1. Jason Springer MD MS Mei Liu PhD
TAPIR trial
Jason Springer MD MS
Mei Liu PhD

2. TAPIR computable phenotype
GPA computable phenotype
(446.4-[288.3 OR 493.*]) + [446.4 on 3 consecutive days OR twice 3 months apart] + [Seen by Rheumatology OR Nephrology OR ENT OR Pulmonology]
PPV (at KUMC) = 86%
TAPIR computable phenotype
+ Visit in last year
+ prednisone script in the last year
TAPIR computable phenotype

3. Identifying Specialists
Steps done at KUMC
Identify specialists seeing patients as outpatient
Reason: Specialists only seeing patient on inpatient service will not be following long- term
Note: ENT physicians will typically not be managing long term prednisone
Identifying Specialists
Specialist (outpatient)
Percentage of GPA list seen
Rheumatology
89% (63/71)
Pulmonology
45% (32/71)
Nephrology
8% (6/71)
ENT
61% (43/71)
Rheum OR Pulm
93% (66/71)
Rheum OR Pulm OR Neph
97% (69/71)
Rheum OR Pulm OR Neph OR ENT
100%

4. Advertising TAPIR (prior to starting trial)
Two approaches:
Contact Division Directors
Rheumatology
Pulmonary
Nephrology
Mass to individual specialists
Advertising TAPIR (prior to starting trial)

5. Compensation Patients Compensation through V-PPRN
At Enrollment, completion of trial and completion of surveys
Physicians (per patient)
$25 after completing initial questionnaire + patient enrollment
$25 upon completion of study
Compensation

6. Treating Physician’s (specialist’s) role
Complete questionnaire
5 questions
Can we contact your patient? (yes/no)
Confirmation that patient is eligible for this study (yes/no)
Study prednisone dose of either 5mg per day or 0mg per day is appropriate treatment for patient. (yes/no)
Agreement to be contacted for a brief telephone interview regarding experience with assisting my patient to enroll in this study (optional, yes/no)
Indicate plan to taper patient’s prednisone dose down to 5mg/d (or 0mg/d if they are randomized to the 0mg/day study arm)
Treating Physician’s (specialist’s) role

7. Established diagnosis of granulomatosis with polyangiitis (GPA)
Fulfills 1990 ACR criteria
Active disease within the prior 12 months that at time of active disease required treatment with prednisone ≥ 20mg/day
Disease remission at time of enrollment
Prednisone dose at time of enrollment between 5- 20mg/day
Note: subjects can be on other medications for control of GPA besides prednisone and still participate)
Age of 18 years or greater
Inclusion Criteria

8. Comorbid condition that has a moderate likelihood of requiring steroids (COPD, asthma, adrenal insufficiency, etc)
Exclusion Criteria

9. What the physician does not have to do
Alter their treatment strategy
No change in non-steroid therapies
Get IRB approval
Not considered a part of study team
Fax medical records to the V-PPRN
GPC will obtain the medical records
What the physician does not have to do

10. RedCap MRN, PROV, … … MRN, PROV, Eligible?, StudyID, …
Study Coordinator +
Physician
Patient enrolls at TAPIR consent portal
Import
KUMC will generate a random ID
Contact Patient + StudyID
TAPIR notify KUMC that Patient “X” has enrolled, provides informed consent
Data extraction at end of study
Jason will conduct the chart review