
Progress notes
Flow /check sheets
Repeat Mini Mental test
Report of ongoing evaluation
Ongoing Communication
Caregivers, physicians, ref. sources
Link to Community resources
Plan with caregivers for transitions
PROGRAM
 2006 Vanderbilt University Medical Center
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Getting Started with
Flowcharts
• Start at a high level – 10-12 boxes that
show the overall process for the research.
• Decide which box needs to be broken
down into steps that will allow everyone
to see the “what” and the “who”
• If a timeline is important, add it to the
flowchart.
 2006 Vanderbilt University Medical Center
11
Color Legend
Proposed
validation
Pneumonia Abstraction and Validation
CCI
UHC CMS
Qsource
Friday, November 03, 2006
Patient is
Discharged
Chart sent to
medical records
for coding.
*ICD-9 PN
*Resp Failure
*Septicemia
(secondary PN)
Data stored in
EDW
All discharges
submitted to UHC
(including ICD-9
data)
Post PN sample
cases on Core
Measure website.
Martha
downloads list of
PN cases to be
abstracted
Merges UHC list
with EDW data.
Creates
decrypted list.
UHC samples PN
cases based on
CMS guidelines
Decrypted list to
Vera for chart
abstraction
CCI Staff:
5
days
Vera abstracts
cases and enters
in UHC database
Quarterly
guideline
updates need to
be reviewed;
Dr. Gaffney
Sharon
Vera
Issues addressed
by Q-Source
Vera requests
charts from
medical records
Martha Newton – Database analyst
Sharon Mullins, RN- Quality consultant
Vera Hunter – Improvement analyst
Timeline
Vera downloads
current UHC
abstraction tool
and guidelines
(published
quaterly)
31-38 days
after end of
month of pt d/c
 2006 Vanderbilt University Medical Center
48-72 hrs
post
submission
24
hrs
48
hrs
2
weeks
Page 1
12
1
Color Legend
Proposed
validation
Pneumonia Abstraction and Validation
CCI
UHC
CMS
Qsource
Friday, November 03, 2006
Martha dowloads
PN data from
UHC and sends
to Eric Griffin (IS)
1
Monthly review of
exception list by
Sharon and Dr.
Russ for ED and
direct admits
CCI Validation
report sent to
designated
accountable
individuals
UHC generates
Core Measure
report
UHC submits
data to CMS
Martha gets HIC
(med insurance)
numbers from
TSI
2
N
Eric loads data
into Dashboard
tables
10% of all charts
will be checked
for reliability.
Identify
appropriate
actions needed.
Martha validates
core measure
data to
Dashboard
N
CMS generates
exception report
(this happens
multiple times)
Numbers
missing
?
Y
Y
Results appear in
Elevate
Dashboard
N
Martha queries
data to generate
exception report
(measure
failures)
Discrepancy
found
?
Sharon will
makes changes
in UHC database
based on review
and data
validation
Y
Martha
reconciles
exceptions and
decides what
actions are
needed.
Martha to decide
who to contact
for corrections:
Eric Griffin
Auston DeVille
Scott McDonnell
Revisions
Final
?
If action needed
there is no
process in place.
Timeline
48
hrs
1 week
Monthly data abstraction timeline
 2006 Vanderbilt University Medical Center
Martha creates a
list of missing
numbers.
Vera looks up
numbers in
MediPac
Martha re-enters
numbers and
resubmits
3-5 weeks
post d/c
Quarterly CMS / JCAHO submission
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Color Legend
Pneumonia Abstraction and Validation
Proposed
validation
CCI
UHC
CMS
Qsource
Friday, November 03, 2006
CMS requests 5
charts per
quarter for Med
Records (which
may include PN)
2
Martha decrypts
list of charts to
be submitted to
Med Records
Med Records
makes 2 copies
of charts (paper
and selected
electronic forms)
for a designated
visit.
Martha, Sharon,
Vera review
charts and flag
where data
elements were
found (based on
prior abstraction
guidelines)
ISSUES
CMS abstracts
PN data from
charts provided
Martha writes
appeal
Internal timeline difficult to
predict because of dependence
on UHC for sample cases.
