2006 Vanderbilt University Medical Center Tables, Flowcharts and Decision Trees: Tools to Keep Research on Track Doris Quinn, PhD Assistant Professor

2006 Vanderbilt University Medical Center

Tables, Flowcharts and Decision Trees:

Tools to Keep Research on Track

Doris Quinn, PhDAssistant Professor

Division of Medical EducationDirector Improvement EducationCenter for Clinical Improvement

Research Support Services Presents

November 9, 2006

2 2006 Vanderbilt University Medical Center

Intervention Outcomes

ConsistencyStrengthPopulationConditionsEtc.

Design Sensitivity

Statisticallysignificant


For research support you need to know:

• Who• What• When• Where• How


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?


How many AEs are caused by process issues

vs not related?


Flowcharts


OutcomesINTERVENTIONSTART PROCESS DECISION

PROCESS

PROCESS END

N

Y


Getting Started with Flowcharts

• Start at a high level – 10-12 boxes that show the overall process for the research.


INQUIRY

Questions from family, ref. sources

and participants.

Admission Criteria

MARKETING 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

ongoing eval. , visitors

attendance, discharge

Set of MW questions for

referral sources, family, participant

CASE FINDING Referral Form

Invitation to visit program

Referral Sources

Family members

EAPs

Health providers

Assisted living facilities CONTACT

Hospital disch. planners 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

DECISION /

ASSIGNMENT

Analysis of:

ASSESSMENT Assessment

Trial period Testing

Competence for w orking Family dynamics

Motivation to w ork Trial period

Appropriate behavior Will participate?

Testing Enrollment

Mini-Mental exam Paperw ork

Geriatric depression scale Application form

Participant and caregiver Agreement form

Global Deterioration Scale Billing

Family dynamics Permission to release info

Supportive Will not participate?

Willing/ability to pay Referral to other services

Communication w ith:

Referral Sources

Physician

Family

EVALUATION


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) Family / participant choice

PM Work 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


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.


Friday, November 03, 2006

Page 1

Pneumonia Abstraction and Validation

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)

UHC samples PN cases based on CMS guidelines

Martha downloads list of PN cases to be

abstracted

Quarterly guideline

updates need to be reviewed;Dr. Gaffney

SharonVera

Merges UHC list with EDW data.

Creates decrypted list.

Decrypted list to Vera for chart abstraction

Vera abstracts cases and enters in UHC database

Vera downloads current UHC

abstraction tool and guidelines

(published quaterly)

Vera requests charts from

medical records

Post PN sample cases on Core Measure web-

site.

1

CCI UHC CMS

Color Legend

Proposed validation

Timeline 5 days

31-38 days after end of

month of pt d/c

48-72 hrs post

submission

24 hrs

48 hrs

2 weeks

Q-source

Issues addressed by Q-Source

CCI Staff:Martha Newton – Database analyst

Sharon Mullins, RN- Quality consultantVera Hunter – Improvement analyst



Page 1


1

Martha dowloads PN data from

UHC and sends to Eric Griffin (IS)

Eric loads data into Dashboard

tables

Results appear in Elevate

Dashboard

Martha queries data to generate exception report

(measure failures)

UHC generates Core Measure

report

Martha validates core measure

data to Dashboard

Martha to decide who to contact for corrections:

Eric GriffinAuston DeVilleScott McDonnell

Monthly review of exception list by Sharon and Dr.

Russ for ED and direct admits

CCI Validation report sent to

designated accountable individuals

Sharon will makes changes in UHC database based on review

and data validation

10% of all charts will be checked for reliability.

Identify appropriate

actions needed.

Revisions Final

?

Discrepancy found

?

If action needed there is no

process in place.

UHC submits data to CMS

CMS generates exception report

(this happens multiple times)

Martha reconciles

exceptions and decides what actions are

needed.

Martha gets HIC (med insurance) numbers from

TSI

Martha creates a list of missing

numbers.

Vera looks up numbers in

MediPac

Martha re-enters numbers and

resubmits

Numbers missing

?

2

N

Y

Y

N

Y

N

CCI UHC CMS

Color Legend

Proposed validation

Monthly data abstraction timeline Quarterly CMS / JCAHO submission

Timeline 48 hrs

1 week3-5 weeks post d/c

Q-source



Page 1


2

CMS requests 5 charts per

quarter for Med Records (which may include PN)

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.

CCI augments chart with missing

components/reports pertinent

to case. (This may involve

going to procedure areas

for reports or additional details).

Martha, Sharon, Vera review

charts and flag where data

elements were found (based on prior abstraction

guidelines)

CCI keeps one copy and second copy returned to Med Records to be sent to CMS

CMS posts validation report

on Web-site

Martha reviews reports

Pass?

