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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 10 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 Page 1 13 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 Page 1 14 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 16 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….. 17 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 18 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