CMS adjudicates
appeal and posts
results
CMS posts
validation report
on Web-site
CCI keeps one
copy and second
copy returned to
Med Records to
be sent to CMS
CMS posts final
results
N
Martha reviews
reports
No process to update project
team on quarterly updates
from CMS
Y
Q-Source
discusses results
with Martha
Freda Scott receives memos from
CMS and sends to Martha but there
is no process in place for Martha to
disseminate this information.
No process in place to send issues
to clinical teams, med records, etc.
Pass
?
Pass
?
IMPROVEMENTS
CCI augments
chart with
missing
components/
reports pertinent
to case. (This
may involve
going to
procedure areas
for reports or
additional
details).
Timeline
N
Y
Martha downloads report
and sends to:
J. Bingham
Dr. Gaffney
S. Moseley
6 month
later
 2006 Vanderbilt University Medical Center
Martha discuss
results with Dr.
Gaffney and J.
Bingham
Bingham and
Gaffney contact QSource if further
appeal needed.
CCI investigating new tool for
monthly data entry.
Dr. Russ writing program for
weekly metrics.
UHC sends abstraction tips
that we have not been getting.
Cross-training needed for
tasks in CCI.
+2 months
later
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Tables
 2006 Vanderbilt University Medical Center
Common
Uncommon
Rare but serious
Nausea and vomiting
Headache
Mouth Sores
Loss of desire to eat
Constipation
Fever and chills including
shaking chills. These
reactions are more
common with the first dose.
Feeling short of breath
Pain in the abdomen
A feeling of tiredness or
weakness
Fewer white blood cells,
red blood cells and
platelets in the blood
oa low number of
white blood cells
can make it easier
to get infections
oa low number of
red blood cells can
make you feel tired
and weak
A decrease or an increase
in blood pressure
Rash, hives or itchiness
during the infusion
Irregular heart beat during
the infusion
Pain in the back
Upset stomach
Diarrhea
Dizziness or fainting
Cough
Abnormal levels of certain
salts in the body like
magnesium, calcium, and
phosphate
Increase in the sugar in
the blood
Anxiety or depression
Difficulty sleeping
Allergic reactions during the
infusion that can be severe and
life-threatening and may lead to
difficulty in breathing, a drop in
blood pressure, irregular heart
beat, fluid in the lungs or damage
to the lungs and shock.
The rapid death of large numbers
of tumor cells, which can cause
the potassium and phosphate
salts and the uric acid in the
blood to rise quickly. This could
lead to a life-threatening irregular
heartbeat or damage to the
kidneys.
Damage to the lungs that can
lead to fluid in the lungs and
affect your ability to breathe and
the levels of oxygen in your
blood.
Bleeding which can occur in the
head, nosebleeds, blood in the
stools or urine and bleeding from
other places in the body.
 2006 Vanderbilt University Medical Center
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Screening
Baseline
Final Visit
Safety
Visit
Visit 1
Visit 2
Visits 3, 4
Visit 5
Visit 6
(Day -14 to -1)
(Day 0)
(Weeks 4, 8)
(Week 12)
(Week 16)
X
X
X
Informed Consent Form
X
Inclusion/Exclusion Criteria
X
X
Vital Signs
X
X
Medical History and PE
X
Urine Pregnancy Test1
X
DAS
Modified Ashworth
Follow-up Visits
X
x
x
x
x
x
x
Fatigue Symptom Inventory
Spasticity Impact Scale
X
X
X
Xxx /Placebo Injection
X
D
C
D4
C
C
X5
X
X
X
X
X
X
X
Assessments
x
Finger Tap Test
Grip Strength
Epworth Sleepiness
x
Quality of Life Assessments:
Oral Study Medication:
Dispense
Collect
D3
Adverse Events
Concomitant Treatment
X
1.Female subjects of child-bearing potential
 2006
Vanderbilt
University Medical Center
2.If deemed
necessary
by the Investigator
3.Baclofen dosing is initiated at 5 mg/TID and increased 5 mg/TID every three days. The subject’s dose will be titrated to a maximum of 20 mg/QID, or highest tolerated dose
as assessed by…..