Martha writes appeal

Martha downloads report and sends to:

J. BinghamDr. GaffneyS. Moseley

Y

N

ISSUES

Internal timeline difficult to predict because of dependence on UHC for sample cases.

No process to update project team on quarterly updates from CMS

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.

IMPROVEMENTS

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.

CCI UHC CMS

Color Legend

Proposed validation

Timeline 6 month later

+2 months later

Q-source

CMS abstracts PN data from

charts provided

CMS adjudicates appeal and posts

results

Q-Source discusses results

with Martha

Pass?

Martha discuss results with Dr. Gaffney and J.

Bingham

Bingham and Gaffney contact Q-

Source if further appeal needed.

CMS posts final results

N

Y

Cross-training needed for tasks in CCI.


Tables


Common Uncommon Rare but serious

Nausea and vomitingHeadacheMouth SoresLoss of desire to eatConstipationFever and chills including shaking chills. These reactions are more common with the first dose.Feeling short of breathPain in the abdomen A feeling of tiredness or weaknessFewer white blood cells, red blood cells and platelets in the blood

oa low number of white blood cells can make it easier to get infectionsoa low number of red blood cells can make you feel tired and weak

A decrease or an increase in blood pressureRash, hives or itchiness during the infusion Irregular heart beat during the infusionPain in the back Upset stomachDiarrheaDizziness or faintingCoughAbnormal levels of certain salts in the body like magnesium, calcium, and phosphateIncrease in the sugar in the bloodAnxiety or depressionDifficulty 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.


Screening Baseline Follow-up Visits Final VisitSafetyVisit

Visit 1(Day -14 to -1)

Visit 2(Day 0)

Visits 3, 4(Weeks 4, 8)

Visit 5(Week 12)

Visit 6(Week 16)

Informed Consent Form X

Inclusion/Exclusion Criteria X X

Vital Signs X X X X X

Medical History and PE X

Urine Pregnancy Test1 X X

Assessments

DASModified Ashworth x x x x x

Finger Tap TestGrip StrengthEpworth Sleepiness

x x x

Quality of Life Assessments:Fatigue Symptom InventorySpasticity Impact Scale

X X X

Xxx /Placebo Injection X

Oral Study Medication: Dispense Collect

D3 DC

D4

CC

Adverse Events X5 X X X

Concomitant Treatment X X X X X1.Female subjects of child-bearing potential2.If deemed necessary by the Investigator3.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…..


Treatment Plan TablesCentral LineFor drugs to be given by vein, your doctor will likely recommend that you have a central venous line placed. Methods for Giving DrugsVarious 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).

DrugHow the drug will be given

Day(s)

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).

DrugHow 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

Gxxxxxxx IV over 2 hours 6

Induction 1 Arm A: Standard arm of therapy in which no gxxxx… is used (28 Days).


Decision Tree

20 2006 Vanderbilt University Medical CenterArm B

Intensification 2 + Gemtuzumab

Arm AIntensification 2

YES Matched Family Donor Stem Cell

Transplant

YES

Alternative donor Stem Cell Transplant

High riskLow risk

Alternative Donor Available?

If no SCT, proceed to more chemotherapy in assigned therapy arm

Matched Family Donor (MFD) Available?

Intermediate risk

Intensification 1 Intensification 1Your doctor will talk to you about

other treatment

Bone Marrow TestIf not responding to

therapy – off therapy Bone Marrow Test

Induction 1 + Gemtuzumab

Patients randomized

Induction 1

Bone Marrow Test Bone Marrow Test

Induction 2 Induction 2

If not responding to therapy – off therapy

Bone Marrow Test Bone Marrow Test

Research Arm BStandard Arm A

Relapse risk groups assigned


Exercise


Population: subjects with a wound that will likely become

infected

Anesthesia, no suturing, wrapped,

antibiotics

Anesthesia, Suturing, wrapped,

antibiotics

Randomization

Treatment Group Control Group

Y

Pass screening??

Purpose:

DECISION TREE

N


3-5 pts will get PNG (no

randomization)

Treatment Group

Control Group

Pt will come to Aid Post with wound

Wound will be evaluated for severity and

possible infection status

Surgeon will suture wound with

PNG method

Wound will be wrapped and

antibiotics given

Wound/area will be anesthetized, PNG procedure will be done by

surgeon

Wound will be wrapped by nurse

and pt given antibiotics

Wound/area will be anesthetized, no procedure will

be done by surgeon

Call patient after procedure

Pt comes to Aid Post for follow-up

RESEARCHPILOT STUDY


PNG ProcedureScreening TX Follow-up calls

Follow-up Visits

Final Visit

Visit Visit Visits Visit

Documents

2006 Vanderbilt University Medical Center Tables, Flowcharts and Decision Trees: Tools to Keep Research on Track Doris Quinn, PhD Assistant Professor