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Treatment Plan Tables
Central Line
For drugs to be given by vein, your doctor will likely recommend that you have a central venous line placed.
Methods for Giving Drugs
Various methods will be used to give drugs to patients.
• PO – Drug is given by tablet or liquid swallowed through the mouth.
• IV – Drug is given using a needle inserted into a vein. It can be given by IV push over several minutes or by IV infusion over minutes or hours.
• IM – Drug is given by inserting a needle into the muscle (IM shot).
• SubQ – Drug is given by inserting a needle into the tissue just under the skin (SubQ shot).
• IT – Drug used to treat the brain and spinal cord is given using a needle inserted into the spinal fluid (intrathecally, IT).
Induction 1 Arm A:
Standard arm of therapy in which no gxxxx… is used (28 Days).
How the drug
will be given
Day(s)
Drug
Cxxxxxx
IT
Day 0 or Day 1
Cxxxxxx (CNS Positive, spinal tap shows blast cells in
the fluid around the brain and spinal cord)
IT
2 (x) weekly plus two additional treatments if spinal tap shows blast
cells in the fluid around the brain and spinal cord
Cyxxxxxx
IV Push given
every 12 hours
1-10
Dxxxxxxx
IV over 6 hours
1, 3, and 5
Exxxxxxx
IV over 4 hours
1-5
Induction 1 Arm B:
Research arm of therapy in which gem is used (28 Days).
How the drug will be given
Days
Cxxxxxx
IT
0, or 1
Cxxxxxxx (CNS Positive)
IT
2 (x) weekly plus two additional
treatments
Cxxxxx
IV Push given directly into the spinal fluid on the first day of
chemotherapy
1-10
Dxxxxxxx
IV over 6 hours
1, 3, and 5
Exxxxxx
IV over 4 hours
1-5
Drug

Gxxxxxxx
2006 VanderbiltIVUniversity
over 2 hoursMedical Center
6
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Decision Tree
 2006 Vanderbilt University Medical Center
Patients randomized
Standard Arm A
Research Arm B
Induction 1
Induction 1 +
Gemtuzumab
Bone Marrow Test
Bone Marrow Test
Induction 2
Bone Marrow Test
Intensification 1
Bone Marrow Test
Induction 2
If not responding to
therapy – off therapy
Bone Marrow Test
Your doctor will talk to you about
other treatment
Intensification 1
If not responding to
therapy – off therapy
Bone Marrow Test
Relapse risk groups assigned
Low risk
High risk
Intermediate risk
YES
Matched Family Donor Stem Cell
Transplant
Matched Family Donor (MFD) Available?
YES
Alternative Donor Available?
Alternative donor Stem Cell Transplant
If no SCT, proceed to more chemotherapy in assigned
therapy arm
 2006 Vanderbilt University Medical Center
Arm A
Intensification 2
Arm B
Intensification 2 +
20
Exercise
 2006 Vanderbilt University Medical Center
DECISION TREE
Purpose:
Population: subjects with a
wound that will likely become
infected
?
N
Pass screening?
Y
Randomization
Treatment Group
Control Group
Anesthesia,
Suturing, wrapped,
antibiotics
Anesthesia, no
suturing, wrapped,
antibiotics
 2006 Vanderbilt University Medical Center
22
PILOT STUDY
RESEARCH
3-5 pts will get
PNG (no
randomization)
Pt will come to Aid
Post with wound
Treatment Group
Wound/area will
be anesthetized,
PNG procedure
will be done by
surgeon
Wound will be
wrapped by nurse
and pt given
antibiotics
Wound will be
evaluated for
severity and
possible infection
status
Control Group
Call patient after
procedure
Pt comes to Aid
Post for follow-up
Wound/area will
be anesthetized,
no procedure will
be done by
surgeon
Surgeon will
suture wound with
PNG method
Wound will be
wrapped and
antibiotics given
 2006 Vanderbilt University Medical Center
23
PNG Procedure
Screening
TX
Follow-up calls
Follow-up
Visits
Visit
Visit
Visits
Visit
 2006 Vanderbilt University Medical Center
Final Visit
24